Diphtheria, tetanus, pertussis and hepatitis B adsorbed vaccine vaccine DTP-HEPB (Suspension) Instructions for Use

Marketing Authorization Holder

Microgen NPO, JSC (Russia)

ATC Code

J07CA05 (Vaccine against diphtheria, hepatitis B, pertussis and tetanus)

Active Substance

Diphtheria, tetanus, pertussis and hepatitis B (rDNA) vaccine (adsorbed)

Diphtheria, tetanus, pertussis and hepatitis B (rDNA) vaccine (adsorbed) (Ph.Eur. European Pharmacopoeia)

Dosage Forms

	Adsorbed vaccine against pertussis, diphtheria, tetanus and hepatitis B (DTP-HEP B vaccine)	Suspension for intramuscular administration 0.5 ml/1 dose (with preservative): amp. 10 pcs.
		Suspension for intramuscular administration 0.5 ml/1 dose (without preservative): amp. 10 pcs.

Dosage Form, Packaging, and Composition

Suspension for intramuscular administration is an opalescent liquid, white in color, which may have a grayish or yellowish tint; upon settling, it separates into a loose white precipitate or white with a grayish or yellowish tint, easily dispersing upon shaking, and a colorless transparent supernatant liquid.

Excipients: aluminum hydroxide (in terms of Al³⁺) – not more than 0.55 mg, formaldehyde – not more than 50 mcg; preservative – thiomersal – 35-50 mcg.

0.5 ml – ampoules with a capacity of 1 ml (10) – containers (1) – cardboard packs**.
0.5 ml – ampoules with a capacity of 2 ml (10) – containers (1) – cardboard packs**.

* The vaccine is a mixture of phase 1 pertussis microbes killed with formaldehyde and diphtheria toxoid, tetanus toxoid, and hepatitis B virus antigen (HBsAg) adsorbed on aluminum hydroxide gel.
** For healthcare institutions

Suspension for intramuscular administration is an opalescent liquid, white in color, which may have a grayish or yellowish tint; upon settling, it separates into a loose white precipitate or white with a grayish or yellowish tint, easily dispersing upon shaking, and a colorless transparent supernatant liquid.

Excipients: aluminum hydroxide (in terms of Al³⁺) – not more than 0.55 mg, formaldehyde – not more than 50 mcg.

0.5 ml – ampoules with a capacity of 1 ml (10) – containers (1) – cardboard packs**.
0.5 ml – ampoules with a capacity of 2 ml (10) – containers (1) – cardboard packs**.

* The vaccine is a mixture of phase 1 pertussis microbes killed with formaldehyde and diphtheria toxoid, tetanus toxoid, and hepatitis B virus antigen (HBsAg) adsorbed on aluminum hydroxide gel.
** For healthcare institutions

Clinical-Pharmacological Group

Diphtheria, tetanus, pertussis and hepatitis B vaccine for prophylaxis

Pharmacotherapeutic Group

Vaccines; combined bacterial and viral vaccines

Pharmacological Action

The vaccine is a mixture of phase 1 pertussis microbes killed with formaldehyde and diphtheria and tetanus toxoids and recombinant yeast surface antigen of hepatitis B virus (HBsAg) adsorbed on aluminum hydroxide gel.

Indications

• Prevention of pertussis, diphtheria, tetanus and hepatitis B in children.

ICD codes

Dosage Regimen

Vaccinations with the DTP-HEP B vaccine are carried out at times that provide for simultaneous vaccinations against hepatitis B, pertussis, diphtheria and tetanus.

Children vaccinated with hepatitis B monovaccine within the first 24 hours of life and not belonging to risk groups are immunized with the DTP-HEP B vaccine at the age of 3 and 6 months. The second vaccination against pertussis, diphtheria and tetanus is carried out with DTP vaccine at 4.5 months.

Children not vaccinated with hepatitis B vaccine before the age of 3 months are immunized with the DTP-HEP B vaccine three times according to the schedule: 3 months, 4.5 months, 6 months. Shortening of intervals is not allowed. If it is necessary to increase the intervals, the next vaccination should be carried out as soon as possible, determined by the health status of the children.

If children have one or two DTP vaccinations and are not vaccinated with hepatitis B vaccine, the missing number of vaccinations (up to 3) can be carried out with the DTP-HEP B vaccine. In this case, the missing number of vaccinations against hepatitis B (up to 3) is carried out with hepatitis B monovaccine at intervals of 1 and 6 months after the first administration. Revaccination against pertussis, diphtheria and tetanus is carried out with DTP vaccine once at the age of 18 months (if vaccination schedules are violated – 12-13 months after the completed vaccination course).

If a child by the age of 4 has not received revaccination with DTP vaccine, it is carried out with ADS toxoid for the age of 4 years – 5 years 11 months 29 days or ADS-M toxoid for the age of 6 years and older.

The DTP-HEP B vaccine is administered intramuscularly into the anterolateral region of the thigh in a dose of 0.5 ml. Before vaccination, the ampoule must be shaken thoroughly until a homogeneous suspension is obtained.

Ampoule opening and the vaccination procedure are carried out in strict compliance with the rules of asepsis and antisepsis. The drug in an opened ampoule is not subject to storage. The drug in ampoules with damaged integrity, missing labeling, changed physical properties (color change, presence of non-dispersible flakes), expired shelf life, or improper storage is not suitable for use. The administration of the drug 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 drug.

Adverse Reactions

Some vaccinated individuals may develop short-term general (fever, malaise) and local (pain, hyperemia, swelling) reactions within the first two days. In rare cases, complications may develop: convulsions (usually associated with fever), episodes of high-pitched crying, allergic reactions (angioedema, urticaria, polymorphic rash).

Considering the possibility of immediate-type allergic reactions in particularly sensitive children, it is necessary to provide medical observation of the vaccinated for 30 minutes. Vaccination sites must be equipped with anti-shock therapy means.

If a child develops a severe general reaction (fever in the first two days above 40°C (104°F), at the injection site – swelling and hyperemia over 8 cm in diameter) or a post-vaccination complication, further vaccinations with the DTP-HEP B vaccine are discontinued for him. If the child was vaccinated with the DTP-HEP B vaccine twice, the vaccination course against diphtheria and tetanus is considered completed, and vaccination against hepatitis B is completed with a monovaccine once, 1 month after the second vaccination. If the child received one vaccination with the DTP-HEP B vaccine, vaccination can be continued with a combined hepatitis B and diphtheria-tetanus toxoid vaccine with reduced antigen content, which is administered once no earlier than 3 months later, and then hepatitis B monovaccine is administered one month later.

In both cases, the first revaccination is carried out with ADS-M toxoid 9-12 months after the last vaccination with the DTP-HEP B vaccine or the combined hepatitis B and diphtheria-tetanus toxoid vaccine with reduced antigen content. If a severe reaction developed after the third vaccination with the DTP-HEP B vaccine, the first revaccination is carried out with ADS-M toxoid after 12-18 months. Subsequent revaccinations are carried out at the prescribed ages with ADS-M toxoid.

If the temperature rises above 38.5°C (101.3°F) in more than 1% of vaccinated individuals or the occurrence of pronounced local reactions (soft tissue swelling with a diameter of more than 5 cm, infiltration with a diameter of more than 2 cm) in more than 4% of vaccinated individuals, as well as the development of post-vaccination complications, vaccinations with the drug of this series are discontinued.

Contraindications

• Progressive diseases of the nervous system;
• History of afebrile seizures;
• Allergic reaction to baker’s yeast;
• Severe reactions (fever in the first two days above 40°C (104°F), at the injection site – swelling and hyperemia over 8 cm in diameter), post-vaccination complications to the administration of the previous dose of DTP-HEP B vaccine, or DTP vaccine, or hepatitis B vaccine.

Use in Pregnancy and Lactation

The drug is used for vaccination of children and is not used during pregnancy and lactation.

Special Precautions

Children who have had acute illnesses are vaccinated no earlier than four weeks after recovery; for mild forms of respiratory diseases (rhinitis, mild hyperemia of the pharynx, etc.), vaccination is allowed 2 weeks after recovery.

Patients with chronic diseases are vaccinated no earlier than four weeks after achieving stable remission.

To identify contraindications, the doctor (paramedic at the FAP) on the day of vaccination conducts a survey of parents and an examination of the child with mandatory thermometry. Children temporarily exempted from vaccination should be taken under observation and registered and vaccinated in a timely manner.

The development of febrile seizures after vaccine administration is not a contraindication to its subsequent administration; in this case, paracetamol should be prescribed in an age-appropriate dosage for 1-2 days when fever occurs.

Stable manifestations of allergic disease (localized skin manifestations, latent bronchospasm, etc.) are not contraindications to vaccination, which can be carried out against the background of appropriate therapy.

Information on the possible effect of the medicinal product on the ability to drive vehicles, mechanisms.

Not applicable. The drug is used for vaccination of children.

Overdose

Cases of overdose have not been established.

Drug Interactions

Vaccinations with the DTP-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.

Storage Conditions

Store 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. Keep out of reach of children.

Transport 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.

Shelf Life

Shelf life – 18 months. The drug with an expired shelf life must not be used.

Dispensing Status

For healthcare 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.