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
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Active substanceDiphtheric anatoxinDiphtheric anatoxin
Dosage form: & nbspsuspension for injections
Composition:

AD-M toxoid is a diphtheria toxoid sorbed on aluminum hydroxide.

A single dose of the drug (0.5 ml) contains: 5 flocculating units (Lf) diphtheria toxoid, 0.25 to 0.55 mg aluminum hydroxide in terms of aluminum (sorbent), from 42,5 before 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.07.A.F   Vaccine for the prevention of diphtheria

J.06.A.A.01   Diphtheria Antitoxin

Pharmacodynamics:

Administration of the drug in accordance with the approved scheme causes the formation of specific immunity against diphtheria.

Indications:

Prevention of diphtheria in children from 6 years of age, adolescents and adults in accordance with the National Calendar of preventive vaccinations and the Calendar preventive vaccinations according to epidemiological indications.

Contraindications:

Constant contraindications are a strong reaction or post-vaccination complication of previous administration of AD-M toxoid. The use of routine vaccinations is not recommended pregnant women and during breastfeeding.

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 month after reaching remission. Persons with neurologic disorders (reflex muscle rigidity, facial asymmetry, hand tremors, neuralgia) are vaccinated after exclusion progression of the process. Patients with allergic diseases are vaccinated 2-4 weeks after the end of exacerbation, while stable manifestations diseases (localized skin phenomena, hidden bronchospasm, etc.) are not contraindications to vaccination, which can be carried out against the background of appropriate therapy.

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

In order to identify contraindications, a doctor (a paramedic in a feldsher-midwifery point) on the day of vaccination, conducts a survey of parents and examines the vaccinated with mandatory thermometry. When vaccinating adults, pre-selection of individuals, subject to inoculation, with their interview by a medical worker on the day of vaccination, conducting vaccination. Persons temporarily released from vaccination should be monitored and accounted for and promptly vaccinated.

Pregnancy and lactation:Application during pregnancy and during breast-feeding 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 to the fetus or of an infant.
Dosing and Administration:

AD-M anatoxin is injected intramuscularly into the upper external quadrant of the buttock or anterolateral part of the thigh, or deeply subcutaneously (adolescents and adults) in the subscapular region at a dose of 0.5 ml (single dose). Before Inoculation of the ampoule should be thoroughly shaken until a homogeneous suspension is obtained.

AD-M toxoid is used:

- For planned age-related revaccinations, those who received a previous vaccination AC-anatoxin in connection with emergency prevention of tetanus. The drug is administered once.

- For planned revaccinations of children at 7 and 14 years, in the case of administration between revaccinations AC-anatoxin in connection with emergency tetanus prophylaxis. The drug is administered once.- To immunize adults (no age limit), vaccinated against tetanus less than 10 years ago in a planned manner. The drug is administered once.

- Adults not previously vaccinated against diphtheria require a full course of immunization (two vaccinations of AD-M with anatoxin at intervals of 30 days and revaccination in 6-9 months). Regular revaccination in 10 years AD-M toxoid.

AD-M anatoxin is administered in accordance with the National Calendar preventive vaccinations and the Calendar of preventive vaccinations for epidemiological indications.

The preparation of the drug is registered in the established registration forms with the indication number of series, expiration date, manufacturer's company, date of introduction.

Side effects:

Individual vaccinated in the first two days can develop short-term general (fever, malaise) and local (soreness, congestion, swelling at the injection site) reactions.

Allergic reactions may develop (Quincke's edema, hives, polymorphous rash), exacerbation of allergic diseases. Given the possibility of development allergic reactions of immediate type in especially sensitive individuals, followed by grafted it is necessary to provide medical supervision for 30 minutes. Locations Inoculations should be provided with anti-shock therapy.

To persons who have given severe forms of allergic reactions to the administration of AD-M toxoid, further routine vaccinations are discontinued.

The use of children and adults with chronic diseases see Contraindications for use.

Overdose:

Symptoms of overdose are not revealed.

Interaction:

AD-M toxoid can be administered simultaneously with poliomyelitis vaccine and other drugs national calendar of vaccinations.

Special instructions:

AD-M toxoid is a grayish white suspension. During storage, the formation of a grayish white precipitate and a transparent supernatant. Before use, the vaccine is necessary shake thoroughly until a homogeneous, greyish-white suspension is obtained and check visually for the absence of foreign particles and / or change in appearance. When detection of foreign particles or changing the appearance of the vaccine is not subject to use. Also, the drug is not suitable for use in ampoules with impaired integrity, lack of marking, improper storage.

The closure of ampoules and the vaccination procedure are carried out under strict observance rules of asepsis and antiseptics. The drug in the opened ampoule is not subject to storage.

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

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 intramuscular and subcutaneous administration.
Packaging:

AD-M toxoid is released as a suspension for intramuscular and 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 cell packs together with instructions for use or 10 ampoules with a separating snake and instruction on application and scarifier ampullum 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, dark place at temperature from 4 to 8 ° С. 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 N002665 / 01-2003
Date of registration:01.07.2008 / 17.05.2012
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: & nbsp29.08.2017
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