Anatoxin diphtheria purified adsorbed with a reduced content of antigens liquid (AD-M-anatoxin) (Anatoxinum diphthericum purificatum adsorptum cum quantitate minore antigenori fluidum)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
Read on
Active substanceDiphtheric anatoxinDiphtheric anatoxin
Dosage form: & nbspsuspension for intramuscular and subcutaneous administration
Composition:

AD-M-anatoxin is a diphtheria toxoid adsorbed on aluminum hydroxide.

1 dose (0.5 ml) contains:

Anatoxin with preservative: diphtheria toxoid - 5 flocculating units (Lf);

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); 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.

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.07.A.F   Vaccine for the prevention of diphtheria

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.

Indications:

Prevention of diphtheria in children, adolescents and adults.

Contraindications:

- FROMa different reaction or post-vaccination complication of the previous administration of the AD-M vaccine;

- acute infectious and non-infectious diseases - vaccinations are given no earlier than 2-4 weeks after recovery. With mild forms of diseases (rhinitis, mild hyperemia of the throat and etc.) Inoculation 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 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 with emergency prevention, when the intended benefit to the mother exceeds the estimated risk for the fetus or the baby.

Dosing and Administration:

AD-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.

AD-M-anatoxin is used:

1. For planned age-related revaccinations at 6-7 and 14 years, in the case of the introduction between revaccinations AC-anatoxin in connection with emergency prevention of tetanus. The drug is administered once.

2. For immunization of adults (without age limit):

- vaccinated against tetanus less than 10 years ago in a planned manner. The drug is administered once;

- in the case e(If it is known that adults have not previously been vaccinated against diphtheria, they should receive a full course of immunization (two vaccinations with AD-M-anatoxin at intervals of 30 days and a booster at 6-9 months). Regular revaccinations are carried out 10 years later by ADS-M-anatoxin.

AD-M-anatoxin, can be administered after a month or simultaneously with poliomyelitis vaccine and other drugs of the national; the 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:

AD-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, 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.

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.

Immunization vaccinations: nonimmune persons with the above diseases, who are in direct contact with patients with diphtheria (family, class, dormitory room, etc.), can be vaccinated according to the expert's conclusion before the 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 (one inoculation dose) or 1 ml (two inoculations) in ampoules.

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

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

When packing ampoules that have a notch, ring or break point, the ampoule scaper does not put it.

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 ° C. 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-000284
Date of registration:27.04.2010 / 25.08.2014
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: & nbsp29.08.2017
Illustrated instructions
    Instructions
    Up