Регевак® B

General characteristics. Structure:

Active ingredient: 10 mkg of the cleared surface antigen of a virus of hepatitis In (HBsAg) in 1 children's dose.

Excipients: hydroxide (sorbent), buffer components, water for injections tiomersat (preservative) (or does not contain), aluminum.

Pharmacological properties:

Pharmacodynamics. Carrying out a course of vaccination leads to formation of specific antibodies to a hepatitis B virus more, than at 90% vaccinated in a protective caption.

Indications to use:

Prevention of hepatitis B at children within a national calendar of preventive inoculations and persons from groups of the increased risk of infection with a hepatitis B virus: children and adults in whose families there is a HBsAg carrier or the patient with chronic hepatitis B; the children of children's homes, orphanages and nursing homes, children and adults who are regularly receiving blood and its drugs, and also, being on a hemodialysis, and oncohematological patients; persons who had a contact with the material infected with a hepatitis B virus; the health workers having contact with blood of patients; the persons occupied in production of immunobiological drugs from donor and placental blood; students of medical institutes and pupils of average medical educational institutions (first of all graduates); the persons using drugs in the injection way.

In addition to above-mentioned categories, inoculations should be carried out to all other groups of the population.

Route of administration and doses:

The vaccine is entered intramusculary into a deltoid muscle, to newborns and children of younger age in a verkhnenaruzhny surface of a middle part of a hip: introduction to other place reduces efficiency of vaccination. Before introduction the ampoule or the syringe are stirred up.

When performing vaccination of children of the first year of life and pregnant women the vaccines which are not containing preservatives are used.

The single dose for newborn children and persons up to 18 years inclusive makes 0,5 ml (10 mkg of HBsAg). The single dose from 19 years makes 1 ml (20 mkg of HBsAg).

Single dose for patients of departments of a hemodialysis - 2 ml (40 mkg of HBsAg).

The vaccine in the ampoules containing 1 ml of drug (an adult dose) can be used for vaccination of 2 children on condition of their simultaneous vaccination.

The vaccine in the syringe is intended for vaccination only of one patient. Vaccination is made within a national calendar of preventive inoculations.

Vaccination against a viral hepatitis In is carried out by all newborn to the first 24 h life of the child.

Newborns from risk group are vaccinated according to the scheme 0-1-2-12 (the first dose – in the first 24 h life, the second dose - at the age of 1 month, the third dose – at the age of 2 months, the fourth dose - at the age of 12 months).

Along with the first inoculation it is recommended to enter intramusculary into other hip hepatitis B immunoglobulin of the person in a dose 100 ME. According to the same scheme vaccinate the children belonging to risk group, who are not imparted in a maternity home on medical contraindications after removal of the last.

The children who did not receive an inoculation aged to 1 g and not belonging to risk group, and also the teenagers and adults who are not imparted earlier are vaccinated according to the scheme:

0-1-6 (1 dose – at the time of the beginning of vaccination, the 2nd dose – in 1 month after 1 inoculation, the 3rd dose - in 6 months from the beginning of immunization.)

Note: in case of lengthening of an interval between the first and second inoculations up to 5 months and more, the third inoculation will be out in 1 month after the second.

Inoculations at persons who had a contact with the material infected with a hepatitis B virus carry out according to the scheme of 0-1-2 months. Along with the first inoculation it is recommended to enter intramusculary (into other place) hepatitis B immunoglobulin of the person in a dose 100 ME (to children up to 10 years) or 6-8 ME/kg (the others of age). At the these persons who received earlier full course of vaccination against hepatitis B before carrying out the second inoculation define the maintenance of antibodies to HBsAg. If antiserum capacities make not less than 100 ME/l, do not carry out the second and third vaccination.

Persons from risk group, owing to professional duties having continuous contact with blood, have to undergo annually inspection on the maintenance of antibodies to HBsAg. In case of decrease in an antiserum capacity lower than 100 ME/l are recommended a revaccination by one dose of a vaccine.

The emergency scheme of vaccination 0-7-21 days, and the subsequent revaccination by one dose of a vaccine in 12 months is recommended not to vaccinated patients to whom surgical interventions are planned.

To patients of department of a hemodialysis the vaccine is entered quadruple according to the scheme of 0-1-2-6 months.

For a drug injection in ampoules only the one-time syringe is used.

The injection site before and after an injection is processed by 70% alcohol. Opening of ampoules or syringes and the procedure of vaccination are carried out at strict observance of rules of an asepsis and antiseptics.

Not to enter intravenously. To use drug in an ampoule or the syringe right after packaging opening.

Features of use:

Pregnancy. Influence of a vaccine on a fruit is not studied. The possibility of vaccination of the pregnant woman can be considered at extremely high risk of infection, on condition of use of a bezkonservantny vaccine.

Use of the vaccine containing preservative is not admissible when performing vaccination of children of the first year of life and pregnant women.

The device and operating procedure with the syringe with the automatic device of protection of a needle:

The syringe device with the automatic device of protection of a needle.

Description: 1. rod; 2. clips; 3. protection cover; 4. protective cap; 5. needle.

The syringe device with the automatic device of protection of a needle.

Description: 1. rod; 2. clips; 3. protection cover; 4. protective cap; 5. needle.

and – a type of the syringe with the device of protection of a needle before an injection,

b – a type of the syringe with the device of protection of a needle after an injection

After end of an injection the needle and the syringe will move back to the protection device.

Attention! It is necessary to avoid contact with clips during preparation of the syringe! The device is activated by pressing a rod to clips.

Rule of use:

1. To attentively examine the prefilled glass syringe with the protection device.

2. To remove a protective cap from a needle.

3. To carry out an injection according to the standard procedure. To press a rod a thumb and to hold until all dose of drug is not entered. The protection device is not activated until all dose of drug is entered.

4. To take a needle, to release a rod, to allow the protection cover to move forward until the needle completely is not protected and blocked on site.

Operating procedure with the syringe with the non-automatic device of protection of a needle

1. To carry out an injection according to the standard procedure. Attention! When carrying out an injection it is necessary to hold fingers on the protection cover to prevent premature activation of the protection device.

2. After an injection to move the protection device along a needle. The sound click will indicate correctness of action. During all procedure fingers have to be behind a needle.

Side effects:

By-effects at use of a vaccine are rare. In 5-10% of cases emergence of pain, an erythema and consolidation in the place of an injection are possible. On administration of drug are occasionally possible: small temperature increase, complaints to an indisposition, weakness, a joint pain, muscle pain, a headache, dizziness, nausea, vomiting, pains in a stomach.

All reactions to introduction weak and usually take place in 2-3 days after an injection.

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. from the moment of vaccination.

Venues of inoculations have to be provided with means of antishock therapy.

Interaction with other medicines:

Planned hepatitis B inoculations can be carried out at the same time (in one day) with vaccines of a national calendar of preventive inoculations (except for vaccine BTsZh), and also the inactivated vaccines of a calendar of preventive inoculations according to epidemic indications.

The vaccine of hepatitis B can be entered with antiallergic drugs.

Interaction with other medicines is not established.

Contraindications:

Hypersensitivity to yeast and other components of a vaccine. The expressed reaction (temperature is higher than 40 ° C, swelled, a hyperemia more than 8 cm in the diameter in an injection site) or a complication to the previous introduction of a vaccine against hepatitis B. Acute infectious and noninfectious diseases, chronic diseases - immunization carry out to aggravation stages not earlier than in 1 month after recovery (remission). At not severe forms of a SARS and acute intestinal infections of an inoculation it is possible to carry out after normalization of temperature.

Storage conditions:

To transport and store according to the joint venture 3.3.2.1248-03. To transport at a temperature from 2 to 8 °C. Transportation is allowed short-term (no more than 72 h) at a temperature from 9 to 30 °C. Freezing is not allowed. To store at a temperature from 2 to 8 °C. Freezing is not allowed. A period of validity - 3 years. Not to use after the period of validity specified on packaging.

Issue conditions:

According to the recipe

Packaging:

The packs containing 1 syringe (0,5 or 1,0 ml) are released according to the recipe. The packs containing 5, 10 ampoules (0,5 or 1,0 ml), or 1, 3 or 6 syringes (0,5 or 1,0 ml) are intended for treatment and prevention facilities.