Composition, form of production and packaging
Suspension for s / w introduction of white or yellowish white color, separated when settled on a clear colorless supernatant and a loose sediment of white or yellowish white color, completely shattered when shaken.
botulinum toxoid (5 units of botulinum toxoid type A binding, 3 units of B botulinum toxoid type B binding, 3 units of botulinum toxoid type E binding) 1 dose
tetanus toxoid (2.5 units of tetanus toxoid binding) 1 dose
[PRING] aluminum hydroxide in terms of aluminum 1.2 mg, thiomersal 100 В± 15 Ојg, formaldehyde 100 Ојg.
1 ml (1 dose) - ampoules (10) - packs of cardboard.
3 ml (3 dose) - ampoules (10) - packs of cardboard.
1 ml (1 dose) - ampoules (5) - packings of cellular contour (2) - packs cardboard.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2014.
The introduction of the drug in accordance with the approved scheme causes the formation of specific antitoxic immunity lasting not less than 5 years.
- prevention of botulism and tetanus in persons aged 16 to 60 years (women under 55).
The course of primary immunization consists of three vaccinations: two-time 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.
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.
- allergic reactions to the previous administration of the drug or its components;
- 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);
- Diseases of the blood;
- diseases of the endocrine system;
- diseases of the circulatory system;
- bronchial asthma and other allergic diseases, severe allergic reactions to food, medicinal and other substances;
- systemic lupus erythematosus and other connective tissue diseases;
- malignant neoplasms;
- Pregnancy, lactation.
PREGNANCY AND LACTATION
Contraindicated in pregnancy and lactation.
Precautions for use
The preparation is not suitable for use in ampoules with broken integrity, lack of marking, changing physical properties (discoloration, presence of non-developing 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.
Impact on the ability to drive vehicles and manage mechanisms
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.
TERMS OF RELEASE FROM PHARMACY
For treatment and prevention institutions.
TERMS AND CONDITIONS OF STORAGE
In accordance with SP 184.108.40.2068-03 at a temperature of 2 to 8 В° C. Keep out of the reach of children. Do not freeze. Shelf life - 3 years.