Anatoxin diphtheria-tetanus purified adsorbed liquid (ADS-toxoid) (Anatoxinum diphterico-tetanicum purificatum adsorptum fluidum)

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 injection
Composition:

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

A 1 dose (0.5 ml) contains: 30 flocculating units (Lf) diphtheria toxoid and 10 binding units (EC) of tetanus toxoid; auxiliary substances: not more than 0.55 mg of aluminum hydroxide (in terms of aluminum), from 42.5 to 57.5 μg of thiomersal and not more than 50 μg of formaldehyde.

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.
Contraindications:

- FROMor a post-vaccination complication of previous vaccine administration

- 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 carried out upon the achievement of complete or partial remission;

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

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

Pregnancy and lactation:

Not applicable, since this drug is intended for use in children.

Dosing and Administration:

ADS-toxoid injected intramuscularly in the antero-external part of the thigh in a dose of 0.5 ml. Before vaccination, the ampoule must be shaken thoroughly until a homogeneous suspension is obtained.

ADS-anatoxin is used:

1. Children who have recovered whooping cough (from 3 months of age until reaching 6 years of age).

2. Children who have contraindications to the introduction of DTP vaccine.

3. Children aged 4-5 years, inclusive, previously not vaccinated against diphtheria and tetanus.

The vaccination course consists of two vaccinations with an interval of 30 days. The reduction of the interval is not allowed. If it is necessary to increase the interval, the next vaccination should be carried out at the nearest possible time, determined by the state of the child's health. Revascularization of ADS-anatoxin is carried out once every 6-12 months after the completed vaccination course. The first revaccination of children aged 6 years and subsequent age-related revaccinations is performed with ADS-M-anatoxin.

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

Note. If the child who had suffered pertussis received three or two DTP vaccines earlier, the vaccination against diphtheria and tetanus is considered complete. In the first case, revaccination with ADS-anatoxin is carried out at 12-18 months, and in the second - 9-12 months after the last injection of the drug. If the child received one DTP vaccine, he is subject to a second vaccination with ADS-anatoxin, followed by a revaccination after 9-12 months. Subsequent age-related revaccinations are performed with ADS-M-anatoxin.

The preparation of the drug is registered in the prescribed registration forms with the indication of the serial number, expiration date, manufacturer, date of introduction, the nature of the reaction to the administration of the drug.

Side effects:

ADS-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.Given the possibility of developing allergic reactions of the immediate type (Quincke's edema, urticaria, polymorphic rash) 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.

Note. When the child develops a strong general reaction (temperature increase to 40 ° C and above) or post-vaccination complication, he is stopped by further ADT-toxoid vaccinations. If the child received two DSA-toxin vaccinations, the vaccination course is considered complete, if the child received one vaccination with an antitumor toxoid, then the vaccination can be continued with ADS-M-anatoxin, which is administered once no earlier than 3 months. In both cases, the first revaccination is performed with ADS-M-anatoxin after 9-12 months after the last inoculation.

Subsequent revaccinations are carried out at 6-7 and 14 years with ADS-M-anatoxin.

When the temperature rises above 38.5 ° C, more than 1% of the vaccinated or the appearance of pronounced local reactions (swelling of soft tissues with a diameter greater than 5 cm, infiltrates with a diameter of more than 2 cm), more than 4%as well as with the development of severe postvaccinal complications of vaccination with the drug of this series are terminated.

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 epidemics: non-immune persons with the diseases listed in the section "Contraindications to use" who are in direct contact with patients with diphtheria (family, class, dormitory room, etc.) may be vaccinated according to the expert's conclusion before the recovery (remission) ) on 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:

Not applicable, since this drug is intended for use in children.

Form release / dosage:Suspension for intramuscular injection.
Packaging:

In ampoules of 0.5 ml (one inoculation dose) or 1 ml (two inoculations). 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, 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.

Conditions of transportation. 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-000331
Date of registration:21.04.2010 / 04.06.2013
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: & nbsp28.08.2017
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