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

AC-toxoid is a tetanus toxoid, adsorbed on aluminum hydroxide.

1 dose (0.5 ml) contains:

Anatoxin with preservative: tetanus toxoid - 10 units of binding (EU); auxiliary substances: aluminum hydroxide (in terms of aluminum) - not more than 0.55 mg; thiomersal - from 42.5 to 57.5 μg; formaldehyde - no more than 100 mcg.

Anatoxin without preservative: tetanus toxoid - 10 units of binding (EU); auxiliary substances: aluminum hydroxide (in terms of aluminum) - not more than 0.55 mg; formaldehyde - no more than 100 mcg.

Specific activity of tetanus toxoid is not less than 1000 EC / mg protein nitrogen.

Description:The suspension is a yellowish white color, separated upon settling onto a clear supernatant and a yellowish-white 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 introduction of the drug in accordance with the approved scheme causes the formation of specific antitoxic immunity against tetanus.
Indications:

The drug is designed for active immunization against tetanus, as well as emergency specific tetanus prophylaxis.

Contraindications:

- Strong reaction or post-vaccination complication of previous vaccine administration;

- acute infectious and non-infectious diseases - vaccinations are given no earlier than 1 month after recovery;

- chronic diseases - vaccinations are carried out at 1 month from the onset of remission;

- neurological changes - vaccinated after exclusion of the progression of the process;

- allergic diseases - vaccinations are carried out after 2-4 weeks of remission,while stable manifestations of the disease (localized skin conditions, hidden bronchospasm, etc.) are not contraindications to vaccination, which can be performed against the background of appropriate therapy.

Immunodeficiency, HIV infection, as well as supported course therapy, including steroid hormones and anticonvulsants, are not contraindications to routine vaccination, which is carried out 12 months after the end of treatment.

In order to identify contraindications, the doctor (paramedic at the FAP) on the day of vaccination is conducting a survey and examination of the vaccinated with mandatory thermometry. Persons temporarily released from vaccination should be monitored and vaccinated in a timely manner.

Pregnancy and lactation:

When routine vaccination is not recommended to administer the vaccine to pregnant women. Application in during pregnancy and during breastfeeding is possible only with emergency prevention when the intended benefit to the mother exceeds the estimated risk to the fetus or child.

Dosing and Administration:

AC-toxoid injected deep subcutaneously in the subscapular region in a dose of 0.5 ml.Before vaccination, the ampoule must be shaken thoroughly until a homogeneous suspension is obtained.

Active immunization. The full course of vaccination with AS-anatoxin (for persons not previously vaccinated against tetanus) consists of two vaccinations with an interval of 30-40 days and a booster at 6-12 months (as an exception, the interval can be extended to 2 years). Subsequent revaccinations are carried out every 10 years by AC- or ADS-M-anatoxin once.

Immunization of some (elderly people, unorganized population), taking into account specific conditions in individual localities, may be carried out by a decision of the Ministry of Health of the Russian Federation according to a reduced scheme providing for a single introduction AC-anatoxin in a double dose (1.0 ml) with the first revaccination in the period from 6 months to 2 years and subsequent revaccinations every 10 years with usual doses of the drug (0.5 ml).

Note. Active immunization of children against tetanus from 3 months is carried out in a planned manner by adsorbed pertussis-diphtheria-tetanus vaccine (DTP-vaccine), or adsorbed diphtheria-tetanus toxoid (ADS- or ADS-M-anatoxin) in accordance with the instructions for the use of drugs.

Emergency prophylaxis of tetanus.

Emergency specific prevention tetanus is carried out at:

-faults with integrity violation skin and mucous membranes;

- frostbite and burns (thermal, chemical, radiation) of the second, third and the fourth degree;

-hospital abortions;

- outside of medical institutions;

gangrene or tissue necrosis of any type, long-term abscesses;

-bites by animals;

penetrating damage gastrointestinal tract.

Emergency tetanus prophylaxis provides for primary surgical treatment of the wound and the creation, if necessary, of specific immunity against tetanus. Emergency Immunoprophylaxis should be carried out as soon as possible from the time of injury, up to 20 days, given the duration of the incubation period for tetanus.

For emergency specific prevention of tetanus use:

-A-toxoid;

-immunoglobulin antitetanus human (IPHS);

- In the absence of IPSH, anti-tetanus horse purified concentrated liquid (PSS) serum.

The choice of prophylactic agents for emergency specific tetanus prophylaxis is presented in Table 1.

The AS-anatoxin is injected deep into the subcutaneous region.

IPSCH is administered at a dose of 250 ME intramuscularly into the upper-outer quadrant of the buttocks.

PSS is administered at a dose of 3000 ME subcutaneously (see the instructions for use of anti-tetanus serum).

Note. Before the introduction of tetanus toxoid to determine the sensitivity to a foreign protein, an intradermal test with horse serum diluted 1: 100 is mandatory (it is available as a complete set with PSS). The introduction of the drug is registered in the established registration forms with the indication of the serial number, expiration date, the enterprise manufacturer, date of introduction.

Table 1

The scheme of the choice of preventive measures in carrying out an emergency specific tetanus prophylaxis

Previous vaccinations against tetanus A drug containing tetanus toxoid

Age group

Dates after the last vaccination

The drugs used

AC1-anatoxin

IPSC2

MSS

1

2

3

4

5

6

There is a documentary evidence of vaccination

Full course of planned vaccinations according to age

Children and teens

Regardless of the term

Do not inject3

Do not inject

Do not inject

The course of routine vaccinations without the last age-related revaccination

Children and teens

Regardless of the term

0.5 ml

Do not inject

Full immunization schedule4

Adults

Not more than 5 years

Do not inject

More than 5 years

0.5 ml

Do not inject

Two Inoculations5

All ages

Not more than 5 years

0.5 ml

Do not inject

More than 5 years

1.0 ml

250 ME

3000 ME7

One inoculation

All ages

Not more than 2 years

0.5 ml

Do not inject6

More than 2 years

1.0 ml

250 ME

3000ME7

Not vaccinated

Children up to 5 months


Not

introduce9

250 ME


Other ages


0.5 ml7, 8

250 ME

3000 ME

There is no documentary evidence of vaccination

In the anamnesis there were no contraindications to inoculations

Children up to 5 months


Do not inject

250 ME


Children from 5 months, teenagers, military personnel


0.5 ml

He introduce6

In the anamnesis there were no contraindications to inoculations

Former servicemen


0.5 ml

He introduce6

Other contingents

All ages


1.0 ml

250 ME

3000 ME







Note. 1. Instead 0,5 ml AC-atoxin can be used ADS-M-anatoxin if vaccination against diphtheria with this drug is necessary. If wound localization allows, the AS-anatoxin is preferably administered to the area of ​​its location by subcutaneous cleavage.

2. Use one of these drugs: IPSC or MSS (it is preferable to introduce IPAH).

3. In case of "infected" wounds, 0.5 ml of AC-anatoxin is administered if after the last booster, 5 years or more have passed.

4. Full immunization schedule AC-anatoxin for adults consists of two inoculations of 0.5 ml each with an interval of 30-40 days and a booster at 6-12 months with the same dose. Under the reduced scheme the full course of immunization includes a single vaccination AC-anatoxin in a doubled dose (1 ml) and revaccination at 6 months - 2 years with a dose of 0.5 ml of AS-toxoid.

5. Two inoculations according to the usual scheme of immunization (for adults and children) or one inoculation under the reduced scheme of immunization for adults.

6. In case of "infected" wounds, IPSH or PSS are administered.

7. All persons who received active-passive prophylaxis should be revaccinated with 0.5 ml of AS-anatoxin to complete the course of immunization after 6 months - 2 years.

8. If necessary, assign AC-Anatoxin for children under 6 years of age the drug should be administered intramuscularly.

9. After the normalization of the post-traumatic state, children should be vaccinated with DTP vaccine.

Side effects:

AC-anatoxin is a slightly reactogenic drug. In individual vaccinated in the first two days, short-term general (fever, malaise) and local (soreness, hyperemia, swelling) reactions can develop.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, vaccinated people should be provided with medical supervision for 30 minutes. Vaccination sites should be provided with anti-shock therapy.

Overdose:Not installed.
Interaction:Not installed.
Special instructions:

The preparation is not suitable for use in ampoules with broken integrity, lack of marking, with changing physical properties (color change, presence of non-breaking flakes and foreign inclusions, turbidity of sera and immunoglobulins), 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.

Effect on the ability to drive transp. cf. and fur:No information.
Form release / dosage:Suspension for subcutaneous administration.
Packaging:

Suspension for subcutaneous administration (with a preservative) of 0.5 ml (one inoculation dose) or 1 ml (two inoculations) in

Suspension for subcutaneous administration (without preservative) 0.5 ml (one inoculum dose) into ampoules.

For 10 ampoules in a box with instructions for use and scarifier or 5 ampoules in a contoured cell pack of polyvinylchloride or polystyrene film, 2 contour packs in a pack with instructions for use and a scarifier.

When packing ampoules that have a notch, a ring or break point, the scarifier is not inserted.

Storage conditions:

Conditions of transportation. According to SP 3.3.2.1248-03 at a temperature of 2 to 8 ° C. Freezing is not allowed.

Shelf life:

3 years. The drug with expired shelf life is subject to application.

Terms of leave from pharmacies:On prescription
Registration number:LS-000434
Date of registration:04.05.2010 / 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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