Anatoxin diphtheritic and tetanic cleared adsorbed with the reduced content of antigens

General characteristics. Structure:

Active ingredient: mix of the purified diphtheritic and tetanic anatoxins adsorbed on aluminum hydroxide. Specific activity of a diphtherial anatoxin not less than 1500 Lf/mg of protein nitrogen, tetanic anatoxin – not less than 1000 EU/mg of protein nitrogen.

Anatoxin  with  preservative: 5 flocculating units (Lf) of a diphtherial anatoxin, 5 binding units (BU) of tetanic anatoxin.

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

Anatoxin  without   preservative: 5 flocculating units (Lf) of a diphtherial anatoxin, 5 binding units (BU) of tetanic anatoxin.

Excipients: aluminum hydroxide (in terms of aluminum), 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, teenagers and adults.

Route of administration and doses:

ADS-m-anatoxin is entered intramusculary into an anteroexternal part of a hip, or deeply subcutaneously (to teenagers and adults) into the infrascapular area in a dose of 0,5 ml. Before an inoculation the ampoule needs to be stirred up carefully before receiving a homogeneous suspension.

ADS-m-anatoxin is applied:

1. For planned age revaccinations in 6-7 and 14 years, then each next 10 years without restriction of age. Note. The adults imparted by tetanic anatoxin less than 10 years ago impart ABP-m-anatoxin.
2. For vaccination of children of 6-7 years is also more senior, earlier not vaccinated against diphtheria and tetanus. The course of a vatsination consists of two inoculations with an interval of 30-45 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. The first revaccination is carried out in 6-9 months after the finished vaccination once, the second revaccination – at an interval of 5 years. The subsequent revaccinations carry out according to item 1.
3. As replacement of the AKDS-vaccine (ADS-anatoxin) at children with strong general reactions (temperature to 40 °C and above) or postvaccinal complications on the specified drugs. If reaction developed on the first vaccination by the AKDS-vaccine (ADS-anatoxin), then the second inoculation is carried out ADS-m-anatoxin not earlier than in 3 months; if reaction developed on the second vaccination by the AKDS-vaccine (ADS-anatoxin), then the course of vaccination against diphtheria and tetanus is considered finished. In both cases the first revaccination by ADS-m-anatoxin is carried out in 9-12 months. If reaction developed on the third vaccination by the AKDS-vaccine (ADS-anatoxin), the first revaccination by ADS-m-anatoxin is carried out in 12-18 months.
4. For carrying out a course of vaccination of adults who earlier authentically were not imparted against diphtheria and tetanus conduct a full course (two vaccination by ADS-m-anatoxin with an interval of 30 days and a revaccination in 6-9 months).

In the diphtheria centers preventive inoculations carry out according to instructive-methodological documents of the Russian Ministry of Health.

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

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.

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. Use during pregnancy and during breastfeeding is possible only when the estimated advantage for mother exceeds estimated risk for a fruit or the child.

Side effects:

ADS-m-anatoxin is one of the least reactogenic drugs. At the separate days imparted in the first two the short-term general can develop (temperature increase, an indisposition) and local (morbidity, a hyperemia, infiltrate, puffiness) reactions. Considering a possibility of development of allergic reactions of immediate type (a Quincke's edema, urticaria, polymorphic rash, an acute anaphylaxis) 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.

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 and hypodermic introduction (with preservative) on 0,5 ml (1 inoculative dose) or 1 ml (2 inoculative doses) in ampoules. Suspension for intramuscular and hypodermic introduction (without preservative) on 0,5 ml (1 inoculative dose) in ampoules. 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.