Canada - English - Health Canada

teva canada limited - topotecan (topotecan hydrochloride) - solution - 1mg - topotecan (topotecan hydrochloride) 1mg - antineoplastic agents

Canada - English - Health Canada

fresenius kabi canada ltd - topotecan (topotecan hydrochloride) - powder for solution - 4mg - topotecan (topotecan hydrochloride) 4mg - antineoplastic agents

Canada - English - Health Canada

pfizer canada ulc - topotecan (topotecan hydrochloride) - solution - 1mg - topotecan (topotecan hydrochloride) 1mg - antineoplastic agents

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

Canada - English - Health Canada

mylan pharmaceuticals ulc - topotecan (topotecan hydrochloride) - powder for solution - 4mg - topotecan (topotecan hydrochloride) 4mg - antineoplastic agents

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

agila australasia pty ltd - topotecan hydrochloride -

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

accord healthcare inc. - topotecan (unii: 7m7ykx2n15) (topotecan - unii:7m7ykx2n15) - 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 when administered to a pregnant woman. in rabbits, a dose of 0.1 mg/kg/day (about equal to the clinical dose of 1.5 mg/m 2 ) given on days 6 through 20 of gestation caused maternal toxicity, embryolethality, and reduced fetal body weight. in the rat, a dose of 0.23 mg/kg/day (about equal to the clinical dose of 1.5 mg/m 2 ) given for 14 days before mating through gestation day 6 caused fetal resorption, microphthalmia, pre-implant loss, and mild maternal toxicity. a dose of 0.1 mg/kg/day (about half the clinical dose of 1.5 mg/m 2 ) given to rats on days 6 through 17 of gestation caused an increase in post-implantation mortality. this dose also caused an increase in total fetal malformations. the most frequent malformations were of the eye (microphthalmia, anophthalmia, rosette formation of the retina, coloboma of the retina, ectopic orbit), brain (dilated lateral and third ventricles), skull, and vertebrae. there are no adequate and well controlled studies of topotecan injection in pregnant women. if this drug is used during pregnancy, or if a patient becomes pregnant while receiving topotecan injection, the patient should be apprised of the potential hazard to the fetus. [see warnings and precautions ( 5.4) ] rats excrete high concentrations of topotecan into milk. lactating female rats given 4.72 mg/m 2 iv (about three times the clinical dose of 1.5 mg/m 2 ) excreted topotecan into milk at concentrations up to 48-fold higher than those in plasma. it is not known whether the drug is excreted in human milk. because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from topotecan injection, discontinue breastfeeding when women are receiving topotecan injection. safety and effectiveness in pediatric patients have not been established. of the 879 patients in a combined experience of topotecan which included patients with small cell lung cancer, 32% (n=281) were 65 years of age and older, while 3.8% (n=33) were 75 years of age and older. of the 140 patients with stage iv-b, relapsed, or refractory cervical cancer in clinical studies of topotecan injection who received topotecan injection plus cisplatin in the randomized clinical trial, 6% (n = 9) were 65 years of age and older, while 3% (n = 4) were 75 years of age and older. no overall differences in effectiveness or safety were observed between these patients and younger adult patients, and other reported clinical experience has not identified differences in responses between the elderly and younger adult patients, but greater sensitivity of some older individuals cannot be ruled out. there were no apparent differences in the pharmacokinetics of topotecan in elderly patients, once the age-related decrease in renal function was considered [see clinical pharmacology ( 12.3) ]. this drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function [see dosage and administration ( 2.3) ]. no dosage adjustment of topotecan injection appears to be required for patients with mild renal impairment (cl cr 40 to 60 ml/min.). dosage reduction is recommended for patients with moderate renal impairment (cl cr 20 to 39 ml/min.). insufficient data are available in patients with severe renal impairment to provide a dosage recommendation for topotecan injection. [see dosage and administration ( 2.3) and clinical pharmacology ( 12.3) ].

Belgium - English - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

accord healthcare b.v. - topotecan hydrochloride 1,0865 mg/ml - eq. topotecan 1 mg/ml - concentrate for solution for infusion - 1 mg/ml - topotecan hydrochloride - topotecan

Belgium - English - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

accord healthcare b.v. - topotecan hydrochloride 1,0865 mg/ml - eq. topotecan 1 mg/ml - concentrate for solution for infusion - 1 mg/ml - topotecan hydrochloride - topotecan