Instruction for use: Vaccinum pertussico-diphtherico-tetanicum aluminio hydroxydato adsorptum fluidum

Dosage form: Suspension for intramuscular injection

Active substance: Vaccinum ad prophylaxim diphtheriae, pertussis et tetani

ATX

J07CA02 Vaccine against diphtheria-pertussis-poliomyelitis-tetanus

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

A37 Pertussis: Bacterial transport of pertussis pathogens; Whooping cough

Composition and release form

1 dose of the vaccine contains a suspension of 10 billion pertussis microbial cells, 15 flocculating (LF) diphtheria and 5 antitoxin-binding units (EC) tetanus toxoid. This corresponds to at least 4 International protective units of pertussis vaccine, at least 30 International units (MIE) of diphtheria toxoid, at least 60 MI of tetanus toxoid. Sorbent - aluminum hydroxide (0.25-0.55 mg / ml), preservative - mertiolate (0.05 mg / ml). Suspension for injection in ampoules of 1 ml (two inoculations), in the package 10 pcs.

Characteristic

A suspension of killed pertussis microbes and purified diphtheria and tetanus antitoxins adsorbed on aluminum hydroxide. It is a suspension of white or slightly yellowish color, separated when standing on a clear liquid part and loose sediment, completely broken up by shaking.

Pharmachologic effect

Mode of action - Immunostimulating.

Forms immunity to pertussis, diphtheria and tetanus viruses.

Indication of the drug Vaccinum pertussico-diphtherico-tetanicum aluminio hydroxydato adsorptum fluidum

Pertussis, diphtheria, tetanus (prophylaxis) in children older than 3 months.

Contraindications

Hypersensitivity, CNS diseases with progressive course; Acute respiratory diseases and exacerbation of chronic diseases, malignant blood diseases, neoplasms, anaphylactic shock, serum sickness, pregnancy, lactation.

Side effects

Increased temperature, malaise, at the site of pain, hyperemia, swelling.

Dosing and Administration

IM in the upper outer quadrant of the buttocks or in the anterior area of the femur, once 0.5 ml. Before vaccination, the ampoule must be shaken thoroughly until a homogeneous suspension is obtained. The vaccination course consists of three vaccinations with an interval of 45 days.

Precautionary measures

After the introduction, it is necessary to observe the vaccinated for 30 minutes (the possibility of developing allergic reactions). Preparations should be made for anti-shock therapy. The preparation is not suitable for use in ampoules with broken integrity and marking, with changing physical properties (turbidity, intense staining, presence of non-breaking flakes), expired shelf life, improper storage.

Storage conditions of the drug Vaccinum pertussico-diphtherico-tetanicum aluminio hydroxydato adsorptum fluidum

At a temperature of 2-8 ° C.

Keep out of the reach of children.

Shelf life of the drug Vaccinum pertussico-diphtherico-tetanicum aluminio hydroxydato adsorptum fluidum

1,5 years.

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