Ország: Egyesült Államok
Nyelv: angol
Forrás: NLM (National Library of Medicine)
CYCLOSPORINE (UNII: 83HN0GTJ6D) (CYCLOSPORINE - UNII:83HN0GTJ6D)
American Regent, Inc.
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 0517-0866 -10) Store at 20°C to 25°C (68°F to 77°F) [See USP Controlled Room Temperature]. Protect from light. Discard unused portion. *Cremophor is the registered trademark of BASF Aktiengesellschaft. **Neoral is a registered trademark of Novartis Pharmaceutical Corporation. Made in Canada Manufactured by: Jubilant HollisterStier General Partnership Kirkland, Quebec H9H 4J4 Canada Manufactured for Perrigo® Minneapolis, MN 55427 USA 2S500 RC J5 Rev 01-19
Unapproved drug for use in drug shortage
CYCLOSPORINE- CYCLOSPORINE INJECTION, SOLUTION AMERICAN REGENT, INC. _Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been_ _approved by FDA. For further information about unapproved drugs, click here._ ---------- CYCLOSPORINE INJECTION, USP _FOR INTRAVENOUS INFUSION ONLY_ RX ONLY PRESCRIBING INFORMATION BOXED 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. Cyclosporine and cyclosporine [MODIFIED] are not bioequivalent and cannot be used interchangeably without physician supervision. 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 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 cyclospor Olvassa el a teljes dokumentumot