New Zealand - English - Medsafe (Medicines Safety Authority)

pierre fabre medicament australia pty ltd - vinorelbine tartrate 55.4mg equivalent to vinorelbine 40 mg - soft gelatin capsule - 40 mg - active: vinorelbine tartrate 55.4mg equivalent to vinorelbine 40 mg excipient: edible ink red ethanol gelatin glycerol   anidrisorb 85/70 85% phosal 53 mct iron oxide red iron oxide yellow macrogol 400 medium-chain triglycerides purified water   titanium dioxide

New Zealand - English - Medsafe (Medicines Safety Authority)

pierre fabre medicament australia pty ltd - vinorelbine tartrate 55.4mg equivalent to vinorelbine 40 mg - soft gelatin capsule - 40 mg - active: vinorelbine tartrate 55.4mg equivalent to vinorelbine 40 mg excipient: edible ink red ethanol gelatin glycerol   anidrisorb 85/70 85% phosal 53 mct iron oxide red iron oxide yellow macrogol 400 medium-chain triglycerides purified water   titanium dioxide

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

Namibia - English - Namibia Medicines Regulatory Council

teva pharmaceuticals (pty) ltd - vinorelbine tartrate - injection - each 1 ml vial contains; vinorelbine tartrate equivalent to vinorelbine 10,0 mg

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

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.

Ireland - English - HPRA (Health Products Regulatory Authority)

accord healthcare ireland ltd. - vinorelbine tartrate - capsule, soft - vinorelbine

Ireland - English - HPRA (Health Products Regulatory Authority)

accord healthcare ireland ltd. - vinorelbine tartrate - capsule, soft - vinorelbine