Tetraanatoxin purified adsorbed (Tetraanatoxin purified adsorbed)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Active substanceAnatoxin botulinum + Anatomix tetanusAnatoxin botulinum + Anatomix tetanus
Dosage form: & nbspsubcutaneous suspension
Composition:

Tetraanatoxin purified adsorbed, suspension for subcutaneous administration is a liquid mixture of hydroxide adsorbed on aluminum gel purified botulinum (types A, B and E) and tetanus toxoid obtained from toxins of the corresponding microorganisms Clostridium botulinum type A, Clostridium botulinum type B (special name beans), Clostridium botulinum type E, Clostridium tetani, neutralized by formaldehyde and heat.

1 dose (1 ml) contains 5 units of binding (EC) of botulinum toxoid type A, 3 EC botulinum toxoid type B, 3 EC botulinum toxoid type E, 2.5 EC tetanus toxoid, not more than 1.2 mg aluminum hydroxide in terms of aluminum, (100 ± 15) μg thiomersal and not more than 100 μg of formaldehyde.

Description:

A suspension of white or yellowish white color, separated upon settling onto a clear, colorless supernatant and a loose white or yellowish white precipitate, completely broken up by shaking.

Pharmacotherapeutic group:MIBP-anatoxin.
ATX: & nbsp

J.06.A.A.04   Botulinum antitoxin

Pharmacodynamics:

The introduction of the drug in accordance with the approved scheme causes the formation of specific antitoxic immunity lasting not less than 5 years.

Indications:

Prevention of botulism and tetanus in individuals aged 16 to 60 years (women under 55).

Contraindications:

1. Allergic reactions to previous administration of the drug or its components.

2. Acute infectious and non-infectious diseases, exacerbation of chronic diseases, infectious and non-infectious diseases of the central nervous system in the anamnesis. Vaccinations are carried out not earlier than one month from the moment of recovery (remission).

3. Diseases of the blood.

4. Diseases of the endocrine system.

5. Diseases of the circulatory system.

6. Bronchial asthma and other allergic diseases, severe allergic reactions to food, medicinal and other substances.

7. Systemic lupus erythematosus and other connective tissue diseases.

8. Malignant neoplasms.

9. Pregnancy, lactation.

Dosing and Administration:

The course of primary immunization consists of three vaccinations: a double vaccination with an interval of 25-30 days and a booster at 6-9 months.If it is necessary to extend the intervals, the next vaccination should be carried out as soon as possible.

Subsequent one-time revaccinations are performed according to indications every 5 years.

A single dose of the drug is 1 ml.

The drug is injected subcutaneously into the subscapular region (1 cm from the lower angle of the scapula to the back median line). Before use, the ampoule with the preparation should be thoroughly shaken until a homogeneous suspension is obtained.

The preparation of the drug is registered in the prescribed registration forms with the manufacturer's name, serial number, expiration date, date of administration and the nature of the reaction to the drug administration.

Side effects:

In the first two days after the administration of the drug, general and local reactions may develop. The general reaction is manifested by fever, malaise, local reactions - the appearance of skin hyperemia, swelling of soft tissues or a small infiltrate, in rare cases, the development of regional lymphadenitis. The presence of seals at the site of the previous injection is not a contraindication for the next vaccination. In this case, the drug is administered on the side opposite the site of the previous administration.

It is necessary to consider the possibility of developing, in exceptional cases, anaphylactic shock in some particularly sensitive individuals.

Overdose:

Not installed.

Interaction:

The drug can be administered simultaneously (with different syringes in different parts of the body) with tick-borne encephalitis vaccine and tularemia vaccine. Persons who are fully immunized against tetanus, it is recommended to introduce botulinum toxoid. The interval from previous vaccinations against other infections should be at least one month.

Special instructions:

The drug is not suitable for use in ampoules with broken integrity, lack of marking, changing physical properties (discoloration, presence of non-breaking flakes), expired shelf life, improper storage.

Opening of ampoules and the vaccination procedure are carried out with strict adherence to aseptic and antiseptic rules. The drug in the opened ampoule is not subject to storage.

Given the possibility of anaphylactic shock, it is necessary to provide medical supervision of the vaccinated within 30 minutes after the administration of the drug. Places of vaccination should be equipped with anti-shock therapy, including epinephrine.

Effect on the ability to drive transp. cf. and fur:No information.
Form release / dosage:

Suspension for subcutaneous administration.

Packaging:1 ml (1 dose) or 3 ml (3 doses) in ampoules. 10 ampoules per box of cardboard.

5 ampoules of 1 ml each in a contiguous cell pack of a polyvinyl chloride film. 2 contour squares in a pack of cardboard.

In the package or box, insert the instructions for use and the ampoule opener or ampoule scarifier.

When packaging ampoules that have a break ring or an opening point, the ampoule knife or the ampoule scapegrator is not put in.

Storage conditions:

Conditions of transportation. In accordance with SP 3.3.2.1248-03 at a temperature of 2 to 8 ° C. Do not freeze.

Storage conditions. In accordance with SP 3.3.2.1248-03 at a temperature of 2 to 8 ° C. Keep out of the reach of children. Do not freeze.

Shelf life:

3 years. The drug with expired shelf life is not subject to application.

Terms of leave from pharmacies:On prescription
Registration number:P N002205 / 01
Date of registration:04.12.2008
The owner of the registration certificate:MICROGEN FGUP Scientific and Production Association MICROGEN FGUP Scientific and Production Association Russia
Manufacturer: & nbsp
Information update date: & nbsp24.04.2013
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