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

apotex corp. - oxaliplatin (unii: 04zr38536j) (oxaliplatin - unii:04zr38536j) - oxaliplatin 5 mg in 1 ml - oxaliplatin injection usp, in combination with infusional fluorouracil and leucovorin, is indicated for: -   adjuvant treatment of stage iii colon cancer in patients who have undergone complete resection of the primary tumor. -   treatment of advanced colorectal cancer. oxaliplatin injection is contraindicated in patients with a history of a hypersensitivity reaction to oxaliplatin or other platinum-based drugs. reactions have included anaphylaxis [see warnings and precautions (5.1)] . risk summary based on its direct interaction with dna, oxaliplatin injection can cause fetal harm when administered to a pregnant woman. the available human data do not establish the presence or absence of major birth defects or miscarriage related to the use of oxaliplatin injection. reproductive toxicity studies demonstrated adverse effects on embryo-fetal development in rats at maternal doses that were below the recommended human dose based on body surface area (see data) . advise a pregnant woman of the potential risk to a

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

cipla usa inc. - oxaliplatin (unii: 04zr38536j) (oxaliplatin - unii:04zr38536j) - oxaliplatin 5 mg in 1 ml - oxaliplatin injection, in combination with infusional fluorouracil and leucovorin, is indicated for: -   adjuvant treatment of stage iii colon cancer in patients who have undergone complete resection of the primary tumor. -   treatment of advanced colorectal cancer. oxaliplatin injection is contraindicated in patients with a history of a hypersensitivity reaction to oxaliplatin or other platinum-based drugs. reactions have included anaphylaxis [see warnings and precautions (5.1)] . risk summary based on its direct interaction with dna, oxaliplatin can cause fetal harm when administered to a pregnant woman. the available human data do not establish the presence or absence of major birth defects or miscarriage related to the use of oxaliplatin injection. reproductive toxicity studies demonstrated adverse effects on embryo-fetal development in rats at maternal doses that were below the recommended human dose based on body surface area (see data) . advise a pregnant woman of the potential risk to a fetus. in the

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

bluepoint laboratories - oxaliplatin (unii: 04zr38536j) (oxaliplatin - unii:04zr38536j) - oxaliplatin 5 mg in 1 ml - oxaliplatin injection, used in combination with infusional 5-fluorouracil/leucovorin, is indicated for: oxaliplatin injection should not be administered to patients with a history of known allergy to oxaliplatin or other platinum compounds [see warnings and precautions (5.1)] . pregnancy category d based on direct interaction with dna, oxaliplatin may cause fetal harm when administered to a pregnant woman. there are no adequate and well-controlled studies of oxaliplatin injection in pregnant women. reproductive toxicity studies in rats demonstrated adverse effects on fertility and embryo-fetal development at maternal doses that were below the recommended human dose based on body surface area. if this drug is used during pregnancy or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus. women of childbearing potential should be advised to avoid becoming pregnant and use effective contraception while receiving treatment with oxaliplatin inje

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

baxter healthcare corporation - oxaliplatin (unii: 04zr38536j) (oxaliplatin - unii:04zr38536j) - oxaliplatin 5 mg in 1 ml - oxaliplatin injection, in combination with infusional fluorouracil and leucovorin, is indicated for: oxaliplatin is contraindicated in patients with a history of a hypersensitivity reaction to oxaliplatin or other platinum-based drugs. reactions have included anaphylaxis [see warnings and precautions (5.1)]. risk summary based on its direct interaction with dna, oxaliplatin can cause fetal harm when administered to a pregnant woman. the available human data do not establish the presence or absence of major birth defects or miscarriage related to the use of oxaliplatin. reproductive toxicity studies demonstrated adverse effects on embryo-fetal development in rats at maternal doses that were below the recommended human dose based on body surface area (see data) . advise a pregnant woman 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 is 2% to 4% and 15% to 20%, respectively. data animal d

Ireland - English - HPRA (Health Products Regulatory Authority)

sanofi-aventis ireland limited - oxaliplatin - concentrate for soln for inf - 5 mg/ml

Ireland - English - HPRA (Health Products Regulatory Authority)

sanofi-aventis ireland limited - oxaliplatin - pdr for soln for infusion - 5 mg/ml

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

sun pharma anz pty ltd - oxaliplatin, quantity: 200 mg - injection, solution - excipient ingredients: lactose monohydrate; water for injections - oxaliplatin, in combination with fluorouracil and folinic acid, is indicated for: - adjuvant treatment of stage iii (duke's c) colon cancer after complete resection of the primary tumour; - treatment of advanced colorectal cancer

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

sun pharma anz pty ltd - oxaliplatin, quantity: 100 mg - injection, solution - excipient ingredients: water for injections; lactose monohydrate - oxaliplatin, in combination with fluorouracil and folinic acid, is indicated for: - adjuvant treatment of stage iii (duke's c) colon cancer after complete resection of the primary tumour; - treatment of advanced colorectal cancer

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

sun pharma anz pty ltd - oxaliplatin, quantity: 50 mg - injection, solution - excipient ingredients: lactose monohydrate; water for injections - oxaliplatin, in combination with fluorouracil and folinic acid, is indicated for: - adjuvant treatment of stage iii (duke's c) colon cancer after complete resection of the primary tumour; - treatment of advanced colorectal cancer

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

hospira, inc. - oxaliplatin (unii: 04zr38536j) (oxaliplatin - unii:04zr38536j) - oxaliplatin 5 mg in 1 ml - oxaliplatin, in combination with infusional fluorouracil and leucovorin, is indicated for: oxaliplatin is contraindicated in patients with a history of a hypersensitivity reaction to oxaliplatin or other platinum-based drugs. reactions have included anaphylaxis [see warnings and precautions (5.1)] . risk summary based on its direct interaction with dna, oxaliplatin can cause fetal harm when administered to a pregnant woman. the available human data do not establish the presence or absence of major birth defects or miscarriage related to the use of oxaliplatin. reproductive toxicity studies demonstrated adverse effects on embryo-fetal development in rats at maternal doses that were below the recommended human dose based on body surface area (see data) . advise a pregnant woman 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 is 2% to 4% and 15% to 20%, respectively. data animal data pregna