Anatoxin the diphtheritic and tetanic cleared adsorbed

General characteristics. Structure:

Active ingredients: mix of the purified diphtheritic and tetanic anatoxins adsorbed on aluminum hydroxide: 30 flocculating units (Lf) of a diphtherial anatoxin, 10 binding units (BU) of tetanic anatoxin in 1 dose.

Excipients: aluminum hydroxide (in terms of aluminum), tiomersat, formaldehyde.

Pharmacological properties:

Pharmacodynamics. Administration of drug according to the approved scheme causes formation of specific  anti-toxic immunity against diphtheria and tetanus.

Indications to use:

Prevention of diphtheria and tetanus at children.

Route of administration and doses:

ADS-anatoxin is entered intramusculary into an anteroexternal part of a hip in a dose of 0,5 ml. Before an inoculation the ampoule needs to be stirred up carefully before receiving a homogeneous suspension.

ADS-anatoxin is applied:

1. To the children who had whooping cough (from 3-month age before achievement of 6-year age).
2. To the children having contraindications to introduction of the AKDS-vaccine.
3. To the children at the age of 4-5 years inclusive who earlier are not imparted against diphtheria and tetanus.

The course of a vatsination consists of two inoculations with an interval of 30 days. Reduction of an interval is not allowed. In need of increase in an interval the next inoculation should be carried out to perhaps next time determined by the state of health of the child. The revaccination by ADS-anatoxin is carried out once in 6-12 months after graduated vaccination. The first revaccination of the children who reached 6 years, and also the subsequent age revaccinations is carried out by ADS-m-anatoxin.

ADS-anatoxin can be entered a month later or along with a poliomyelitic vaccine and other drugs of a national calendar of preventive inoculations.

Note. If the child who had whooping cough received three or two inoculations the AKDS-vaccine earlier, the course of vaccination against diphtheria and tetanus is considered finished. In the first case the revaccination by ADS-anatoxin is carried out in 12-18 months, and in the second – in 9-12 months after the last administration of drug. If the child received one inoculation the AKDS-vaccine, he is subject to the second vaccination by ADS-anatoxin with the subsequent revaccination in 9-12 months.

The subsequent age revaccinations carry out by ADS-m-anatoxin. Administration of drug is registered in the established registration forms with the indication of number of a series, period of validity, manufacturer, Date of Introduction, the nature of reaction to administration of drug.

Features of use:

Drug in ampoules with the broken integrity, lack of marking is not suitable for use, at change of physical properties (discoloration, existence of not breaking flakes), at the expired period of validity, the wrong storage.

Opening of ampoules and the procedure of vaccination are carried out at strict observance of rules of an asepsis and antiseptics. Drug in the opened ampoule is not subject to storage.

Use at pregnancy and during breastfeeding. It is not applicable as this drug is intended for use for children.

Side effects:

It ADS-anatoksinyavlyatsya by slaboreaktogenny drug. At the separate days imparted in the first two the short-term general can develop (temperature increase, an indisposition) and local (morbidity, a hyperemia, puffiness) reactions. Considering a possibility of development of allergic reactions of immediate type (a Quincke's edema, urticaria, polymorphic rash) at especially sensitive persons, for vaccinated it is necessary to provide medical observation within 30 min. Venues of inoculations have to be provided with means of antishock therapy.

Note. At development in the child of strong general reaction (temperature increase to 40 ºС above) or a postvaccinal complication to it further inoculations ADS-anatoxin stop. If the child received two inoculations ADS-anatoxin, the course of vaccination is considered finished if the child received one inoculation ADS-anatoxin, then vaccination can be continued by ADS-m-anatoxin which is entered once not earlier than in 3 months. In both cases the first revaccination is carried out by ADS-m-anatoxin in 9-12 months after the last inoculation.

The subsequent revaccinations carry out in 6-7 and 14 years by ADS-m-anatoxin. At temperature increase it is above 38,5 °C more than at 1% vaccinated or emergence of the expressed local reactions (hypostasis of soft tissues with a diameter more than 5 cm, infiltrates with a diameter more than 2 cm) more than at 4% vaccinated, and also at development of heavy postvaccinal complications of an inoculation by drug of this series stop.

Interaction with other medicines:

It is not established.

Contraindications:

• strong reaction or postvaccinal complication to the previous introduction of a vaccine
• acute infectious and noninfectious diseases – inoculations carry out not earlier than in 2-4 weeks after recovery. At easy forms of diseases (rhinitis, an easy hyperemia of a pharynx, etc.) the inoculation is allowed after disappearance of clinical symptoms;
• chronic diseases – inoculations carry out on reaching full or partial remission;
• neurologic changes – impart after a process progressing exception;
• allergic diseases – inoculations carry out in 2 - 4 weeks after the termination of an aggravation, at the same time stable displays of a disease (the localized skin phenomena, the hidden bronchospasm, etc.) are not contraindications to vaccination which can be carried out against the background of the corresponding therapy.

Immunodeficiencies, HIV infection, and also the supporting course therapy, including steroid hormones and psychopharmaceutical drugs, are not contraindications to an inoculation.

For the purpose of identification of contraindications the doctor (the paramedic on medical and obstetrical center) in day of an inoculation conducts survey and survey imparted with obligatory thermometry. At vaccination of adults preliminary selection of the persons which are subject to an inoculation with their poll by the health worker who is carrying out vaccination in day of an inoculation is allowed. The persons which are temporarily exempted from an inoculation have to be put under observation and the account and are timely imparted.

Inoculations on epidpokazaniye: not immune faces with the diseases specified in the section "Contraindications to Use" which are in direct contact with patients with diphtheria (a family, a class, the room of the hostel, etc.) can be imparted according to the conclusion of the specialist before recovery (remission) against the background of the corresponding therapy.

Storage conditions:

To store at a temperature from 2 to 8 °C. Freezing is not allowed. To store in the places not available to children. A period of validity - 3 years.

Issue conditions:

According to the recipe

Packaging:

Suspension for intramuscular introduction in ampoules on 0,5 ml (one inoculative dose) or 1 ml (two inoculative doses). On 10 ampoules in a box with the application instruction and the scarificator or on 5 ampoules in a blister strip packaging from a film polyvinyl chloride or polystyrene, on 2 planimetric packagings in a pack with the application instruction and the scarificator. When packaging the ampoules having a notch, a ring or a point of a fiasco, the scarificator is not put.