Instruction for use: Atgam

Dosage form: Concentrate for solution for infusion

Active substance: Immunoglobulinum antithymocytarum

ATX

L04AA04 Immunoglobulin antimitocyte (rabbit)

Pharmacological group:

Immunodepressants

Composition and release form

Solution for injection 1 ml

Immunoglobulin antimitocyte (horse) 50 mg

(Stabilized with 0.3 molar glycine to a pH of about 6.8)

In ampoules of 5 ml; In a pack of cardboard 5 ampoules.

Pharmachologic effect

Mode of action - Immunosuppressive.

Dosing and Administration

IV, recipients of kidney transplants: adults - 10-30 mg / kg / day, children - 5-25 mg / kg / day. Atgam is used to delay the first attack of rejection and during the first attack of rejection. Most patients with acute reaction rejection Atgam was appointed for the first time since transplantation.

Usually used in combination with azathioprine and corticosteroids, which are most often used to suppress the immune reaction. At repeated prescriptions of the drug, Atgam should be especially careful and carefully examine the patient with regard to the symptoms of allergic reactions. Delay of transplant rejection: a constant dose of 15 mg / kg / day for 14 days, then every other day for 14 days, only 21 doses for 28 days. Enter the first dose no earlier than 24 hours before or no later than 24 hours after transplantation. Treatment of rejection: the administration of the first dose can be delayed until the diagnosis of the first attack of rejection. The recommended dose is 10-15 mg / kg / day for 14 days. In addition, the drug can be administered every other day until the total number of doses is equal to 21.

Aplastic anemia: the recommended dose is 10-20 mg / kg / day for 8-14 days. In addition, the drug can be administered every other day for up to 14 days, until the total number of doses is reached. Since the appointment of Atgam may involve thrombocytopenia, patients receiving this drug for aplastic anemia may require platelet transfusion.

Preparation of the solution.

Parenterally administered preparations should be inspected for foreign particles and discoloration. However, since Atgam is a gamma globulin preparation, it can be transparent or slightly opalescent, colorless or slightly pinkish or brownish, and can also form light granular or flaky particles during storage. The bottle with Atgam (diluted or undiluted) should not be shaken, as the foaming and / or denaturation of the protein may occur.

For intravenous infusion, the total daily dose of Atgam should be added to the sterile diluent (see "Compatibility and Stability"), avoiding the contact of undiluted Atgam with the outside air. The concentration should not exceed 4 mg / ml. Stir the solution by gently rocking or rotating the bottle.

Introduction.

The diluted Atgam preparation should be heated to room temperature before infusion. The most convenient place of administration for the drug Atgam is arteriovenous anastomosis or a shunt or central vein with a high blood flow velocity. The introduction is carried out through the infusion system through a filter with a pore diameter from 0.2 to 1 micron. The filter in the infusion system should be used in all cases of administration of Atgam to prevent the introduction of insoluble particles that can form during storage. Introduction to a vein with a high blood flow speed minimizes the possibility of developing phlebitis and thrombosis. The duration of administration of the dose of the drug should be at least 4 hours. During the introduction of the drug near the bed of the patient should always have the necessary reanimation equipment. Constantly observe the patient for possible allergic reactions during infusion.

Compatibility and stability.

The Atgam solution with a concentration of up to 4 mg / ml retains its physical and chemical stability up to 24 hours using the following diluents: 0.9% sodium chloride solution for injection; Injection for 5% dextrose and 0.225% sodium chloride; Injection for 5% dextrose and 0.45% sodium chloride. Addition of Atgam to a solution of dextrose for injection is not recommended, since a low salt concentration may cause the formation of a precipitate. Solutions for infusions with a pronounced acidic reaction of the environment can also lead after a while to physical instability. If the solution of the preparation is prepared in advance, then it is recommended to store it in the refrigerator. Even when stored in a refrigerator, the total storage time of the solution should not exceed 24 hours (including the infusion time).

Storage conditions of the drug Atgam

In the dark place at a temperature of 2-8 ° C (do not freeze).

Keep out of the reach of children.

Shelf life of the drug Atgam

3 years.

Do not use after the expiry date printed on the package.