Canada - English - Health Canada

david bull laboratories (pty) ltd. - vincristine sulfate - powder for solution - 5mg - vincristine sulfate 5mg - antineoplastic agents

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

hospira, inc. - vincristine sulfate (unii: t5iro3534a) (vincristine - unii:5j49q6b70f) - vincristine sulfate injection is indicated in acute leukemia. vincristine sulfate injection has also been shown to be useful in combination with other oncolytic agents in hodgkin's disease, non–hodgkin's malignant lymphomas, rhabdomyosarcoma, neuroblastoma, and wilms' tumor. patients with the demyelinating form of charcot–marie–tooth syndrome should not be given vincristine sulfate injection. careful attention should be given to those conditions listed under warnings and precautions .

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

hospira, inc. - vincristine sulfate (unii: t5iro3534a) (vincristine - unii:5j49q6b70f) - vincristine sulfate injection is indicated in acute leukemia. vincristine sulfate injection has also been shown to be useful in combination with other oncolytic agents in hodgkin's disease, non–hodgkin's malignant lymphomas, rhabdomyosarcoma, neuroblastoma, and wilms' tumor. patients with the demyelinating form of charcot–marie–tooth syndrome should not be given vincristine sulfate injection. careful attention should be given to those conditions listed under warnings and precautions .

Malta - English - Medicines Authority

central procurement & supplies unit ub002 industrial estate, san gwann sgn 3000, malta - vincristine sulfate - solution for injection - vincristine sulfate 1 mg/ml - antineoplastic agents

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

pfizer laboratories div pfizer inc - crisaborole (unii: q2r47hgr7p) (crisaborole - unii:q2r47hgr7p) - crisaborole 20 mg in 1 g - eucrisa is indicated for topical treatment of mild to moderate atopic dermatitis in adult and pediatric patients 3 months of age and older. eucrisa is contraindicated in patients with known hypersensitivity to crisaborole or any component of the formulation. [see warnings and precautions (5.1)] risk summary available data from case reports with eucrisa use in pregnant women are insufficient to inform a drug-associated risk for major birth defects, miscarriage, or other adverse maternal or fetal outcomes. in animal reproduction studies, there were no adverse developmental effects observed with oral administration of crisaborole in pregnant rats and rabbits during organogenesis at doses up to 3 and 2 times, respectively, the maximum recommended human dose (mrhd) (see data ). the background risk of major birth defects and miscarriage for the indicated population is unknown. all pregnancies carry some risk of birth defect, loss, or other adverse outcomes. the background risk of major birth defects in the u.s. general population is 2% to 4% and of miscarriage is 15% to 20% of clinically recognized pregnancies. data animal data rat and rabbit embryo-fetal development was assessed after oral administration of crisaborole. crisaborole did not cause adverse effects to the fetus at oral doses up to 300 mg/kg/day in pregnant rats during the period of organogenesis (3 times the mrhd on an area under the curve (auc) comparison basis). no crisaborole-related fetal malformations were noted after oral treatment with crisaborole in pregnant rats at doses up to 600 mg/kg/day (13 times the mrhd on an auc comparison basis) during the period of organogenesis. maternal toxicity was produced at this high dose of 600 mg/kg/day in pregnant rats and was associated with decreased fetal body weight and delayed skeletal ossification. crisaborole did not cause adverse effects to the fetus at oral doses up to the highest dose tested of 100 mg/kg/day in pregnant rabbits during the period of organogenesis (2 times the mrhd on an auc comparison basis). in a prenatal/postnatal development study, pregnant rats were treated with crisaborole at doses of 150, 300, or 600 mg/kg/day by oral gavage during gestation and lactation (from gestation day 7 through day 20 of lactation). crisaborole did not have any adverse effects on fetal development at doses up to 300 mg/kg/day (3 times the mrhd on an auc comparison basis). maternal toxicity was produced at the high dose of 600 mg/kg/day in pregnant rats and was associated with stillbirths, pup mortality, and reduced pup weights. risk summary there is no information available on the presence of eucrisa in human milk, the effects of the drug on the breastfed infant or the effects of the drug on milk production after topical application of eucrisa to women who are breastfeeding. eucrisa is systemically absorbed. the lack of clinical data during lactation precludes a clear determination of the risk of eucrisa to a breastfed infant. therefore, the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for eucrisa and any potential adverse effects on the breastfed infant from eucrisa or from the underlying maternal condition. the safety and effectiveness of eucrisa have been established in pediatric patients ages 3 months and older for topical treatment of mild to moderate atopic dermatitis. use of eucrisa administered twice daily in this age group is supported by data from two 28-day adequate, vehicle-controlled safety and efficacy trials (1,313 pediatric subjects ages 2 years to 17 years of whom 874 received eucrisa), a 28-day open-label, safety and pharmacokinetics (pk) trial (137 subjects ages 3 months to less than 2 years who received eucrisa), and another trial with an open-label period of up to 8 weeks (327 pediatric subjects ages 5 months to less than 18 years who received eucrisa) [see clinical pharmacology (12.3) and clinical studies (14)] . the safety and effectiveness of eucrisa in pediatric patients below the age of 3 months have not been established. clinical studies of eucrisa did not include sufficient numbers of subjects age 65 and over to determine whether they respond differently from younger subjects.

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

hospira australia pty ltd - vincristine sulfate -

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

vincristine sulfate -

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

hospira australia pty ltd - vincristine sulfate, quantity: 1 mg/ml - injection, solution - excipient ingredients: benzyl alcohol; mannitol; water for injections - vincristine sulphate injection is used in the treatment of cancers of the blood (eg. leukaemia or lymphomas), breast, head and neck or lung. it may be used to treat multiple myeloma (a cancer of plasma cells) and it may also be used in the treatment of some cancers in children. it may be used in a blood disorder known as idiopathic thrombocytopenic purpura (itp) after other treatments have not been successful. vincristine sulphate injection may be given alone or in combination with other anti-cancer medicines.

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

hospira australia pty ltd - vincristine sulfate, quantity: 1 mg/ml - injection - excipient ingredients: mannitol; water for injections; sulfuric acid; sodium hydroxide - vincristine sulfate is indicated in the treatment of acute leukemia. it has also been used in combination with other antineoplastic drugs in hodgkin's disease, soft-tissue sarcoma, bony-tissue sarcoma, sarcomas of specialized structures, breast cancer, small cell cancer of the lung, cancer of uterine cervix, malignant melanoma, colorectal cancer, non-hodgkin's lymphoma, and wilm's tumor.

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

hospira australia pty ltd - vincristine sulfate, quantity: 1 mg/ml - injection - excipient ingredients: mannitol; water for injections; sulfuric acid; sodium hydroxide - vincristine sulphate is used either alone or in conjunction with other oncolytic drugs for the treatment of: leukaemias, malignant lymphomas, multiple myeloma, breast carcinoma, small cell bronchogenic carcinoma, head and neck carcinoma, soft tissue sacomas, paediatric solid tumours and idiopathic thrombocytopenic purpura.