Vaccine for the prevention of diphtheria, pertussis, polio, stolbnyaka and infections Haemophilus Influenzae | Ginfsp1 dsfrewaf gagrex pfsff dafrewaf 5g gfxfsff dafrewaf , 1 dose 0.5 ml

Release form

Suspension for intramuscular administration

Packaging

Syringe 0.5 ml.

Pharmacological action

Infanrix complies with WHO requirements for the production of substances of biological origin and vaccines against diphtheria, tetanus and pertussis.

1 month after a three-dose course of the initial Infanrix vaccination in the first months of life, more than 99% of children with diphtheria and tetanus toxoid antibodies titrated to more than 0 in children immunized with Infanrix vaccine, 1 IU / ml.

Antibodies to pertussis antigens (CA, PHA and pertactin) are produced in more than 95% of vaccinees.

After revaccination with the Infanrix vaccine in the second year of life (13-24 months) in all children who were primarily immunized with the Infanrix vaccine, antibody titers to diphtheria and tetanus toxoids are more than 0.1 IU / ml.

A secondary immune response to pertussis antigens occurs in more than 96% of children.

The protective efficacy of the Infanrix vaccine is on average 88%.

Indications

Primary vaccination against diphtheria, tetanus and pertussis in children from 3 months.

Revaccination of children who have previously been immunized with three doses of acellular pertussis-diphtheria-tetanus or whole-cell pertussis-diphtheria-tetanus vaccines.

When a vaccination course of whole-cell pertussis-diphtheria-tetanus vaccine is started, subsequent doses of acellular pertussis-diphtheria-tetanus vaccine and vice versa may be administered.

Contraindications

Known hypersensitivity to any component of this vaccine, as well as if the patient had hypersensitivity symptoms after the previous administration of Infanrix.

Severe reaction (temperature above 40 РC, hyperemia or edema of more than 8 cm in diameter) or complication (collapse or shock-like condition that developed within 48 hours after the vaccine was administered, continuous crying lasting 3 hours or more, convulsions that occurred within 48 hours after vaccine administration, accompanied or not accompanied by a fever, occurred within 3 days after vaccination) on the previous Infanrix vaccine administration.

Encephalopathy that developed within 7 days of the previous administration of a vaccine containing the pertussis component. In this case, the vaccination course should be continued with diphtheria-tetanus vaccine.

Special instructions

Caution is advised to administer a vaccine to people with thrombocytopenia or impaired hematopoietic function, since such patients have a risk of bleeding after an intramuscular injection.

To prevent bleeding, press on the injection site without rubbing for 2 minutes.

Composition of

In one dose (0.5 ml) contains:

diphtheria toxoid - at least 30 IU

tetanus toxoid - not less than 40 IU

pertussis toxoid (CA) - 25 Ојg

filamentous hemagglut outer membrane protein (pertactin) with a molecular weight of 69 kD - 8 Ојg

Dosage and administration of

A single dose of the vaccine is 0.5 ml.

The primary vaccination course consists of 3 doses of the vaccine, administered according to the National Calendar of Preventive Vaccinations of Russia at 3, 4.5 and 6 months. life revaccination is carried out in 18 months.

Before administration, the vaccine is shaken well until a homogeneous turbid suspension is formed and carefully examined. If foreign particles, unbreakable flakes or a change in appearance are found, the vaccine is not used.

Infanrix vaccine must be administered intramuscularly and alternate the injection site during the course of vaccination.

Under no circumstances should an iv vaccine be given!

Side effects

Clinical trials

The following set of safety parameters is based on data obtained from immunization of more than 16,000 patients.

As in the case of the AaKDS vaccine and combination vaccines that contain AaKDS, an increase in the frequency of local reactogenicity and fever after booster vaccination of Infanrix Hex was compared with the initial course.

The following incidence of side effects per dose has been determined: very often (> 10%) often (> 1% and 0.1% and 0.01% and infections and infestations

Infrequent upper respiratory tract infections.

metabolic and nutritional disorders

Very often - loss of appetite.

Mental disorders

Very often - irritability, abnormal cry, anxiety is often nervousness.

From the nervous system

Infrequently - drowsiness is very rare - cramps (with and without fever).

Impaired breathing, function of the organs of the chest cavity and mediastinum

Rarely - bronchitis.

Gastrointestinal Disorders

Often - vomiting, diarrhea.

Dysfunction of the skin and subcutaneous tissue

Rarely - rashes are very rare - dermatitis, urticaria **.

General disorders and pathological reactions at the injection site

Very often - pain, hyperemia, swelling at the injection site (38 РC, fatigue often - swelling at the injection site (39.5 РC, pathological reactions at the injection site, including infiltration infrequently - diffuse swelling of the extremity, in which the injection was carried out, occasionally including the adjacent joint.

Post-marketing pharmacovigilance

Circulatory and lymphatic disorders

Lymphadenopathy, thrombocytopenia.

Immunity disorders

Allergic reactions (including anaphylactic and anaphylactoid reactions).

Impaired cardiovascular function

Collapse or shock-like state (hypotonic - hyporeactive episodes).

General disorders and pathological reactions at the injection site

Extensive swelling reactions, swelling of the entire extremity injected **, vesicles at the injection site.

* In children who have been given primary doses of an acellular vaccine to prevent pertussis, the likelihood of swelling reactions after administration of a booster dose is higher compared with those who received whole-cell vaccines for the prevention of whooping cough. These reactions pass on average after 4 days.

** Observed with other GSK vaccines produced by GSK.

Clinical experience with Infanrix Hexa vaccine with hepatitis B vaccine

It has been reported that side effects such as paralysis, neuropathy, Guillaume-Barré syndrome, encephalopathy have been reported during post-marketing pharmacovigilance after the hepatitis B vaccine was administered. encephalitis, meningitis. A causal relationship between these side effects and vaccine administration has not been established.

Drug interaction

To provide relevant recommendations, the amount of data regarding the efficacy and safety of the vaccine for administering the Infanrix Hex vaccine simultaneously with the measles / mumps / rubella vaccine is insufficient.

Data on the simultaneous administration of the Infanrix Hex vaccine and the Prevnar / Prevenar vaccine (a vaccine based on the conjugated pneumococcal polysaccharide) indicate the absence of a corresponding clinically significant cross-interaction of the immune response in the form of production (production) of antibodies to each of the individual antigens, provided that three doses of the primary vaccination.

However, there are reports of a high incidence of fever (at body temperature> 39.5 РC) in newborns who received the Infanrix hexa and Prevnar / Prevenar vaccines compared to those immunized with only one hexavalent vaccine.

As with other vaccines, it can be expected that patients receiving immunosuppressive therapy may not achieve an adequate immune response.

Infanrix Hex vaccine cannot be mixed in the same syringe with any other vaccine.

Storage conditions

At 2–8 РC (do not freeze)

Expiration

3 years.

dosage form

solution for injection