Vereinigte Staaten - Englisch - 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

Vereinigte Staaten - Englisch - NLM (National Library of Medicine)

ingenus pharmaceuticals, llc - vinorelbine tartrate (unii: 253gqw851q) (vinorelbine - unii:q6c979r91y) - 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 injection 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

Vereinigte Staaten - Englisch - 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

Vereinigte Staaten - Englisch - NLM (National Library of Medicine)

pierre fabre pharmaceuticals, inc. - vinorelbine tartrate (unii: 253gqw851q) (vinorelbine - unii:q6c979r91y) - vinorelbine 10 mg in 1 ml - navelbine is a vinca alkaloid 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))] , navelbine 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 ar

Vereinigte Staaten - Englisch - 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

Irland - Englisch - HPRA (Health Products Regulatory Authority)

kyowa hakko kirin uk ltd - mitomycin - pdr for soln for injection - 10 milligram

Irland - Englisch - HPRA (Health Products Regulatory Authority)

kyowa hakko kirin uk ltd - mitomycin - pdr for soln for injection - 40 milligram

Irland - Englisch - HPRA (Health Products Regulatory Authority)

kyowa hakko kirin uk ltd - mitomycin - pdr for soln for injection - 2 milligram

Irland - Englisch - HPRA (Health Products Regulatory Authority)

kyowa hakko kirin uk ltd - mitomycin - pdr for soln for injection - 20 milligram

Australien - Englisch - Department of Health (Therapeutic Goods Administration)

pierre fabre medicament australia pty ltd - vinflunine ditartrate -