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

Anatoxin tetanus purified adsorbed liquid is formaldehyde and heat neutralized tetanus toxin, purified from ballast proteins, adsorbed on aluminum hydroxide.

A single dose of the preparation (0.5 ml) contains: 10 units of tetanus toxoid binding (EC), not more than 1.25 mg aluminum hydroxide in terms of aluminum (sorbent), from 42.5 to 57.5 μg thiomersal (preservative).

Description:The suspension is grayish white, separated when standing on a loose sediment of grayish-white color, shattering when shaken, and a clear, colorless supernatant.
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 immunity against tetanus.
Indications:

The drug is intended for active immunization against tetanus (for persons previously not vaccinated against tetanus), as well as for emergency specific prevention tetanus.

Contraindications:

Constant contraindications are a strong reaction or post-vaccination complication of previous treatment AC/ RTI & gt; It is not recommended to use routine vaccinations for pregnant women and during difficult feeding.

Persons who have had acute illnesses are vaccinated not earlier than 1 month after clinical recovery.

Patients with chronic diseases are vaccinated not earlier than 1 month after reaching remission. Children with neurologic disorders (reflex muscle rigidity, facial asymmetry, hand tremors, neuralgia) are vaccinated after excluding the progression of the process. Patients with allergic diseases are vaccinated after 2-4 weeks, after the end of exacerbation,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 supporting course therapy, in including steroid hormones and anticonvulsants, are not contraindications to vaccination.

In order to identify contraindications, the doctor (paramedic at the feldsher-midwife) on the day of vaccination is conducting a survey of parents and examining the vaccinated with mandatory thermometry. When vaccinating adults, preliminary selection of persons to be vaccinated is possible with their interview by a medical worker on the day of vaccination, which conducts the vaccination. Persons temporarily released from vaccination should be monitored and accounted for and promptly vaccinated.

Carefully:

Vaccination with caution is carried out in patients with chronic diseases, neurological disorders and allergic reactions.

The use of children and adults with chronic diseases is given in the section "Contraindications for use".

Pregnancy and lactation:

It is not recommended to use routine vaccinations for pregnant women and during difficult feeding.

Application during pregnancy and during breastfeeding is possible only on absolute epidemiological indications, taking into account the risk / benefit ratio, i.e. when the intended benefit to the mother exceeds the estimated risk for the fetus or infant.

Dosing and Administration:

AC-anatoxin is injected deeply subcutaneously into the subscapular region at a dose of 0.5 ml (single dose). Before vaccination, the ampoule must be shaken thoroughly until a homogeneous suspension is obtained.

The introduction of the drug is registered in the prescribed accounting forms with the indication of the serial number, expiration date, the manufacturer's enterprise, the date of introduction.

Active immunization:

Full course of vaccination AC-anatoxin (for persons not previously vaccinated against tetanus) consists of two inoculations of 0.5 ml with an interval of 30-40 days. And a booster vaccine at 6-12 months once in the same dose (as an exception the interval can be extended to 2 years). Subsequent revaccinations every 10 years AC or ADS-M toxoid once in the same dose.

Immunization some hard-to-reach contingents (elderly people, unorganized population), taking into account the specific conditions in in accordance with the decision of the Ministry of Health and Social Development of the Russian Federation, can be carried out 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 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 use of the drugs.

Emergency prevention of tetanus:

Emergency specific tetanus prophylaxis is performed with:

- trauma with violation of the integrity of the skin and mucous membranes;

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

- community-acquired abortions;

- Delivery outside medical institutions;

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

- bites by animals;

- penetrating lesions of the gastrointestinal tract.

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

For emergency specific prevention of tetanus use:

- AC-toxoid;

- antitetanus, human immunoglobulin (PCMI);

- in the absence of ANTI serum anti-tetanus horse purified concentrated liquid (PSS).

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

PSCHI is administered at a dose of 250 ME intramuscularly into the upper-outer quadrant of the buttock (see the instructions for the use of tetanus antitumor immunoglobulin).

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

Note: before administration of antitetanus serums to determine the sensitivity to a foreign protein is required to place an intradermal test with horse serum diluted 1: 100 (available in complete with PSS).

Table 1 Scheme of the choice of preventive measures in the conduct emergency specific tetanus prophylaxis.

Prior vaccinations against tetanus

Age

Group

Timing, after the last inoculation

The drugs used

Presence of documents on previous vaccinations

Previous vaccinations against tetanus by any drug,

containing tetanus toxoid

AC1

PCMI1

MSS

There is a documentary immunization confirmation

Full course of planned vaccinations according to age

Children and teens

Regardless of the term

Not

Introduce3

Not

introduce

He

introduce

Course of planned inoculations without the last age-related revaccination

Children and teens

Regardless of the term

0.5 ml

Not

introduce

He

introduce

Full immunization schedule4

Adults

Not more than 5 years

More than 5 years

Do not inject,

0.5 ml

Do not inject Do not inject

Do not inject

Do not inject

Two Inoculations5

All ages

Not more than 5 years

More than 5 years

0.5 ml 1.0 ml

Not

250 ME

He

introduce

3000

ME7

One inoculation

All ages

Not more than 2 years More than 2 years

0.5 ml 1.0 ml

Do not inject6

250 ME

Do not inject6

3000

ME7

Not vaccinated

Children up to 5 months.

The rest of the age

-

Do not inject8

0.5 ml 7

250 ME 250 ME

3000

ME

3000 ME

No documented confirmation of vaccination

In the anamnesis was not contraindications to vaccinations

Children up to 5 months.

-

Not

introduce

250 ME

3000

ME

Children from 5 months., adolescents

-

0.5 ml

He introduce6

He

Introduce6

military personnel,

ex-servicemen

-

0.5 ml

He

Introduce6

He

Introduce6

Other contingents

All ages

-

1.0 ml

250 ME

3000

ME

Notes:

1. Instead of 0.5 ml of AS, you can use ADS-M if vaccination against diphtheria is necessary.

2. Use one of these drugs: PSIH or PSS (it is preferable to introduce PCHI).

  1. In case of "infected" wounds, 0.5 ml of AS are injected, if after the last revaccination has passed 5 or more years.
  2. The full course of immunization of AS for adults consists of two inoculations of 0.5 ml each with an interval of 30-40 days and a revaccination through 6-12 months in the same dose. According to the reduced scheme, the full course of immunization includes a single vaccination of the AC in a doubled dose (1.0 ml) and a booster dose after 1-2 years in a dose of 0.5 ml AS.
  3. Two vaccinations according to the usual immunization schedule (for adults and children) or one inoculation with a reduced immunization schedule for adults.
  4. In the case of "infected" wounds, POCs or PSS are administered.
  5. All persons who received active-passive prophylaxis should be revaccinated with 0.5 ml of AS to complete the course of immunization after 6 months - 2 years.
  6. After normalizing the post-traumatic state, children should be vaccinated with DTP vaccine.
Side effects:

AC-anatoxin is slightly reactogenic drug. In individual vaccinated in the first two days, short-term general (fever, malaise) and local (soreness, hyperemia, swelling at the injection site) may develop.

Allergic reactions may develop (Quincke's edema, hives, polymorphous rash), exacerbation of allergic diseases. Given the possibility of developing allergic reactions of immediate type in particularly sensitive individuals, vaccinated patients should be provided with medical supervision for 30 minutes. Vaccination sites should be provided with anti-shock therapy.

Persons who gave the introduction AC-anatoxin heavy forms of allergic reactions, further routine vaccinations with the drug are discontinued.

Overdose:

Symptoms of overdose are not revealed.

Interaction:

Interactions with other drugs have not been established.

Special instructions:

AC-anatoxin is a grayish-white suspension. During storage, it is possible to form a grayish white precipitate and a transparent supernatant. Before use, the vaccine should be thoroughly shaken until a homogeneous, greyish white suspension is obtained and checked visually for the absence of foreign particles and / or change in appearance. In case of detection of foreign particles or change in appearance, the vaccine is not to be used. Also, the drug is not suitable for use in ampoules with broken integrity, lack of marking, 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:

The drug does not affect the ability to drive vehicles.

Form release / dosage:Suspension for subcutaneous administration.
Packaging:

AC-anatoxin is released as a suspension for subcutaneous administration in ampoules containing 0.5 ml (one inoculation dose) or 1.0 ml (two inoculations).

5 ampoules in the outline of the cell.Two contour mesh packages together with instructions for use or 10 ampoules with a separating snake and instructions for use and a scapegrator ampoule in a pack of cardboard.

When using ampoules with a kink ring or break point, a scarifier ampoule does not invest.
Storage conditions:

Store in a dry, protected from light place at a temperature of 4 to 8 ° C. Do not freeze. The drug, which has been frozen, is not subject to application.

Keep out of the reach of children.

Shelf life:

3 years. Do not use after the expiration date.

Terms of leave from pharmacies:On prescription
Registration number:P N002667 / 01-2003
Date of registration:04.07.2008 / 18.05.2012
Expiration Date:Unlimited
The owner of the registration certificate:BIOMED them. I.I.Mechnikova, OJSC BIOMED them. I.I.Mechnikova, OJSC Russia
Manufacturer: & nbsp
Information update date: & nbsp01.09.2017
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