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Instructions

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Instruction for use: Tetracoq 05

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Dosage form: Suspension for injections

Active substance: Vaccinum ad prophylaxim diphtheriae, pertussis, poliomyelitidis 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

B91 Consequences of poliomyelitis: Poliomyelitis consequences; Post-poliomyelitis syndrome

Composition and release form

Suspension for injection. 1 dose (0.5 ml) of the vaccine contains purified diphtheria toxoid - 1 vaccine dose, purified tetanus toxoid - 1 vaccine dose, Bordetella pertussis - minimum 4 IU, inactivated vaccine for the prevention of poliomyelitis type 1 - 1 vaccine dose, inactivated vaccine For the prevention of poliomyelitis type 2 - 1 vaccine dose, inactivated vaccine for the prevention of poliomyelitis type 3 - 1 vaccine dose, aluminum hydroxide (in terms of Al) - a maximum of 1.25 mg, formaldehyde - a maximum of 0.1 mg, 2 -phenol ethanol - a maximum of 0.005 ml. Produced in syringes for 1 dose; In the box 1 syringe and in bottles of 10 and 20 doses; In a box of 10 bottles. One vaccine dose of diphtheria toxoid corresponds to at least 30 IU, when measuring 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 60 IU, when measuring protective activity in parallel with the WHO standard or with another standard titrated according to an international standard. One dose of inactivated polio vaccine for types 1, 2 and 3 corresponds to the amount of antigens that meet the standards of the test for antigenic activity described in the French and European pharmacopoeias.

Characteristic

Adsorbed vaccine for the prevention of diphtheria, tetanus, pertussis and poliomyelitis. The vaccine is made from diphtheria and tetanus toxins (inactivated and purified), pertussis (subjected to thermal inactivation) and 3 types of poliovirus, prepared on the culture of BERO cells and formalin-inactivated.

Pharmachologic effect

Mode of action - Immunostimulating.

Forms specific immunity to diphtheria and tetanus toxins, pertussis and poliovirus.

Clinical Pharmacology

Immunity is acquired after the second injection of the vaccine, increases with the subsequent vaccine and lasts no less than 5 years. Seroconversion to diphtheria toxin is observed in 92-100% of vaccinated, to tetanus toxin - in 100%, to pertussis toxin - in 93% and to poliovirus - in 100%.

Indication of the drug Tetracoq 05

Combined prophylaxis of diphtheria, tetanus, pertussis and poliomyelitis in children aged 2 months to 4 years.

Contraindications

Hypersensitivity (including the previous administration of a vaccine containing a pertussis component: an increase in temperature to 40 ° C and higher, a prolonged crying syndrome, seizures, a shock (in the event that these reactions occurred within 48 hours after the administration of the vaccine). Encephalopathy, accompanied by cramps or without.

Side effects

Erythematous rashes and / or seals at the injection site, increase in body temperature (up to 38-39 ° C) in the first 24-48 hours. As a rule, adverse reactions are transient, especially if salicylates, barbiturates or antihistamines are prophylactically prescribed. In very rare cases, the pertussis component can cause neurologic reactions (convulsions, encephalitis, encephalopathy).

Dosing and Administration

SC or IM (before use, you must shake it thoroughly) according to the following scheme:

1) primary vaccination, consisting of three injections - 0.5 ml each with an interval of 1 month;

2) revaccination - 0.5 ml 1 year after the third injection of primary vaccination.

When carrying out mass vaccinations, the vaccine can be administered with a needleless IMOJET injector.

Precautionary measures

Vaccination should be delayed in cases of an active phase of any disease, especially infectious. It should be administered with caution in case of streptomycin allergy.

Special instructions

The presence in the anamnesis of convulsions not related to the previous administration of the vaccine is not a contraindication to its use (if the patient does not have progressive encephalopathy); When vaccinating such patients, prophylactic administration of anticonvulsants and / or antipyretics may be useful.

Storage conditions of the drug Tetracoq 05

At a temperature of 2-8 ° C (don’t freezing).

Keep out of the reach of children.

Shelf life of the drug Tetracoq 05

3 years.

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

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