Država: Združene države Amerike
Jezik: angleščina
Source: NLM (National Library of Medicine)
CYCLOSPORINE (UNII: 83HN0GTJ6D) (CYCLOSPORINE - UNII:83HN0GTJ6D)
Padagis US LLC
CYCLOSPORINE
CYCLOSPORINE 50 mg in 1 mL
INTRAVENOUS
PRESCRIPTION DRUG
Cyclosporine is indicated for the prophylaxis of organ rejection in kidney, liver, and heart allogeneic transplants. It is always to be used with adrenal corticosteroids. The drug may also be used in the treatment of chronic rejection in patients previously treated with other immunosuppressive agents. Because of the risk of anaphylaxis, cyclosporine injection should be reserved for patients who are unable to take the soft gelatin capsules or oral solution. Cyclosporine injection is contraindicated in patients with a hypersensitivity to cyclosporine and/or Cremophor® EL (polyoxyethylated castor oil).
Cyclosporine Injection USP, 50 mg/mL FOR INTRAVENOUS INFUSION Supplied as a 5 mL sterile ampule containing 50 mg of cyclosporine per mL, in boxes of 10 ampules. (NDC 0574-0866 -10) Store at 20°C to 25°C (68°F to 77°F) [See USP Controlled Room Temperature]. Protect from light. Discard unused portion. FOR INFUSION ONLY *Cremophor® is the registered trademark of BASF Aktiengesellschaft. Made in Canada Manufactured by: Jubilant HollisterStier General Partnership Kirkland, Quebec H9H 4J4 Canada Manufactured For Padagis Minneapolis, MN 55427 USA Rev 10-23
Abbreviated New Drug Application
CYCLOSPORINE- CYCLOSPORINE INJECTION, SOLUTION PADAGIS US LLC ---------- CYCLOSPORINE INJECTION, USP _FOR INFUSION ONLY_ RX ONLY PRESCRIBING INFORMATION WARNING ONLY PHYSICIANS EXPERIENCED IN IMMUNOSUPPRESSIVE THERAPY AND MANAGEMENT OF ORGAN TRANSPLANT PATIENTS SHOULD PRESCRIBE CYCLOSPORINE. PATIENTS RECEIVING THE DRUG SHOULD BE MANAGED IN FACILITIES EQUIPPED AND STAFFED WITH ADEQUATE LABORATORY AND SUPPORTIVE MEDICAL RESOURCES. THE PHYSICIAN RESPONSIBLE FOR MAINTENANCE THERAPY SHOULD HAVE COMPLETE INFORMATION REQUISITE FOR THE FOLLOW-UP OF THE PATIENT. CYCLOSPORINE SHOULD BE ADMINISTERED WITH ADRENAL CORTICOSTEROIDS BUT NOT WITH OTHER IMMUNOSUPPRESSIVE AGENTS. INCREASED SUSCEPTIBILITY TO INFECTION AND THE POSSIBLE DEVELOPMENT OF LYMPHOMA MAY RESULT FROM IMMUNOSUPPRESSION. DESCRIPTION Cyclosporine, the active principle in cyclosporine injection, USP is a cyclic polypeptide immunosuppressant agent consisting of 11 amino acids. It is produced as a metabolite by the fungus species _Beauveria nivea_. Chemically, cyclosporine is designated as [_R_-[_R_*,_R_*-(_E_)]]-cyclic(L-alanyl-D-alanyl-_N_- methyl-L-leucyl-_N-_methyl-L-leucyl-_N_-methyl-L-valyl-3-hydroxy-_N_,4-dimethyl-L-2-amino-6- octenoyl-L-α-amino-butyryl-_N-_methylglycyl-_N_-methyl-L-leucyl-L-valyl-_N_-methyl-L-leucyl). Cyclosporine injection, USP is available in a 5 mL sterile ampule for intravenous (IV) administration. Each mL contains Cyclosporine USP, 50 mg; *Cremophor EL (polyoxyethylated castor oil), 650 mg; Absolute Alcohol, 32.9% (v/v). Cyclosporine injection, USP must be diluted further with 0.9% Sodium Chloride Injection or 5% Dextrose Injection before use. The chemical structure of cyclosporine (also known as cyclosporin A) is CLINICAL PHARMACOLOGY Cyclosporine is a potent immunosuppressive agent, which in animals prolongs survival of allogeneic transplants involving skin, heart, kidney, pancreas, bone marrow, small intestine, and lung. Cyclosporine has been demonstrated to suppress some humoral immunity and to a greater extent, cell-mediated reac Preberite celoten dokument