CYCLOSPORINE injection, solution

Country: মার্কিন যুক্তরাষ্ট্র

ভাষা: ইংরেজি

সূত্র: NLM (National Library of Medicine)

সক্রিয় উপাদান:

CYCLOSPORINE (UNII: 83HN0GTJ6D) (CYCLOSPORINE - UNII:83HN0GTJ6D)

থেকে পাওয়া:

American Regent, Inc.

প্রশাসন রুট:

INTRAVENOUS

প্রেসক্রিপশন টাইপ:

PRESCRIPTION DRUG

থেরাপিউটিক ইঙ্গিত:

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).

পণ্য সারাংশ:

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

অনুমোদন অবস্থা:

Unapproved drug for use in drug shortage

পণ্য বৈশিষ্ট্য

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._
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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