Irska - angleščina - HPRA (Health Products Regulatory Authority)

accord healthcare ireland ltd. - fludarabine phosphate - concentrate for solution for injection/infusion - 25 milligram(s)/millilitre - purine analogues; fludarabine

Irska - angleščina - HPRA (Health Products Regulatory Authority)

pharmachemie bv - fludarabine phosphate - concentrate for soln for inj - 25 mg/ml - purine analogues

Združene države Amerike - angleščina - 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

Združene države Amerike - angleščina - 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.

Izrael - angleščina - Ministry of Health

novartis israel ltd - fludarabine phosphate - concentrate for solution for injection / infusion - fludarabine phosphate 50 mg/dose - fludarabine - fludarabine - palliative treatment of patients with cll refractory to other therapy. treatment of less malignant non-hodgkin lymphoma of stage 3 to 4 in patients who have not responded to standard therapy with at least one alkylating agent or in whom the disease progressed during or after standard therapy. fludarabine is indicated for the initial treatment of patients with b- cell chronic lymphocytic leukaemia (cll) or after first line therapy, in patients with sufficient bone marrow reserves.

Združene države Amerike - angleščina - 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

Malta - angleščina - Medicines Authority

accord healthcare limited - fludarabine phosphate - concentrate for solution for infusion or injection - fludarabine phosphate 25 mg/ml - antineoplastic agents