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At birth, a child is faced with a considerable number of infections, and his body is sometimes not ready for them. To ensure that the first contact with the pathogen does not lead to illness, you need a fairly strong immune system. For this purpose, a wide range of vaccines has been developed, but preference is given to the Pentaxim vaccine.

Composition of the vaccine, its detailed characteristics and leading manufacturer

Pentaxim is a comprehensive set of components against several dangerous infections that a fragile body may encounter. It is produced by the world famous concern in France “Sanofi Pasteur, S.A.” Products are supplied to many countries near and far abroad. This is one of the few five-component vaccinations registered in the Russian Federation.

By using this drug, the baby receives prevention not from single diseases, as in conventional vaccinations, but from five pathogens. The kit contains two elements: a syringe with a suspension and a bottle with the contents of the lyophilisate. The suspension includes components from four pathogens:

• diphtheria bacillus;
• polio virus;
• whooping cough pathogen;
• Clostridia tetanus.

The bottle contains only one ingredient: administering the vaccine with it protects against a number of infectious lesions caused by Haemophilus influenzae (also called Hib).

The liquid base contains three types of toxoids - diphtheria, pertussis and tetanus. They do not contain pathogens, but only their neutralized toxins, they encourage the body to develop an immune response. It also contains the “killed” polio virus; it does not cause disease. Thus, the drug does not contain live weakened microorganisms and is completely safe in terms of infection.

The suspension contains additional elements: Hanks' medium, non-ionized water, acetic acid, formaldehyde, aluminum hydroxide. An ampoule with dry lyophilisate contains 10 micrograms of membrane particles of Haemophilus influenzae and additional substances: trometamol and sucrose. All ingredients in an amount of 0.5 milliliters is 1 dose of medicine.

The right choice: why is the Pentaxim vaccine better?

Firstly, it is the drug of choice, allowing the child to undergo fewer invasive procedures. The Pentaxim vaccine is multicomponent: with just one injection, the effect of immune protection against five pathogens is achieved at once.

Is it possible to combine with other vaccines?

In Russia, all vaccines are replaceable.

Important! Vaccination is carried out under the strict supervision of a pediatrician, all manipulations are carried out only after a thorough examination.

Pentaxim contains an element from polio, it is absent in Infanrix. If in previous procedures the child received an inactivated vaccine, now this medication will perfectly replace it, receiving protection from three more terrible ailments.

Compatibility with other drugs registered in the Russian Federation

This vaccine is fully compatible with others that are used in the Russian Federation. The exception is left by the living weakened.

Possible adverse reactions to the vaccine

Since a foreign agent is introduced into the body during the process of vaccination, one or another reaction of the body may be detected during the production of antibodies. Each child is individual, therefore, the response is different for everyone.

Side effects may be local, which is quite acceptable, or general.

Local manifestations:

• redness at the injection site, slight soreness;
• compaction around it;
• slight swelling.

Typically, such phenomena do not require additional treatment and disappear on their own within a week. Dynamic monitoring and proper care are required.

General manifestations can be dangerous, so if negative symptoms occur, immediately consult a doctor or call an ambulance.

These include:

• increased body temperature;
• refusal to eat;
• digestive disorders;
• swelling, rash;
• convulsive syndrome;
• anaphylaxis.

The last group of complications is rare, with the exception of low-grade fever. This can be managed by giving your child antipyretic medications.

Parents who decide to inject the French drug for the first time have a question about what complications Pentaxim can cause.

Instructions for use of the vaccine

Measures to prevent negative consequences of vaccination:

• until the wound formed during the injection heals and the condition returns to normal. If you wet the puncture area, infection will get there and severe inflammation will occur. Taking a shower at elevated temperatures can cause your child to catch a cold. In these cases, all protective forces will be aimed at fighting the disease, and not at forming specific immunity;
• . It is important to avoid contact with other children and adults to reduce the chance of infection. During the post-vaccination period, the body weakens and you can get sick. It is better that the child does not attend kindergarten, school, or communicate with friends for a couple of days;
• Do not allow the child to rub or scratch the area where the injection was given. It is prohibited to treat the injection site with ointments or lotions in order to speed up healing. This may cause allergies;
• if the baby is breastfed, then the mother should not introduce new foods into her diet;
• to prevent fever, some pediatricians advise giving the baby an antipyretic for several days after vaccination;
• Sensitive children are advised to take antihistamines three days before and after the procedure.

Video on the topic

About possible complications of vaccination at Dr. Komarovsky’s School:

Thus, Pentaxim, like any vaccine, can cause adverse reactions and complications. But the French drug has low reactogenicity and is tolerated normally by most children. If unpleasant symptoms appear, it is better to consult a doctor rather than self-medicate.

Name:

Pentaxym

Pharmacological
action:

Pentaxim– a vaccine intended for the prevention of tetanus and diphtheria (adsorbed), polio (inactivated), whooping cough (acellular) and infections caused by Haemophilus influenzae type b (conjugated).
Pentaxim promotes the development of stable immunity (subject to timely revaccination) to diphtheria, whooping cough, polio, tetanus and a number of diseases caused by Haemophilus influenzae type b.

Pentaxim is well tolerated and can be used in children over 3 months of age.
It should be borne in mind that the drug Pentaxim does not induce immunity against diseases caused by other serotypes of Haemophilus influenzae, as well as immunity to meningitis caused by other microorganisms.

The pharmacokinetics of the drug Pentaxim is not presented.

Indications for
application:

Pentaxim is used to vaccinate children over 3 months of age. for the purpose of prevention:
- tetanus,
- diphtheria,
- polio and whooping cough,
- invasive infection caused by Haemophilus influenzae type b (including septicemia and meningitis).

Pentaxim can be used for primary vaccination of children over 12 months of age for the prevention of polio, whooping cough, tetanus and diphtheria (children over 12 months of age who have not previously been vaccinated against whooping cough, tetanus, polio, invasive infections caused by Haemophilus influenzae type b, and diphtheria are recommended administer only Pentaxim suspension).

Mode of application:

Pentaxim is intended for intramuscular administration. The injection is recommended to be performed in the middle third of the anterolateral surface of the thigh. It is prohibited to administer the drug intravenously and intradermally. Immediately before administering the vaccine, you should make sure that the needle does not enter the vessel. If needles are included in the kit, immediately before preparing the vaccine, the needle should be secured to the syringe (when securing the needle, it is recommended to turn it a quarter turn relative to the syringe).

To prepare the vaccine Pentaxim from the bottle with lyophilized powder (vaccine for the prevention of infections caused by Haemophilus influenzae type b), the colored cap should be removed and the suspension from the syringe should be completely introduced into the bottle (vaccine for the prevention of tetanus, whooping cough, diphtheria and polio). Without removing the needle, you should gently shake the bottle until the lyophilisate is completely dissolved (usually 3 minutes is enough) and a cloudy suspension with a whitish tint without foreign particles is obtained. If the color of the vaccine changes, as well as if there are foreign inclusions, it is prohibited to use the vaccine. The finished vaccine is completely drawn into the same syringe and administered immediately after preparation.

Usually, vaccination course with Pentaxim includes 3 injections containing 1 dose of the drug, which are carried out at intervals of 1.5 months. The first injection is recommended at 3 months of age. Revaccination is carried out by administering 1 dose of Pentaxim at the age of 18 months.
National vaccination calendar recommends that for the prevention of tetanus, diphtheria, polio and whooping cough, injections of the appropriate vaccine at the age of 3, 4.5 and 6 months with revaccination at the age of 18 months.
If the vaccination schedule has been violated, the specified intervals between administrations of the drug Pentaxim should be observed (1.5 months between the first three administrations and 12 months between the last administration and revaccination).

During vaccination children over 3 months The vaccination schedule may change:
If the first dose of the drug Pentaxim was administered at the age of 6-12 months, then the subsequent doses are administered at intervals of 1.5 months, but for the third dose only Pentaxim suspension is used to prevent tetanus, diphtheria, whooping cough and polio (in this case, lyophilisate is not used to prevent infections caused by Haemophilus influenzae type b). Revaccination in this case is carried out with a full dose of Pentaxim, including lyophilisate for the prevention of infections caused by Haemophilus influenzae type b.

If the first dose of Pentaxim was administered over 12 months of age, then for subsequent injections, including revaccination, only the suspension is used for the prevention of whooping cough, poliomyelitis, tetanus and diphtheria without the use of lyophilisate for the prevention of infections caused by Haemophilus influenzae type b.
In case of any violations of the vaccination schedule, it is recommended to use the recommendations of the National Preventive Vaccination Calendar.

Side effects:

Local: soreness (usually expressed by short crying at rest or with gentle pressure in the injection area); redness and thickening at the injection site (in 0.1-1% of cases - >5 cm in diameter). These reactions may develop within 48 hours after vaccination.
Are common: increased body temperature: >38°C - with a frequency of 1-10%; >39°С - with a frequency of 0.1-1%; rarely (0.01-0.1%) - over 40°C. (Rectal temperature was assessed; as a rule, it is higher than axillary (axillary) by 0.6-1.1 ° C.)
Irritability, drowsiness, sleep disturbances, anorexia, diarrhea, vomiting, and less often, prolonged crying were also noted.
In very rare (< 0.01%) случаях отмечались сыпь, крапивница, фебрильные и афебрильные судороги, гипотония и гипотонический-гипореактивный синдром, анафилактические реакции (отек лица, отек Квинке, шок)
Rarely, after administration of vaccines containing the HIb component, cases of edema of one or both lower extremities (with a predominance of edema in the limb where the vaccine was administered) were observed. Swelling was mainly observed during the first few hours after primary vaccination. These reactions were sometimes accompanied by increased body temperature, soreness, prolonged crying, cyanosis or change in skin color, less often by redness, petechiae or transient purpura, increased body temperature, and rash. These reactions resolved spontaneously within 24 hours without any residual effects and are not associated with any adverse events from the heart or respiratory system.
Very rarely, after administration of vaccines containing acellular pertussis component, cases of severe reactions (more than 5 cm in diameter) at the site of vaccine administration, including swelling extending to one or both joints, have been reported. These reactions appeared 24-72 hours after vaccine administration and may be accompanied by redness, increased skin temperature at the injection site, sensitivity or pain 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 administrations of the acellular pertussis component; this likelihood is greater after the 4th and 5th doses of such a vaccine. The Company has evidence that Guillain-Barré syndrome and brachial neuritis have occurred following administration of other vaccines containing tetanus toxoid.

Contraindications:

Progressive encephalopathy, accompanied by or without seizures;
- encephalopathy that developed within 7 days after administration of any vaccine containing Bordetella pertussis antigens;
- a strong reaction that developed within 48 hours after a previous vaccination with a vaccine containing a pertussis component: an increase in body temperature to 40 ° C or higher, prolonged unusual crying syndrome, febrile or afebrile convulsions, hypotonic-hyporeactive syndrome;
- an allergic reaction that developed after a previous administration of a vaccine to prevent diphtheria, tetanus, whooping cough, polio and a vaccine to prevent infection caused by Haemophilus influenzae type b;
- diseases accompanied by an increase in body temperature, acute manifestations of an infectious disease or exacerbation of a chronic disease. In these cases, vaccination should be postponed until recovery;
- confirmed systemic hypersensitivity reaction to any vaccine ingredient, as well as glutaraldehyde, neomycin, streptomycin and polymyxin B.

Carefully: if a child has a history of febrile seizures that are not associated with previous vaccination, the vaccinated person’s body temperature should be monitored for 48 hours after vaccination and, if it increases, antipyretic (antipyretic) drugs should be regularly used throughout this period.

Interaction
other medicinal
by other means:

With the exception of immunosuppressive therapy there is no reliable data on possible mutual influence when used with other medications, including other vaccines.
The doctor should be informed about the recent or concurrent administration of any other drug to the child (including over-the-counter drugs).

Pregnancy:

Information is absent.

Release form:

Pentaxim vaccine for the prevention of tetanus and diphtheria, adsorbed, inactivated polio and acellular whooping cough in the form of a suspension for intramuscular administration, 0.5 ml in a glass syringe with a capacity of 1 ml with or without a fixed needle.
Vaccine Pentaxim for the prevention of infections caused by Haemophilus influenzae type b, conjugated in the form of a lyophilisate for the preparation of a suspension for intramuscular administration, 1 dose in glass vials.

The cardboard package contains 1 bottle with lyophilized powder and one glass syringe with a suspension for intramuscular administration, packed in a closed cell packaging made of polymer materials. If the glass syringe does not have a needle, 2 separate sterile games, sealed in cell packaging, are also placed in the cardboard box.

Storage conditions:

Keep refrigerated(at temperatures from 2° to 8°C). Do not freeze. Keep out of the reach of children. Shelf life - 3 years.
Conditions for dispensing from pharmacies - On prescription.

1.1 Dose of vaccine for the prevention of diphtheria and tetanus adsorbed; acellular whooping cough; inactivated poliomyelitis (in the form of a suspension for intramuscular administration) contains:
Diphtheria toxoid – 30 IU;
Tetanus toxoid - 40 IU;
Pertussis toxoid – 25 mcg;
Filamentous hemagglutinin – 25 mcg;
Inactivated polio virus type 1 – 40 units of D antigen;
Inactivated poliovirus type 2 – 8 units of D antigen;
Inactivated polio virus type 3 – 32 units of D antigen;
Additional ingredients.

2.1 Vaccine dose to prevent infections caused by Haemophilus influenzae type b, conjugated (in the form of a lyophilisate for the preparation of a suspension for intramuscular administration) contains:
Haemophilus influenzae type b polysaccharide conjugated with tetanus toxoid – 10 mcg;

Excipients: aluminum hydroxide - 0.3 mg, Hanks medium 199* - 0.05 ml, formaldehyde - 12.5 mg, phenoxyethanol - 2.5 µl, acetic acid or sodium hydroxide - to pH 6.8-7.3, water for injection - up to 0.5 ml.

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

Dosage

A single dose of the vaccine is 0.5 ml.

Primary vaccination

In accordance with the National Calendar of Preventive Vaccinations 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 schedules (for example, 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 carried out 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, incl. the interval before the 4th (booster) dose is 12 months. When carrying out vaccination/re-vaccination, follow the following schedule:

In all cases of violation of the vaccination schedule, the doctor must be guided by the instructions for use of the drug and the recommendations of the National Calendar of Preventive Vaccinations of the Russian Federation.

Method of administration

Do not administer intravenously or intravenously.

Before insertion, you must ensure 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 tightly secured by rotating it a quarter turn relative to the syringe. The choice of needle depends on the thickness of the child’s subcutaneous fat layer at the injection site.

To prepare the vaccine, having previously removed the plastic colored cap from the bottle, completely introduce the pre-shaken suspension for intramuscular administration (vaccine for the prevention of diphtheria, tetanus, whooping cough and polio) through a needle from a syringe into the bottle with lyophilisate (vaccine for the prevention of infection caused by Haemophilus influenzae type b).

Shake the bottle without removing the syringe from it and wait until the lyophilisate 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 if there is a change in color or 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

Adverse events presented below are listed according to systemic 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 trial data

In three studies of 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 vaccine 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 tendency to increase the incidence of general disorders and disorders at the injection site.

Metabolism and nutrition: very often - anorexia.

From the mental side: 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), pain and swelling at the injection site; often - compaction at the injection site; uncommon - redness and swelling (≥5 cm) at the injection site, fever (≥39°C); rarely - fever (≥40°C), diffuse swelling of one or both extremities can be observed after administration of vaccines containing Haemophilus influenzae type b capsular polysaccharide. If such a reaction develops, it occurs mainly after the primary vaccination and is observed within the first few hours after vaccination. This reaction may be accompanied by cyanosis, redness, transient purpura, and severe crying. The listed symptoms disappear spontaneously without consequences within 24 hours.

Post-marketing surveillance data

Because Spontaneous reports of adverse events during commercial use of the drug were received very rarely and from a population with an unknown number of patients, and their frequency was classified as “frequency unknown.”

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

From the respiratory system: In extremely premature infants (born at 28 weeks or earlier), cases of prolonged intervals between respiratory movements may occur within 2-3 days after vaccination.

From the nervous system: convulsions, accompanied or not accompanied by fever, hypotensive reactions or episodes of hypotension-hyporesponsiveness.

For the skin and skin tissues: rash, urticaria.

General disorders and disorders at the injection site: severe swelling (≥5 cm) at the injection site, incl. swelling that extends beyond one or both joints. These reactions appeared 24-72 hours after vaccine administration and may be accompanied by redness, increased skin temperature at the injection site, tenderness or pain at the injection site. These symptoms disappeared on their own within 3-5 days without any additional treatment. It is assumed that the likelihood of developing such reactions increases depending on the number of administrations 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 evidence that brachial neuritis and Guillain-Barré syndrome have occurred following administration of other vaccines containing tetanus toxoid.

Overdose

No data available.

Drug interactions

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

A suspension containing adsorbed vaccine for the prevention of diphtheria and tetanus, acellular pertussis, inactivated poliomyelitis cannot be mixed with any other drugs, with the exception of the enclosed lyophilisate of the vaccine for the prevention of infection caused by Haemophilus influenzae type b conjugate.

Reconstituted vaccine must not be mixed with other medicines and vaccines.

The doctor should be informed about the recent or concurrent administration of any other drug to the child (including over-the-counter drugs).

special instructions

The Pentaxim vaccine does not provide immunity against infections caused by other serotypes of Haemophilus influenzae, as well as against meningitis of other etiologies.

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 must clarify the state of health, immunization history, medical history of the patient and immediate family (in particular, allergic), and cases of side effects from previous vaccinations. The doctor should have the medications and instruments necessary for the development of a hypersensitivity reaction.

Immunosuppressive therapy or an immunodeficiency condition may cause a poor 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 persons with chronic immunodeficiency (eg, HIV infection), vaccination is recommended, even though the immune response may be weakened.

If there is a history of Guillain-Barré syndrome or brachial neuritis 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 primary immunization in children of the first year of life (if less than 3 doses are administered).

The potential risk of apnea and the need for respiratory monitoring for 48–72 hours should be considered when administering the primary course of immunization to very preterm infants born at or before 28 weeks, especially those with a history of respiratory immaturity. Because the benefits of immunization for this group of children are 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 infection caused by Haemophilus influenzae type b may be recorded within 1-2 weeks after vaccination. During this period, other tests are necessary to confirm the diagnosis of Haemophilus influenzae type b infection.

Impact on the ability to drive vehicles and operate machinery

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 is no data on the effect of the drug on pregnancy and breastfeeding.

Conditions for dispensing from pharmacies

The drug is available with a prescription.

Storage conditions and periods

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.

Filterable list

Active substance:

Instructions for medical use

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

Last modified date: 26.04.2016

Dosage form

Lyophilisate for preparing a suspension for intramuscular administration 1 dose, complete with a suspension for intramuscular administration 0.5 ml.

Compound

One dose (0.5 ml) contains:

* - does not contain phenol red

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

The vaccine was produced under conditions that meet the requirements of Good Manufacturing Practice (GMP).

Description of the dosage form

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

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

Reconstituted vaccine: an opaque whitish liquid that, when allowed to stand, separates into a colorless liquid to form a white precipitate that is easily resuspended by shaking.

Pharmacological group

MIBP - vaccine

Indications

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

Contraindications

• Progressive encephalopathy, accompanied by or without seizures.
• Encephalopathy of unknown etiology that developed within 7 days after administration of any vaccine (whole cell or acellular) containing Bordetella pertussis antigens.
• A severe reaction that developed within 48 hours after 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, 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. For mild ARVI, acute intestinal diseases, etc., vaccinations are carried out immediately after the temperature has normalized.

Use during pregnancy and breastfeeding

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

Directions for use and doses

Vaccination scheme

A single dose of the vaccine is 0.5 ml.

Primary vaccination

In accordance with the National Calendar of Preventive Vaccinations of the Russian Federation, the course of primary vaccination 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 schedules (eg, 2–3–4 months, 2–4–6 months, or 3–4–5 months) may also be used as recommended by your physician.

Revaccination

Revaccination is carried out once at the age of 18 months. If the vaccination schedule is violated, subsequent intervals between the next dose of the vaccine do not change, including the interval before the 4th (revaccination) dose - 12 months. When carrying out vaccination/re-vaccination, follow the following schedule:

In all cases of violation of the vaccination schedule, the doctor must be guided by the instructions for use of the drug and the recommendations of the National Calendar of Preventive Vaccinations of the Russian Federation.

Method of administration

Do not administer intradermally or intravenously.

Before insertion, you must ensure that the needle does not penetrate 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 tightly secured by rotating it a quarter turn relative to the syringe. The choice of needle depends on the thickness of the child’s subcutaneous fat layer at the injection site.

To prepare the vaccine, having previously removed the plastic colored cap from the bottle, completely introduce the pre-shaken suspension for intramuscular administration (vaccine for the prevention of diphtheria, tetanus, whooping cough and polio) through a needle from a syringe into the bottle with lyophilisate (vaccine for the prevention of infection caused by Haemophilus influenzae type b).

Shake the bottle without removing the syringe from it and wait until the lyophilisate 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 if there is a change in color or 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

Adverse events presented below are listed according to systemic 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 trial data

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

In a study conducted in Sweden, after three doses of Pentaxim ® vaccine given at 3, 5 and 12 months of age, the most commonly reported reactions included irritability (24.1%) and injection site reactions such as flushing (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 tendency to increase the incidence of general disorders and disorders at the injection site.

Metabolic and nutritional disorders

Very common: anorexia

From the mental side

Very common: nervousness (irritability), unusual crying

Common: sleep disturbances

Uncommon: prolonged crying

From the nervous system

Very common: insomnia

From the gastrointestinal tract

Very common: vomiting

Common: diarrhea

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

Common: lump at the injection site

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

Rarely: fever (≥40°C) and diffuse swelling of one or both extremities may occur after administration of vaccines containing Haemophilus influenzae type b capsular polysaccharide. If such a reaction develops, it occurs mainly after the primary vaccination and is observed within the first few hours after vaccination. This reaction may be accompanied by cyanosis, redness, transient purpura, and severe crying. The listed symptoms disappear spontaneously without consequences within 24 hours.

Post-marketing surveillance data

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

Immune system disorders

Anaphylactic reactions such as facial swelling, angioedema, shock.

From the respiratory system

In very premature infants (born at 28 weeks or earlier), cases of prolonged time intervals between respiratory movements may be observed within 2-3 days after vaccination (see section “Special Instructions”).

From the nervous system

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

From the skin and skin tissues

Rash, hives.

General and administration site disorders

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, increased skin temperature at the injection site, tenderness or pain at the injection site. These symptoms disappeared on their own within 3-5 days without any additional treatment. It is assumed that the likelihood of developing such reactions increases depending on the number of administrations 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 evidence that brachial neuritis and Guillain-Barré syndrome have occurred following administration of other vaccines containing tetanus toxoid.

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.

A suspension containing adsorbed vaccine for the prevention of diphtheria and tetanus, acellular pertussis, inactivated poliomyelitis cannot be mixed with any other drugs, with the exception of the enclosed lyophilisate of the vaccine for the prevention of infection caused by Haemophilus influenzae type b conjugate.

Reconstituted vaccine must not be mixed with other medicines and vaccines.

The doctor should be informed about the recent or concurrent administration of any other drug to the child (including over-the-counter drugs).

Precautionary measures

• If a child has a history of febrile seizures that are not associated with previous vaccination, the vaccinated person’s body temperature should be monitored for 48 hours after vaccination and, if it increases, antipyretic (antipyretic) drugs should be used as prescribed by a doctor.
• In case of 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 provide immunity against infections caused by other serotypes of Haemophilus influenzae, as well as against meningitis of other etiologies.

The doctor should be informed of 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 must clarify the state of health, immunization history, medical history of the patient and immediate family (in particular, allergic), and cases of side effects from previous vaccinations. The doctor should have the medications and instruments necessary for the development of a hypersensitivity reaction.

Immunosuppressive therapy or an immunodeficiency condition may cause a poor 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 persons with chronic immunodeficiency (eg, HIV infection), vaccination is recommended, even though 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 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 primary immunization in children in the first year of life (if less than 3 doses are administered).

The potential risk of apnea and the need for respiratory monitoring for 48–72 hours should be considered when administering the primary course of immunization to very preterm infants born at or before 28 weeks, especially those with a history of respiratory immaturity. Because the benefits of immunization for this group of children are high, vaccination should not be delayed or considered contraindicated.

Because Haemophilus influenzae type b capsular polysaccharide antigen is excreted through the kidneys, a positive test for Haemophilus influenzae type b infection may be detected on a urine test within 1-2 weeks after vaccination. During this period, other tests are necessary to confirm the diagnosis of Haemophilus influenzae type b infection.

Impact 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 whooping cough, inactivated polio – suspension for intramuscular administration 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 administration, 1 dose.

One dose of lyophilisate in a glass bottle 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 bottle and 1 syringe in a closed cell packaging (PET/PVC). If the syringe does not have a needle attached, then 2 separate sterile needles are placed in the package.

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

Storage conditions

Store in the refrigerator (at a temperature of 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 expiration date stated on the package.