Instruction for use: ATG-Fresenius S

Dosage form: Concentrate for solution for infusion

Active substance: Immunoglobulinum antithymocytarum

ATX

L04AA04 Immunoglobulin antimitocyte (rabbit)

Pharmacological group:

Immunodepressants

The nosological classification (ICD-10)

T86 Dying and rejection of transplanted organs and tissues: Transplant disease vs. host; The rejection crisis in organ and tissue transplantation; The crisis of immunological incompatibility in organ transplantation; Incompatibility of tissues; Graft rejection; Graft rejection; Rejection reactions during organ transplantation; Rejection reactions during tissue transplantation; Graft versus host response; Rejection of transplant rejection; Graft-versus-host syndrome; Fabric incompatibility

Composition and release form

1 ml of concentrate for infusion contains rabbit immunoglobulin 20 mg, sodium dihydrogen phosphate, phosphoric acid, water for injection up to 1 ml; In bottles of 5 and 10 ml, in the package 1 and 10 pcs.

Pharmachologic effect

Mode of action - Immunosuppressive.

Heterologic antisera.

Indication of the drug ATG-Fresenius S

Crisis of rejection during transplantation of organs and tissues (prevention and treatment).

Contraindications

Allergy to rabbit protein, bacterial and viral infections, mycoses, marked thrombocytopenia, accompanied by bleeding, planned pregnancy.

Side effects

Anaphylactoid reactions (a sharp decrease in blood pressure, a feeling of tension in the chest, a fever, urticaria), lymphocytopenia, thrombocytopenia, granulocytopenia, serum sickness.

Interaction

When combined with other immunosuppressants, hematotoxicity increases and the risk of infectious complications increases.

Dosing and Administration

IV by drop infusionin 250-300 ml of physiological sodium chloride solution for a minimum of 4 hours under the constant supervision of a doctor.

For prophylactic purposes, a dose of 0.1 ml / kg per day is administered for 21 days from the day of transplantation.

In the treatment of kidney transplantation - 0.15 ml (about 3 mg) / kg body weight per day for 14 days. When transplanting other organs and tissues, if necessary, the dose is selected in each individual case. To improve the tolerance, preliminary treatment of patients with glucocorticoids and antihistamines is carried out.

Precautionary measures

Treatment requires careful clinical observation of the patient, including daily monitoring of the pattern of red and white blood. To reduce the risk of anaphylactoid reactions, in each case, before beginning treatment, check the tolerability of rabbit proteins with iv or conjunctival tests using normal rabbit globulin. To improve the tolerability, it is advisable to prescribe corticoids and antihistamines.

Storage conditions of the drug ATG-Fresenius S

In the dark place at a temperature of 2-8 ° C.

Keep out of the reach of children.

Shelf life of the drug ATG-Fresenius S

1 year.

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