United States - English - NLM (National Library of Medicine)

sagent pharmaceuticals - fludarabine phosphate (unii: 1x9vk9o1sc) (fludarabine - unii:p2k93u8740) - fludarabine phosphate 25 mg in 1 ml - fludarabine phosphate for injection, usp is indicated for the treatment of adult patients with b-cell chronic lymphocytic leukemia (cll) who have not responded to or whose disease has progressed during treatment with at least one standard alkylating-agent containing regimen. the safety and effectiveness of fludarabine phosphate for injection, usp in previously untreated or non-refractory patients with cll have not been established. fludarabine phosphate for injection is contraindicated in those patients who are hypersensitive to this drug or its components.

United States - English - NLM (National Library of Medicine)

sandoz inc - fludarabine phosphate (unii: 1x9vk9o1sc) (fludarabine - unii:p2k93u8740) - fludarabine phosphate 25 mg in 1 ml - fludarabine phosphate injection is indicated for the treatment of adult patients with b-cell chronic lymphocytic leukemia (cll) who have not responded to or whose disease has progressed during treatment with at least one standard alkylating-agent containing regimen. the safety and effectiveness of fludarabine phosphate injection in previously untreated or non-refractory patients with cll have not been established. fludarabine phosphate injection should not be used in patients with severe renal impairment (creatinine clearance less than 30 ml/min/1.73 m2 ). [see warnings and precautions (5.7) ] none pregnancy category d. [see warnings and precautions (5.9) ] it is not known whether fludarabine phosphate is excreted in human milk. because many drugs are excreted in human milk and because of the potential for serious adverse reactions including tumorigenicity in nursing infants, a decision should be made to discontinue nursing or discontinue the drug, taking into account the importance of the drug for the mother

Australia - English - Department of Health (Therapeutic Goods Administration)

sandoz pty ltd - fludarabine phosphate, quantity: 50 mg - injection, concentrated - excipient ingredients: dibasic sodium phosphate dihydrate; sodium hydroxide; water for injections; nitrogen - fludarabine ebewe is indicated for the treatment of b-cell chronic lymphocytic leukaemia.

United States - English - NLM (National Library of Medicine)

hospira, inc. - fludarabine phosphate (unii: 1x9vk9o1sc) (fludarabine - unii:p2k93u8740) - fludarabine phosphate 50 mg in 2 ml - fludarabine phosphate for injection, usp is indicated for the treatment of adult patients with b-cell chronic lymphocytic leukemia (cll) who have not responded to or whose disease has progressed during treatment with at least one standard alkylating-agent containing regimen. the safety and effectiveness of fludarabine phosphate, usp in previously untreated or non-refractory patients with cll have not been established. fludarabine phosphate, usp is contraindicated in those patients who are hypersensitive to this drug or its components.

United States - English - NLM (National Library of Medicine)

actavis pharma, inc. - fludarabine phosphate (unii: 1x9vk9o1sc) (fludarabine - unii:p2k93u8740) - fludarabine phosphate 50 mg in 2 ml - fludarabine phosphate for injection, usp is indicated for the treatment of adult patients with b-cell chronic lymphocytic leukemia (cll) who have not responded to or whose disease has progressed during treatment with at least one standard alkylating-agent containing regimen. the safety and effectiveness of fludarabine phosphate for injection, usp in previously untreated or non-refractory patients with cll have not been established. fludarabine phosphate for injection, usp is contraindicated in those patients who are hypersensitive to this drug or its components.

United States - English - NLM (National Library of Medicine)

hikma pharmaceuticals usa inc. (dba leucadia pharmaceuticals) - fludarabine phosphate (unii: 1x9vk9o1sc) (fludarabine - unii:p2k93u8740) - fludarabine phosphate 25 mg in 1 ml - fludarabine phosphate for injection, usp is indicated for the treatment of adult patients with b-cell chronic lymphocytic leukemia (cll) who have not responded to or whose disease has progressed during treatment with at least one standard alkylating-agent containing regimen. the safety and effectiveness of fludarabine phosphate for injection, usp in previously untreated or non-refractory patients with cll have not been established. fludarabine phosphate for injection is contraindicated in those patients who are hypersensitive to this drug or its components.

United States - English - NLM (National Library of Medicine)

sagent pharmaceuticals - fludarabine phosphate (unii: 1x9vk9o1sc) (fludarabine - unii:p2k93u8740) - fludarabine phosphate 25 mg in 1 ml - fludarabine phosphate injection is indicated for the treatment of adult patients with b-cell chronic lymphocytic leukemia (cll) who have not responded to or whose disease has progressed during treatment with at least one standard alkylating-agent containing regimen. the safety and effectiveness of fludarabine phosphate injection in previously untreated or non-refractory patients with cll have not been established. none teratogenic effects pregnancy category d [see warnings and precautions (5.6)]. based on its mechanism of action, fludarabine phosphate can cause fetal harm when administered to a pregnant woman. there are no adequate and well-controlled studies of fludarabine phosphate in pregnant women. in rats, repeated intravenous doses of fludarabine phosphate at 2.4 times and 7.2 times the recommended human iv dose (25 mg/m2 ) administered during organogenesis caused an increase in resorptions, skeletal and visceral malformations (cleft palate, exencephaly, and fetal vertebrae deformities) and decreased f

United States - English - NLM (National Library of Medicine)

antisoma research limited - fludarabine phosphate (unii: 1x9vk9o1sc) (fludarabine - unii:p2k93u8740) - tablet, film coated - 10 mg - fludarabine phosphate is indicated as a single agent for the treatment of adult patients with b-cell chronic lymphocytic leukemia (cll) whose disease has not responded to or has progressed during or after treatment with at least one standard alkylating-agent containing regimen. studies demonstrating clinical benefit such as prolongation of survival or relief of symptoms have not been performed. studies providing a direct comparison of the clinical efficacy and safety of orally administered fludarabine phosphate relative to intravenously administered fludarabine phosphate have not been performed. none “pregnancy category d. see ‘ warnings and precautions ’ section.” based on its mechanism of action, fludarabine phosphate can cause fetal harm when administered to a pregnant woman. there are no adequate and well-controlled studies of fludarabine phosphate in pregnant women. fludarabine phosphate was embryolethal and teratogenic in both rats and rabbits. if fludarabine phosphate is used during pregnancy, or if

Australia - English - Department of Health (Therapeutic Goods Administration)

juno pharmaceuticals pty ltd - fludarabine phosphate, quantity: 50 mg - injection, powder for - excipient ingredients: mannitol; sodium hydroxide - treatment of b-cell chronic lymphocytic leukaemia

United States - English - NLM (National Library of Medicine)

fresenius kabi usa, llc - fludarabine phosphate (unii: 1x9vk9o1sc) (fludarabine - unii:p2k93u8740) - fludarabine phosphate 25 mg in 1 ml - fludarabine phosphate injection, usp is indicated for the treatment of patients with b-cell chronic lymphocytic leukemia (cll) who have not responded to or whose disease has progressed during treatment with at least one standard alkylating-agent containing regimen.  the safety and effectiveness of fludarabine phosphate injection, usp in previously untreated or non-refractory patients with cll have not been established. fludarabine phosphate injection, usp is contraindicated in those patients who are hypersensitive to this drug or its components.