Kanada - angličtina - Health Canada

hikma canada limited - bendamustine hydrochloride - powder for solution - 25mg - bendamustine hydrochloride 25mg

Kanada - angličtina - Health Canada

hikma canada limited - bendamustine hydrochloride - powder for solution - 100mg - bendamustine hydrochloride 100mg

Spojené státy - angličtina - 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

Austrálie - angličtina - Department of Health (Therapeutic Goods Administration)

luminarie 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.

Austrálie - angličtina - Department of Health (Therapeutic Goods Administration)

luminarie 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.

Austrálie - angličtina - Department of Health (Therapeutic Goods Administration)

luminarie 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.

Austrálie - angličtina - Department of Health (Therapeutic Goods Administration)

luminarie 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.

Irsko - angličtina - HPRA (Health Products Regulatory Authority)

fresenius kabi oncology plc - bendamustine hydrochloride - pdr/conc/soln for infus - 25 milligram - bendamustine

Irsko - angličtina - HPRA (Health Products Regulatory Authority)

fresenius kabi oncology plc - bendamustine hydrochloride - pdr/conc/soln for infus - 100 milligram - bendamustine

Belgie - angličtina - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

chemi s.p.a. - bendamustine hydrochloride 100 mg - eq. bendamustine 90,8 mg - powder for concentrate for solution for infusion - 2,5 mg/ml - bendamustine hydrochloride 25 mg - bendamustine