Bebi-Khib (Lyophilisate) Instructions for Use

Marketing Authorization Holder

St. Petersburg Research Institute of Vaccines and Sera of the FMBA, FSUE (Russia)

ATC Code

J07AG01 (Haemophilus influenzae B antigen purified conjugated)

Active Substance

Haemophilus influenza conjugate vaccine (Ph.Eur. European Pharmacopoeia)

Dosage Form

Bebi-Khib

Lyophilisate for preparation of solution for intramuscular administration 1 dose/0.5 ml: fl. 10 pcs.

Dosage Form, Packaging, and Composition

Lyophilisate for preparation of solution for intramuscular administration in the form of a white lyophilized mass; the reconstituted preparation is a colorless transparent liquid.

Excipients: sucrose – 37.5 mg, trometamol – 0.6 mg.

1 dose* – colorless glass vials (10) – contour cell packaging (1) – cardboard packs.

* 1 dose of the vaccine lyophilisate corresponds to 0.5 ml of the reconstituted solution.

Clinical-Pharmacological Group

Diseases caused by Haemophilus influenzae type b vaccine for prophylaxis

Pharmacotherapeutic Group

Vaccines; bacterial vaccines; vaccines against infections caused by Haemophilus influenzae type b

Pharmacological Action

A lyophilized conjugated vaccine for the prevention of infections caused by Haemophilus influenzae type b. The vaccine antigen is the capsular polysaccharide (polyribosylribitol phosphate) of Haemophilus influenzae type b, conjugated to tetanus toxoid used as a carrier.

Conjugation of polyribosylribitol phosphate with the carrier protein gives the polysaccharide the properties of a T-dependent antigen. The immune response as a result of vaccination is formed due to the activation of B-lymphocytes by lymphokines secreted by T-lymphocytes stimulated by the vaccine.

As a result, antibodies (mainly of the IgG class) with specificity for the polyribosylribitol phosphate of Haemophilus influenzae type b are produced. Furthermore, repeated administration of the vaccine shows a pronounced booster effect, which confirms the formation of immunological memory as a result of primary vaccination.

The use of this vaccine provides prevention of infections caused by Haemophilus influenzae type b in at least 95% of fully vaccinated individuals.

Indications

Prevention of diseases caused by Haemophilus influenzae type b (including meningitis, septicemia, epiglottitis) in children aged from 2 months to 5 years.

ICD codes

Dosage Regimen

The vaccine is administered subcutaneously or intramuscularly.

For primary vaccination of children aged from 2 to 6 months, 3 injections of the drug are administered at intervals of 1-2 months; for primary vaccination of children aged from 6 to 12 months, 2 injections of the drug are administered at an interval of 1-2 months.

For children of the specified age, a single revaccination is indicated one year after completion of the primary vaccination course.

For children aged from 1 year to 5 years, a single administration of the vaccine is sufficient.

For children under 2 years of age, the vaccine is administered into the anterolateral region of the thigh or into the buttock.

For children over 2 years of age, the vaccine is administered into the deltoid muscle region.

Adverse Reactions

Infrequently increased body temperature, irritability, drowsiness, unusual crying.

Local reactions are possible pain, erythema, induration at the injection site (these reactions are transient).

Contraindications

Hypersensitivity to this vaccine.

Use in Pregnancy and Lactation

Not applicable.

Pediatric Use

The vaccine is used in children aged from 2 months to 5 years.

Geriatric Use

Not applicable.

Special Precautions

Vaccine administration is not recommended in case of elevated body temperature and during acute infectious diseases.

Storage Conditions

Store at 2°C (36°F) to 8°C (46°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

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.