Negara: Amerika Serikat
Bahasa: Inggris
Sumber: NLM (National Library of Medicine)
LAPINE T-LYMPHOCYTE IMMUNE GLOBULIN (UNII: D7RD81HE4W) (LAPINE T-LYMPHOCYTE IMMUNE GLOBULIN - UNII:D7RD81HE4W)
Genzyme Corporation
LAPINE T-LYMPHOCYTE IMMUNE GLOBULIN
LAPINE T-LYMPHOCYTE IMMUNE GLOBULIN 5 mg in 1 mL
INTRAVENOUS
PRESCRIPTION DRUG
THYMOGLOBULIN is indicated for the prophylaxis and treatment of acute rejection in patients receiving a kidney transplant. THYMOGLOBULIN is to be used in conjunction with concomitant immunosuppression. THYMOGLOBULIN is contraindicated in patients with history of allergy or anaphylactic reaction to rabbit proteins or to any product excipients, or who have active acute or chronic infections that contraindicate any additional immunosuppression [see Warnings and Precautions (5.2, 5.5) and Adverse Reactions (6.2)] . Risk Summary Animal reproduction studies have not been conducted with THYMOGLOBULIN. It is also not known whether THYMOGLOBULIN can cause fetal harm. THYMOGLOBULIN should be given to a pregnant woman only if the benefit outweighs the risk. Risk Summary THYMOGLOBULIN has not been studied in nursing women. It is not known whether this drug is excreted in human milk. Because other immunoglobulins are excreted in human milk, breastfeeding should be discontinued during THYMOGLOBULIN therapy. Contracepti
THYMOGLOBULIN is supplied as a single-dose clear glass 10 mL vial containing 25 mg of lyophilized (solid) THYMOGLOBULIN. Each carton contains one THYMOGLOBULIN vial (NDC 58468-0080-1).
Biologic Licensing Application
THYMOGLOBULIN- ANTI-THYMOCYTE GLOBULIN (RABBIT) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION GENZYME CORPORATION ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE THYMOGLOBULIN SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR THYMOGLOBULIN. THYMOGLOBULIN (ANTI-THYMOCYTE GLOBULIN [RABBIT]) FOR INJECTION, FOR INTRAVENOUS USE INITIAL U.S. APPROVAL: 1998 WARNING: IMMUNOSUPPRESSION THYMOGLOBULIN SHOULD ONLY BE USED BY PHYSICIANS EXPERIENCED IN IMMUNOSUPPRESSIVE THERAPY IN TRANSPLANTATION. (5.1) INDICATIONS AND USAGE THYMOGLOBULIN is an immunoglobulin G indicated for the prophylaxis and treatment of acute rejection in patients receiving a kidney transplant. (1) Use in conjunction with concomitant immunosuppression. (1) DOSAGE AND ADMINISTRATION The first dose should be infused over at least 6 hours; doses on subsequent days should be infused over at least 4 hours. (2.2) Premedication with corticosteroids, acetaminophen, and/or an antihistamine prior to each infusion is recommended. (2.2) The THYMOGLOBULIN dose should be reduced by one-half if the white blood cell (WBC) count is between 2,000 and 3,000 cells/mm or if the platelet count is between 50,000 and 75,000 cells/mm . Stopping THYMOGLOBULIN treatment should be considered if the WBC count falls below 2,000 cells/mm or if the platelet count falls below 50,000 cells/mm . (2.3) INDICATION DOSE Prophylaxis of acute rejection 1.5 mg/kg of body weight administered daily for 4 to 7 days Treatment of acute rejection 1.5 mg/kg of body weight administered daily for 7 to 14 days For complete dosing instructions, see full prescribing information. (2) DOSAGE FORMS AND STRENGTHS Single-dose 10 mL vial containing 25 mg of anti-thymocyte globulin (rabbit) lyophilized, sterile powder. (3) CONTRAINDICATIONS Allergy or anaphylactic reaction to rabbit proteins or to any product excipients, or active acute or chronic infections which contraindicate any additional immunosuppression (4) WARNINGS AND PRECAUTIONS Baca dokumen lengkapnya