Jungtinės Valstijos - anglų - NLM (National Library of Medicine)

novartis pharmaceuticals corporation - topotecan hydrochloride (unii: 956s425zcy) (topotecan - unii:7m7ykx2n15) - topotecan 4 mg in 4 ml - hycamtin® 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. hycamtin 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. hycamtin 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. hycamtin 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, hycamtin can cause fetal harm when administered to a pregnant woman. there are no available clinical data on the use of hycamtin in pregnancy. topotecan cau

Jungtinės Valstijos - anglų - NLM (National Library of Medicine)

novartis pharmaceuticals corporation - topotecan hydrochloride (unii: 956s425zcy) (topotecan - unii:7m7ykx2n15) - topotecan .25 mg - hycamtin® capsules are indicated for the treatment of relapsed small cell lung cancer (sclc) in patients with a prior complete or partial response and who are at least 45 days from the end of first-line chemotherapy. hycamtin 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, hycamtin can cause fetal harm when administered to a pregnant woman. there are no available clinical data on the use of hycamtin 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 animal data in

Jungtinės Valstijos - anglų - NLM (National Library of Medicine)

glaxosmithkline llc - topotecan hydrochloride (unii: 956s425zcy) (topotecan - unii:7m7ykx2n15) - topotecan 0.25 mg

Australija - anglų - Department of Health (Therapeutic Goods Administration)

alphapharm pty ltd - topotecan hydrochloride -

Australija - anglų - Department of Health (Therapeutic Goods Administration)

alphapharm pty ltd - topotecan hydrochloride -

Australija - anglų - Department of Health (Therapeutic Goods Administration)

accord healthcare pty ltd - topotecan hydrochloride, quantity: 1.09 mg (equivalent: topotecan, qty 1 mg) - injection, concentrated - excipient ingredients: hydrochloric acid; water for injections; tartaric acid; sodium hydroxide - topotecan intas 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.,topotecan intas is indicated in combination with cisplatin for the treatment of patients with:,? histologically confirmed stage iv-b, recurrent, or persistent carcinoma of the cervix, which is not amenable to curative treatment with surgery and/or radiation therapy.

Airija - anglų - HPRA (Health Products Regulatory Authority)

martindale pharmaceuticals ltd - topotecan hydrochloride - pdr/conc/soln for infus - 1 milligram

Airija - anglų - HPRA (Health Products Regulatory Authority)

martindale pharmaceuticals ltd - topotecan hydrochloride - pdr/conc/soln for infus - 4 milligram

Airija - anglų - HPRA (Health Products Regulatory Authority)

pliva pharma limited - topotecan hydrochloride - pdr/conc/soln for infus - 4 milligram

Airija - anglų - HPRA (Health Products Regulatory Authority)

ebewe pharma ges.m.b.h nfg. kg - topotecan hydrochloride - concentrate for soln for inf - 1 mg/ml