Anatoxin diphtheria-tetanus purified adsorbed with a reduced content of antigens liquid (ADS-M-anatoxin) (Anatoxinum diphtherico-tetanicum purificatum adsorptum cum quantitate minore antigenorum)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Active substanceAnatoxin diphtheria-tetanusAnatoxin diphtheria-tetanus
Dosage form: & nbspsuspension for intramuscular and subcutaneous administration
Composition:

ADS-M-anatoxin consists of a mixture of purified diphtheria and tetanus toxoid adsorbed on aluminum hydroxide.

In 1 dose (0.5 ml) contains:

Anatoxin with preservative: diphtheria toxoid - 5 flocculating units (Lf); tetanus toxoid - 5 units of binding (EU);

Excipients: aluminum hydroxide (in terms of aluminum) - not more than 0.55 mg; thiomersal - from 42.5 to 57.5 μg; formaldehyde - no more than 50 mcg.

Anatoxin without preservative:

diphtheria toxoid - 5 flocculating units (Lf), tetanus toxoid - 5 units of binding (EU); Excipients: aluminum hydroxide (in terms of aluminum) - not more than 0.55 mg; formaldehyde - no more than 50 mcg.

Specific activity of diphtheria toxoid is not less than 1500 Lf / mg protein nitrogen, tetanus toxoid - 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.A   Immune Serums

J.06.A.A.02   Tetanus antitoxin

J.06.A.A.01   Diphtheria Antitoxin

Pharmacodynamics:

The introduction of the drug in accordance with the approved scheme causes the formation of specific antitoxic immunity against diphtheria and tetanus.

Indications:

Prevention of diphtheria and tetanus in children, adolescents and adults.

Contraindications:

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

- acute infectious and non-infectious diseases - vaccinations are given no earlier than 2-4 weeks after recovery. In mild forms of diseases (rhinitis, mild hyperemia of the throat, etc.), grafting is allowed after the disappearance of clinical symptoms;

- chronic diseases - vaccinations are performed after complete or partial remission;

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

- allergic diseases - vaccinations are carried out 2 to 4 weeks after the end of the 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.

Pregnancy and lactation:

Application during pregnancy and during breastfeeding is possible only if the intended benefit to the mother exceeds the estimated risk for the fetus or child.

Dosing and Administration:

Method of application and dosage. ADS-M-anatoxin is administered intramuscularly in the antero-external part of the thigh, or deep subcutaneously (adolescents and adults) in the subscapular region at a dose of 0.5 ml.Before vaccination, the ampoule must be shaken thoroughly until a homogeneous suspension is obtained.

ADS-M-anatoxin is used:

1. For planned age-related revaccinations in 6-7 and 14 years, then every subsequent 10 years without age restriction.

Note. Adults vaccinated with tetanus toxoid less than 10 years ago are vaccinated with AD-M-anatoxin.

2. To vaccinate children 6-7 years of age and older, previously unvaccinated against diphtheria and tetanus.

The vaccination course consists of two vaccinations with an interval of 30-45 days. The reduction of the interval is not allowed. If it is necessary to increase the interval, the next vaccination should be carried out as soon as possible.

The first revaccination is carried out 6-9 months after the completed vaccination once, the second revaccination - with an interval of 5 years. Subsequent revaccinations are performed in accordance with claim 1.

3. As a substitute for DTP vaccine (ADS-anatoxin) in children with strong general reactions (temperature up to 40 ° C and above) or post-vaccination complications for these drugs. If the reaction has developed for the first vaccination with DTP vaccine (ADS-toxoid), the second inoculation is performed by ADS-M-anatoxin no earlier than 3 months; if the reaction developed into a secondvaccination with DTP vaccine (ADS-toxoid), then the vaccination against diphtheria and tetanus is considered complete. In both cases, the first revaccination with ADS-M-anatoxin is carried out after 9-12 months. If the reaction has developed for the third vaccination with DTP vaccine (ADS-toxoid), the first revaccination with ADS-M-anatoxin is carried out after 12-18 months.

4. For the vaccination of adults who had not previously been immunized against diphtheria and tetanus, a full course (two vaccinations with ADS-M-anatoxin at intervals of 30 days and a booster at 6-9 months) are carried out.

In the foci of diphtheria, prophylactic vaccinations are carried out in accordance with the instructive and methodological documents of the Ministry of Health of Russia.

ADS-M-anatoxin can be administered after a month or simultaneously with poliomyelitis vaccine and other preparations of the national calendar of preventive vaccinations.

The preparation of the drug is registered in the established registration forms with the indication of the serial number, expiry date, manufacturer, date of introduction.

Side effects:

ADS-M-anatoxin is one of the least reactogenic drugs. In individual vaccinated in the first two days, short-term general (fever, malaise) and local (soreness, hyperemia, infiltration, swelling) reactions can develop.Given the possibility of developing allergic reactions of the immediate type (Quincke's edema, urticaria, polymorphic rash, anaphylactic shock) in particularly sensitive individuals, it is necessary to provide medical supervision for vaccinated persons within 30 minutes. Vaccination sites should be provided with anti-shock therapy.

Overdose:

Not installed.

Interaction:Not installed.
Special instructions:

Immunodeficiencies, HIV infection, as well as supporting course therapy, including steroid hormones and psychopharmaceuticals, are not contraindications to vaccination.

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. When vaccinating adults, a preliminary selection of persons to be vaccinated is possible with their interview by a medical worker who performs vaccination on the day of vaccination. Persons temporarily released from vaccination should be monitored and accounted for and promptly vaccinated.

Vaccinations for epidopokazaniyam: nonimmune persons with the diseases listed in the section "Contraindications to use," in direct contact with patients with diphtheria (family, class,dorm room, etc.), can be vaccinated according to the conclusion of a specialist before the onset of recovery (remission) against the background of appropriate therapy.

Precautions for use. 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.

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 intramuscular and subcutaneous administration.
Packaging:

Suspension for intramuscular and subcutaneous administration (with preservative) to 0.5 ml (1 inoculation dose) or 1 ml (2 inoculations) in ampoules.

Suspension for intramuscular and subcutaneous administration (without preservative) 0.5 ml (1 inoculation dose) into ampoules.

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

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

Storage conditions:

According to SP 3.3.2.1248-03 at a temperature of 2 to 8 ° C. Freezing is not allowed. Keep out of the reach of children.

Transportation conditions. According to SP 3.3.2.1248-03 at a temperature of 2 to 8 FROM. Freezing is not allowed.

Shelf life:3 years. The drug with expired shelf life is not subject to application.
Terms of leave from pharmacies:On prescription
Registration number:LS-000283
Date of registration:27.04.2010 / 08.11.2013
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: & nbsp29.08.2017
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