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Instructions

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Instruction for use: D.T. Vax

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Dosage form: Suspension for injections

Active substance: Vaccinum ad prophylaxim diphtheriae et tetani

ATX

J07AM51 Tetanus toxoid in combination with diphtheria toxoid

Pharmacological group:

Vaccines, serums, phages and toxoids

The nosological classification (ICD-10)

A35 Other forms of tetanus: Tetanus local; Tetanus; Muscle spasms in tetanus; Clostridiosis wound; Tetanus; Hydrophobia (hydrophobia)

A36.9 Diphtheria, unspecified

Composition and release form

Suspension for injection. Each dose of vaccine (0.5 ml) contains purified diphtheria toxoid - 1 vaccine dose, purified tetanus toxoid - 1 vaccine dose, aluminum hydroxide (in terms of Al) - maximum 1.25 mg, thiomersal (preservative) - maximum 0, 05 mg, isotonic sodium chloride solution qs Up to 0.5 ml. One vaccine dose of diphtheria toxoid corresponds to at least 30 IU when measuring the protective activity in parallel with the WHO standard or with another standard titrated according to an international standard. One vaccine dose of tetanus toxoid corresponds to at least 40 IU when measuring protective activity in parallel with the WHO standard or with another standard titrated according to an international standard.

The vaccine is produced:

In ampoules of 1 dose, in a box of 20 ampoules;

In syringes for 1 dose, in a box 1 syringe;

In bottles of 10 or 20 doses, in a box 10 bottles of 5 and 10 ml respectively.

Characteristic

Adsorbed vaccine for the prevention of diphtheria and tetanus. It is made from diphtheria and tetanus toxins, formalin-inactivated and purified.

Pharmachologic effect

Mode of action - Immunostimulating.

Formation of specific immunity against diphtheria and tetanus toxins.

Clinical Pharmacology

Immunity develops after the second injection and persists for at least 5 years after the first revaccination.

Indication of the drug D.T.Vax

Combined prophylaxis of diphtheria and tetanus in children aged 2 months to 8 years, prevention of diphtheria and tetanus with contraindications for immunoprophylaxis of whooping cough (instead of pertussis-diphtheria-tetanus vaccine).

Contraindications

Fever, acute infectious diseases; The second or third injection is canceled if the first administration was a pronounced reaction.

Side effects

Local reactions (soreness at the injection site, passing for 24-48 hours. In some cases, for 1 week or longer, there may be a seal or subcutaneous nodule). General reactions (slight increase in body temperature, impaired renal function (single cases).

Dosing and Administration

SC, IM. Vaccine prophylaxis is carried out according to the following scheme:

1) 3 injections (0.5 ml each) - with an interval of 1-2 months,

2) 1 year after the last injection, another 0.5 ml,

3) the last injection - after another 5 years.

Before opening, the ampoule is carefully shaken to form a homogeneous suspension and its contents are used for the same day.

Storage conditions of the drug D.T.Vax

At a temperature of 2-8 į C (donít freezing).

Keep out of the reach of children.

Shelf life of the drug D.T.Vax

3 years.

Do not use after the expiry date printed on the package.

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