The vaccine combined against hepatitis B and anatoxin diphtheritic and tetanic with the reduced content of antigen

General characteristics. Structure:

Active ingredients: 10 mkg of a surface antigen of a virus of hepatitis B, 5 pieces of a diphtherial anatoxin, 5 pieces of tetanic anatoxin.

Excipients: aluminum hydroxide, mertiolit, formaldehyde.

Pharmacological properties:

Pharmacodynamics. The vaccine represents a combination of the diphtheritic and tetanic anatoxins adsorbed on gel of aluminum of hydroxide of a recombinant barmy surface antigen of a virus of hepatitis In (HBsAg) and purified of ballast proteins.

Structure of 1 dose (0.5 ml): 5 flocculating units (Lf) of a diphtherial anatoxin, 5 binding units (BU) of tetanic anatoxin, 10 mkg of HBsAg, from 0.35 to 0.55 mg of aluminum of hydroxide (Al+3), preservative - mertiolit - from 15 to 35 mkg and no more than 50 mkg of formaldehyde.

Drug represents the homogeneous suspension of yellow-white color without foreign inclusions which is divided when standing into transparent nadosadochny liquid and the friable deposit which is completely breaking when stirring.

Indications to use:

Prevention of hepatitis B, diphtheria and tetanus at persons aged from 6 up to 19 years.

The vaccine is applied:

— when carrying out a course of vaccination at earlier not imparted against diphtheria, tetanus and hepatitis B;

— at a planned age revaccination against diphtheria and tetanus at earlier not imparted against hepatitis B.

Route of administration and doses:

The vaccine is entered in oil into a deltoid muscle in a dose of 0,5 ml. П / to administration of drug and introduction to a gluteus it is not recommended because of decrease in efficiency of a gepatitny component and a possibility of strengthening of local reactions.

Before an inoculation the ampoule needs to be stirred up carefully before receiving a homogeneous suspension.

Primary immunization of children is more senior than 6 years and is carried out the teenagers who earlier are not imparted against diphtheria, tetanus and hepatitis B is triple according to the scheme: 1 dose - in the chosen day, the 2nd dose - in 1-1.5 months, the 3rd dose - in 6-7 months after the first dose.

In need of increase in intervals the inoculation should be carried out to perhaps next time determined by the state of health of vaccinated. The subsequent revaccinations against diphtheria and tetanus are carried out according to a calendar of inoculations.

The revaccination of persons against the diphtheria and tetanus which earlier are not imparted against hepatitis B is carried out once with the subsequent end of a course of inoculations a hepatitis B vaccine in an age dosage.

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.

Administration of drug is registered in the established registration forms with the indication of number of a series, period of validity, the manufacturing enterprise, Date of Introduction, the nature of reaction to administration of drug.

Features of use:

Use at pregnancy and feeding by a breast. Use of this medical supply at pregnancy and during breastfeeding since safety during controlled clinical trials is not studied is not recommended.

Use for children. According to indications since 6 years.

Special instructions. Persons with neurologic changes impart after a process progressing exception.

Carry out by the patient with allergic diseases of an inoculation 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.

Influence on ability to driving of motor transport and to control of mechanisms. It is not established.

Side effects:

At a part of the days imparted in the first two the short-term general can develop (temperature increase, an indisposition, a joint pain and muscles, dizziness) and local (morbidity, a hyperemia, puffiness) reactions. In exclusively exceptional cases allergic reactions (a Quincke's edema, urticaria, polymorphic rash), an insignificant exacerbation of allergic diseases can develop.

Considering a possibility of development of allergic reactions of immediate type in 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:

Inoculations can be carried out by vaccine ADS-M-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:

— strong and unusual reactions to the previous administration of ADS-anatoxin and/or vaccine of hepatitis B: temperature is above 40 °C, hypostasis, a hyperemia more than 8 cm in the diameter in an injection site, and also allergic reactions to baking yeast and other components of a vaccine. Vaccination is postponed until the end of acute displays of a disease and an exacerbation of chronic diseases.

At not severe forms of a SARS, acute intestinal diseases and other inoculations carry out after disappearance of clinical symptoms.

Patients with chronic diseases impart on reaching full or partial remission.

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 of the parents and survey imparted with obligatory thermometry. At vaccination of adults preliminary selection of the persons which are subject to an inoculation with their subsequent poll by the health worker who is carrying out vaccination in day of an inoculation is allowed.

Overdose:

Cases of overdose are not established.

Storage conditions:

Vaccine period of validity - 3 years. Drug is not subject to expired use. Storage conditions. At a temperature from 2 °C to 8 °C according to the joint venture 3.3.2.1248-03. To store in the place, unavailable to children. Freezing is not allowed. Transportation conditions. At a temperature from 2 °C to 8 °C According to the joint venture 3.3.2.1248-03. Freezing is not allowed.

Issue conditions:

According to the recipe

Packaging:

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