The vaccine against whooping cough, diphtheria, tetanus and hepatitis B adsorbed (AKDS-Gep In)

General characteristics. Structure:

Active ingredient: 10 billion Bordetella pertussis, 15 FE diphtherial anatoxins, 5 EU of tetanic anatoxin, 5 mkg of a virus of hepatitis B a surface antigen recombinant (HBsAg) in 1 dose of 0,5 ml.

Excipients: aluminum hydroxide, formaldehyde, preservative - tiomersat.

Pharmacological properties:

Pharmacodynamics. The vaccine presents mix of the pertussoid microbes of 1 phase and the diphtheritic and tetanic anatoxins and a recombinant barmy surface antigen of a virus of hepatitis occluded on gel of aluminum of hydroxide killed with formaldehyde To (HBsAg).

Indications to use:

— prevention of whooping cough, diphtheria, tetanus and hepatitis B at children.

Route of administration and doses:

Inoculations carry out by the vaccine AKDS-Gep B to the terms providing simultaneous carrying out inoculations against hepatitis B, whooping cough, diphtheria and tetanus.

The children imparted by a hepatitis B monovalent vaccine in the first 24 h life and who are not belonging to risk groups are immunized the vaccine AKDS-Gep B at the age of 3 and 6 months. The second vaccination against whooping cough, diphtheria and tetanus is carried out by the AKDS-vaccine in 4.5 months.

The children who are not imparted by a hepatitis B vaccine up to 3 months of age are immunized the vaccine AKDS-Gep B it is triple according to the scheme of 3 months, 4.5 months, 6 months. Reduction of intervals is not allowed. In need of increase in intervals the next inoculation should be carried out to perhaps next time determined by the state of health of children.

In the presence of one or two inoculations the AKDS-vaccine at the children who are not imparted by a hepatitis B vaccine, the quantity of inoculations lacking to the 3rd can be carried out by the vaccine AKDS-Gep B. At the same time the quantity of inoculations against hepatitis B lacking to the 3rd is carried out a hepatitis B monovalent vaccine with an interval of 1 and 6 months after the first introduction. The revaccination against whooping cough, diphtheria and tetanus is carried out by the AKDS-vaccine once at the age of 18 months (at disturbance of terms of inoculations - in 12-13 months after graduated vaccination).

If the child on reaching 4 years did not receive a revaccination the AKDS-vaccine, then it is carried out by ADS-anatoxin for age by 4 years - 5 years 11 months 29 days or ADS-m-anatoxin for age of 6 years and are more senior.

The vaccine AKDS-Gep B is entered intramusculary into the anteroexternal area 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.

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

Use at pregnancy and feeding by a breast. Drug is used for vaccination of children and not applied at pregnancy and in the period of a lactation.

Special instructions. The children who had acute diseases impart not earlier than in four weeks after recovery, at easy forms of respiratory diseases (rhinitis, an easy hyperemia of a pharynx, etc.) the inoculation is allowed in 2 weeks after recovery.

Patients with chronic diseases impart not earlier than in four weeks after achievement of permanent remission.

For the purpose of identification of contraindications the doctor (the paramedic on medical and obstetrical center) in day of an inoculation conducts survey of parents and survey of the child with obligatory thermometry. The children who are temporarily exempted from an inoculation have to be put under observation and the account and are timely imparted.

Development of febrile spasms after introduction of a vaccine is not a contraindication to its subsequent introduction, in this case at temperature increase it is necessary to appoint in an age dosage paracetamol during 1-2 days.

Stable displays of an allergic disease (the localized skin manifestations, the hidden bronchospasm, etc.) are not contraindications to vaccination which can be carried out against the background of the corresponding therapy.

Data on possible influence of medicine on ability to manage vehicles, mechanisms.

It is not applicable. Drug is used for vaccination of children.

Side effects:

At a part of the days imparted in the first two the short-term general can develop (temperature increase, an indisposition) and local (morbidity, a hyperemia, puffiness) reactions. In rare instances complications can develop: the spasms (which are usually connected with temperature increase), shriek episodes, allergic reactions (a Quincke's edema, urticaria, polymorphic rash).

Considering a possibility of development of allergic reactions of immediate type in especially sensitive children, it is necessary to provide medical observation for imparted within 30 min. Venues of inoculations have to be provided with means of antishock therapy.

At development in the child of strong general reaction (temperature increase in the first two days is above 40 °C, in a vaccine injection site - hypostasis and a hyperemia over 8 cm in the diameter) or a postvaccinal complication to it stop further inoculations the vaccine AKDS-Gep B. If the child was imparted by the vaccine AKDS-Gep B twice, the course of vaccination against diphtheria and tetanus is considered finished, and vaccination against hepatitis B is completed a monovalent vaccine once in 1 month after the second vaccination. If the child received one inoculation the vaccine AKDS-Gep B, vaccination can be continued by the vaccine combined hepatitis B and anatoxin diphtheritic and tetanic with the reduced content of antigens which is entered once not earlier than in 3 months, and then in one month enter a hepatitis B monovalent vaccine.

In both cases the first revaccination is carried out by ADS-m-anatoxin in 9-12 months after the last inoculation the vaccine AKDS-Gep B or a vaccine combined hepatitis B and anatoxin diphtheritic and tetanic with the reduced content of antigens. If strong reaction developed after the third inoculation the vaccine AKDS-Gep B, the first revaccination is carried out by ADS-m-anatoxin in 12-18 months. The subsequent revaccinations carry out at dekretirovanny age 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, infiltrate with a diameter more than 2 cm) more than at 4% vaccinated, and also development of postvaccinal complications, inoculations by drug of this series stop.

Interaction with other medicines:

Inoculations can be carried out by the vaccine AKDS-Gep B along with other vaccines of a national calendar of preventive inoculations (except for vaccine BTsZh) or in 1 month after other infections inoculations.

Contraindications:

— the progressing diseases of a nervous system;

— afebrilny spasms in the anamnesis;

— allergic reaction to baking yeast;

— strong reactions (temperature increase in the first two days is above 40 °C, in a vaccine injection site - hypostasis and a hyperemia over 8 cm in the diameter), postvaccinal complications to introduction of the previous dose of the vaccine AKDS-Gep B, either AKDS-vaccine, or hepatitis B vaccine.

Overdose:

Cases of overdose are not established.

Storage conditions:

To store at a temperature from 2 °C to 8 °C according to the joint venture 3.3.2.1248-03. Freezing is not allowed. To store in the place, unavailable to children. To transport at a temperature from 2 °C to 8 °C according to the joint venture 3.3.2.1248-03. Freezing is not allowed. A period of validity - 18 months. Drug is not subject to expired use.

Issue conditions:

According to the recipe

Packaging:

0.5 ml - ampoules (10) - containers (1) - packs cardboard.