Malta - English - Medicines Authority

central procurement & supplies unit ub002 industrial estate, san gwann sgn 3000, malta - concentrate for solution for infusion - topotecan hydrochloride 1 mg/ml - antineoplastic agents

Malta - English - Medicines Authority

central procurement & supplies unit ub002 industrial estate, san gwann sgn 3000, malta - concentrate for solution for infusion - topotecan 1 mg/ml - antineoplastic agents

Malta - English - Medicines Authority

accord healthcare limited - topotecan - concentrate for solution for infusion - topotecan 1 mg/ml - antineoplastic agents

Malta - English - Medicines Authority

accord healthcare limited - topotecan - concentrate for solution for infusion - topotecan 1 mg/ml - antineoplastic agents

Ireland - English - HPRA (Health Products Regulatory Authority)

accord healthcare ireland ltd. - topotecan (as hydrochloride) - concentrate for solution for infusion - 1 milligram(s)/millilitre - other antineoplastic agents; topotecan

Malta - English - Medicines Authority

accord healthcare ireland ltd euro house, euro business park, little island cork, t45 k857, ireland - topotecan - concentrate for solution for infusion - topotecan 1 mg/ml - antineoplastic agents

Malta - English - Medicines Authority

accord healthcare ireland ltd euro house, euro business park, little island cork, t45 k857, ireland - topotecan - concentrate for solution for infusion - topotecan 1 mg/ml - antineoplastic agents

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

sandoz inc - topotecan hydrochloride (unii: 956s425zcy) (topotecan - unii:7m7ykx2n15) - topotecan hydrochloride 1 mg in 1 ml - topotecan injection is indicated for the treatment of: - small cell lung cancer sensitive disease after failure of first-line chemotherapy. in clinical studies submitted to support approval, sensitive disease was defined as disease responding to chemotherapy but subsequently progressing at least 60 days (in the phase 3 study) or at least 90 days (in the phase 2 studies) after chemotherapy [see clinical studies (14) ] . topotecan injection in combination with cisplatin is indicated for the treatment of: - stage iv-b, recurrent, or persistent carcinoma of the cervix which is not amenable to curative treatment with surgery and/or radiation therapy. topotecan injection is contraindicated in patients who have a history of severe hypersensitivity reactions (e.g., anaphylactoid reactions) to topotecan or to any of its ingredients. topotecan injection should not be used in patients with severe bone marrow depression. pregnancy category d [see warnings and precautions (5.4) ]. topotecan injection can cause fetal harm

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

bedford laboratories - topotecan hydrochloride (unii: 956s425zcy) (topotecan - unii:7m7ykx2n15) - topotecan 4 mg in 4 ml - topotecan hydrochloride for injection is indicated for the treatment of:  - small cell lung cancer sensitive disease after failure of first-line chemotherapy. in clinical studies submitted to support approval, sensitive disease was defined as disease responding to chemotherapy but subsequently progressing at least 60 days (in the phase 3 study) or at least 90 days (in the phase 2 studies) after chemotherapy [see clinical studies (14) ].  - topotecan hydrochloride for injection in combination with cisplatin is indicated for the treatment of: stage iv-b, recurrent, or persistent carcinoma of the cervix which is not amenable to curative treatment with surgery and/or radiation therapy.  topotecan hydrochloride for injection is contraindicated in patients who have a history of severe hypersensitivity reactions (e.g., anaphylactoid reactions) to topotecan or to any of its ingredients. topotecan hydrochloride for injection should not be used in patients with severe bone marrow depression.  pregnancy category d [see

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

sagent pharmaceuticals - topotecan hydrochloride (unii: 956s425zcy) (topotecan - unii:7m7ykx2n15) - topotecan 1 mg in 1 ml - topotecan injection, as a single agent, is indicated for the treatment of patients with metastatic carcinoma of the ovary after disease progression on or after initial or subsequent chemotherapy. topotecan injection, as a single agent, is indicated for the treatment of patients with small cell lung cancer with platinum-sensitive disease who progressed at least 60 days after initiation of first-line chemotherapy. topotecan injection in combination with cisplatin is indicated for the treatment of patients with stage iv-b, recurrent, or persistent carcinoma of the cervix not amenable to curative treatment. topotecan injection is contraindicated in patients who have a history of severe hypersensitivity reactions to topotecan. risk summary based on animal data, topotecan can cause fetal harm when administered to a pregnant woman. topotecan caused embryolethality, fetotoxicity, and teratogenicity in rats and rabbits when administered during organogenesis at doses similar to the clinical dose [see data]. there are