Vaccine combined hepatitis & anatoxine diphtheria & tetanus (Suspension) Instructions for Use

Marketing Authorization Holder

Microgen NPO, JSC (Russia)

ATC Code

J07CA07 (Vaccine against diphtheria, hepatitis B and tetanus)

Dosage Form

Vaccine combined hepatitis & anatoxine diphtheria & tetanus

Suspension for intramuscular administration 1 dose/0.5 ml: amp. 10 pcs.

Dosage Form, Packaging, and Composition

Excipients: aluminum hydroxide (from 0.35 to 0.55 mg), merthiolate (from 15 to 35 µg), formaldehyde (not more than 50 µg).

0.5 ml (1 dose) – ampoules (10) – carton packs.

Clinical-Pharmacological Group

Diphtheria, tetanus and hepatitis B vaccine for prophylaxis

Pharmacotherapeutic Group

MIBP-vaccine

Pharmacological Action

The vaccine is a combination of recombinant yeast surface antigen of hepatitis B virus (HBsAg) and diphtheria and tetanus toxoids purified from ballast proteins, adsorbed on aluminum hydroxide gel.

Composition of 1 dose (0.5 ml): 5 flocculating units (Lf) of diphtheria toxoid, 5 binding units (BU) of tetanus toxoid, 10 µg HBsAg, from 0.35 to 0.55 mg aluminum hydroxide (Al⁺³), preservative – merthiolate – from 15 to 35 µg and not more than 50 µg formaldehyde.

The preparation is a homogeneous suspension of yellowish-white color without foreign inclusions, which separates upon standing into a clear supernatant and a loose sediment that completely breaks up upon shaking.

Indications

Prophylaxis of hepatitis B, diphtheria and tetanus in persons aged 6 to 19 years. The vaccine is used

• For conducting a course of vaccination in those not previously vaccinated against diphtheria, tetanus and hepatitis B;
• For scheduled age-related revaccination against diphtheria and tetanus in those not previously vaccinated against hepatitis B.

ICD codes

Dosage Regimen

The vaccine is administered intramuscularly into the deltoid muscle in a dose of 0.5 ml.

Subcutaneous administration of the preparation and administration into the gluteal muscle is not recommended due to reduced efficacy of the hepatitis component and the possibility of increased local reactions.

Before the injection, the ampoule must be shaken thoroughly until a homogeneous suspension is obtained.

Primary vaccination of children over 6 years of age and adolescents, not previously vaccinated against diphtheria, tetanus and hepatitis B, is carried out three times according to the scheme: 1st dose – on the selected day, 2nd dose – after 1-1.5 months, 3rd dose – after 6-7 months after the first dose.

If it is necessary to extend the intervals, the vaccination should be carried out at the earliest possible time, determined by the health status of the vaccinee. Subsequent revaccinations against diphtheria and tetanus are carried out in accordance with the vaccination calendar.

Revaccination of persons against diphtheria and tetanus, not previously vaccinated against hepatitis B, is carried out once, followed by completion of the vaccination course with hepatitis B vaccine in the age-specific dosage.

The preparation in ampoules with damaged integrity, missing labeling, changed physical properties (change in color, presence of non-dispersible flakes), expired shelf life, or improper storage is not suitable for use.

Ampoule opening and the vaccination procedure are carried out in strict compliance with the rules of asepsis and antisepsis. The preparation in an opened ampoule must not be stored.

The administration of the preparation is recorded in the established accounting forms indicating the batch number, expiration date, manufacturer, date of administration, and the nature of the reaction to the administration of the preparation.

Adverse Reactions

In some vaccinated individuals, short-term general (fever, malaise, pain in joints and muscles, dizziness) and local (pain, hyperemia, swelling) reactions may develop within the first two days. In exceptionally rare cases, allergic reactions (angioedema, urticaria, polymorphic rash), slight exacerbation of allergic diseases may develop.

Given the possibility of immediate-type allergic reactions in particularly sensitive individuals, medical supervision should be provided for the vaccinated for 30 minutes.

Vaccination sites must be equipped with anti-shock therapy means.

Contraindications

• Severe and unusual reactions to previous administration of ADS-toxoid and/or hepatitis B vaccine: temperature above 40°C (104°F), swelling, hyperemia more than 8 cm in diameter at the injection site, as well as allergic reactions to baker’s yeast and other vaccine components. Vaccination is postponed until the acute manifestations of the disease and exacerbation of chronic diseases have ended.

For mild forms of ARVI, acute intestinal diseases and others, vaccinations are carried out after the disappearance of clinical symptoms.

Patients with chronic diseases are vaccinated upon achieving complete or partial remission.

Immunodeficiencies, HIV infection, as well as maintenance course therapy, including with steroid hormones and psychopharmaceutical drugs, are not contraindications to vaccination.

To identify contraindications, the doctor (paramedic at the FAP) on the day of vaccination conducts a survey of parents and an examination of the vaccinees with mandatory thermometry. When vaccinating adults, preliminary selection of persons subject to vaccination is allowed, with their subsequent questioning by the medical worker conducting the vaccination on the day of vaccination.

Use in Pregnancy and Lactation

The use of this medical preparation during pregnancy and breastfeeding is not recommended, as safety during controlled clinical studies has not been studied.

Pediatric Use

According to indications from 6 years of age.

Special Precautions

Persons with neurological changes are vaccinated after excluding progression of the process.

Patients with allergic diseases are vaccinated 2-4 weeks after the end of exacerbation, while stable manifestations of the disease (localized skin phenomena, latent bronchospasm, etc.) are not contraindications to vaccination, which can be carried out against the background of appropriate therapy.

Effect on ability to drive vehicles and machinery

Not established.

Overdose

Cases of overdose have not been established.

Drug Interactions

Vaccinations with ADS-M-Hep B vaccine can be carried out simultaneously with other vaccines of the national calendar of preventive vaccinations (except for BCG vaccine) or 1 month after vaccinations against other infections.

Shelf Life

The shelf life of the vaccine is 3 years. The preparation with an expired shelf life must not be used.

Storage conditions. At a temperature from 2°C (35.6°F) to 8°C (46.4°F) in accordance with SP 3.3.2.1248-03. Keep out of reach of children. Freezing is not allowed.

Transport conditions. At a temperature from 2°C (35.6°F) to 8°C (46.4°F) In accordance with SP 3.3.2.1248-03. Freezing is not allowed.

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.