FLUDARABINE phosphate injection powder lyophilized for solution

দেশ: মার্কিন যুক্তরাষ্ট্র

ভাষা: ইংরেজি

সূত্র: NLM (National Library of Medicine)

সক্রিয় উপাদান:

FLUDARABINE PHOSPHATE (UNII: 1X9VK9O1SC) (FLUDARABINE - UNII:P2K93U8740)

থেকে পাওয়া:

APP Pharmaceuticals, LLC

INN (আন্তর্জাতিক নাম):

FLUDARABINE PHOSPHATE

রচনা:

FLUDARABINE PHOSPHATE 25 mg in 1 mL

প্রেসক্রিপশন টাইপ:

PRESCRIPTION DRUG

অনুমোদন অবস্থা:

Abbreviated New Drug Application

পণ্য বৈশিষ্ট্য

FLUDARABINE- FLUDARABINE PHOSPHATE INJECTION, POWDER, LYOPHILIZED, FOR
SOLUTION
APP PHARMACEUTICALS, LLC
----------
FLUDARABINE PHOSPHATE FOR INJECTION, USP
FOR INTRAVENOUS USE ONLY
Rx only
WARNING
Fludarabine should be administered under the supervision of a
qualified physician experienced in
the use of antineoplastic therapy. Fludarabine can severely suppress
bone marrow function.
When used at high doses in dose-ranging studies in patients with acute
leukemia, fludarabine was
associated with severe neurologic effects, including blindness, coma,
and death. This severe
central nervous system toxicity occurred in 36% of patients treated
with doses approximately four
times greater (96 mg/m /day for 5 to 7 days) than the recommended
dose. Similar severe central
nervous system toxicity has been rarely (≤ 0.2%) reported in
patients treated at doses in the range
of the dose recommended for chronic lymphocytic leukemia.
Instances of life-threatening and sometimes fatal autoimmune hemolytic
anemia have been reported
to occur after one or more cycles of treatment with fludarabine.
Patients undergoing treatment
with fludarabine should be evaluated and closely monitored for
hemolysis.
In a clinical investigation using fludarabine in combination with
pentostatin (deoxycoformycin) for
the treatment of refractory chronic lymphocytic leukemia (CLL), there
was an unacceptably high
incidence of fatal pulmonary toxicity. Therefore, the use of
fludarabine in combination with
pentostatin is not recommended.
DESCRIPTION
Fludarabine Phosphate for Injection, USP contains fludarabine
phosphate, a fluorinated nucleotide
analog of the antiviral agent vidarabine,
9-ß-D-arabinofuranosyladenine (ara-A) that is relatively
resistant to deamination by adenosine deaminase. Each vial of sterile
lyophilized solid cake contains 50
mg of the active ingredient fludarabine phosphate, 50 mg of mannitol,
and sodium hydroxide to adjust
pH to 7.7. The pH range for the final product is 7.2 to 8.2.
Reconstitution with 2 mL of Sterile Water
for Injection,