Haemophilus influenzae type B vaccine conjugated (Lyophilisate) Instructions for Use

Marketing Authorization Holder

Rostov Research Institute Of Microbiology And Parasitology Of Rospotrebnadzor, FSUE (Russia)

ATC Code

J07AG01 (Haemophilus influenzae B antigen purified conjugated)

Active Substance

Haemophilus influenza conjugate vaccine (Ph.Eur.)

Dosage Form

Haemophilus influenzae type B vaccine conjugated

Lyophilizate for preparation of solution for intramuscular injection 0.5 ml/1 dose: amp. 5 pcs. in set with solvent

Dosage Form, Packaging, and Composition

Lyophilizate for preparation of solution for intramuscular injection white in color; the supplied solvent is a transparent, colorless liquid without odor.

Excipients: stabilizer – sucrose – 20-30 mg/dose.

Solvent water for injections – 0.5 ml/1 dose.

1 dose – ampoules (5) in a set with solvent (amp. 5 pcs.) – 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 infections caused by Haemophilus influenzae type b.

One month after completion of the full vaccination course, 90-100% of children have antibodies to the capsular polysaccharide in serum in an amount of >0.15 mcg/ml, and in 80% the antibody level exceeds 1 mcg/ml.

Indications

• Prophylaxis of purulent-septic diseases (meningitis, septicemia, epiglottitis and others) caused by Haemophilus influenzae type b in children from 3 months of age to 5 years.

ICD codes

Dosage Regimen

The vaccine is administered intramuscularly into the upper outer quadrant of the gluteal muscle. It is necessary to ensure that the syringe needle has not entered the lumen of a blood vessel. Do not administer intravenously.

For patients with thrombocytopenia and other disorders of the blood coagulation system, the vaccine is administered subcutaneously.

The solvent should be inspected before use for the absence of foreign particles. If foreign particles are present or the appearance of the solvent has changed, it should not be used.

Immediately before use, add the solvent from the syringe into the ampoule with the vaccine lyophilisate at the rate of 0.5 ml per one dose. Shake the ampoule well until the contents are completely dissolved. The dissolution time should not exceed 3 minutes. The dissolved preparation is a transparent colorless liquid. If foreign inclusions are detected or if the color has changed, the vaccine should not be used.

The preparation in an opened ampoule must not be stored.

The procedure for vaccine administration is carried out in strict compliance with the rules of asepsis.

The vaccination course consists of:

• For children aged from 3 to 6 months: 3 injections of 0.5 ml with an interval of 1-1.5 months.
• For children aged from 6 to 12 months: 2 injections of 0.5 ml with an interval of 1-1.5 months.
• For children from 1 year to 5 years: a single injection of 0.5 ml.

Revaccination is carried out once at the age of 15-18 months in children vaccinated in the first year of life.

Adverse Reactions

Within the first 48 hours after vaccine administration, pain at the injection site is possible, which usually disappears within 24-48 hours, as well as the development of slight redness and swelling (up to 1%).

Within the first 48 hours after vaccine administration, a subfebrile temperature reaction may develop, and decreased appetite, restlessness, and unusual crying may be observed, which are usually mild and do not require therapy. Allergic reactions (including anaphylactic shock) have not been reported.

Adverse reactions are mostly of mild intensity and short-lived.

Parents should be warned that in case of development of adverse reactions other than those indicated, they should consult a doctor.

Contraindications

• Severe reactions (temperature above 40°C (104°F), swelling and redness over 8 cm in diameter) to a previous vaccination;
• Acute infectious and non-infectious diseases, exacerbations of chronic diseases;
• Hypersensitivity to any component of the vaccine, especially to tetanus toxoid.

Children who have had acute diseases are vaccinated 1 month after recovery (remission). For non-severe acute respiratory viral infections, acute intestinal and other diseases, vaccinations are carried out after the temperature has normalized.

In each individual case of a somatic disease, the question of indications for vaccination is decided by the doctor.

Special Precautions

As with the use of any vaccine, the vaccinated person should be under observation for at least 30 minutes, and vaccination sites should be equipped with anti-shock therapy means. All individuals must be examined by a doctor (paramedic) before vaccination with mandatory temperature measurement.

Vaccinations are administered by nursing staff under the guidance of a doctor.

Use of the vaccine in children suffering from congenital or acquired immunodeficiency, as well as in patients who have undergone immunosuppressive therapy, may cause an insufficient immune response.

Although the Haemophilus type b vaccine contains tetanus antitoxin, its use does not replace vaccination against tetanus.

Considering that the vaccine contains sucrose, vaccination of children with diabetes should be carried out with caution, taking into account the patient’s condition.

Immunodeficiency, HIV infection, as well as a course of therapy with steroid drugs are not contraindications to vaccination.

Drug Interactions

Haemophilus influenzae type B vaccine conjugated can be used simultaneously with other vaccines of the national immunization schedule: against diphtheria and tetanus (ADS and ADS-M); pertussis, diphtheria and tetanus (DTP with whole-cell and acellular pertussis component), hepatitis B (HBV); DTP-HBV; Bubo-Kok and live or inactivated polio vaccine. In this case, the preparations must be administered with different syringes into different anatomical areas.

Storage Conditions

The vaccine is transported and stored in accordance with SP 3.3.2.1248-03 at a temperature from 2°C (35.6°F) to 8°C (46.4°F). Do not freeze. Keep out of reach of children.

Shelf Life

Shelf life – 2 years. The vaccine must not be used after the expiration date.

Dispensing Status

For medical and preventive institutions.

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.