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

Today, imported vaccines are 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 injection... The suspension is filled into 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 poliomyelitis virus of the second type - 8 units of D-antigen;
• attenuated poliomyelitis virus of the third type - 32 units;
• pertussis toxoid - 40 D-antigen units;
• aluminum hydroxide;
• formaldehyde;
• Hanks Wednesday;
• injection water;
• phenoxyethanol;
• sodium hydroxide.

The powder is packed into vials. Contents of a single dose of the product:

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

The injection solution is a whitish cloudy liquid. Designed for intramuscular injection. The lyophilisate is a white powder. The package of Pentaxim includes a syringe with a suspension, two sterile needles, a bottle 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 vaccinations that contain inactivated viruses. This element is used as a preservative. Mercury has fungicidal and antiseptic properties.

There is an assumption that thimerosal is capable of damaging the child's nervous system and causing autism.... This substance is really 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 the amount of mercury that a person receives from other sources enters the body with the vaccine. 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, hemophilic infection,. Moreover, such drugs are recognized by WHO as high-quality and safe.

Vaccine Pentaxim

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

The Research Council of the US National Academy 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 higher than the limit.

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

What is formaldehyde and aluminum oxide for inoculation?

Formaldehyde (formalin in liquid form) is used in vaccines as an inactivator of bacteria and viruses. The substance is carcinogenic and can cause damage.

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

So far, scientists have not been able to figure 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 vaccines as adjuvants that prolong the immune response.

Studies show that prolonged exposure of aluminum to brain cells decreases the ability to learn and is at risk of developing dementia. This fact was confirmed during an experiment on animals.

Aluminum and formaldehyde are present in Pentaxime.

Instructions for the use of the five-component vaccination

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

Before using Pentaxim, you need to study the annotation that comes with the drug. According to the instructions, the agent 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.

Algorithm for the use of a five-component vaccination:

• fix the needle on the syringe with the suspension, turning it one fourth of a turn relative to the medical instrument;
• take a bottle of lyophilisate and remove the colored plastic cap;
• enter the prepared 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 get vaccinated. Before pressing the plunger of the syringe, make sure that the needle has not entered the vessel;
• remove the needle and disinfect the injection site with alcohol again.

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

The manufacturer warns that you should not use Pentaxim in such conditions:

• hyperthermia;
• intolerance to the components of the drug;
• adverse reactions to the previous one;
• 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:

• 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 glue it or treat it with ointments and creams for better healing;
• do not use medications without the consent of your doctor;
• if any adverse reactions occur, immediately consult a doctor.

Vaccines containing similar ingredients

There are many vaccines that protect against tetanus, polio, diphtheria, whooping cough, and haemophilus influenzae diseases. Pentaxim has analogues of domestic and foreign production. The drugs 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 pertussis bacteria - 20 billion microbial bodies per 1 ml of the drug;
• merthiolate (preservative);
• formaldehyde;
• aluminum hydroxide.

DPT, unlike Pentaxim, does not protect against polio virus and haemophilus influenzae. In addition, this drug is less tolerated and often causes complications.

In Pentaxime, the pertussis component is split, the shell has been removed from it, which often adversely affects health and increases the number of contraindications. DTP 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 necessary vaccinations, which means it reduces stress for the child's body.

DPT, BCG, vaccinations against poliomyelitis - all these drugs and vaccines are widely known to more than one generation of people. But progress does not stand still, new drugs appear to combat more a wide range infectious conditions. On the other hand, newer means for vaccination are obtained as a result of a kind of "fusion" in one vaccine at once several antigens. An example of such a drug is Pentaxim , a complex vaccine of a new generation, developed in 1997 and only recently fully approved for use in Russia. Moreover, it is allowed to use it within National calendar preventive vaccinations, where one injection of Pentaxim can sometimes replace up to 5 injections of other vaccines.

What the vaccine protects from. The composition of Pentoxim .:

Through long research in terms of the most favorable joint use, it was found that not every antigen (which contributes to the development of an immune response, and subsequently immunity) can normally be combined with others. Therefore, the main principle in the development of Pentaxim was the selection of the most compatible antigens that do not affect each other. But at the same time, with their joint introduction an individual and full-fledged immune response should develop for each. Ultimately, a multi-antigen complex was obtained, which formed the basis of this vaccine. Pentaxim contains the following components:

Diphtheria toxoid.
Tetanus toxoid.
Pertussis toxoid.
Filamentous hemagglutinin (comes in powder form separately from the main vaccine, added if necessary).
Inactivated poliomyelitis virus (types 1, 2 and 3).

Thus, such a vaccine is able to induce the formation of immunity to diphtheria, tetanus, whooping cough, pathogens of hemophilic infections, which can cause sepsis, meningitis and other conditions. In addition, Pentaxim provides broad protection against several types of polio virus at once.

This wide composition of antigens contributes not only to the high universality of such vaccination, but also reduces the pharmacological load on the baby's body, because in addition to antigens, any drug contains a number of auxiliary substances. It is logical to assume that the fewer such injections, the less unnecessary excipients will enter the child's body. It also saves time for parents who only need to go to the clinic once instead of 2-3. And we must not forget how stressful a preventive vaccination can be for a child, and the fewer such shocks he has, the better.

Vaccine administration schedule:

The classic scheme for using Pentaxim is three times the introduction of one dose of the vaccine with an interval of one and a half months. The ideal time for the first injection is the baby's age of three months, respectively, the next injections are made at 4.5 and 6 months. It is very important to understand that Pentaxim is NOT an additional vaccination, it replaces some of the vaccines included in the National Vaccination Schedule. Therefore, the question of using this particular drug should be addressed even before the child reaches three months of age and the doctor should be notified in advance. If the decision to use Pentaxim was made at a later age, then before buying and, even more so, using this drug, it is necessary to consult a pediatrician, providing him with data on the baby's vaccinations.

After three injections, the next appointment of the drug (revaccination) is made at 18 months or exactly one year after the last vaccination.

For greater clarity, you can compare the vaccination according to the classical scheme and using Pentaxim in the form of a table, which is an extract from the National Calendar of Preventive Vaccinations.

As you can see, with the use of this vaccine, the number of injections is significantly reduced. Where, according to the classical technology, up to 4 injections are required different drugs Pentaxim alone is quite enough. And this, as already mentioned, is the main advantage of such an immunostimulating drug over its counterparts.

An important note: the vaccine is produced in the form of a four-component vaccine (against whooping cough, diphtheria, tetanus and poliomyelitis), while hemagglutinin is located separately, although it is sold in a package along with Pentaxim. This form of release is due to the fact that hemophilic infection currently does not exist in all regions and vaccination against it is carried out only in certain risk groups. If there is no danger (Haemophilus influenzae are not registered in the region) and the child is not included in the risk group according to the doctor, then you can refuse to add an extra component to the vaccine.

Vaccine reactions and contraindications:

Pentaxim is injected intramuscularly, on the anterolateral surface of the child's thigh. After the injection, a number of reactions may develop, which are generally characteristic of other preventive vaccinations:

Redness and swelling at the injection site.
A slight increase in temperature (sometimes up to 38 degrees).
Regional lymphadenopathy (enlargement of the inguinal lymph nodes).
Decreased appetite, lethargy, drowsiness.

Among the complications, sometimes there are intolerance to the components of the drug with the subsequent development of allergic reactions (anaphylactic shock, angioedema). But this is extremely rare, basically Pentaxim is very well tolerated by most small patients.

Contraindications to vaccination with Pentaxim are the following conditions:

A strong reaction to a previous vaccination of this type (allergy, sudden rise in temperature, febrile convulsions).
Allergy to various components of the drug, as well as to some antibiotics (neomycin, streptomycin) - a cross reaction is possible.
Availability elevated temperature body or any acute illness... In such a situation, vaccination is postponed until complete recovery.
Encephalopathy of various origins.

Progress in the field of disease prevention is undeniable and, despite widespread discussion and debate in society, mass vaccination plays an important role in this. At the same time, a decrease in the number of injections and the volume of injected drugs while maintaining the effect, as is the case with the use of Pentaxim, is a significant step forward. It is quite possible that the future of vaccination is precisely in such universal and versatile drugs.

The imported vaccine "Pentaxim" is produced by the famous French concern "SANOFI PASTEUR, S. A." and is supplied to many European countries and the USA. In Russia, the drug has been registered since July 2008 and is successfully used to prevent five childhood diseases.

What is included in the "Pentaxim" vaccination, and what are the advantages of the vaccine in comparison with the usual means of immunoprophylaxis in children? Let's take a closer look at the composition of the drug, its biological characteristics, instructions for use and side effects.

What diseases are they vaccinated against "Pentaxim"

What does the Pentaxim vaccine protect against? It is used to build immunity to five diseases:

• polio;
• diphtheria;
• tetanus;
• whooping cough;
• infections caused by the bacterium Haemophilus influenzae type b - HIB (meningitis, pneumonia, septicemia, etc.).

The vaccine "Pentaxim" contains three toxoids (tetanus, diphtheria and pertussis), filamentous hemagglutinin, inactivated (killed) polio virus three types... There is a separate hemophilic component combined with tetanus toxoid. Among the accompanying substances, there is no mercury, phenol red, but there is aluminum hydroxide and formaldehyde.

The vaccine is intended for intramuscular administration and is available in a double pack. Components for four diseases are packaged in 1 ml glass syringes and represent 0.5 ml of a whitish cloudy suspension. Hemophilic antigen comes separately in vials in the form of a lyophilized mass (dried powder) white... It is diluted according to the instructions for the Pentaxim vaccine with the first suspension immediately before use. One syringe and vial contains one dose of the vaccine.

Analogs of "Pentaxim" are:

• DPT vaccine - it has three components: whooping cough, diphtheria, tetanus;
• Infanrix;
• Imovax Polio;
• "Hiberix";
• Infanrix Hexa;
• Infanrix Penta.

What is the difference between the Pentaxim vaccine and similar immunoprophylaxis in children?

Features of the vaccine "Pentaxim"

Compared to other drugs, Pentaxim has several advantages.

1. Until recently, it was the only vaccine in Russia that allows one to be vaccinated against five diseases at the same time (later the Infanrix Hexa and Infanrix Penta drugs appeared). Pentaxim allows a child to be vaccinated in just four visits to the doctor, as opposed to twelve visits when DPT, polio vaccines and HIB infection are used separately.
2. The pertussis component of the vaccine is cellular, that is, acellular, in contrast to the whole cell in DPT. This significantly reduces the negative reaction to the Pentaxim vaccine, and also reduces the risk of developing vaccine pertussis in weakened children to zero.
3. The polio antigen is inactivated, meaning it contains the killed virus, while the oral vaccines (by mouth) include live attenuated strains. This completely eliminates the risk of developing vaccine-associated poliomyelitis, which today is one of the most formidable complications after vaccination with live vaccines.
4. Due to its good tolerance, the Pentaxim vaccine is recommended for use in children with an acute reaction to DPT or those who have withdrawn from DPT vaccination, with perinatal encephalopathy, infected with HIV, suffering from allergic and neurological diseases, dysbiosis, other diseases; prone to febrile seizures.
5. Children vaccinated with Pentaxim have high level antibodies against three types of poliovirus, pertussis, tetanus and diphtheria, HIB infection.

Preparing a child for the Pentaxim vaccination

Preparation for vaccination "Pentaxim" is carried out in the same way as for other vaccinations.

Monitor your baby's body temperature for two to three days after vaccination. If it rises, then it is removed with drugs based on paracetamol or ibuprofen. Do not be afraid to bring down the temperature - it does not play any positive role and this will not affect the development of immunity in any way. If the antipyretic does not have the desired effect, then consult your doctor.

At what age do you get the Pentaxim vaccine?

According to the National Calendar of Preventive Vaccinations, "Pentaxim" is used in children from the age of three months. The course of these vaccinations consists of three injections:

Terms of revaccination "Pentaxim" - once at the age of 18 months.

If the first vaccination was postponed for some reason, then the Pentaxim vaccination scheme is used as follows.

1. The intervals between doses are maintained and are 1.5–1.5 months. And 12 months for revaccination.
2. If the first dose is given within 6–12 months, then the third vaccination does not include the CIB component.
3. After a year of life, the first dose is administered in full, and the second, third and fourth (revaccinating) doses are administered without the HIB component.
4. The Pentaxim vaccine without the HIB component can be used up to the age of six.

If there is no need to use the HIB component, revaccination can be performed with the Tetraxim vaccine. This is a biological product from the same manufacturer, similar to Pentaxim, but without an unnecessary hemophilic component.

Such a course forms immunity in children to five diseases for a period of five years. After this period, at the age of 6–7 years, re-vaccination against poliomyelitis, pertussis, tetanus and diphtheria is carried out. In this case, another vaccine is used - for example, ADS-M.

Compatibility with other vaccines

All vaccines used in our country are interchangeable. Therefore, instead of Pentaxim, you can continue with another vaccine, for example, DPT or revaccination after Infanrix.

It must be remembered that the polio component in Pentaxim is inactivated, unlike most other biological products. Therefore, if polio vaccines were previously used by mouth, then the polio vaccination will have to be continued with live vaccines (drops). Or consider "Pentaxim" the first dose of poliomyelitis, and in the future use intramuscular injections for revaccination ("Imovax Polio").

Contraindications to vaccination

It is impossible to vaccinate "Pentaxim" in the following cases:

• encephalopathy;
• diseases accompanied by febrile conditions - an increase in body temperature;
• exacerbation of chronic diseases;
• if a pronounced reaction to previous vaccine injections was previously noted - an increase in body temperature over 40 ° C, allergic manifestations, convulsions, hypotonic-hyporeactive syndrome;
• individual intolerance to the components of the vaccine;
• allergy to neomycin, streptomycin, polymyxin B, glutaraldehyde.

Use "Pentaxim" with caution if the baby has previously had febrile convulsions not associated with vaccinations. In this case, body temperature is monitored for 48 hours, using antipyretics if necessary.

Side effects

Complications after vaccination "Pentaxim" are rare, but they do happen. Such manifestations are considered a normal adverse reaction to vaccination.

In less than 0.01% of cases, the body temperature rises above 40 ° C. Systemic reactions are possible - skin rash, urticaria, febrile (temperature-induced) and afebrile seizures, anaphylactic shock, drop in blood pressure and hypotonic-hyporeactive syndrome.

Studies conducted in France indicate that side effects of the Pentaxim vaccination, requiring medical attention, were observed in 0.6% of vaccinated children.

Summing up, we can say that the imported vaccine "Pentaxim" has a number of advantages over domestic counterparts. The drug allows a child to be vaccinated against five diseases in four trips to the vaccination room. With a better degree of purification and no live viruses in its composition, this vaccine is easier for children to tolerate, and a small number of antigens significantly reduces the load on the body's immune system.

The Pentaxim vaccine is a polyvalent drug that has been widely used during the immunization of children against 5 dangerous diseases in Russia since 2008. Pentaxim allows you to replace drugs such as the DPT vaccine, vaccine preparations against poliomyelitis and HIB infections. But many parents are wondering how the side effects of immunization can be avoided. How effective and safe is Pentaxim? It is worth taking a closer look at these issues.

Who needs immunization?

The Pentaxim vaccine is widely used for the general immunization of children who are 3 months old, in order to prevent diphtheria, poliomyelitis, whooping cough, tetanus, and invasive infections. The listed infectious diseases can lead to serious consequences: disability and death of the child. Therefore, it is important to get immunized in a timely manner. Vaccination with Pentaxim can also be carried out for children over 1 year old, if the patient has not been vaccinated against these diseases.

Composition and general characteristics

The Pentaxim vaccine, produced in France, is a multivalent vaccine. Therefore, it is widely used to prevent diphtheria, poliomyelitis, whooping cough, tetanus, and haemophilus influenzae type B.

Each cardboard package of the drug includes:

1. A syringe with a vaccine preparation in the form of a suspension. One dose of the vaccine contains the pertussis component, diphtheria and tetanus toxoids, inactivated poliomyelitis virus particles of three types. The listed ingredients pre-pass the stage of inactivation, therefore they are not able to start a pronounced infectious process. And also the preparation contains additional components: formaldehyde, Hanks medium, aluminum hydroxide, acetic acid and deionized water. The syringe contains a dose for one vaccination with Pentaxim;
2. A vial containing a dry lyophilisate, which is a mixture of 10 μg of particles of membranes of Haemophilus influenzae type B, sucrose, trometamol. The vial contains a sufficient dosage to administer the vaccine to 1 child.

This division of the Pentaxim vaccine is not accidental. This is due to the different rate of development of the immune response to dangerous diseases in young patients. So for the prevention of diphtheria, tetanus, poliomyelitis and whooping cough, children under 5 years of age need 4 immunizations. To protect against the disease caused by haemophilus influenzae type B, 1-3 vaccinations are sufficient, the number of which is determined by the patient's age.

Vaccination schedule

The full course of immunization consists of three doses of the vaccine with an interval of 45 days. This allows you to form a reliable immune defense for the next 5 years. In Russia, immunization is carried out according to the following principle:

• The first injection of the Pentaxim vaccine is given to a child at 3 months;
• Second vaccination - 4.5 months;
• Third immunization - 6 months;
• Revaccination is indicated at 1.5 years.

If vaccination begins in a baby older than 6 months, then during the third immunization, the introduction of the Pentaxim vaccine is shown without prior dilution of the lyophilisate. But for revaccination, the usual dose of the drug with the HIB component is used.

When the first immunization is given to a child over 1 year old, the complete vaccine is used. Further, vaccination is carried out without diluting the lyophilisate. Then the child is vaccinated only against diphtheria, tetanus, whooping cough and polio. If the immunization schedule is violated, then the doctor must follow the rules of the vaccination calendar.

Important! The use of the Pentaxim vaccine is possible only until the child reaches 6 years of age. The following shows immunization with drugs that do not contain the pertussis component.

If during revaccination it is necessary to administer Pentaxim without the HIB component, then the drug can be replaced with Tetraxim. This vaccine is produced by the same French pharmaceutical concern and does not contain a hemophilic component.

How is vaccination carried out?

Before each immunization, the doctor must change the body temperature, carefully examine the throat, skin, and listen to the lungs. This will prevent the vaccine from being given to sick children. One dose of the vaccine contains viral particles and toxoids in an amount that is sufficient to develop reliable protection against 5 dangerous infections.

Vaccine Pentaxim - instructions for use:

1. Before vaccination, a vaccine preparation should be prepared. To dilute the lyophilisate, remove the lid from the neck of the vial, inject the contents of the syringe into the vial. Next, shake the bottle thoroughly so that the dry mass is completely dissolved. In this case, the needle does not need to be removed from the cover. The resulting vaccine should be a cloudy white suspension. If the Pentaxim vaccine has a different shade, then it is recommended to abandon its use.
2. The finished suspension is drawn back into the syringe to immediately inject the child intramuscularly into the anterior thigh area.

How to prepare your child for vaccination?

Important! Parents should tell the pediatrician if the child was sick 2-3 weeks before vaccination, had contact with infectious patients. In such situations, the introduction of the Pentaxim vaccine will need to be postponed.

1. If there is a history of allergic reactions, then doctors recommend taking antihistamines 2-3 days before immunization.
2. It is necessary to abandon the introduction of new dishes into the diet of the child or mother if the baby is breastfed.
3. Do not start taking new medicines without consulting your doctor within a week before the vaccine is given.
4. It is recommended to prepare antipyretic drugs in the form of suppositories or syrup in advance, because after vaccination, an increase in body temperature is often noted.

To distract the child, you can take his favorite toy with you. Do not be afraid to ask the pediatrician questions if you still have doubts about the Pentaxim vaccine.

Features of care after vaccination

After vaccination, you need to sit for up to 30 minutes on the territory of the clinic where the vaccination was carried out. This time will be enough for the child to calm down after receiving the vaccine. And also this will allow you to get timely medical assistance if allergies start.

If an increase in body temperature is noted in the evening, then antipyretic drugs can be used: Panadol, Tsefekon, Nurofen, Ibufen. It is also recommended to wipe the child's skin with warm water, a weak solution of vinegar.

Important! During rubdowns, you should not apply vodka, which irritates and dries the delicate skin of babies.

It is necessary to monitor the child's condition, measure the temperature for 3 days after immunization. At higher values, antipyretics are recommended. Shouldn't be afraid to knock down high fever because they do not contribute to the formation of an immune response in the child. If taking antipyretics does not lead to the normalization of the condition, then you should consult a pediatrician or call an ambulance.

After vaccination, in the absence of hyperthermia, you can walk with the child, but it is recommended to avoid large crowds and communication with sick people. Within a few days, you should refuse to introduce new dishes into the menu in order to prevent the appearance of allergies. Doctors do not prohibit bathing the child with normal health, however, they recommend not to rub the injection site in order to avoid the addition of a secondary infection.

What are the possible side reactions?

The use of the Pentaxim vaccine can lead to the following side effects:

• Soreness, swelling, redness of the injection site. Symptoms usually develop within 48 hours after vaccination and resolve on their own without treatment;
• Increased body temperature. The symptom is easily stopped by antipyretic drugs;
• Slight lethargy and drowsiness of the baby;
• Stool disorder;
• Decreased appetite and complete refusal to eat;
• Crying baby for 2-3 hours.

The Pentaxim vaccine contains an acellular pertussis component, therefore, the listed symptoms develop quite rarely (in 10-15% of patients). Adverse symptoms usually go away on their own, so no special therapy is required.

Important! It is extremely rare for parents to note such reactions to the vaccine: a rash on the skin, a decrease in pressure, the development of seizures, anaphylactic shock, angioedema Quincke. In such situations, the help of a doctor is required.

Advantages of a vaccine preparation

Doctors highlight the following positive aspects of the Pentaxim vaccine:

1. Can be used to prevent diphtheria, HIB infections, whooping cough, polio, tetanus. To create reliable immunity, the child will need to do only 5 injections instead of 12, if three domestic vaccines are used separately;
2. Contains inactivated polio virus particles. Therefore, vaccination helps prevent the occurrence of vaccine-associated poliomyelitis, which is considered to be one of the most dangerous complications after the introduction of a live vaccine product through the mouth;
3. The Pentaxim vaccine contains acellular pertussis component. This helps to reduce the risk of side effects, development of post-vaccination pertussis during immunization of immunocompromised patients. Therefore, Pentaxim can be used in children and adults who have not previously been vaccinated. However, patients over 5 years of age are shown immunization without prior dissolution of the lyophilisate;
4. Due to the good tolerance of the Pentaxim vaccine, it became possible to immunize children suffering from perinatal encephalopathy, immunodeficiency, allergic and neurological diseases;
5. The drug is highly effective. Large-scale studies have proven that immunization with Pentaxim leads to 100% development of immunity to all 5 dangerous infectious diseases.

Compatibility with other vaccine products

Pentaxim can be combined with other vaccines included in the National Immunization Schedule. In situations like this, the vaccines are given on the same day, but injections are given in different extremities. Simultaneous immunization does not change the immunogenicity of vaccine preparations, does not increase the risk of adverse reactions.

Important! The simultaneous administration of the vaccine Pentaxim and BCG is prohibited.

All drugs for immunization that are used in Russia are interchangeable. Therefore, the DPT vaccine can be replaced with Pentaxim, Infanrix and Tetraxim.

Important! Pentaxim contains an inactivated poliomyelitis component. Therefore, if a small patient was previously administered polio vaccine by mouth, then it is recommended to stop using Pentaxim.

There are such analogs of the vaccine preparation:

• DTP. It is a domestic drug. Vaccination involves the introduction of components that make it possible to develop immunity against diseases such as tetanus, diphtheria, whooping cough. The vaccine often provokes the development of severe adverse reactions due to the content of the cellular pertussis component;
• Infanrix. The drug is produced in Belgium in several modifications: against 4 infections (tetanus, diphtheria, whooping cough, poliomyelitis), Infanrix Penta (the listed infections and a hemophilic component), Infanrix Hexa additionally protects against hepatitis B;
• Tetracock. Manufactured in France. The vaccine will effectively protect the child's body from polio, tetanus, diphtheria, whooping cough.

special instructions

If undesirable symptoms appear after the immunization, you must immediately notify the doctor about this. Before any vaccination, the pediatrician must clarify the current condition of the child, his anamnesis. This will reduce the risk of developing allergies and complications.

Important! Pentaxime does not contribute to the formation of immunity against meningitis of other origins and infections that cause other serotypes of haemophilus influenzae.

Against the background of immunosuppressive therapy or a child's history of an immunodeficiency state, vaccination can lead to the development of a weak immune response. In such cases, it is recommended to postpone immunization to full recovery health.

Important! For children with a history of chronic immunodeficiency, vaccination with Pentaxim is recommended, despite a weakened immune response.

It is important to remember that the Pentaxim vaccine requires a fee. Its cost is within 2.5 thousand rubles. If you buy it yourself, you must ensure that the vaccine is transported correctly. After all, Pentaxim is stored at temperatures below 4 0 C. Therefore, during the transportation of the vaccine to the district clinic, you should use a thermo-bag with a cold element.

Pentaxim vaccine: protection or threat?

The vaccine is characterized by a gentle effect on the body of children, therefore, the development of undesirable symptoms is extremely rare. However, Pentaxim has a number of contraindications that the pediatrician must take into account before vaccination. It is recommended to refuse immunization in the following cases:

1. Encephalopathy, which develops against the background of vaccination or a long-term form of this disease;
2. The presence of hypersensitivity to any components of the vaccine preparation;
3. Acute infectious process, which is accompanied by hyperthermia, sore throat, runny nose, wheezing in the lungs;
4. Exacerbation of any chronic pathology. It is recommended to refuse vaccination until the symptoms are completely eliminated;
5. A pronounced reaction to vaccines containing pertussis particles: the child cries for 2-3 hours, there is an increase in body temperature, convulsions and neurological symptoms appear;
6. Intolerance to Glutaraldehyde, Polymyxin B, Streptomycin, Neomycin;
7. Development of organic brain damage, which progresses and may be accompanied by convulsive readiness or epilepsy;
8. Against the background of brain damage that arose within a week after immunization with the use of a drug based on pertussis antigen;
9. The development of allergies in the patient or close relatives (parents, brothers or sisters) after vaccination;
10. With impaired hemocoagulation, when any intramuscular injection of the drug can provoke bleeding.

Use with caution in patients with seizures with a history of hyperthermia. During immunization, the child will need constant monitoring of the condition for 2 days.

Compliance with the instructions for use allows you to make immunization with Pentaxim as safe as possible. The vaccine product is characterized by high degree cleaning, therefore rarely provokes the development of unwanted side reactions. The absence of live viral particles in the composition allows to reduce the load on the fragile immune system of the child, prevents the development of vaccine-associated infections. Poliovalent vaccine is the only immunization method for children who have immunodeficiency states history.

Catad_pgroup Vaccines for the prevention of CDS

Pentaxim - instructions for use

vaccine for the prevention of diphtheria and tetanus adsorbed, acellular pertussis, inactivated poliomyelitis, infection caused by Haemophilus influenzae type of b conjugated

REGISTRATION CERTIFICATE: LSR-005121/08

TRADE NAME
Pentaxim ®

GROUP NAME
Vaccine for the prevention of diphtheria and tetanus, adsorbed, acellular pertussis, inactivated poliomyelitis, infection caused by Haemophilus influenzae type of b conjugated

DOSAGE FORM
Lyophilisate for the preparation of a suspension for intramuscular administration 1 dose, complete with a suspension for intramuscular administration of 0.5 ml.

COMPOSITION
One dose (0.5 ml) contains:

Component name	Quantity per dose (0.5 ml)
Vaccine for the prevention of diphtheria and tetanus adsorbed, acellular pertussis, inactivated poliomyelitis (suspension for intramuscular administration)
Active substances
Diphtheria toxoid	≥30 ME
Tetanus toxoid	≥40 ME
Pertussis toxoid	25 mcg
Filamentous hemagglutinin	25 mcg
Poliomyelitis virus type 1 inactivated	40 units of D antigen
Poliomyelitis virus type 2 inactivated	8 units of D antigen
Poliomyelitis virus type 3 inactivated	32 units of D antigen
Excipients
Aluminum hydroxide	0.3 mg
Wednesday Hanks 199 *	0.05 ml
Formaldehyde	12.5 mcg
Phenoxyethanol	2.5 μl
Water for injections	Up to 0.5 ml
Acetic acid or sodium hydroxide - up to pH 6.8-7.3
Haemophilus influenzae type of b, conjugated (lyophilisate for preparation of a suspension for intramuscular administration)
Active substance
Polysaccharide Haemophilus influenzae type of b tetanus toxoid conjugated	10 mcg
Excipients
Sucrose	42.5 mg
Trometamol	0.6 mg

* - does not contain phenol red

Antibiotics (streptomycin, neomycin and polymyxin B) are used in vaccine production but are not present in detectable amounts in the final product. The vaccine was produced under conditions that meet the requirements of Good Manufacturing Practice (GMP).

DESCRIPTION
Vaccine for the prevention of diphtheria and tetanus, adsorbed, acellular pertussis, inactivated poliomyelitis (suspension for intramuscular administration): a whitish, turbid suspension.
Vaccine to prevent infection caused by Haemophilus influenzae type of b, conjugated (lyophilisate for preparation of suspension for intramuscular administration): white homogeneous lyophilisate.
Reconstituted vaccine: an opaque, whitish liquid that, upon standing, separates into a colorless liquid with the formation of a white precipitate, which is easily resuspended by shaking.

PHARMACOTHERAPEUTIC GROUP
MIBP vaccine

ATX CODE
J07CA06

IMMUNOLOGICAL PROPERTIES

Immunogenicity after primary immunization
In studies of immunogenicity in children vaccinated with three doses of the drug Pentaxim, starting at three months of age, 100% of children achieved seroprotective levels of antibodies to diphtheria and tetanus antigens (≥ 0.01 IU / ml). More than 88% of children showed a fourfold increase in antibody titers to pertussis toxoid and filamentous agglutinin 1 month after completion of primary immunization. In the absence of a serological correlate of protection, a fourfold increase in titers after immunization can be considered seroconversion. At least 99% of children after a course of primary immunization achieved post-vaccination titers against poliomyelitis viruses type 1, 2 and 3, exceeding the threshold value of 5 (the reciprocal of the dilution at which seroneutralization is observed), which is considered protective. 1 month after the end of the primary immunization course, consisting of three doses, in at least 92% of vaccinated children of the 1st year of life, the titer of antibodies to the capsular polysaccharide Haemophilus influenzae type of b was higher than the protective level of 0.15 μg / ml required for short-term protection against invasive haemophilus influenzae. 1 month after the third inoculation, the concentration of antibodies to the capsular polysaccharide Haemophilus influenzae type of b more than 1 μg / ml, necessary to provide long-term protection against invasive hemophilic infection, was observed in more than 67% of the vaccinated.

Immunogenicity after revaccination
Immunogenicity studies in children in the second year of life, vaccinated with three doses of Pentaxim® vaccine as part of primary immunization, showed a high level of antibodies to all active substances medicinal product after revaccination with the same vaccine. In all children, the antibody level exceeded 0.1 IU / ml for the tetanus component, and there was an average five-fold increase in antibody titers to pertussis toxoid and filamentous agglutinin. All children had a sufficient level of antibodies to poliomyelitis viruses types 1, 2 and 3. In more than 97% of children, the level of antibodies to the causative agent of diphtheria exceeded 0.1 IU / ml.
Antibody titer to capsular polysaccharide Haemophilus influenzae type of b exceeded 1 μg / ml after revaccination in more than 99% of children.
These data support the induction of immunological memory after primary vaccination.

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

CONTRAINDICATIONS FOR USE

• Progressive encephalopathy with or without seizures.
• Encephalopathy of unknown etiology that developed within 7 days after the administration of any vaccine (whole cell or acellular) containing Bordetella pertussis antigens.
• A strong reaction that developed within 48 hours after the previous immunization with a vaccine containing a pertussis component: body temperature equal to or exceeding 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 vaccines, polio vaccines, or infection caused by Haemophilus influenzae type of b.
• Established hypersensitivity to any component of the vaccine, as well as glutaraldehyde, neomycin, streptomycin, and polymyxin B.
• Disease accompanied by an increase in body temperature, acute infectious or chronic illness in the stage of exacerbation. Vaccination is carried out 2-4 weeks after recovery or during the period of convalescence or remission. For mild ARVI, acute intestinal diseases, etc., vaccinations are carried out immediately after the temperature has returned to normal.

PRECAUTIONS FOR USE

• If the child has a history of febrile seizures not associated with previous vaccination, the body temperature of the vaccinated person should be monitored within 48 hours after vaccination and when it rises, as prescribed by the doctor, use antipyretic (antipyretic) drugs.
• For thrombocytopenia and other blood clotting disorders, vaccine administration
  should be carried out with caution because of the risk of bleeding with intramuscular injection.

APPLICATION DURING PREGNANCY AND DURING BREASTFEEDING
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 APPLICATION

Vaccination schedule
A single dose of the vaccine is 0.5 ml.

Primary vaccination
According to the National Calendar of Preventive Vaccinations Russian Federation the primary vaccination course consists of three doses of the 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 recommendation of a physician.

Revaccination
Revaccination is performed once at the age of 18 months. If the vaccination schedule is violated, the subsequent intervals between the administration of the next dose of the vaccine do not change, including the interval before the 4th (revaccination) 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 Vaccinations of the Russian Federation.

Method of administration
The vaccine is administered intramuscularly. For children of the first years of life, intramuscular injections are carried out only in the upper outer surface of the middle part of the thigh, for children over the age of 24 months - in the deltoid muscle of the shoulder.
Do not inject intradermally or intravenously. Before insertion, make sure that the needle has not penetrated 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 tightly fastened by rotating it a quarter turn relative to the syringe. The choice of needle depends on the thickness of the child's subcutaneous fat at the injection site.
To prepare the vaccine, after removing the plastic colored cap from the vial, completely inject the previously shaken suspension for intramuscular administration (vaccine for the prevention of diphtheria, tetanus, pertussis and poliomyelitis) through a syringe needle into a vial with lyophilisate (vaccine for the prevention of infection caused by Haemophilus influenzae type of b).

Shake the bottle without removing the syringe from it, and wait until the lyophilisate dissolves completely (no more than 3 minutes). The resulting suspension should be cloudy and have a whitish tint. The vaccine should not be used if discoloration or foreign particles are present. The vaccine prepared in this way should be completely drawn into the same syringe.
The finished vaccine should be administered immediately.

SIDE EFFECT
The adverse events below are listed according to systemic organ class and frequency of occurrence. The frequency of occurrence was determined based on 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 trial data
In three studies of infants who received the first three doses of Pentaxim® vaccine in their first year of life, the most frequent reported 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 vaccine given at 3, 5 and 12 months of age, the most frequent reported reactions included 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 go away spontaneously, without requiring specific treatment.
With revaccination, there is a tendency to an increase in the incidence of general disorders and disorders at the injection site.

Metabolic and nutritional disorders
Very common: anorexia

From the psyche
Very common: nervousness (irritability), unusual crying
Often: sleep disturbances
Uncommon: prolonged crying

From the nervous system
Very common: insomnia
From the gastrointestinal tract
Very common: vomiting
Often: diarrhea

Very common: redness at the injection site, fever (≥ 38 ° C), tenderness and swelling at the injection site
Often: 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 the capsular polysaccharide Haemophilus influenzae type of b... If such a reaction develops, then it occurs mainly after the primary vaccination and is observed within the first few hours after vaccination. This reaction can be accompanied by cyanosis, redness, transient purpura, and intense crying. The listed symptoms disappear spontaneously without consequences within 24 hours.

Post-registration observation data
Since spontaneous reports of adverse events during the commercial use of the drug were received very rarely and from a population with an undetermined number of patients, their frequency was classified as "frequency unknown".

Violations from the outside immune system
Anaphylactic reactions such as facial edema, Quincke's edema, shock

From the respiratory system
In very premature babies (born at 28 weeks of age or earlier), there may be cases of lengthening the intervals between breathing movements(see section " special instructions»).

From the nervous system
Convulsions, accompanied or not accompanied by fever, hypotonic reactions or episodes of hypotension-hyporesponsivity.

On the part of the skin and skin tissues
Rash, urticaria.

General disorders and disorders at the injection site
Severe edema (≥ 5 cm) at the injection site, including edema extending beyond one or both joints. These reactions appeared 24-72 hours after vaccine administration and could be accompanied by redness, increased skin temperature at the injection site, tenderness or soreness at the injection site. These symptoms disappeared on their own within 3-5 days without any complementary treatment... It is assumed that the likelihood of developing such reactions increases depending on the number of injections of the acellular pertussis component, this probability is higher after the 4th and 5th doses of such a vaccine.

Potential Adverse Reactions
The company has information that neuritis has been observed after administration of other vaccines containing tetanus toxoid. brachial nerve and Guillain-Barré syndrome.

OVERDOSE
No data available.

INTERACTION WITH OTHER DRUGS
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.
Suspension containing adsorbed vaccine for the prevention of diphtheria and tetanus, acellular pertussis, inactivated poliomyelitis, should not be mixed with any other medicinal products, with the exception of the supplied vaccine lyophilisate for the prevention of infection caused by Haemophilus influenzae type of b conjugated.
The reconstituted vaccine must not be mixed with other drugs or vaccines.
The doctor should be informed about any other drug (including over-the-counter) administered to the child recently or concurrently with vaccination.

SPECIAL INSTRUCTIONS
The Pentaxim® vaccine does not form immunity against infection caused by other serotypes of Haemophilus influenzae, as well as against meningitis of other etiology. The doctor should be informed about all cases of adverse reactions, including those not listed in this instruction. 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 the next of kin (in particular, the allergic one), the cases of side effects on the previous vaccine administration. The doctor should have medicines and tools necessary for the development of a hypersensitivity reaction.

Immunosuppressive therapy or an immunodeficiency state 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, for people with chronic immunodeficiency (eg, HIV infection), vaccination is recommended, even if the immune response may be weakened.
If you have a history of Guillain-Barré syndrome or brachial neuritis in response to any vaccine containing tetanus toxoid, the decision to vaccinate drug Pentaxim ® should be based on a careful assessment of the potential benefit and possible risk... 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 have been administered).

The potential risk of apnea and the need to monitor breathing for 48-72 hours should be taken into account when conducting an initial course of immunization in very preterm infants born at or before 28 weeks of age, especially those with a history of signs of immaturity of the respiratory system. Since the benefits of immunizing this group of children are high, vaccination should not be delayed or considered contraindicated. Since the capsular polysaccharide antigen Haemophilus influenzae type of b is excreted through the kidneys, within 1-2 weeks after vaccination, a positive test for an infection caused by Haemophilus influenzae type of b... During this period, other tests are necessary to confirm the diagnosis of an infection caused by Haemophilus influenzae type of b.

INFLUENCE ON ABILITY TO DRIVE VEHICLES AND DO OTHER POTENTIALLY HAZARDOUS ACTIVITIES
Since the Pentaxim® vaccine is used to vaccinate children, the effect of the drug on the ability to administer vehicles and engage in other potentially dangerous species activity has not been studied.

RELEASE FORM
Vaccine for the prevention of diphtheria and tetanus, adsorbed, acellular pertussis. inactivated poliomyelitis - suspension for intramuscular administration of 0.5 ml; complete with vaccine to prevent infection caused by Haemophilus influenzae type of b, conjugated - lyophilisate for preparation of suspension for intramuscular administration 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 chlorinated bromobutyl piston.
1 bottle and 1 syringe in a closed cell packaging (PET / PVC). If the syringe does not have a fixed needle, then 2 separate sterile needles are inserted into the package. 1 blister pack in an individual cardboard box with instructions for use.

SHELF LIFE
Lyophilisate - 3 years. Suspensions - 3 years.
Do not use after the expiration date printed on the package.

STORAGE CONDITIONS
Store in a refrigerator (at a temperature of 2 to 8 ° C). Do not freeze. Keep out of the reach of children.

TERMS OF HOLIDAY
Dispensed by prescription.

LEGAL ENTITY IN WHICH REGISTRATION CERTIFICATE IS ISSUED
Sanofi Pasteur S.A., France

MANUFACTURER
1541, avenue Marcel Merieux, 69280 Marcy l "Etoile, France
Sanofi Pasteur S.A., France Sanofi Pasteur S.A.,

SECONDARY PACKAGER / RELEASE QUALITY CONTROL
Sanofi Pasteur S.A., France Sanofi Pasteur S.A.,
1541, avenue Marcel Merieux, 69280 Marcy l "Etoile. France
Sanofi Pasteur S.A., France Sanofi Pasteur S.A.,
Pare Industriel d "Incarville, 27100 Val de Reuil, France
LLC "Nanolek", Russia 612079, Kirov region.
Orichevsky district, Levintsy village, Biomedical complex
"NANOLEK"

Consumer claims should be sent to the address in Russia:
Federal Service for Surveillance in Healthcare (Roszdravnadzor) 109074, Moscow. Slavyanskaya sq. 4, bldg. 1
and / or
Sanofi-aventis group JSC 125009, Moscow, st. Tverskaya, 22
and / or
OOO Nanolek, 127055, Moscow, Butyrskiy Val, 68/70 bldg. 1.