Active substanceAnatoxin tetanusAnatoxin tetanus
Dosage form: & nbspsubcutaneous suspension
Composition:

The drug is a formaldehyde neutralized and heated tetanus toxin, purified from ballast proteins and adsorbed on an aluminum hydroxide gel.

The drug contains 40 units of tetanus toxoid binding (EC), not more than 1.1 mg aluminum hydroxide (sorbent), 80 to 120 μg merthiolate (preservative) and not more than 200 μg of formaldehyde in 1 ml (1 dose).

Description:

Suspension yellowish white without foreign inclusions, separated when settled on a transparent supernatant and a loose sediment, completely broken up by shaking.

Pharmacotherapeutic group:MibP-anatoxin
ATX: & nbsp

J.06.A   Immune Serums

J.06.A.A.02   Tetanus antitoxin

Pharmacodynamics:

The drug causes the formation of specific antitoxic antibodies in people who have been immunized.

Indications:Immunization of donors to obtain tetanus toxoid and tetanus immunoglobulin.
Contraindications:

Donors who have had acute illnesses are immunized no earlier than 1 month after recovery or remission.

Dosing and Administration:

AC-anatoxin for donors is administered deep subcutaneously into the subscapular region. Before vaccination, the ampoule must be shaken thoroughly until a homogeneous suspension is obtained.

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.

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

AC-anatoxin for donors is used in accordance with the current "Instruction on immunization of donors for the production of tetanus antiglobulin".

The drug is administered in the following cases:

- For the first revaccination of donors who received two injections of AC-anatoxin containing 20 EC / ml.

- For subsequent revaccinations of donors with a known vaccination history after 5 years after the previous administration of preparations containing tetanus toxoid. For revaccination of donors with an unknown vaccination history, in the blood serum of which, during the initial background examination, the content of tetanus antitoxin (according to ELISA) was found in the range of 0.01-4 ME in 1 ml.

Note: Donors whose serum contains 8 or 16 IU should be given tetanus toxoid containing 20 EC / ml.

When selecting donors for immunization and conducting plasmapheresis, it is necessary to be guided by the general provisions stipulated in the Instructions for the Medical Examination of Blood Donors, Plasma and Blood Cells, approved by the Ministry of Health of the Russian Federation on 16.11.98.

Side effects:

AC-anatoxin for donors is a weakly reactogenic preparation. In individual donors, short-term general reactions (fever, malaise) and local (soreness, congestion, swelling) may develop in the first two days.In extremely rare cases, allergic reactions (Quincke's edema, hives, polymorphic rash), slight exacerbation of allergic diseases can develop.

Given the possibility of developing allergic reactions of immediate type in particularly sensitive individuals, it is necessary to ensure that the vaccinated persons are observed for 30 minutes. Immunization sites should be provided with antishock therapy.

Interaction:Interaction with other drugs has not been established.
Special instructions:
Form release / dosage:

Suspension for subcutaneous administration.

Packaging:In ampoules of 1 ml. 10 ampoules with instructions for use, with an ampoule or ampoule knife in a pack.
Storage conditions:

The drug is stored (inaccessible to children) and transported in accordance with SP 3.3.2.1248-03 at a temperature of 2 to 8 ° C. Freezing is not allowed.

Shelf life:3 years.
Terms of leave from pharmacies:On prescription
Registration number:LS-002154
Date of registration:05.10.2011 / 04.08.2014
Expiration Date:Unlimited
The owner of the registration certificate:MICROGEN FGUP Scientific and Production Association MICROGEN FGUP Scientific and Production Association Russia
Manufacturer: & nbsp
Information update date: & nbsp01.09.2017
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