2010/09/21

Antihep

Composition, structure and packing

An injection is transparent or slightly opalescent, colorless or weak yellow coloring in the storage process allowed the emergence of a small precipitate disappears at room temperature with shaking. 2 ml (1 dose) of anti-HBs-antibodies 100 IU Clinico-pharmacological group: drugs affecting immunity. Immunoglobulin.

Pharmacological action

Immunological medicine. Active principle of the drug is an antibody to surface antigen of hepatitis B virus antibodies block the receptors and thereby reduce the risk of infection. Pharmacokinetics Absorption Cmax antibodies in the blood is reached after 24 hours Stain T1 / 2 antibodies is 4-5 weeks.

Statement
Emergency prevention of hepatitis B in children and adults.

Dosage regimen

The dose of the drug and the multiplicity of its introduction depends on the testimony. Newborns from mothers HBsAg carriers or patients with acute hepatitis B in the period of delivery, introduced 1 dose (100 IU) of the drug in the first 24 hours after birth, simultaneously with hepatitis B vaccine, but in different parts of the body. Persons who had not passed the previously vaccinated against hepatitis B or those persons whose vaccination is not completed, or when the level of HBs-antibodies below the protective (less than 10 IU / l), after the accidental contamination through contact with infected materials (for injection, dental manipulation, blood transfusion, splashed in the mouth or eyes), a drug injected at the rate of 8.6 IU / kg of body weight as soon as possible after exposure (preferably within 24-48 hours).

At the same time to start (continue) vaccination against hepatitis B. Persons belonging to groups at high risk of infection with hepatitis B virus and not vaccinated against hepatitis B (including points of chronic hemodialysis patients, patients receiving life-saving indications frequent transfusions of blood and blood drugs; contact in hepatitis B) introducing drug for adults and children over 10 years at the rate of 6-8 IU / kg of body weight, children under the age of 10 years - 100 IU. Simultaneously with the introduction of immunoglobulin should begin a course of hepatitis B vaccination for a shorter circuit - 3 vaccine with an interval of 1 month. After 12 months after the start of immunization introduces additional fourth dose of vaccine. The first dose of vaccine is introduced, together with immunoglobulin, but in different parts of the body.

The drug is introduced into / m in the upper outer quadrant of the gluteal muscles or the outer surface of the thigh. Before use, the ampoule with the preparation to stand for 2 h at room temperature.

The drug is introduced in strict compliance with the rules of asepsis and antisepsis. To avoid formation of foam drug syringe needle with a wide lumen. A large amount of the drug (more than 5 ml) should be entered in different parts of the body.

Side effect

Reactions to the introduction of generally absent.

Local reactions: seldom - flushing of the skin. Systemic reactions: rarely - increased body temperature to 37.5 ° C during the first days after injection, and in some cases - different types of allergic reactions (in patients with altered reactivity) in isolated cases - anaphylactic shock.

Contraindications
severe allergic reaction to the introduction of drugs in human blood in history.

Pregnancy and lactation

Data on the safety of the drug Antigep during pregnancy and lactation have not been described.

Cautions

Vaccination against measles, mumps and rubella is not earlier than 2 months after drug administration Antigep.

If you have a history of clinically expressed allergic reactions in the day of administration of the drug and over the next 3 days showed Appointment antihistamines. Patients with systemic immunological diseases (collagen, immune blood diseases, nephritis), the medication should be administered on a background of relevant pathogenetic therapy.

In offices around the immunization, you must have medicines for anti-shock measures and cupping anaphylactic reaction. After the introduction Antigepa patient should be under medical observation for 30 minutes. Introduction immunoglobulin registered in accordance with accounting forms indicating the batch number, date of issue, expiry date, manufacturer, date of administration, dose, nature of the reaction to the introduction.

It should be borne in mind that is not suitable for use in injectable drug to violate the integrity or markings, changing the physical properties (color, transparency, availability nonseparating sediment), and expired, the violation of the requirements for storage conditions.

Cases of increased reactogenicity or development of complications after injection of the drug should be reported by phone (fax) or by cable to the National Institute of Standardization and Control of Medical Biological Preparations. LATarasevitch (121002, Moscow, Sivtsev Vrazhek, 41, tel. / fax. 241-39-22), followed by the provision of medical records. Complaints on the quality of the product and packaging should be directed to the GISCO them. LA Tarasevich and address of the company, manufactured the drug, with the obligatory indication of the batch number, date of issue and expiry date.

Overdose

Cases of overdose have Antigep not marked.

Drug Interactions

Drug Interactions drug Antigep not described.

Terms and Conditions of storage

The drug should be stored and transported at a temperature of 2 ° to 8 ° C. Freezing is not allowed.

Shelf life - 2 years. The drug in the showdown ampoule storage is not subject.