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medicalmeds.eu Medicines Vaccines, serums, phage and anatoxins. Tetraanatoxin the cleared adsorbed

Tetraanatoxin the cleared adsorbed

Препарат Тетраанатоксин очищенный адсорбированный. ФГУП НПО «Микроген» Россия


Producer: Federal state unitary enterprise NPO Mikrogen Russia

Code of automatic telephone exchange: J07AX

Pharm group: Vaccines

Release form: Liquid dosage forms. Solution for injections.

Indications to use: Botulism. Tetanus.


General characteristics. Structure:

Active ingredient: liquid mix of the cleared botulinic (types A, B and E) adsorbed on gel of aluminum of hydroxide and tetanic the anatoxins received from toxins of the corresponding microorganisms Clostridium botulinum of type A, Clostridium botulinum of type B (the special name beans), Clostridium botulinum of type E, Clostridium tetani neutralized by formaldehyde and heat in 1 ml (1 dose): 5 binding units (BU) of botulinic anatoxin of type A, 3 EU of botulinic anatoxin of type B, 3 EU of botulinic anatoxin like E, 2,5 EU of tetanic anatoxin.

Excipients: aluminum hydroxide in terms of aluminum, tiomersat, formaldehyde.





Indications to use:

Prevention of botulism and tetanus at persons aged from 16 up to 60 years (the woman up to 55 years).


Route of administration and doses:

The course of primary immunization consists of three inoculations: double vaccination with an interval of 25-30 days and revaccinations in 6-9 months.

In need of lengthening of intervals the next inoculation should be carried out to perhaps next time. The subsequent single revaccinations spend each 5 years according to indications.

The single dose of drug makes 1 ml. The drug is administered subcutaneously to the infrascapular area (on 1 cm from a bottom corner of a shovel to a back midline).

Before use the ampoule with drug needs to be stirred up carefully before receiving a homogeneous suspension. Administration of drug is registered in the established registration forms with the indication of manufacturer, number of a series, period of validity, Date of Introduction and the nature of reaction to administration of drug.


Features of use:

Drug in ampoules with the broken integrity, lack of marking is unsuitable to use, at change of physical properties (discoloration, existence of not breaking flakes), at the expired period of validity, the wrong storage.

Opening of ampoules and the procedure of vaccination are carried out at strict observance of rules of an asepsis and antiseptics.

Drug in the opened ampoule is not subject to storage. Considering possibility of an acute anaphylaxis, it is necessary to provide medical observation for imparted within 30 minutes after administration of drug.

Venues of inoculations have to be equipped with means of antishock therapy, including adrenaline (Epinephrinum).


Side effects:

In the first two days after administration of drug the general and local reactions can develop. The general reaction is shown by temperature increase, an indisposition, local reactions – emergence of a dermahemia, puffiness of soft tissues or small infiltrate, in rare instances development of regional lymphadenitis.

Existence of consolidations on site of the previous injection is not a contraindication for carrying out the following inoculation. In this case the drug is administered on the party opposite to the place of the previous introduction. It is necessary to consider a possibility of development in exceptional cases of an acute anaphylaxis at certain especially sensitive persons.


Interaction with other medicines:

The drug can be administered at the same time (different syringes in different body parts) with a vaccine of a tick-borne encephalitis and a vaccine tulyaremiyny. To persons, fully vaccinated from tetanus, it is recommended to enter anatoxin botulinic. The interval from the previous other infections inoculations has to be not less than one month.


Contraindications:

1. Allergic reactions to the previous administration of drug or its components.
2. Acute infectious and noninfectious diseases, an exacerbation of chronic diseases, infectious and noninfectious diseases of the central nervous system in the anamnesis. Inoculations carry out not earlier than one month from the moment of recovery (remission).
3. Blood diseases.
4. Diseases of endocrine system.
5. Blood circulatory system diseases.
6. Bronchial asthma and other allergic diseases, heavy allergic reactions to foodstuff, medicinal and other substances.
7. System lupus erythematosus and other diseases of connecting fabric.
8. Malignant new growths.
9. Pregnancy, lactation period.



Storage conditions:

To store at a temperature from 2 to 8 °C. Freezing is not allowed. To store in the places not available to children. A period of validity - 3 years. Drug in the opened ampoule is not subject to storage!


Issue conditions:

According to the recipe


Packaging:

Suspension for hypodermic introduction. On 1 ml (1 dose) or 3 ml (3 doses) in ampoules. On 10 ampoules in a box from a cardboard. On 5 ampoules on 1 ml in a blister strip packaging from a film polyvinyl chloride. On the 2nd blister strip packagings in a pack from a cardboard. Put the application instruction and a knife in a pack or a box ampoule or the scarificator ampoule. When packaging the ampoules having a ring of a break or a point for opening the knife ampoule or the scarificator ampoule is not put.



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