Pentaxim vaccine: indications, composition, instructions, side effects. Pentaxim reaction after vaccination What is included in Pentaxim

The appearance of a small child in the family is always associated with a lot of excitement and trouble. The mouth is full of worries - these words fully apply to every young parent. One such headache is the issue of vaccinations. To put or not to put, what are the pluses, what are the minuses, when it is possible and when it is impossible ... One of the vaccinations given to newborn children is the Pentaxim vaccine. It is worth figuring out what kind of animal this is and how painfully it bites.

What is a vaccination

In simple terms, an inoculation or vaccine is the introduction of a virus of a disease into the body. This is done so that the human body recognizes the substance “thrown” to it as the causative agent of the disease and fights it, thereby developing immunity against this infection. And if the virus enters the inside of a person again, the antibodies present there will recognize it and neutralize it. Thus, the disease is not terrible for the vaccinated person, although, of course, in rare cases, he can also be exposed to the infection. But even if this happens, the disease will pass in a milder form and almost imperceptibly.

In total, there are several types of vaccines, different in composition - live, inactivated, recombinant and toxoids. The first contain the pathogens themselves, so to speak, alive, the second - they are the same, but already “killed”, the third contain only parts of the cells with bacteria, and the fourth are obtained due to the inactivation of pathogen toxins.

Why vaccinations are needed

Many today are asking a similar question, but the answer to it is the simplest - so as not to get sick. It is thanks to the existence and action of vaccinations that a large number of diseases have now been eliminated, which did not allow them to live in peace and often caused the death of a huge number of people in past centuries. For example, smallpox - how many people have become its victims!

Vaccines also help fight liver and cervical cancer, and prevent the development of the human papillomavirus. And in general, if the vast majority of the population is vaccinated, then even the unvaccinated (the one who has certain contraindications) simply does not get infected from anyone - therefore, the disease can come to naught.

To bet or not to bet

This is another sore point that plagues more than one generation of moms and dads. Many are sure that vaccinations are evil, they carry a danger, it is because of them that a child can get sick. But if the baby is not vaccinated, then nothing will happen to him. It often comes to the point that even in the maternity hospital, women write a refusal to vaccinate the baby against hepatitis and BCG.

To vaccinate or not vaccinate your baby is the business of each individual parent. Some believe that without vaccination, the child will not be taken to kindergarten. This is not so - when applying for vaccinations, of course, they will be asked, but if the refusal to them was written officially, in a children's clinic, then the baby will be enrolled in a kindergarten, assigning him a specific number. Such numbers are issued to all children without vaccinations - this shows that only parents, and not healthcare, are responsible for the life and health of the child. At school, all the more so, all vaccinations are given only with the written consent of mom and dad, they do not forcefully persuade anyone.

By the way, some doctors themselves are of the opinion that it is not worth vaccinating a baby before the age of two. It is necessary that the baby acquire its own immunity, and you should not interfere with it. This practice is widespread in many countries.

Vaccination effectiveness

In order for everything to work as it should, you should follow certain simple rules:

1. Necessary intervals between vaccinations must be observed.
2. It is worth buying a vaccine immediately before the procedure itself.
3. Only a specialist - that is, a medical worker - can and should carry out the procedure.
4. When buying a vaccine yourself, you should follow the rules for its storage and transportation.

Vaccine "Pentaxim"

One of the mandatory vaccinations for newborn babies is the whooping cough, tetanus and diphtheria vaccine - three in one. It is called DPT and is first introduced to crumbs at the age of three months (in the absence of contraindications). This vaccine is Russian-made, it is regarded by many as too harsh, heavy for babies. That is why many parents who decide to vaccinate their child turn to the French analogue of DTP - the Pentaxim vaccine. What is dangerous for each of the above diseases, we will not describe here, but what is good about Pentaxim, you should definitely tell.

The main difference between the imported Pentaxim vaccine and its domestic counterpart is that, although DPT is also combined, it includes three vaccines, and the foreign vaccine - as many as five (more on the composition of the French vaccine will be discussed a little lower). Only healthy children can be vaccinated, and according to the rules, it is necessary to pass urine and blood tests before the procedure (although this is often not done). In addition, there should be no medical challenge from the neurologist.

Pentaxim is a cell-free vaccine that has been widely used in our country since 2008. Among other things, the Pentaxim vaccine gives a very good immune effect and serious protection of the body, but does not save from meningitis and pneumonia (for some reason, many believe the opposite).

DPT or Pentax?

Both domestic and foreign vaccines have both their supporters and opponents. Which one is better for a child?

DTP is inexpensive - what is its advantage, unlike the more expensive Pentaxim. The DTP vaccine is quite simple, protects, as mentioned above, from diphtheria, tetanus and whooping cough, the mortality of children from which, unfortunately, is extremely high. It is placed three times. If you introduce DTP to a baby, you will need to do separate vaccinations against polio and Haemophilius influenza - also several times, then when using Pentaxim, the number of injections will be reduced to only four (versus twelve).

What diseases is the Pentaxim vaccine against? From all of the above, and these are five different viruses at once. This is the advantage of Pentaxim over DTP. In addition, he wins with his composition. Whooping cough in "Pentax" does not have a shell that is capable of producing a negative reaction to the introduction of the vaccine. Pentaxim after DPT is well tolerated, on the contrary, it is bad.

Both DTP and Pentaxim have their drawbacks. It is believed that they are present in the domestic vaccine in a more pronounced volume. So, you can not prick children during an illness, at a temperature, sensitivity to the components of the vaccine, with encephalopathy and allergies.

The composition of the vaccine "Pentaksim"

So, Pentaxim, as has been repeatedly repeated, is a combined type vaccine that protects against five different serious diseases at once. The Pentaxim vaccine contains toxoids against diphtheria, tetanus and whooping cough, a Haemophilus influenzae polysaccharide (it is in a separate vial and mixed with the rest when the drug is diluted) and three types of polio virus. Excipients are also present in the vaccine, such as formaldehyde and acetic acid.

At what age is vaccination required?

The instruction of the Pentaxim vaccine states that the first injection of her baby should be made at the age of three months. The second and third vaccinations are carried out subsequently at four and a half months and at half a year, and revaccination - a year later. Of course, if there are any contraindications, the timing of injections is shifted - a child over a year old can also be vaccinated, if for some reason this was not done earlier. However, if a child older than six months is vaccinated, the third vaccination is done without diluting the vial with Haemophilus influenzae. And in the case of a baby older than a year (if he has not been vaccinated before), he receives only the first vaccine against five diseases, and in the future, such a child is given injections without the introduction of a hemophilic bacillus.

Medotvod

If a child has any of the following, vaccination should be delayed (or discontinued, depending on the pediatrician's recommendation).

1. Hypersensitivity to the drug and / or its components.
2. Allergy that appeared after the previous injection, if the injection is not the first time.
3. Fever, disease - infectious or exacerbation of chronic.
4. encephalopathy.
5. Seizures and any other neurological symptoms.
6. Brain damage and/or epilepsy.
7. Violation of hemocoagulation.

Side effects

Any medication can have side effects in one form or another, and the Pentaxim vaccine is no exception. The vaccine can provoke a temperature increase of more than thirty-eight degrees, a rash, convulsions, and allergic reactions. Extremely rarely, but drowsiness and lethargy were noted, and, on the contrary, irritability, insomnia, headaches and lingering tears. After the Pentaxim vaccine, the injection site may hurt, it can turn red, it is likely that a seal will appear there, which will resolve in the very near future on its own, without the use of any measures. Also, swelling of the injection site is called as a side effect, which, however, also passes on its own. However, if Quincke's edema has suddenly begun, one should not expect it to disappear - it is urgent to call a doctor.

Instructions for use

How to properly administer the Pentaxim vaccine? First, it is important to know that a single dose is half a milliliter. Secondly, Pentaxim has its own special syringe that prevents overdose and minimizes pain in the child. According to the instructions for use of the Pentaxim vaccine, it should be administered intramuscularly. Intravenous and subcutaneous administration is strictly prohibited. The crumbs are given an injection in the thigh, for older children - in the shoulder. As a rule, babies do not feel pain - only a slight tingling, and therefore do not cry during vaccination and behave calmly.

As for the simultaneous use of Pentaxim with other vaccines, it is allowed if these vaccines are from the vaccination calendar (except for BCG). According to the instructions for the Pentaxim vaccine, this vaccination does not affect their ability to develop immunity. However, the pediatrician should be aware of some nuances. For example, what kind of medicine, in addition to Pentaxim, was or will be given to the baby. Before a child is vaccinated, the doctor should carefully examine him to assess the state of health of the baby. If something seems to the doctor to be inconsistent with vaccination recommendations, the vaccination should be postponed. By the way, if the crumbs had a disease a few weeks before the vaccination (less than a month ago), it is also not recommended to put it.

It is necessary to store the Pentaxim vaccine in the refrigerator for no more than three years at a temperature regime of two to eight degrees above zero. Freezing the drug is strictly prohibited.

Preparation for vaccination

There are some simple rules that must be followed before vaccination.

1. Take blood and urine tests.
2. Be examined by a neurologist.
3. When breastfeeding a child, you do not need to introduce new dishes into his diet (and also the mother herself should not start eating some new food).
4. If you previously had any allergic manifestations, then a couple of days before vaccination it is better to drink antihistamines.
5. A week before the vaccination, you should not take any new medicines without first consulting a doctor.
6. It may not come in handy, but it’s better to have this at hand: you should take care of purchasing antipyretics for the baby in advance (both suppositories and syrup are perfect) - a temperature above normal can be a frequent negative reaction to the vaccine.
7. As a rule, children tolerate the procedure well, but in case the child is very afraid or gets hurt, it is necessary to bring his favorite toy with him.

Vaccination Care

After the baby has been injected, it is recommended not to leave the clinic immediately. It is best to stay in it for half an hour - then in case of an allergy or any other negative reaction, medical assistance will be provided immediately. In addition, if the child is in an excited state, this time is more than enough for him to calm down.

Within three days after the introduction of the vaccine, it is necessary to measure the temperature of the baby. If it rises above the normal value, you should give the baby any antipyretic - Panadol, for example, or Nurofen. It is also permissible to wipe the child with warm water or a very weak vinegar solution, but in no case with vodka. If the antipyretic did not help the baby, you need to call a doctor.

On the day of vaccination, the baby should not be bathed, and you should not walk with him. The injection site should not be scratched.

Filterable List

Active substance:

Instructions for medical use

Pentaxim ® (adsorbed vaccine for the prevention of diphtheria and tetanus, acellular pertussis, inactivated poliomyelitis, conjugated infection caused by Haemophilus influenzae type b)
Instructions for medical use - RU No. LSR-005121/08

Last Modified Date: 26.04.2016

Dosage form

Lyophilizate for the preparation of a suspension for intramuscular injection 1 dose, complete with a suspension for intramuscular injection 0.5 ml.

Compound

One dose (0.5 ml) contains:

* - does not contain phenol red

Antibiotics (streptomycin, neomycin and polymyxin B) are used in the manufacture of the vaccine but are not present in detectable amounts in the final product.

The vaccine has been manufactured under Good Manufacturing Practice (GMP) conditions.

Description of the dosage form

Vaccine for the prevention of diphtheria and tetanus adsorbed, acellular pertussis, inactivated poliomyelitis (suspension for intramuscular administration): whitish cloudy suspension.

Vaccine for the prevention of infection caused by Haemophilus influenzae type b. conjugated (lyophilisate for suspension for intramuscular injection): white homogeneous lyophilisate.

Reconstituted vaccine: an opaque whitish liquid, which, on standing, separates into a colorless liquid with the formation of a white precipitate, which is easily resuspended by shaking.

Pharmacological group

MIBP - vaccine

Indications

Primary vaccination and revaccination of children against diphtheria, tetanus, whooping cough, poliomyelitis and infection caused by Haemophilus influenzae type b (meningitis, septicemia, arthritis, epiglottitis, pneumonia, osteomyelitis, etc.).

Contraindications

• Progressive encephalopathy with or without seizures.
• Encephalopathy of unknown etiology that developed within 7 days after the introduction of any vaccine (whole cell or acellular) containing Bordetella pertussis antigens.
• A severe reaction that developed within 48 hours after a previous immunization with a vaccine containing a pertussis component: body temperature equal to or greater than 40 ° C, prolonged unusual crying syndrome (longer than 3 hours), febrile and afebrile convulsions, hypotonic-hyporeactive syndrome.
• Hypersensitivity to previous administration of diphtheria, tetanus, pertussis, polio or Haemophilus influenzae type b vaccines.
• Established hypersensitivity to any component of the vaccine, as well as glutaraldehyde, neomycin, streptomycin and polymyxin B.
• A disease accompanied by an increase in body temperature, an acute infectious or chronic disease in the acute stage. Vaccination is carried out 2-4 weeks after recovery or during the period of convalescence or remission. In case of non-severe SARS, acute intestinal diseases, etc., vaccinations are carried out immediately after the temperature returns to normal.

Use during pregnancy and lactation

Since the Pentaxim ® vaccine is used to vaccinate children, there are no data on the effect of the drug on the course of pregnancy and breastfeeding.

Dosage and administration

Vaccination schedule

A single dose of the vaccine is 0.5 ml.

Primary vaccination

In accordance with the National Immunization Schedule of the Russian Federation, the course of primary vaccination consists of three doses of vaccine administered at intervals of 1.5 months: at the age of 3, 4.5 and 6 months. However, other three-dose immunization regimens (eg, 2–3–4 months, 2–4–6 months, or 3–4–5 months) may also be used on the advice of a physician.

Revaccination

Revaccination is carried out once at the age of 18 months. In case of violation of the vaccination schedule, subsequent intervals between the introduction of the next dose of the vaccine do not change, including the interval before the 4th (revaccinating) dose - 12 months. When carrying out vaccination / revaccination, they are guided by the following schedule:

In all cases of violation of the vaccination schedule, the doctor should be guided by the instructions for the use of the medicinal product and the recommendations of the National Calendar of Preventive Immunizations of the Russian Federation.

Method of administration

Do not administer intradermally or intravenously.

Before insertion, it is necessary to make sure that the needle has not penetrated into the blood vessel.

For the packaging option with two separate needles (16 mm 25G, 25 mm 23G), before preparing the vaccine, one of the two needles should be firmly fixed by rotating it a quarter of a turn relative to the syringe. The choice of needle depends on the thickness of the subcutaneous fat layer in the child at the injection site.

To prepare the vaccine, after removing the plastic colored cap from the vial, completely inject the pre-shaken suspension for intramuscular injection (vaccine for the prevention of diphtheria, tetanus, whooping cough and poliomyelitis) through the needle from the syringe into the vial with lyophilisate (vaccine for the prevention of infection caused by Haemophilus influenzae type b).

Shake the vial without removing the syringe from it and wait until the lyophilizate is completely dissolved (no more than 3 minutes). The resulting suspension should be cloudy and have a whitish tint. The vaccine should not be used in case of discoloration or the presence of foreign particles.

The vaccine prepared in this way should be completely drawn into the same syringe.

The finished vaccine should be administered immediately.

Side effects

The adverse events below are listed according to system organ class and frequency of occurrence. The frequency of occurrence was determined based on the following criteria: very often (≥ 1/10), often (≥ 1/100 to< 1/10), нечасто (≥ 1/1000 до < 1 / 100), редко (≥ 1/10000 до < 1 / 1000), очень редко < 1 / 10000), частота неизвестна (нельзя оценить по имеющимся данным).

Clinical Study Data

In three studies in infants receiving the first three doses of Pentaxim®, the most commonly reported reactions were irritability (15.2%) and injection site reactions such as redness (11.2%) and induration >2 cm (15.1%).

In a Swedish study, after three doses of Pentaxim® vaccine given at 3, 5 and 12 months of age, the most commonly reported reactions were irritability (24.1%) and injection site reactions such as redness (13.4%) and compaction (12.5%).

These signs and symptoms usually develop within 48 hours after vaccination and resolve spontaneously without requiring specific treatment.

With revaccination, there is a trend towards an increase in the incidence of general disorders and disorders at the injection site.

Metabolic and nutritional disorders

Very common: anorexia

From the side of the psyche

Very common: nervousness (irritability), unusual crying

Common: sleep disturbances

Uncommon: prolonged crying

From the side of the nervous system

Very common: insomnia

From the gastrointestinal tract

Very common: vomiting

Common: diarrhea

Very common: injection site redness, fever (≥ 38°C), injection site soreness and swelling

Common: Induration at the injection site

Uncommon: redness and swelling (≥5 cm) at the injection site, fever (≥39°C)

Rare: Fever (≥40°C), diffuse edema of one or both limbs may occur after administration of vaccines containing Haemophilus influenzae type b capsular polysaccharide. If such a reaction develops, then it occurs mainly after the primary vaccination and is observed during the first few hours after vaccination. This reaction may be accompanied by cyanosis, redness, transient purpura, and intense crying. These symptoms disappear spontaneously without consequences within 24 hours.

Post-registration data

Since spontaneous reports of adverse events in the commercial use of the drug were received very rarely and from a population with an indeterminate number of patients, their frequency was classified as "frequency unknown".

Immune System Disorders

Anaphylactic reactions such as swelling of the face, Quincke's edema, shock.

From the respiratory system

In very premature babies (born at 28 weeks or earlier), within 2-3 days after vaccination, there may be cases of lengthening the time intervals between respiratory movements (see section "Special instructions").

From the side of the nervous system

Convulsions with or without fever, hypotonic reactions or episodes of hypotension-hyporesponsiveness.

From the skin and skin tissues

Rash, hives.

General disorders and disorders at the injection site

Severe swelling (≥5 cm) at the injection site, including swelling extending beyond one or both joints. These reactions appeared 24-72 hours after vaccine administration and may be accompanied by redness, fever at the injection site, or tenderness or tenderness at the injection site. These symptoms disappeared on their own within 3-5 days without any additional treatment. It is believed that the likelihood of developing such reactions increases depending on the number of injections of the acellular pertussis component, this likelihood is higher after the 4th and 5th dose of such a vaccine.

Potential adverse reactions

The company has data that after the introduction of other vaccines containing tetanus toxoid, neuritis of the brachial nerve and Guillain-Barré syndrome were observed.

Overdose

No data available.

Interaction

With the exception of immunosuppressive therapy (see section "Special Instructions"), there is no reliable data on the possible mutual influence when used with other drugs, including other vaccines.

The suspension containing the vaccine for the prevention of diphtheria and tetanus adsorbed, pertussis acellular, polio inactivated, must not be mixed with any other medicinal products, with the exception of the attached lyophilisate of the vaccine for the prevention of infection caused by Haemophilus influenzae type b conjugated.

The reconstituted vaccine must not be mixed with other medicines or vaccines.

The doctor should be informed about the recent or coinciding with the vaccination of the introduction of a child of any other drug (including over-the-counter).

Precautionary measures

• If a child has a history of febrile seizures that are not associated with previous vaccination, the body temperature of the vaccinated person should be monitored for 48 hours after vaccination and, if it rises, as prescribed by the doctor, antipyretic (antipyretic) drugs should be used.
• In thrombocytopenia and other bleeding disorders, the vaccine should be administered with caution due to the risk of bleeding during intramuscular injection.

special instructions

The Pentaxim ® vaccine does not form immunity against infection caused by other serotypes of Haemophilus influenzae, as well as against meningitis of a different etiology.

The doctor should be informed about all cases of adverse reactions, including those not listed in this leaflet. Before each vaccination, in order to prevent possible allergic and other reactions, the doctor should clarify the state of health, the history of immunization, the history of the patient and close relatives (in particular, allergic), cases of side effects on previous vaccines. The doctor must have the drugs and tools necessary for the development of a hypersensitivity reaction.

Immunosuppressive therapy or a state of immunodeficiency may cause a weak immune response to the vaccine. In these cases, it is recommended to postpone vaccination until the end of such therapy or remission of the disease. However, in individuals with a chronic immunodeficiency (such as HIV infection), vaccination is recommended even if the immune response may be weakened.

If you develop a history of Guillain-Barré syndrome or neuritis of the brachial nerve in response to any vaccine containing tetanus toxoid, the decision to vaccinate with Pentaxim® should be based on a careful assessment of the potential benefits and possible risks. As a rule, in such cases, it is justified to complete the primary immunization in children of the first year of life (if less than 3 doses are administered).

The potential risk of developing apnea and the need to monitor breathing for 48-72 hours should be considered when conducting a primary course of immunization in very preterm infants born at or before 28 weeks of gestation, especially those with a history of respiratory immaturity. Because the benefit of immunizing this group of children is high, vaccination should not be delayed or considered contraindicated.

Since the capsular polysaccharide antigen of Haemophilus influenzae type b is excreted through the kidneys, a positive test for an infection caused by Haemophilus influenzae type b can be recorded in the urine test within 1-2 weeks after vaccination. During this period, other tests are needed to confirm the diagnosis of Haemophilus influenzae type b infection.

Influence on the ability to drive vehicles and engage in other potentially hazardous activities

Since the Pentaxim ® vaccine is used to vaccinate children, the effect of the drug on the ability to drive vehicles and engage in other potentially hazardous activities has not been studied.

Release form

Vaccine for the prevention of diphtheria and tetanus adsorbed, acellular pertussis, inactivated poliomyelitis - suspension for intramuscular injection 0.5 ml; complete with a vaccine for the prevention of infection caused by Haemophilus influenzae type b, conjugated - lyophilisate for the preparation of a suspension for intramuscular injection 1 dose.

One dose of lyophilisate in a glass vial and 0.5 ml (1 dose) of suspension in a glass syringe (with or without a fixed needle) with a capacity of 1 ml, with a chlorobromobutyl piston.

1 vial and 1 syringe in a closed cell package (PET/PVC). If the syringe does not have a fixed needle, then 2 separate sterile needles are put into the package.

1 cell pack in an individual carton box with instructions for use.

Storage conditions

Store in refrigerator (2 to 8°C). Do not freeze.

Keep out of the reach of children.

Best before date

Lyophilisate - 3 years,

Suspensions - 3 years.

Do not use after the expiry date stated on the packaging.

The Pentaxim vaccine is a cell-free (acellular) drug of a new generation, which is much easier for babies to tolerate, since the body's reaction to it is much weaker than to its cellular precursor counterparts. The substance is devoid of bacterial membranes of lipopopolysaccharides, which cause complications after vaccination, so Pentaxim can be called a relatively safe drug.

The vaccine has a highly immunogenic effect, causing a strong immune response of the baby, it provides strong protection against infectious diseases such as tetanus, diphtheria, whooping cough, hemophilia (type B) and polio.

The predecessor of the drug can be called the well-known DTP vaccination, which most babies endure quite hard, because they have many contraindications to it, which doctors sometimes (as parents say) do not pay attention to.

Pentaxim can significantly reduce the risk of possible complications that occur after vaccination with other drugs, it is safe and reliable.

Vaccination Schedule

The primary course requires the introduction of 3 doses of the vaccine with an interval of 45 days and subsequent revaccination a year later. It is important to follow the timing of vaccinations, according to the schedule. Sometimes the next vaccination can be postponed for several days (weekends, malaise in the baby, colds, fever).

In this case, the resumption of the drug regimen does not occur, but the protective result may be reduced, since the child's immunity will be less responsive to incoming bacteria.

Parents need to remember that the component of the drug against hemophilia for children older than a year is administered only 1 time. Therefore, if the baby was injected with Pentaxim at this age, then such an injection was the last. In the future, the introduction of the drug is possible only without a hemophilic component.

The national calendar for the introduction of preventive vaccinations prescribes vaccination with the drug in 3 stages, at 3, 4.5 and 6 months, followed by revaccination in a year and a half.

Mode of application

The packaging of the vaccine is aseptic, while the blister contains not only a syringe with a dose of the drug for tetanus, diphtheria, whooping cough and polio, but also a bottle with a specially dried mixture for hemophilia. The dry component dissolves in the liquid immediately before the injection, which is administered to the baby from the same syringe intramuscularly.

Many reviews of mothers indicate that children practically do not feel this vaccination, since the needle is very thin, and the procedure is fast.

For babies up to a year, the drug is injected into the thigh, into the quadriceps muscle, for older children - into the shoulder, into the deltoid muscle. This vaccine is not injected into the buttock, intravenous injections of the substance are strictly prohibited.

Contraindications

• Hypersensitivity to any of the components of Pentaxim, systemic reactions to its administration, medically confirmed, as well as to neomycin, glutaraldehyde, polyximin B and streptomycin.
• Any infectious infection, accompanied by high fever and other symptoms, as well as exacerbation of existing chronic diseases. In these cases, the procedure is postponed until the child recovers.
• Allergy development after administration of any vaccine against polio, tetanus, diphtheria, whooping cough and Haemophilus influenzae type B.
• Encephalopathy in a progressive form (with or without seizures), as well as developed within a week after vaccination.
• A strong reaction that occurred to the previous administration of the pertussis component, expressed by a syndrome of prolonged crying, uncharacteristic for a baby, high fever (40 ° or more), hypotonic-hyporeactive syndrome, convulsions of an afebrile or febrile nature.

If the baby has febrile seizures that are not related to previously administered vaccines, the use of the drug is possible, but with caution. At the same time, it is important to monitor the temperature level during the first two days, and if it rises, immediately give the child antipyretics.

Normal reaction

The response of the immune system, as a rule, causes the introduction of any vaccine, since this substance is foreign to him, but sometimes the reaction can have clinical manifestations. In most cases, this behavior of the body is considered normal.

Reactions after vaccination can be divided into:

• Local, usually expressed in a slight thickening of the tissues at the injection site, the appearance of redness in this area. Sometimes there may be some soreness in the treated area, but such symptoms quickly pass. Thickening of tissues with redness is considered normal if the size of the swelling is no more than 8 cm in diameter. Similar reactions are observed on the introduction of many types of vaccines, occur in about 20% of babies and disappear on their own after 1 to 3 days.
• General, manifested in the form of malaise, sleep disturbances, fever, loss of appetite, headaches, which disappear quickly enough without additional intervention. In cases of severe fever, it may be necessary to take antipyretics.

Possible Complications

Pentaxim is a combined drug designed to protect against five diseases at once. According to the reviews of parents who observed the babies after vaccination of both individual doses and the entire course, complications occurred in less than 1% of vaccinated children. Only in isolated cases, the response of the body required the provision of medical assistance, while not a single lethal outcome was recorded.

A big plus of the vaccine is that it contains a component that is guaranteed to protect the baby's body from polio, which cannot be said about cases when the substance was administered orally.

Immune reactions, as well as complications, after Pentaxim occur only in isolated cases. Usually, according to parents, the introduction of this vaccine is tolerated by babies calmly and easily. In some cases, small normal reactions are observed in the form of irritability unusual for an infant, fever, tissue thickening at the injection site, prolonged causeless crying. But this does not require medical attention and, as a rule, all symptoms disappear after 1 - 2 days.

Even less commonly, there are manifestations of a neurological nature, such as convulsions, muscle pain, especially at the injection site, digestive disorders, lack of appetite. According to mothers, such complications can sometimes occur on the introduction of the second dose of the drug, while the first and third are easily tolerated.

More serious consequences may result from incorrect administration of the vaccine, violation of the established interval, or from the fact that the injection was given to an unhealthy child in the presence of obvious contraindications. Therefore, before allowing your child to have an injection, you need to make sure that the doctor is convinced that the baby is healthy.

If complications arise, how can parents help?

It is important to understand that an increase in temperature is a normal and acceptable reaction of the body to the introduction of a vaccine, so you should not panic because of this. According to parents, it is this factor that causes a lot of unrest. This answer suggests that the baby's immune system is working normally and, having detected potentially dangerous elements, entered into a natural struggle with them, during which further protection is developed.

An increase in temperature to 39 ° is considered normal, but this does not mean at all that nothing needs to be done. When the indicator on the thermometer reaches 38.5 °, the baby must be given an antipyretic in any convenient form. If the child has a history of disorders in the neurological system or there is a tendency to convulsions, it is necessary to lower the temperature starting from 37.5 °.

In order not to give medicine once again, the best thing to do is to wipe it with a damp towel or soft sponge, and also increase the amount of drinking, which can be used as a decoction of birch buds, chamomile or linden flowers. Pharmaceutical antipyretics should be resorted to when, despite all the measures, the temperature continues to rise.

But here it is important to observe the dose and not to abuse such means. If the fever persists for more than 7 to 8 hours and cannot be brought down, you should immediately call a doctor, as well as if you experience other symptoms in the form of diarrhea, vomiting, severe cough or runny nose.

It is not necessary to give antipyretics after vaccination just for prophylaxis, in order to prevent a rise in temperature, since such actions are unjustified and may interfere with the proper functioning of the immune system.

Preparing for the introduction of Pentaxim

Parents' comments indicate that doctors do not explain the need for preparation for the procedure, and it depends on this in many respects how the baby will endure the injection. There are certain rules regarding any vaccination, but with the introduction of Pentaxim, as well as similar drugs, their observance is especially important.

• The baby at the time of the procedure must be absolutely healthy. As the reviews of many mothers say, doctors often do not pay attention to minor ailments of children and prescribe a vaccine, despite the presence of a runny nose, allergic rash or diathesis, cough, constipation, runny nose, diarrhea and other problems, although all this is the reason for postponing the date of vaccination.
• When placing under the control of any specialist (neurologist, surgeon, allergist, etc.), you must obtain his written permission to administer the drug.
• It is important to conduct tests, at least the main ones - a general analysis of urine and blood. According to mothers, doctors usually conduct only a superficial examination of the baby, without delving into the details, after which they issue a referral. Therefore, it is better to require analysis, such a precaution will not hurt.
• 7-8 days before the scheduled vaccination, you do not need to give the baby new products, and you should not do this for a week after the procedure.
• The day before the introduction of Pentaxim, you need to limit the amount of food the child has (feed less), but increase the drink. You also need to do 1-2 days after vaccination.
• When going for a vaccination, you should not wrap the child, because if the baby sweats, this will not be a plus.

What to do after

The goal of any vaccine is to develop strong immunity against the disease, and the baby's body should not be interfered with in this process. It is important to understand that a weakened baby will not have enough strength to simultaneously fight with any virus, therefore, for several days after the introduction of Pentaxim, it is better to refrain from walking, as well as from swimming (especially in the pool). The main thing is to prevent a possible infection with an infection, so as not to create an additional load on the baby's immune system.

Information about Pentaxim vaccine

mama66.ru

Vaccine pentaxim

There is no doubt that the vaccination of children for decades has made it possible to significantly reduce the mortality of children. A few years ago, a change was made to the vaccination schedule: hemophilic infection type b was added to the list of infections. To vaccinate children in 97 countries against this infection, the Pentaxim or Pentavac vaccine is used, which does not change its essence.

Pentaxim contains acellular whooping cough. Thanks to this component, the risk of developing adverse reactions in a child is significantly reduced. Pentaxim is a combination vaccine. It provides children with immunity from diphtheria, tetanus, whooping cough, poliomyelitis and infections caused by Haemophilus Influenzae type b (epilottitis, meningitis, septicemia). This vaccine is produced in France. Due to the multicomponent nature, the number of injections is reduced. Thus, separate vaccination against the infections mentioned above requires 12 injections, and the use of Pentaxim requires only four. In addition, clinical studies have shown that children vaccinated with Pentaxim have high levels of antibodies against three types of polyviruses, Hib infection, whooping cough, tetanus and diphtheria.

Indications and contraindications

It is no secret that the fear of vaccinating children is common to many parents. Which children can be vaccinated with this vaccine, what reaction to Pentaxim can be expected? Age for vaccination? The instructions for the vaccine indicate that healthy children can be vaccinated with Pentaxim at the age of three months. This vaccine is recommended for babies who have had an unusual reaction to the DTP vaccine, as well as the following group of children:

• who received a medical exemption for DTP;
• HIV-infected;
• suffering from non-progressive chronic diseases of the central nervous system;
• allergy sufferers;
• with febrile convulsions (in history), etc.

If a child is often sick, has records of perinatal encephalopathy, atopic dermatitis, anemia, dysbacteriosis in the card, which is not a reason for providing a medical exemption from vaccination, then parents in most cases refuse to vaccinate him. But with regard to the use of Pentaxim, these fears are in vain. Russian scientists who conducted research on the vaccine confirmed that vaccination and revaccination with Pentaxim is effective for children with various health conditions.

Contraindications for the use of Pentaxim vaccine include:

• progressive encephalopathy;
• severe reaction after a previous vaccination;
• exacerbation of allergies;
• individual hypersensitivity to the components of Pentaxim;
• infectious diseases.

Reaction after vaccination with pentaxim

In most cases, the child tolerates Pentaxim vaccination absolutely normally. If side effects and reactions appear after the injection of Pentaxim, then it is necessary to consult a doctor. The most common effects of pentaxim are an increase in body temperature. Sometimes the child feels discomfort after the injection, less often there is a seal after pentaxim at the injection site, which disappears in a few days. Pediatricians believe that the temperature after pentaxim vaccination should not be brought down, since the immune response of the child's body will be reduced, which is undesirable. But if the thermometer is more than 38 degrees, then the antipyretic is quite appropriate.

Vaccination Schedule

The course consists of three injections of pentaxim, which are administered from the age of three months (interval - one to two months). One dose is about 5 ml of vaccine. At 18 months, revaccination is carried out (one dose). If the standard pentaxim vaccination schedule has been violated, then the pediatrician adjusts it for a particular child.

Store Pentaxim, as indicated in the instructions, should be in the refrigerator (at a temperature of +2 - +8 degrees). The vaccine must not be frozen.

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womanadvice.ru

Pentaxim - tetanus and diphtheria vaccine, adverse reactions and instructions for use

The vaccine Pentaxim (France) against whooping cough, diphtheria, pneumonia, polio, tetanus, meningitis, thrombocytopenia and infections caused by the HIB bacterium is used for childhood vaccinations. With the help of vaccination, epidemics of the above diseases can be avoided. The drug is registered in the USA, Europe, Russia.

Vaccine Pentaxim - instructions for use

The manipulative nurse who administers the vaccination must strictly follow the rules. Instructions for use Pentaxim includes several basic requirements:

• before starting vaccination, the expiration date of the drug is checked;
• the injection is done intramuscularly, immediately after opening the package, carefully shaking the contents of the syringe;
• for children under one year old, the injection site should be the outer part of the thigh (its middle part) or the forearm of the hand (for older children);
• an injection in the buttock is prohibited because the thick layer of muscle and fat will prevent the components of the vaccine from entering the bloodstream.

Not only doctors, but also responsible parents should know what is included in Pentaxim. Useful information can prevent a negative reaction of the child's body to any component that is part of Pentaxim. Scientists have found that antigens are not always well combined with each other, therefore they will not be able to fully benefit by developing immunity to the effects of certain viruses. The components of Pentaxim have been matched perfectly, so that they do not interfere with each other to act individually. The vaccine consists of the following substances:

• pertussis acellular acellular toxoid;
• tetanus toxoid;
• diphtheria toxoid;
• inactivated poliovirus of all three types;
• an additional component that comes with the kit in the form of a powder (lyophilisate) is filamentous hemagglutinin.

Reaction to Pentaxim in a child

The children's body of a 3-6 month old baby may not respond equally to the introduction of the vaccine and septicemia. There should be a reaction to the Pentaxim vaccine, but it is expressed to varying degrees, as well as to suspensions of other drugs. Here are the main indicators that the vaccine "works" and gave a side effect that is considered normal:

• slight redness at the injection site with the Pentaxim vaccine, sometimes with induration;
• slight soreness with pressure;
• fever up to 38 C, rarely up to 39 C;
• increased moodiness, crying, sleep disturbance, loss of appetite.

Rarely, there are reactions to the Pentaxim vaccine, in which it is worth seeking medical advice and help without putting the child at risk by leaving him at home:

• body temperature reaches 40 degrees;
• the appearance of a rash on the skin;
• anaphylactic shock;
• convulsions;
• open bleeding;
• lowering blood pressure.

Pentaxim - vaccination schedule

In order for the vaccination, as a prophylaxis, to be useful, it is necessary to strictly follow the Pentaxim vaccination schedule. When the child is healthy and has no contraindications, then the course of injections of 0.5 ml is divided into three stages with an interval of one and a half months, starting from 12 weeks of age. Subject to the schedule, in a year and a half, revaccination is done with a single dose. In the case when the initial vaccination against diphtheria and tetanus is carried out late, the doctor calculates the next vaccination dates and decides on the advisability of introducing the Hib component.

Pentaxim - contraindications

Before starting the vaccination, the pediatrician should carefully examine the child, check with the parents for details about his well-being in recent days, look at the medical record in order not to miss contraindications to the use of Pentaxim and prevent negative side effects. Adults should be alerted (vaccination should be postponed) if at least one of the following items is found in the baby:

• chronic disease in the acute phase;
• individual hypersensitivity, immunity of the vaccine components by the body;
• allergy to streptomycin, neomycin, polymyxin B;
• increase in body temperature;
• during previous vaccinations, a hyper-high temperature was observed, reaching up to 40 C, a convulsive state;
• encephalopathy disease.

Pentaxim - storage conditions

Transportation of the Pentaxim vaccine should take place at low temperatures, in containers or bags with dry ice. After getting into the room, containers with drugs are placed inside the refrigerator. Proper storage conditions for Pentaxim guarantee the safety of the event and the preservation of the quality of the administered drug. Store at the optimum temperature for the content of the vaccine - in the range from 2 to 8 degrees above zero.

Pentaxim - expiration date

Subject to storage conditions, the shelf life of Pentaxim is limited to 3 years from the date of issue. Employees of medical institutions, especially children's, must strictly monitor the quality of incoming vaccines. To avoid negative side effects, it is not recommended to use the Pentaxim vaccine with a deadline or those vials that are in doubt, having flakes and an uncharacteristic sediment. After opening the ampoule, according to the instructions, it is impossible to store the drug.

Price for Pentaxim

The cost of Pentaxim - vaccines ranges from 1200 to 1900 rubles per vial. You can buy the drug in pharmacies by making a reservation. Before buying, you should check the conditions under which the Pentaxim vaccine is stored. Specialized medical centers offer the drug at a price of 2100-2700 rubles. Online pharmacies can offer discounts when buying a small batch of Pentaxim, which will be intended for a group of babies or for a children's clinic.

Pentaxim - analogues

In those situations when the time for vaccination is approaching, where you need to strictly adhere to the schedule, and Pentaxim - there is no vaccine in pharmacies, the doctor may recommend replacing it with medicines from the radar reference book, the effect of which, according to the description, does not differ from the complex vaccination. There is a list of drugs, which includes analogues of Pentaxim, interchangeable in their structure. These include:

• DPT;
• DTP Hep B;
• Synflorix;
• Tetraxim;
• Bubo-M;
• Bubo-Kok;
• Infanrix;
• Infanrix Hexa;
• Infanrix Penta;
• D.T.Vaks;
• Imovax Polio;
• Synflorix;
• Hiberix;
• Tetrakok 05.

Video: Pentaxim vaccine

sovets.net

Vaccine Pentaxim - Composition and advantages of the vaccine, instructions for use, advice from doctors

Preventive measures to prevent dangerous diseases such as poliomyelitis and tetanus, diphtheria and whooping cough, as well as other possible infections that can be caused by Haemophilus influenzae type B, are carried out in all children without exception.

Vaccination starts after 3 months. To avoid the epidemiological situation, in the course of long-term scientific and laboratory research in 1997, a universal immunobiological preparation was created - the Pentaxim complex vaccine.

An improved formula, compared to previous analogues, makes it possible to develop a protective ability in the body of a small child to resist more infections.

What diseases are prescribed Pentaxim

The main principle in the development of each monovaccine is to strengthen the immune response. But, unfortunately, this does not take into account the combination of some antigens with pathogens of other diseases.

Therefore, the immunobiological preparations included in the vaccination schedule are prescribed with some interruption. This allows the body to adapt to the individual characteristics of a particular infection and learn to fully cope with it.

The advantages that Pentaxim vaccination has eliminate the disadvantages of previously administered prophylactic vaccinations: DTP, Infanrix, Tetraxim. With the help of a single multicomponent drug of a new generation, medicine has been able to reduce the pharmacological impact on the child's body. Let us consider in more detail what Pentaxim is vaccinated against.

First of all, it should be noted hemophilic infection. It includes purulent meningitis and arthritis, acute pneumonia, inflammation of the subcutaneous tissue, epiglottis and sinus mucosa, damage to the serous membrane of the heart. Next come diphtheria, tetanus, whooping cough and polio.

For the use of antigens isolated in the laboratory for prophylactic purposes, it was planned to introduce several agents that additionally contained chemical and synthetic substances. This created a burden on the still not too strong, weak body and injured the children.

One injection, which ideally combines several sources of possible diseases, made life easier for both medical workers and parents. Especially if they are worried about the future condition of their beloved child.

When and is it possible for a child to do Pentaxim

The emergence of a universal vaccine preparation was preceded by a long study of the vital activity of bacteria that cause whooping cough, tetanus and diphtheria, poliomyelitis and infections that provoke Pfeiffer's bacilli. More than 10 thousand children took part in clinical studies of the action of the immunobiological substance.

As a result, the scheme provided for vaccination with Pentaxim showed positive results.

In almost 100% of the recorded cases, the presence of antibodies to dangerous pathogens of a bacterial infection was confirmed. These include whooping cough and tetanus. The immune response in the form of T-cells to diphtheria bacilli, poliomyelitis enterovirus, Haemophilus influenzae was also determined in the blood.

Since 2011, on the recommendation of the World Health Organization, Pentaxim has been included in the list of mandatory and permitted preventive measures. They can and are recommended for children with an atypical reaction after traditional DPT.

Vaccination is also available for babies who need acellular pertussis injections in the presence of HIV infection and immunodeficiency. It must be prescribed to a healthy child from the first 3 months of life, the drug is also recommended for children suffering from atopic dermatitis, dysbacteriosis, with low hemoglobin levels and anemia, anemia.

Pentaxim or DTP: which is better

Let's compare the two most effective vaccines, one of which, DTP, was developed back in the 40s, and the other, Pentaxim, a modern one, appeared in 1997. Both of these biological preparations responsible for activating and strengthening the immune system were created in order to prevent the most dangerous diseases in the children's group.

Previously adsorbed DPT is intended, following the manufacturer's instructions and research center recommendations, to prevent whooping cough, viral hepatitis B, diphtheria, and tetanus.

Whereas Pentaxim, in addition to similar infections, also develops resistance in the body to gram-negative bacteria of the species Haemophilus influenzae, as well as their strains, united by a single antigenic structure, serotype B.

They are the cause of about 40% of the incidence of childhood meningitis, 20% of pneumonia and up to 80% of the cases of inflammatory processes of the epiglottis.

Any side effects are available, both on the part of Pentaxim and after DPT. Basically, they are expressed by allergic reactions, fever, seals at the injection site. Unlike the old vaccine, which specifically forms immunity, the new French drug only prevents the disease and facilitates its course.

The composition of the vaccine Pentaxim

What is a combined immunobiological preparation with such a broad preventive effect. Let us consider in detail what exactly is included in the composition of the vaccine, and what distinguishing characteristics it has in comparison with DTP.

The foreign drug consists of so-called toxoids. These include laboratory-isolated, safe for possible infection, but effective toxins. They are able to activate immune cells to fight pathogens.

In what quantitative indicators are toxoids in one dose of the vaccine:

1. poliomyelitis. Virus type I, II and III;
2. protein hemagglutinin and whooping cough - 25 mcg;
3. diphtheria - 30 IU;
4. tetanus - 40 IU.

The second stage consists of polymeric carbohydrates of a bacterium that causes hemophilic and tetanus toxins in an amount of 10 μg. The route of administration is intramuscular.

The content of the domestic DPT vaccination differs. It includes diphtheria and tetanus toxoids, pertussis microbial cells, protective units and preservatives containing mercury.

Naturally, it is much more expedient to use a new remedy that prevents infectious and inflammatory processes in children in the absence of adverse reactions.

Preparation for vaccination

The package consists of two separate needles, a syringe filled with vaccine. It is intended for the prevention of whooping cough, tetanus and diphtheria. Separately, in a bottle hermetically sealed with a plastic colored cap, there is a lyophilizate, a substance for the prevention of Haemophilus influenzae type B.

Such a division of toxoids was provided if there are contraindications for vaccination against hemophilic infections. In this case, the lyophilisate remains in a separate container and is not used.

The use of all components of the drug occurs by connecting the contents of the syringe and vial.

The resulting substance is shaken for about 3 minutes until a cloudy, with a white tint of a homogeneous liquid is formed. A change in color or the presence of poorly soluble particles of a substance against hemophilic infection indicates the unsuitability of the medicinal composition for the procedure.

Application of Pentaxim

The process itself, which involves the use of Pentaxim, determines a specially designed vaccination schedule. The classical scheme consists of successive injections. There are only three of them. The interval between them is up to 2 months.

Each vaccination is carried out with subcutaneous injection of 0.5 ml of the active active drug into the middle third of the outer surface of the thigh. At an older age, children are given an injection in the forearm. During the procedure, it is necessary to avoid getting the immunobiological substance into the subcutaneous fat layer, blood vessels.

If the very first injection was made in accordance with the approved vaccination schedule, at 3 months, subsequent revaccinations should be carried out at 4 months and 2 weeks, 6 months. The last dosage is prescribed after 12 months. In case of violation of the schedule, enter the same scheme: each injection is carried out at an interval of 1.5 months. The final dose is after 1 year.

If the vaccine is given to children over 6 months old and under 1 year old, there are slight changes in the procedure. The first dosage corresponds to the introduction of the entire substance. The second injection is carried out after 1.5 months. For the third vaccine, the lyophilisate substance contained in the vial is not used. The last dosage involves a combination of the composition of the syringe and the glass additional container against HiB infection.

After 1 year of life, Pentaxim is used without a reaction to a hemophilic infection. Only the contents that are originally in the syringe itself are entered.

All recommendations and appointments for the subsequent use of a new approved drug depend on the attending physician and the vaccination schedule. In case of intolerance to the composition of Pentaxima, the pediatrician has the right to stop the injection. It will have to be replaced with the traditional DPT vaccination.

Complications and side effects in children after Pentaxim

The ability of the body to activate the immune system when foreign dangerous microorganisms, viruses and bacteria penetrate, is expressed by a deterioration in health. It is much more difficult for children than for an adult with an already developed protective reaction to cope with possible unpleasant symptoms of vaccination.

Parents need to monitor any changes after the injection to avoid serious consequences and complications.

Usually, vaccination using the substance contained in Pentaxime is accompanied by a 10% increase in body temperature up to 38-39 ° C. Fever and fever above 40°C are much less common.

Unfortunately, the pain of any injection causes excessive tearfulness, irritability, screaming and crying in babies, which are replaced by drowsiness and weakness. After the injection, redness up to 5 mm in diameter and a seal appear on the damaged area of ​​the skin, when pressed, the child feels itching, unpleasant aching pain. This lasts no more than 24-72 hours from the moment of administration of antitoxins.

Cases have been reported when in 0.01% of vaccinated children Pentaxim caused dermatological consequences in the form of an allergic extensive small rash, urticaria. Possible anaphylactic shock. Quincke's edema and a sharp drop in blood pressure are not uncommon. The risk of intramuscular bleeding increases in young patients with bleeding disorders.

Do not exclude the inflammatory process of the peripheral nerve, paresis or temporary paralysis in the shoulder area. This happens in patients with an acute autoimmune disorder such as Guillain-Barré syndrome.

Vaccine Contraindications

Even the most harmless drugs can be banned from use. As for Pentaxim, it contains components that are dangerous for some babies and a large number of contraindications.

Prevention should be postponed if, after examination, the doctor diagnosed the children with ARVI, influenza, an inflammatory or infectious process in the body was detected. This also applies to intestinal infections.

Vaccination is strictly prohibited if, at the first injection, cross-reactions were observed during the interaction of the active substance contained in the injection and other drugs that the child receives.

If a small patient is diagnosed with progressive or acquired after an injection with an antigen of Bordetella pertussis encephalopathy, accompanied by damage to the brain and convulsions. Concomitant symptoms are possible: migraine, noise in the head, sleep disturbance, nervousness and causeless crying.

If the response to Pentaxim is a pronounced decrease or increase in blood pressure, fever, which causes a body temperature of more than 40 ° C, even 48 hours after the prophylactic vaccination.

It is dangerous to prescribe injections to children with a history of febrile convulsions, distinct allergic reactions to drugs such as Streptomycin, Neomycin, Polymyxin B and the substance glutaraldehyde.

After mantoux, how long can I get vaccinated

Quarantine after rabies vaccination in cats

To protect children and adults from severe infectious and viral pathologies, vaccination is carried out. Increasingly, doctors are giving preference to multicomponent ones, which protect against several diseases at once and are much better tolerated than drugs containing only one type of antigen.

Today, among imported vaccines, it is popular. Reviews about this tool are quite contradictory. To understand how effective and harmless the drug is, you need to know what composition Pentaxim has and how its elements affect the body.

What is included in Pentaxim: the composition of the vaccine

Pentaxim is a polyvalent one that protects against five dangerous infectious and viral diseases:, poliomyelitis, and pathologies provoked (, septicemia,).

The manufacturer is the French pharmaceutical company Sanofi Pasteur. The drug is produced in the form of a lyophilisate for the preparation of an injection solution and a suspension for intramuscular administration. The suspension is packaged in a sterile syringe with or without a needle.

A single dose (0.5 ml) contains the following components:

• tetanus toxoid - about 40 IU;
• - not less than 30 IU;
• inactivated poliovirus type 2 - 8 units of D-antigen;
• weakened poliomyelitis virus of the third type - 32 units;
• pertussis toxoid - 40 units of D-antigen;
• aluminum hydroxide;
• formaldehyde;
• Hank's medium;
• injection water;
• phenoxyethanol;
• sodium hydroxide.

The powder is packaged in vials. The contents of a single dose of the drug:

• polysaccharide Haemophilus influenzae type B, conjugated with tetanus toxoid - 10 mcg;
• trometamol;
• sucrose.

The injection solution is a whitish cloudy liquid. Designed for intramuscular injection. The lyophilisate is in the form of a white powder. The Pentaxim package includes a syringe with a suspension, two sterile needles, a vial of lyophilisate and instructions for use.

In the production of the vaccine, the antibiotics Neomycin, Streptomycin, Polymyxin B are used. But these substances are absent in the final product.

Does it contain thimerosal (mercury)?

Mercury is added to many vaccines that contain inactivated viruses. This element is used as a preservative. Mercury has fungicidal, antiseptic properties.

There is speculation that thimerosal can affect the nervous system of a child and cause autism.. This substance is indeed considered a poison and is highly toxic. But its content in the preparation for immunization is so small that there can be no harm to health.

Less than 0.1% of mercury enters the body with the vaccine compared to the amount that a person receives from other sources. In addition to vaccinations, thimerosal is present in medications, eye and nasal drops, antidotes, tattoo inks, and antigen tests.

Mercury is present in many modern: DTP, Haemophilus influenzae,. At the same time, such drugs are recognized by WHO as high-quality and safe.

Vaccine Pentaxim

But parents are still wary of immunizing their children with vaccines containing mercury. It should be noted that during the first six months of life, an infant receives about 112 micrograms of thimerosal with routine vaccinations.

The Research Council of the US National Academy of Sciences has set the acceptable concentration of mercury at 0.1 micrograms per kilogram of body weight. This means that up to six months, the baby receives a dose of mercury, which is many times greater than the limit.

Thimerosal is absent in Pentaxima. Therefore, you can be absolutely calm: the drug will not harm your health.

What is the use of formaldehyde and aluminum oxide in grafting?

Formaldehyde provokes chromosomal aberrations and gene mutations. When it enters the esophagus, this element causes severe pain in the abdomen, nausea and vomiting with blood, the appearance of protein and blood cells in urine, and kidney damage. The result of poisoning is acidosis, coma and.

So far, scientists have not been able to find out the safety of the presence of formaldehyde in vaccines. Although the substance is in small quantities, it can still harm the body. Aluminum salts are used in vaccination preparations as adjuvants that prolong the immune response.

Studies show that long-term contact of aluminum with brain cells in humans reduces the ability to learn, and there is a risk of developing dementia. This fact was confirmed during the experiment on animals.

In Pentaksim aluminum and formaldehyde are present.

Instructions for use of the five-component vaccination

Vaccinations are subject only to completely healthy children. Therefore, before proceeding with the manipulation, it is necessary to undergo a diagnosis. The doctor examines the child, measures body temperature and blood pressure, prescribes a number of examinations if necessary and sends for a consultation to narrow specialists.

Before using Pentaxim, you need to study the annotation that is attached to the drug. According to the instructions, the drug should be administered only intramuscularly. A single dose is 0.5 ml. An injection of Pentaxim is placed in the area of ​​the outer surface of the thigh.

The algorithm for applying a five-component vaccination:

• fix the needle on the syringe with the suspension by turning it one fourth of a turn relative to the medical instrument;
• take the vial with lyophilisate and remove the colored plastic cap;
• inject the finished solution in a syringe into a container with powder;
• shake the composition for several minutes without removing the needle. You should get a whitish cloudy liquid;
• install a new sterile needle on the syringe and draw up the contents of the vial;
• wipe the injection area with alcohol;
• make a puncture and administer the vaccine. Before pressing the syringe plunger, you need to make sure that the needle does not enter the vessel;
• remove the needle and decontaminate the injection site with alcohol again.

For the formation of stable immunity to diphtheria, tetanus, poliomyelitis, whooping cough and hemophilic infection, the child must be given three doses of Pentaxim. The interval between vaccinations should be 30-60 days. Babies from the age of three months are allowed to immunize with Pentaxim. Revaccination is carried out at 1.5 years.

The manufacturer warns that Pentaxim should not be used under such conditions:

• hyperthermia;
• intolerance to the components of the drug;
• adverse reactions to the previous;
• the presence of an infectious or non-infectious disease;
• exacerbation of chronic pathology.

When vaccinated with Pentaxim, in the presence of contraindications, the risk of developing such adverse reactions increases:

• drowsiness;
• allergy;
• hypotension;
• convulsions;
• irritability;
• prolonged crying;
• vomit;
• diarrhea.

In the post-vaccination period, the following recommendations should be followed:

• do not visit crowded places;
• do not rub the puncture site, do not seal it and do not treat it with ointments and creams for better healing;
• do not use medicines without the consent of the doctor;
• If any adverse reactions occur, contact your doctor immediately.

Vaccines containing similar components

There are many vaccinations that protect against tetanus, polio, diphtheria, whooping cough, and diseases caused by Haemophilus influenzae. Pentaxim has analogues of domestic and foreign production. Preparations may differ in the main and additional components.

Vaccine Imovax Polio

DTP includes the following components:

• diphtheria toxoid - 10 units;
• tetanus toxoid - 30 units;
• killed whooping cough bacteria - 20 billion microbial bodies per 1 ml of the drug;
• merthiolate (preservative);
• formaldehyde;
• aluminum hydroxide.

DPT, unlike Pentaxim, does not protect against the polio virus and Haemophilus influenzae. In addition, this drug is worse tolerated and often gives complications.

In Pentaksim, the pertussis component is split, the shell is removed from it, which often negatively affects health and increases the number of contraindications. DPT vaccination often contributes to the development of inadequate immunity to whooping cough. Pentaxim creates reliable protection against this disease in 100% of cases.

When choosing between DTP and Pentaxim, it is better to give preference to the second option. So the baby receives high-quality protection from five diseases at once. This reduces the number of required vaccinations, and therefore reduces stress for the child's body.

Carefully: if the child has a history of febrile seizures that are not associated with previous vaccination, the body temperature of the vaccinated person should be monitored for 48 hours after vaccination and, if it increases, as prescribed by the doctor, antipyretic (antipyretic) drugs should be used; in thrombocytopenia and other bleeding disorders, the vaccine should be administered with caution due to the risk of bleeding during intramuscular injection.

Dosage

A single dose of the vaccine is 0.5 ml.

Primary vaccination

In accordance with the National Immunization Schedule of the Russian Federation, the course of primary vaccination consists of 3 doses of vaccine administered at intervals of 1.5 months: at the age of 3, 4.5 and 6 months. However, other three-dose immunization regimens (eg, 2-3-4 months, 2-4-6 months, or 3-4-5 months) may also be used on the advice of a physician.

Revaccination

Revaccination is carried out once at the age of 18 months. If the vaccination schedule is violated, subsequent intervals between the administration of the next dose of the vaccine do not change, incl. the interval before the 4th (revaccinating) dose is 12 months. When carrying out vaccination / revaccination, they are guided by the following schedule:

In all cases of violation of the vaccination schedule, the doctor should be guided by the instructions for the use of the medicinal product and the recommendations of the National Calendar of Preventive Immunizations of the Russian Federation.

Method of administration

Do not administer i.v. or i.v.

Before insertion, make sure that the needle does not enter a blood vessel.

For the packaging option with two separate needles (16 mm 25G, 25 mm 23G), before preparing the vaccine, one of the two needles should be firmly fixed by rotating it a quarter of a turn relative to the syringe. The choice of needle depends on the thickness of the subcutaneous fat layer in the child at the injection site.

To prepare the vaccine, after removing the plastic colored cap from the vial, completely inject the pre-shaken suspension for intramuscular injection (vaccine for the prevention of diphtheria, tetanus, whooping cough and polio) through the needle from the syringe into the vial with lyophilisate (vaccine for the prevention of infection caused by Haemophilus influenzae type b).

Shake the vial without removing the syringe from it and wait until the lyophilizate is completely dissolved (no more than 3 minutes). The resulting suspension should be cloudy and have a whitish tint. The vaccine should not be used in case of discoloration or the presence of foreign particles.

The vaccine prepared in this way should be completely drawn into the same syringe.

The finished vaccine should be administered immediately.

Side effects

The adverse events presented below are listed according to system organ classes and frequency of occurrence. The frequency of occurrence was determined based on the following criteria: very often (≥1/10), often (≥1/100 to<1/10), нечасто (≥1/1000 до <1/100), редко (≥1/10 000 до <1/1000), очень редко (<1/10 000), частота неизвестна (нельзя оценить по имеющимся данным).

Clinical Study Data

In three studies in infants receiving the first three doses of Pentaxim, the most common reactions included irritability (15.2%) and injection site reactions such as redness (11.2%) and induration >2 cm (15.1%).

In a Swedish study, after three doses of Pentaxim given at 3, 5 and 12 months of age, the most common reactions included irritability (24.1%) and injection site reactions such as redness (13.4%) and induration (12.5 %).

These signs and symptoms usually develop within 48 hours after vaccination and resolve spontaneously without requiring specific treatment.

With revaccination, there is a trend towards an increase in the incidence of general disorders and disorders at the injection site.

From the side of metabolism and nutrition: very often - anorexia.

From the side of the psyche: very often - nervousness (irritability), unusual crying; often - sleep disturbances; infrequently - prolonged crying.

From the nervous system: very often - insomnia.

From the digestive system: very often - vomiting; often - diarrhea.

very often - redness at the injection site, fever (≥38 ° C), soreness and swelling at the injection site; often - a seal at the injection site; infrequently - redness and swelling (≥5 cm) at the injection site, fever (≥39 ° C); rarely - fever (≥40 ° C), diffuse edema of one or both limbs can be observed after the introduction of vaccines containing capsular polysaccharide Haemophilus influenzae type b. If such a reaction develops, then it occurs mainly after the primary vaccination and is observed during the first few hours after vaccination. This reaction may be accompanied by cyanosis, redness, transient purpura, and intense crying. These symptoms disappear spontaneously without consequences within 24 hours.

Post-registration data

Because spontaneous reports of adverse events in the commercial use of the drug were received very rarely and from a population with an indeterminate number of patients, their frequency was classified as "frequency unknown".

From the immune system: anaphylactic reactions such as swelling of the face, shock.

From the respiratory system: in very preterm infants (born at 28 weeks or earlier) within 2-3 days after vaccination, there may be cases of lengthening the time intervals between respiratory movements.

From the nervous system: convulsions with or without fever, hypotonic reactions or episodes of hypotension-hyporesponsiveness.

From the side of the skin and skin tissues: rash, hives.

General disorders and disorders at the injection site: pronounced edema (≥5 cm) at the injection site, incl. swelling extending beyond one or both joints. These reactions appeared 24-72 hours after vaccine administration and may be accompanied by redness, fever at the injection site, or tenderness or tenderness at the injection site. These symptoms disappeared on their own within 3-5 days without any additional treatment. It is believed that the likelihood of developing such reactions increases depending on the number of injections of the acellular pertussis component, this likelihood is higher after the 4th and 5th doses of such a vaccine.

Potential adverse reactions

The company has data that after the introduction of other vaccines containing tetanus toxoid, neuritis of the brachial nerve and Guillain-Barré syndrome were observed.

Overdose

No data available.

drug interaction

With the exception of immunosuppressive therapy, there are no reliable data on the possible mutual influence when used with other drugs, incl. with other vaccines.

The suspension containing the vaccine for the prevention of diphtheria and tetanus adsorbed, pertussis acellular, polio inactivated, must not be mixed with any other medicinal products, with the exception of the attached lyophilisate of the vaccine for the prevention of infection caused by Haemophilus influenzae type b conjugated.

The reconstituted vaccine must not be mixed with other medicines or vaccines.

The doctor should be informed about the recent or coinciding with the vaccination of the introduction of a child of any other drug (including over-the-counter).

special instructions

The Pentaxim vaccine does not form immunity against infection caused by other serotypes of Haemophilus influenzae, as well as against meningitis of a different etiology.

The doctor should be informed about all cases of adverse reactions, incl. not listed in this manual. Before each vaccination, in order to prevent possible allergic and other reactions, the doctor should clarify the state of health, the history of immunization, the history of the patient and close relatives (in particular, allergic), cases of side effects on previous vaccines. The doctor must have the drugs and tools necessary for the development of a hypersensitivity reaction.

Immunosuppressive therapy or a state of immunodeficiency may cause a weak immune response to the vaccine. In these cases, it is recommended to postpone vaccination until the end of such therapy or remission of the disease. However, in individuals with a chronic immunodeficiency (such as HIV infection), vaccination is recommended even if the immune response may be weakened.

If you develop a history of Guillain-Barré syndrome or neuritis of the brachial nerve in response to any vaccine containing tetanus toxoid, the decision to vaccinate with Pentaxim should be based on a careful assessment of the potential benefits and possible risks. As a rule, in such cases, it is justified to complete the primary immunization in children of the first year of life (if less than 3 doses are administered).

The potential risk of developing apnea and the need to monitor breathing for 48-72 hours should be considered when conducting a primary course of immunization in very preterm infants born at or before 28 weeks of gestation, especially those with a history of respiratory immaturity. Because the benefit of immunizing this group of children is high, vaccination should not be delayed or considered contraindicated.

Since the capsular polysaccharide antigen of Haemophilus influenzae type b is excreted through the kidneys, a positive test for an infection caused by Haemophilus influenzae type b can be recorded within 1-2 weeks after vaccination. During this period, other tests are needed to confirm the diagnosis of Haemophilus influenzae type b infection.

Influence on the ability to drive vehicles and control mechanisms

Since the Pentaxim vaccine is used to vaccinate children, the effect of the drug on the ability to drive vehicles and engage in other potentially hazardous activities has not been studied.

Pregnancy and lactation

Since the Pentaxim vaccine is used to vaccinate children, there are no data on the effect of the drug on the course of pregnancy and breastfeeding.

Terms of dispensing from pharmacies

The drug is dispensed by prescription.

Terms and conditions of storage

The drug should be stored in the refrigerator (at a temperature of 2 ° to 8 ° C); do not freeze. Keep out of the reach of children. The shelf life of the lyophilisate and suspension is 3 years.