Антигеп®

General characteristics. Structure:

Active ingredient: not less than 100 ME of antibodies to HBsAg of a virus of hepatitis B.

Excipients: glycine (aminoacetic acid), stabilizer. Contents is settlement, in ready drug do not define. Drug does not contain preservatives and antibiotics.

Pharmacological properties:

Pharmacodynamics. An effective agent of drug are antibodies to a surface antigen of a virus of hepatitis In (HBsAg) which block virus receptors.

Pharmacokinetics. The maximum concentration of antibodies in blood is reached in 24 h, the period of their semi-removal makes 4-5 weeks.

Indications to use:

The emergency prevention of hepatitis B at children and adults; treatment of easy and medium-weight forms of an acute viral hepatitis In at adults.

Route of administration and doses:

Immunoglobulin is entered intramusculary.

Prevention. The dose of drug and frequency rate of its introduction depend on indications to use:

• the newborn from mothers - HBsAg carriers or patients with an acute hepatitis In in the period of delivery enters 1 dose of drug (100 ME) into the first 12 h after the birth along with a vaccine against hepatitis B, but into different body parts (further children are subject to an inoculation a hepatitis B vaccine at the age of 1, 2 and 12 months);
• to the faces which are not imparted earlier against hepatitis B or persons at whom vaccination is not finished or in case the level of NVS-antibodies is lower protective (<than 10 ME/l), after accidental infections as a result of contact with the infected material (at injections, dental manipulations, hemotransfusion, hits of splashes of the infected material in a mouth or eyes, etc.), the drug is administered at the rate of 0,1 ml/kg of weight as soon as possible after contact (whenever possible during 24 - 48 h). At the same time (in the same day) it is necessary to begin (to continue) vaccination against hepatitis B according to the scheme of 0-1-2-12 months.
• to the persons belonging to groups of high risk of infection with a virus of hepatitis B (patients of the centers of a chronic hemodialysis; the patients having various diseases which according to vital indications receive frequent transfusions of blood and its drugs, contact in the hepatitis B centers, etc.), not imparted against hepatitis B, enter immunoglobulin prior to the procedure - a hemodialysis, hemotransfusion and its drugs, etc.; to children up to 10 years – 100 ME, to children 10 years and the adult - at the rate of 0,1 ml/kg of weight are more senior. Along with administration of immunoglobulin it is necessary to begin a course of vaccination against hepatitis B according to the shortened scheme - 3 introductions of a vaccine with an interval of 1 month. In 12 months after the beginning of immunization the 4th additional dose of a vaccine is entered. The first dose of a vaccine is entered along with immunoglobulin, but into different body parts.

In need of use of large volumes (more than 5 ml) of drug it is recommended to carry out injections to different sites of a gluteus and the outside surface of a hip.

Drug is used only on doctor's orders (paramedic). Administration of immunoglobulin is registered in the established registration forms with the indication of number of a series, date of issue, a period of validity, the manufacturing enterprise, Date of Introduction, a dose, reaction to introduction.

Treatment. With the medical purpose drug is appointed in the first five days from the beginning of the icteric period of a viral hepatitis of Century.

The drug is administered in a single dose 0,1 ml/kg of body weight, daily for 3 days.

Features of use:

Prior to the beginning of an ampoule injection with drug maintain during 2 h at the room temperature. Opening of ampoules and the procedure of introduction are carried out at strict observance of rules of an asepsis and antiseptics.

Drug in the opened ampoule is not subject to storage. He is suitable for use drug in ampoules with the broken integrity or marking, at change of physical properties (discoloration, opacification, existence of not breaking deposit), at the expired period of validity, at disturbance of storage conditions.

In order to avoid foaming drug is gathered in the syringe a needle with a wide gleam.

Side effects:

Reactions to introduction, as a rule, are absent. In rare instances local reactions in the form of a hyperemia, temperature increase to 37,5 ºС within the first days after introduction can develop.

At individuals with the changed reactivity allergic reactions of various type, and in exclusively exceptional cases - an acute anaphylaxis in this connection the persons who received drug have to be under medical observation within 30 min. after administration of immunoglobulin can develop.

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

Interaction with other medicines:

Administration of immunoglobulins can negatively influence efficiency of live attenuirovanny vaccines. Immunization by live vaccines (against measles and other viral infections) is possible not earlier than in 3 months after administration of immunoglobulin with the preventive or medical purpose.

Contraindications:

Administration of immunoglobulin of the person against hepatitis B is contraindicated to the persons which had heavy allergic reactions to introduction of blood preparations of the person in the anamnesis.

In the presence in the anamnesis of clinically expressed allergic reactions in day of administration of immunoglobulin and during the next 3 days purpose of antihistaminic drugs is recommended. To the persons suffering from immune general diseases (diseases of blood, connecting fabric, nephrite, etc.), it is necessary to administer the drug against the background of the corresponding therapy.

Storage conditions:

In the dry, protected from light place, at a temperature of 2-8 °C. To store in the place, unavailable to children. A period of validity - 2 years.

Issue conditions:

According to the recipe

Packaging:

Solution for intramuscular introduction 1 dose (not less than 100 ME) of 2 ml in an ampoule. 10 ampoules in a pack from a cardboard with the application instruction, and the scarificator ampoule. When packaging the ampoules having a notch, a ring or a point of a fiasco, the scarificator is not put.