Act-Hib (Lyophilisate) Instructions for Use

Marketing Authorization Holder

Aventis Pasteur S.A. (France)

ATC Code

J07AG51 (Vaccine against Hemophilus influenza B in combination with toxin)

Dosage Form

Act-Hib

Lyophilizate for preparation of solution for intramuscular and subcutaneous injection 1 dose/fl.: 1 pc. incl. with solvent

Dosage Form, Packaging, and Composition

* – Haemophilus influenzae type b.

Solvent 4% sodium chloride solution – 0.5 ml.

Vials (1) in a kit with solvent (syringe – 1 pc.) – cardboard packs.

Clinical-Pharmacological Group

Diseases caused by Haemophilus influenzae type b vaccine for prophylaxis

Pharmacotherapeutic Group

MIBP-vaccine

Pharmacological Action

Vaccine for the prophylaxis of purulent-septic diseases caused by Haemophilus influenzae type b.

Indications

• Prophylaxis of purulent-septic diseases (meningitis, sepsis, arthritis, epiglottitis, pneumonia) caused by Haemophilus influenzae type b (Hib infection) in children from three months of age.

ICD codes

Dosage Regimen

Inject the entire contents of the syringe with the solvent into the vial with the vaccine, shake the vial until the lyophilisate is completely dissolved. The resulting solution should be colorless and transparent.

The vaccine is administered intramuscularly or deep subcutaneously in a single dose of 0.5 ml. Before administration, it is necessary to ensure that the needle has not entered a blood vessel.

Children under 2 years of age: vaccine administration is performed into the middle third of the anterolateral region of the thigh.

Children over 2 years of age: vaccine administration is performed into the deltoid muscle area.

Vaccination course

If vaccination is started at the age of under 6 months: 3 injections with an interval of 1-2 months. Revaccination is performed once a year after the 3rd vaccination.

If vaccination is started at the age of 6 to 12 months: 2 injections with an interval of 1 month. Revaccination is performed once at the age of 18 months.

If vaccination is started at the age of 1 to 5 years: single injection.

Adverse Reactions

The following were noted during clinical studies.

Common (1-10% and more) local reactions: pain, erythema, swelling and/or inflammation, induration at the injection site, irritability, vomiting.

Possible (no more than 10%) increase in body temperature, prolonged crying.

Sometimes (no more than 1%) increase in body temperature above 39°C (102.2°F). During practical use, based on passive pharmacovigilance data, very rarely (less than 0.01% of cases of use) the following were noted

• Peripheral edema of the lower extremities (see section “Special Precautions”)
• Hypersensitivity reactions, febrile or afebrile convulsions, urticaria, rash and itching.

Contraindications

• Acute diseases;
• Exacerbation of chronic diseases;
• Allergy to vaccine ingredients, especially to tetanus toxoid;
• Allergic reaction to previous administration of a vaccine for prophylaxis of infection caused by Haemophilus influenzae type b (Hib infection).

Vaccinations are carried out 2-4 weeks after recovery (remission). For mild forms of respiratory and intestinal infections, vaccination can be carried out immediately after temperature normalization.

Pediatric Use

Isolated cases of peripheral edema of the lower extremities occurred in children under 4 months of age after the 1st or 2nd injection of a vaccine containing the Hib component (71% of cases), more than half of the cases occurred within 6 hours. Such reactions developed when the Hib component was administered as part of combined vaccines (e.g., against diphtheria, pertussis, and tetanus). The edema spread to one or both lower extremities (with a predominance of edema on the limb where the vaccine was administered). These reactions may be accompanied by pain, unusual or high-pitched crying, cyanosis or skin discoloration, redness, petechiae or transient purpura, increased body temperature, rash. These cases resolved on their own within 24 hours without any residual effects, they are not associated with any adverse events from the cardiac and respiratory systems.

Special Precautions

Act-Hib does not provide immunity against infection caused by other serotypes of Haemophilus influenzae, nor against meningitis of other etiologies. The tetanus protein contained in the vaccine cannot be considered as a substitute for vaccination against tetanus. Immunosuppressive therapy or immunodeficiency conditions may be the cause of a weak immune response to vaccine administration.

Isolated cases of peripheral edema of the lower extremities occurred in children under 4 months of age after the 1st or 2nd injection of a vaccine containing the Hib component (71% of cases), more than half of the cases occurred within 6 hours. Such reactions developed when the Hib component was administered as part of combined vaccines (e.g., against diphtheria, pertussis, and tetanus).

The edema spread to one or both lower extremities (with a predominance of edema on the limb where the vaccine was administered). These reactions may be accompanied by pain, unusual or high-pitched crying, cyanosis or skin discoloration, redness, petechiae or transient purpura, increased body temperature, rash. These cases resolved on their own within 24 hours without any residual effects, they are not associated with any adverse events from the cardiac and respiratory systems.

Drug Interactions

Act-Hib can be used simultaneously with other vaccines of the national immunization schedule and the schedule of preventive vaccinations for epidemic indications, provided that different syringes are used and injections are given into different parts of the body.

The physician should be informed about any other medication (including over-the-counter) recently administered to the child or administered concurrently with vaccination.

Storage Conditions

In a refrigerator (at a temperature from 2 to 8°C (46.4°F)). Do not freeze. Keep out of reach of children.

Shelf Life

Shelf life – 3 years.

Dispensing Status

By prescription.

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.