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

eagle pharmaceuticals, inc - bendamustine hydrochloride (unii: 981y8sx18m) (bendamustine - unii:9266d9p3pq) - bendamustine hydrochloride injection is indicated for the treatment of patients with chronic lymphocytic leukemia. efficacy relative to first line therapies other than chlorambucil has not been established. bendamustine hydrochloride injection is indicated for the treatment of patients with indolent b-cell non-hodgkin lymphoma that has progressed during or within six months of treatment with rituximab or a rituximab-containing regimen. bendamustine hydrochloride injection is contraindicated in patients with a known hypersensitivity (e.g., anaphylactic and anaphylactoid reactions) to bendamustine, polyethylene glycol 400, propylene glycol, or monothioglycerol. [see warnings and precautions (5.3)] pregnancy category d [see warnings and precautions (5.9)] risk summary bendamustine hydrochloride can cause fetal harm when administered to a pregnant woman. bendamustine caused malformations in animals, when a single dose was administered to pregnant animals. advise women to avoid becoming pregnant while receiving be

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

juno pharmaceuticals pty ltd - bendamustine hydrochloride, quantity: 100 mg - injection, powder for - excipient ingredients: mannitol - first-line treatment of chronic lymphocytic leukaemia (binet stage b or c). efficacy relative to first-line therapies other than chlorambucil has not been established.,previously untreated indolent cd20-positive, stage iii-iv non-hodgkin?s lymphoma, in combination with rituximab.,previously untreated cd20-positive, stage iii-iv mantle cell lymphoma in combination with rituximab, in patient?s ineligible for autologous stem cell transplantation.,relapsed/refractory indolent non-hodgkin?s lymphoma.

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

juno pharmaceuticals pty ltd - bendamustine hydrochloride, quantity: 25 mg - injection, powder for - excipient ingredients: mannitol - first-line treatment of chronic lymphocytic leukaemia (binet stage b or c). efficacy relative to first-line therapies other than chlorambucil has not been established.,previously untreated indolent cd20-positive, stage iii-iv non-hodgkin?s lymphoma, in combination with rituximab.,previously untreated cd20-positive, stage iii-iv mantle cell lymphoma in combination with rituximab, in patient?s ineligible for autologous stem cell transplantation.,relapsed/refractory indolent non-hodgkin?s lymphoma.

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

sandoz pty ltd - bendamustine hydrochloride monohydrate, quantity: 100 mg - injection, powder for - excipient ingredients: mannitol - first-line treatment of chronic lymphocytic leukaemia (binet stage b or c). efficacy relative to first- line therapies other than chlorambucil has not been established.,previously untreated indolent cd20-positive, stage iii-iv non-hodgkin?s lymphoma, in combination with rituximab.,previously untreated cd20-positive, stage iii-iv mantle cell lymphoma in combination with rituximab, in patients ineligible for autologous stem cell transplantation.,relapsed/refractory indolent non-hodgkin?s lymphoma.

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

sandoz pty ltd - bendamustine hydrochloride monohydrate, quantity: 25 mg - injection, powder for - excipient ingredients: mannitol - first-line treatment of chronic lymphocytic leukaemia (binet stage b or c). efficacy relative to first- line therapies other than chlorambucil has not been established.,previously untreated indolent cd20-positive, stage iii-iv non-hodgkin?s lymphoma, in combination with rituximab.,previously untreated cd20-positive, stage iii-iv mantle cell lymphoma in combination with rituximab, in patients ineligible for autologous stem cell transplantation.,relapsed/refractory indolent non-hodgkin?s lymphoma.

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

meitheal pharmaceuticals inc. - bendamustine hydrochloride (unii: 981y8sx18m) (bendamustine - unii:9266d9p3pq) - bendamustine hydrochloride for injection is indicated for the treatment of patients with chronic lymphocytic leukemia. efficacy relative to first line therapies other than chlorambucil has not been established. bendamustine hydrochloride for injection is indicated for the treatment of patients with indolent b-cell non-hodgkin lymphoma that has progressed during or within six months of treatment with rituximab or a rituximab-containing regimen. bendamustine hydrochloride is contraindicated in patients with a known hypersensitivity (e.g., anaphylactic and anaphylactoid reactions) to bendamustine [see warnings and precautions (5.4)]. risk summary in animal reproduction studies, intraperitoneal administration of bendamustine to pregnant mice and rats during organogenesis at doses 0.6 to 1.8 times the maximum recommended human dose (mrhd) resulted in embryo-fetal and/or infant mortality, structural abnormalities, and alterations to growth (see data) . there are no available data on bendamustine hydrochloride use i

Armenia - English - Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

accord healthcare polska sp. z o.o. - bendamustine (bendamustine hydrochloride) - powder for concentrate for solution for infusion - 2.5mg/ml

Armenia - English - Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

thymoorgan pharmazie gmbh - bendamustine (bendamustine hydrochloride) - powder for concentrate for solution for infusion - 25mg

Armenia - English - Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

thymoorgan pharmazie gmbh - bendamustine (bendamustine hydrochloride) - powder for concentrate for solution for infusion - 100mg

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

cephalon, llc - bendamustine hydrochloride (unii: 981y8sx18m) (bendamustine - unii:9266d9p3pq) - bendamustine hydrochloride 45 mg in 0.5 ml - treanda® is indicated for the treatment of patients with chronic lymphocytic leukemia. efficacy relative to first line therapies other than chlorambucil has not been established. treanda is indicated for the treatment of patients with indolent b-cell non-hodgkin lymphoma that has progressed during or within six months of treatment with rituximab or a rituximab-containing regimen. treanda is contraindicated in patients with a known hypersensitivity (e.g., anaphylactic and anaphylactoid reactions) to bendamustine. [see warnings and precautions (5.4)] risk summary in animal reproduction studies, intraperitoneal administration of bendamustine to pregnant mice and rats during organogenesis at doses 0.6 to 1.8 times the maximum recommended human dose (mrhd) resulted in embryo-fetal and/or infant mortality, structural abnormalities, and alterations to growth (see data) . there are no available data on bendamustine hydrochloride use in pregnant women to evaluate for a drug-associated risk of major birth defects, mis