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

hospira, inc. - vinorelbine tartrate (unii: 253gqw851q) (vinorelbine - unii:q6c979r91y) - vinorelbine 10 mg in 1 ml - vinorelbine injection, usp is indicated: none pregnancy category d risk summary vinorelbine can cause fetal harm when administered to a pregnant woman. in animal reproduction studies in mice and rabbits, embryo and fetal toxicity were observed with administration of vinorelbine at doses approximately 0.33 and 0.18 times the human therapeutic dose, respectively. if this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, apprise the patient of the potential hazard to a fetus. animal data in a mouse embryofetal development study, administration of a single dose of vinorelbine at a dose level of 9 mg/m2 or greater (approximately 0.33 times the recommended human dose based on body surface area) was embryotoxic and fetotoxic. vinorelbine was embryotoxic and fetotoxic to pregnant rabbits when administered every 6 days during the period of organogenesis at doses of 5.5 mg/m2 (approximately 0.18 times the recommended human dose based on body surface area) or greater. at doses t

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

sagent pharmaceuticals - vinorelbine tartrate (unii: 253gqw851q) (vinorelbine - unii:q6c979r91y) - vinorelbine 10 mg in 1 ml - vinorelbine injection is indicated: - in combination with cisplatin for first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer (nsclc) - as a single agent for the treatment of patients with metastatic nsclc none risk summary based on findings from animal studies and its mechanism of action [see clinical pharmacology (12.1)] , vinorelbine can cause fetal harm when administered to a pregnant woman. available human data are insufficient to inform the drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. in animal reproduction studies in mice and rabbits, embryo and fetal toxicity were observed with administration of vinorelbine at doses approximately 0.33 and 0.18 times the human therapeutic dose, respectively (see data) . advise pregnant women of the potential risk to a fetus. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies are 2 to 4% and

Malta - English - Medicines Authority

accord healthcare limited - vinorelbine tartrate - concentrate for solution for infusion - vinorelbine tartrate 10 mg/ml - antineoplastic agents

Malta - English - Medicines Authority

accord healthcare ireland ltd euro house, euro business park, little island cork, t45 k857, ireland - vinorelbine tartrate - concentrate for solution for infusion - vinorelbine tartrate 10 mg/ml - antineoplastic agents

Malta - English - Medicines Authority

accord healthcare ireland ltd euro house, euro business park, little island cork, t45 k857, ireland - vinorelbine tartrate - concentrate for solution for infusion - vinorelbine tartrate 10 mg/ml - antineoplastic agents

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

actavis pharma, inc. - vinorelbine tartrate (unii: 253gqw851q) (vinorelbine - unii:q6c979r91y) - vinorelbine 10 mg in 1 ml - vinorelbine injection is indicated: - in combination with cisplatin for first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer (nsclc) - as a single agent for the treatment of patients with metastatic nsclc none risk summary based on findings from animal studies and its mechanism of action [see clinical pharmacology (12.1)], vinorelbine can cause fetal harm when administered to a pregnant woman. available human data are insufficient to inform the drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. in animal reproduction studies in mice and rabbits, embryo and fetal toxicity were observed with administration of vinorelbine at doses approximately 0.33 and 0.18 times the human therapeutic dose, respectively (see data). advise pregnant women of the potential risk to a fetus. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies are 2 to 4% and 1

Canada - English - Health Canada

teva canada limited - vinorelbine (vinorelbine tartrate) - solution - 10mg - vinorelbine (vinorelbine tartrate) 10mg - antineoplastic agents

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

sandoz pty ltd - vinorelbine tartrate, quantity: 13.85 mg/ml - injection, concentrated - excipient ingredients: nitrogen; water for injections - treatment of advanced breast cancer after failure of standard therapy, as a single agent or in combination; and as first line treatment for advanced non-small cell lung cancer, as a single agent or in combination.

New Zealand - English - Medsafe (Medicines Safety Authority)

sandoz new zealand limited - vinorelbine tartrate 13.85 mg/ml equivalent to 10 mg/ml of vinorelbine - concentrate for injection - 10 mg/ml - active: vinorelbine tartrate 13.85 mg/ml equivalent to 10 mg/ml of vinorelbine excipient: water for injection - treatment of advanced breast cancer after failure of standard therapy, as a single agent or in combination; and as first-line treatment for advanced non-small cell lung cancer, as a single agent or in combination.

Canada - English - Health Canada

sandoz canada incorporated - vinorelbine (vinorelbine tartrate) - solution - 10mg - vinorelbine (vinorelbine tartrate) 10mg - antineoplastic agents