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 toxoid consists of a mixture of purified diphtheria and tetanus toxoids sorbed on aluminum hydroxide.

In one dose of the drug (0.5 ml) contains:

Active substances: 5 flocculating units (Lf) diphtheria and 5 units of binding (EC) tetanus toxoid.

Excipients: from 0.25 to 0.55 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.A   Immune Serums

J.06.A.A.02   Tetanus antitoxin

J.06.A.A.01   Diphtheria Antitoxin

Pharmacodynamics:

Administration of the preparation in accordance with approved scheme causes the formation of specific immunity against diphtheria and tetanus.

Indications:

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

Contraindications:

Constant contraindications are a strong reaction or postvaccinal complication of the previous administration of ADS-M toxoid.

Pregnancy and lactation:

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 for the mother exceeds the estimated risk to the fetus or infant.

Dosing and Administration:

ADS-M toxoid is injected intramuscularly into the upper outer quadrant of the buttock or the anterolateral part of the thigh, or deeply subcutaneously (to adolescents and adults) in 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.

ADS-M toxoid is used:

1. For planned age-related revaccinations of children previously vaccinated against diphtheria and tetanus, at the age of 7 and 14 years, then every subsequent 10 years without age restriction. The drug is administered once.

Note. Persons vaccinated with tetanus toxoid between revaccinations are inoculated with AD-M toxoid.

2. For vaccination of children 6 years 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 booster vaccine - at intervals of 5 years once.Subsequent revaccinations are performed every 10 years without age limitation.

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 DTP vaccination, then the ADS-M toxoid is administered only once, after 3 months, if the reaction develops for a second vaccination, then the vaccination against diphtheria and tetanus is considered complete. In both cases, the first revaccination with anatoxin is carried out after 9-12 months. If the reaction has developed for the third vaccination of DTP (ADP), the first revaccination of ADS-M with 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 of immunization (two vaccinations of ADS-M with anatoxin at intervals of 30 days and a booster at 6-9 months) are performed.

5. For planned revaccinations of children at 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.

6. To immunize adults (no age limit), vaccinated against tetanus less than 10 years ago in a planned manner. The drug is administered once.

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

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

Side effects:

ADS-M toxoid is one of the least reactogenic drugs. In individual vaccinated in the first two days, there may develop short-term general (fever, malaise) and local (pain, hyperemia, swelling at the injection site) reactions. To persons who have given severe forms of allergic reactions to ADS-M administration of anatoxin, the planned vaccinations with the drug are stopped.

Allergic reactions may develop (Quincke's edema, urticaria, polymorphic 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 severe toxicity to the administration of ADS-M toxoplasm, further routine vaccinations with the drug are discontinued.

Overdose:Symptoms of overdose are not revealed.
Interaction:

ADS-M toxoid can be administered concomitantly with poliomyelitis vaccine and other preparations of the national immunization schedule.

Special instructions:

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 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.

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

In order to identify contraindications, the doctor (paramedic assistant of the feldsher-midwife station) 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.

Precautions for use: The drug is not suitable for use in ampoules with broken integrity, lack of marking, with changing physical properties (discoloration, presence of non-breakable flakes), incorrect 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 intramuscular and subcutaneous administration.
Packaging:

ADS-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. A pack of cardboard is placed 2 contour mesh packages together with instruction for use and ampoule scarifier.

In a pack of cardboard with a separating snake is placed on, 10 ampoules with instructions for use and a scarifier ampoule.

When using ampoules with a break ring or break point, the ampoule scapegrator is not inserted.
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 N002668 / 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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