Anatoxin the tetanic cleared adsorbed

General characteristics. Structure:

Active ingredient: the tetanic anatoxin adsorbed on aluminum hydroxide. Specific activity of tetanic anatoxin not less than 1000 EU/mg of protein nitrogen.

Anatoxin with preservative: 10 binding units (BU) of tetanic anatoxin.

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

Anatoxin  without   preservative: 10 binding units (BU) of tetanic anatoxin.

Excipients: aluminum hydroxide (in terms of aluminum), formaldehyde.

Pharmacological properties:

Pharmacodynamics. Administration of drug according to the approved scheme causes formation of specific anti-toxic immunity against tetanus.

Indications to use:

Drug is intended for active immunization against tetanus, and also the emergency specific prevention of tetanus.

Route of administration and doses:

The EXPERT anatoxin enter deeply subcutaneously into the infrascapular area in a dose 0,5 ml. Before an inoculation the ampoule needs to be stirred up carefully before receiving a homogeneous suspension.

Active immunization. The full course of vaccination the EXPERT anatoxin (for the faces which earlier are not imparted against tetanus) consists of two inoculations with an interval of 30-40 days and revaccinations in 6-12 months (as an exception lengthening of an interval up to 2 years is allowed). The subsequent revaccinations spend each 10 years the EXPERT - or ADS-m-anatoxin once.

Immunization of some hardly covered contingents of the population (elderly people, the unorganized population), taking into account specific conditions in certain   areas,  according to  the decision   of the Ministry of Health of the Russian Federation can be carried out according to the reduced scheme providing single introduction the EXPERT anatoxin in the doubled dose (1,0 ml) with the first revaccination during the period from 6 months to 2 years and the subsequent revaccinations every 10 years usual doses of drug (0,5 ml).

Note. Active immunization of children against tetanus of  3 months is carried out in a planned order by the adsorbed pertussoid and diphtheritic and tetanic vaccine (AKDS-vaccine), or the adsorbed diphtheria tetanus vaccine (ADS-or ADS-m-anatoxin) according to application instructions of drugs.

Emergency prevention of tetanus. The emergency specific prevention of tetanus is carried out at:
• injuries with disturbance of integrity of integuments and mucous membranes;
• frostbites and burns (thermal, chemical, radiation) second, third and fourth degree;
• extra hospital abortions;
• childbirth out of medical institutions;
• gangrene or a necrosis of fabrics of any type, it is long the current abscesses;
• stings animals;
• the getting injuries of digestive tract.

The emergency prevention of tetanus provides primary   surgical treatment of a wound and creation, if necessary, of specific immunity against tetanus. The emergency immunoprevention should be carried out from the moment of getting injured, up to the 20th day as soon as possible, considering incubation interval duration at a disease of tetanus.

Apply to the emergency specific prevention of tetanus:

• EXPERT anatoxin;
• immunoglobulin antitetanic person (IPSCh);
• in the absence of IPSCh serum antitetanic horse the cleared concentrated liquid (PSS).

The choice of prophylactics when performing the emergency specific prevention of tetanus is presented in table 1.

The EXPERT anatoxin enter deeply subcutaneously into the infrascapular area. IPSCh enter in a dose 250 ME intramusculary into an upper outside quadrant of a buttock. PSS enter in a dose 3000 ME subcutaneously (see the application instruction of serum antitetanic).

Note. Before administration of antitetanic serum for definition of sensitivity to a foreign protein without fail put an intracutaneous   test with horse serum, divorced 1:100 (is issued complete with PSS).

Administration of drug is registered in the established registration forms with the indication of number of a series, period of validity, manufacturer, Date of Introduction.

Features of use:

Drug in ampoules with the broken integrity, lack of marking is not suitable for use, at change of physical properties (discoloration, existence of not breaking flakes and foreign inclusions, opacification of serums and immunoglobulins), 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.

Use at pregnancy and during breastfeeding. At planned immunization introduction of a vaccine is not recommended to pregnant women. Use during pregnancy and during breastfeeding is possible only when performing the emergency prevention when the estimated advantage for mother exceeds estimated risk for a fruit or the child.

Side effects:

The EXPERT anatoxin is slaboreaktogenny drug. At the separate days imparted in the first two the short-term general can develop (temperature increase, an indisposition) and local (morbidity, a hyperemia, puffiness) reactions.

In exclusively exceptional cases allergic reactions (a Quincke's edema, urticaria, polymorphic rash), an insignificant exacerbation of allergic diseases can develop.

Considering a possibility of development of allergic reactions of immediate type in especially sensitive persons, for vaccinated it is necessary to provide medical observation within 30 min. Venues of inoculations have to be provided with means of antishock therapy.

Interaction with other medicines:

It is not established.

Contraindications:

• strong reaction or postvaccinal complication to the previous introduction  of a vaccine;
• acute infectious and noninfectious diseases – inoculations carry out not earlier than in 1 month after recovery;
• chronic diseases – inoculations carry out in 1 month from the beginning of remission;
• neurologic changes – impart after a process progressing exception;
• allergic diseases – inoculations carry out in 2 - 4 weeks of remission, at the same time stable displays of a disease (the localized skin phenomena, the hidden bronchospasm, etc.) are not contraindications to vaccination which can be carried out against the background of the corresponding therapy.

Immunodeficiencies, HIV infection, and also the supported course therapy, including steroid hormones and anticonvulsant drugs, are not contraindications to planned immunization which is carried out in 12 months after the end of treatment.

For the purpose of identification of contraindications the doctor (the paramedic on medical and obstetrical center) in day of an inoculation conducts survey and survey imparted with obligatory thermometry. The persons which are temporarily exempted from an inoculation have to be put under observation and are timely imparted.

Table 1. The scheme of the choice of prophylactics when performing the emergency specific prevention of tetanus.

Note.

1. Instead of 0,5 ml the EXPERT anatoxin it is possible to use ADS-m-anatoxin if vaccination against diphtheria this drug is necessary. If localization of a wound allows, the EXPERT anatoxin it is preferable to enter into the area of its arrangement by a hypodermic obkalyvaniye.
2. To apply one of the specified drugs: IPSCh or PSS (it is more preferable to enter IPSCh).
3. At the "infected" wounds enter 0,5 ml the EXPERT anatoxin if after the last revaccination there passed 5 and more years.
4. The full course of immunization the EXPERT anatoxin for adults consists of two inoculations on 0,5 ml everyone with an interval of 30-40 days and revaccinations in 6-12 months the same dose. According to the reduced scheme a full course of immunization the EXPERT anatoxin in the doubled dose (1 ml) and a revaccination in 6 months - 2 years a dose of 0,5 ml the EXPERT anatoxin includes single vaccination.
5. Two inoculations according to the usual scheme of immunization (for adults and children) or one inoculation according to the reduced scheme of immunization for adults.
6. At the "infected" wounds enter IPSCh or PSS.
7. All persons who received active and passive prevention for end of a course of immunization in 6 months – 2 years have to be revaktsinirovana of 0,5 ml the EXPERT anatoxin.
8. If necessary to appoint the EXPERT anatoxin children up to 6 years should administer the drug intramusculary.
9. After normalization of a posttraumatic state children have to be imparted by AKDS - a vaccine.

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.

Issue conditions:

According to the recipe

Packaging:

Suspension for hypodermic introduction (with preservative) on 0,5 ml (one inoculative dose) or 1 ml (two inoculative doses) in ampoules. Suspension for hypodermic introduction (without preservative) on 0,5 ml (one inoculative dose) in ampoules. On 10 ampoules in a box with the application instruction and the scarificator or on 5 ampoules in a blister strip packaging from a film polyvinyl chloride or polystyrene, on 2 planimetric packagings in a pack with the application instruction and the scarificator. When packaging the ampoules having a notch, a ring or a point of a break, the scarificator is not put.