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

Canada - English - Health Canada

accord healthcare inc - topotecan (topotecan hydrochloride) - powder for solution - 4mg - topotecan (topotecan hydrochloride) 4mg - antineoplastic agents

Canada - English - Health Canada

accord healthcare inc - topotecan (topotecan hydrochloride) - solution - 1mg - topotecan (topotecan hydrochloride) 1mg - antineoplastic agents

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

fresenius kabi australia pty ltd - topotecan hydrochloride, quantity: 4.346 mg - injection, powder for - excipient ingredients: mannitol; tartaric acid; hydrochloric acid; sodium hydroxide - topotecan is indicated as single agent therapy for the treatment of patients with: - small cell lung carcinoma, after failure of first line chemotherapy. - metastatic carcinoma of the ovary after failure of first-line or subsequent therapy.

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

accord healthcare, inc. - topotecan hydrochloride (unii: 956s425zcy) (topotecan - unii:7m7ykx2n15) - topotecan hydrochloride for injection, as a single agent, is indicated for the treatment of patients with metastatic ovarian cancer after disease progression on or after initial or subsequent chemotherapy. topotecan hydrochloride for injection, as a single agent, is indicated for the treatment of patients with small cell lung cancer (sclc) with platinum-sensitive disease who progressed at least 60 days after initiation of first-line chemotherapy. topotecan hydrochloride for injection, in combination with cisplatin, is indicated for the treatment of patients with stage iv-b, recurrent, or persistent cervical cancer not amenable to curative treatment. topotecan hydrochloride for injection is contraindicated in patients who have a history of severe hypersensitivity reactions to topotecan. reactions have included anaphylactoid reactions [see adverse reactions ( 6.2)] . risk summary based on animal data and its mechanism of action, topotecan hydrochloride for injection can

Malta - English - Medicines Authority

fresenius kabi oncology plc lion court, farnham road, bordon, hampshire, gu35 0nf, united kingdom - topotecan - concentrate for solution for infusion - topotecan 1 mg/ml - antineoplastic agents

Malta - English - Medicines Authority

fresenius kabi oncology plc lion court, farnham road, bordon, hampshire, gu35 0nf, united kingdom - topotecan - concentrate for solution for infusion - topotecan 1 mg/ml - antineoplastic agents

Ireland - English - HPRA (Health Products Regulatory Authority)

accord healthcare limited - topotecan (as hydrochloride) - pdr/conc/soln for infus - 4 milligram

Canada - English - Health Canada

sandoz canada incorporated - topotecan (topotecan hydrochloride) - powder for solution - 4mg - topotecan (topotecan hydrochloride) 4mg - antineoplastic agents

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

mylan institutional llc - topotecan hydrochloride (unii: 956s425zcy) (topotecan - unii:7m7ykx2n15) - topotecan injection is indicated for the treatment of patients with small cell lung cancer (sclc) with platinum-sensitive disease who progressed at least 60 days after initiation of first-line chemotherapy. topotecan injection is contraindicated in patients who have a history of severe hypersensitivity reactions to topotecan. reactions have included anaphylactoid reactions [see adverse reactions (6.2)] . risk summary based on animal data and its mechanism of action, topotecan injection can cause fetal harm when administered to a pregnant woman. there are no available clinical data on the use of topotecan in pregnancy. topotecan caused embryolethality, fetotoxicity, and teratogenicity in rats and rabbits when administered during organogenesis at doses similar to the clinical dose (see data). advise pregnant women of the potential risk to a fetus. in the u.s. general population, the background risk of major birth defects is 2% to 4% and of miscarriage is 15% to 20% of clinically recognized pregnancies. data an