Jungtinės Valstijos - anglų - 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.

Australija - anglų - Department of Health (Therapeutic Goods Administration)

pfizer (perth) pty ltd - vincristine sulfate, quantity: 1 mg/ml - injection, solution - excipient ingredients: mannitol; sodium hydroxide; sulfuric acid; water for injections - the treatment of acute leukaemia, usually as a component of various chemotherapeutic regimens. it has also been used as part of combination therapy in the treatment of hodgkins disease, non-hodgkin?s malignant lymphomas, rhabdomyosarcoma, neuroblastoma, wilm?s tumour, osteogenic sarcoma, mycosis fungoides, ewing?s sarcoma, carcinoma of the uterine cervix, breast cancer, malignant melanoma, oat-cell carcinoma of the lung and gynaecological tumours of childhood. vincristine may be useful in patients with true idiopathic thrombocytopenic purpura resistant to the usual treatment, but not recommended as primary treatment for this disorder.

Malta - anglų - Medicines Authority

jv healthcare limited navi buidlings, pantar road, lija, lja 2021, malta - vincristine sulfate - solution for injection - vincristine sulfate 1 mg/ml - antineoplastic agents

Kanada - anglų - Health Canada

david bull laboratories (pty) ltd. - vincristine sulfate - liquid - 1mg - vincristine sulfate 1mg - antineoplastic agents

Kanada - anglų - Health Canada

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

Malta - anglų - 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

Jungtinės Valstijos - anglų - NLM (National Library of Medicine)

teva parenteral medicines, inc. - vincristine sulfate (unii: t5iro3534a) (vincristine - unii:5j49q6b70f) - vincristine sulfate 1 mg in 1 ml - vincasar pfs is indicated in acute leukemia. vincasar pfs 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 vincasar pfs. careful attention should be given to those conditions listed under warnings  and precautions .

Australija - anglų - Department of Health (Therapeutic Goods Administration)

hospira australia pty ltd - vincristine sulfate -

Australija - anglų - Department of Health (Therapeutic Goods Administration)

vincristine sulfate -

Australija - anglų - 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.