Իռլանդիա - անգլերեն - HPRA (Health Products Regulatory Authority)

alliance pharmaceuticals ltd. - penicillamine - film coated tablet - 125 milligram

Թայվան - չինարեն - 衛生福利部食品藥物管理署 (Ministry of Health and Welfare, Food And Drug Administration)

立信藥品有限公司 台北巿承德路三段１３５號二樓 (31186558) - penicillamine d- - （粉） - 主成分 () ; penicillamine d- (6400000501) 95.0+% - 重金屬解毒劑

Թայվան - չինարեն - 衛生福利部食品藥物管理署 (Ministry of Health and Welfare, Food And Drug Administration)

亨元股份有限公司 台北巿松江路１２９號１０樓 (12124322) - penicillamine - （粉） - 主成分 () ; penicillamine (6400000500) 97.0-100.5% - 重金屬中毒之解毒劑

Իռլանդիա - անգլերեն - HPRA (Health Products Regulatory Authority)

merck sharp and dohme limited - penicillamine - capsule - 250mg

Ավստրալիա - անգլերեն - Department of Health (Therapeutic Goods Administration)

alphapharm pty ltd - penicillamine -

Ամերիկայի Միացյալ Նահանգներ - անգլերեն - NLM (National Library of Medicine)

orphalan sa - trientine tetrahydrochloride (unii: 7360ure56q) (trientine - unii:sj76y07h5f) - cuvrior is indicated for the treatment of adult patients with stable wilson's disease who are de-coppered and tolerant to penicillamine. cuvrior is contraindicated in patients with hypersensitivity to trientine or to any of the excipients in cuvrior [see warnings and precautions (5.4)] . risk summary available data from published literature and postmarketing experience over several decades with use of trientine for the treatment of wilson's disease have not identified any drug-associated risks for major birth defects, miscarriages, or other adverse maternal or fetal outcomes. untreated wilson's disease may result in worsening disease symptoms during pregnancy and increase the risk of miscarriages in some symptomatic patients (see clinical considerations) . in animal reproduction studies, oral administration of trientine in rats during organogenesis resulted in increased embryo-fetal loss at a dose lower than the maximum recommended dose and produced fetal abnormalities at 2.7 times the maximum recommended dose. copper supplementation in pregnant rats produced a marked reduction in trientine-induced fetal abnormalities. oral administration of trientine dihydrochloride to pregnant mice during organogenesis increased the percentage of mice with total embryo-fetal loss at approximately 4.3 times the maximum recommended dose and produced fetal abnormalities at approximately 1.1 times the maximum recommended dose. the mechanism of embryo-fetal harm (e.g., copper depletion) was not determined in the mouse study [see warnings and precautions (5.2) and data]. monitor copper levels throughout pregnancy and use the minimum effective dosage of cuvrior throughout pregnancy. the estimated background risk of major birth defects and miscarriage for the indicated populations is unknown. all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. 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. clinical considerations disease-associated maternal and/or embryo/fetal risk untreated wilson's disease or discontinuation of treatment during pregnancy may result in worsening neurological and hepatic symptoms, including rare reports of hepatic decompensation and liver failure. untreated wilson's disease may also increase the risk of miscarriage in some symptomatic patients. increased copper deposition in the placenta and fetal liver may adversely impact the fetus. maternal adverse reactions trientine may chelate non-copper cations (e.g., iron, calcium). maintain appropriate levels during pregnancy [see dosage and administration (2.2), warnings and precautions (5.2, 5.3), and drug interactions (7.1)] . fetal/neonatal adverse reactions chelator-induced copper deficiency may have adverse effects on the fetus. data animal data in embryo-fetal development studies in rats, trientine was administered orally at doses up to approximately 835 mg/kg/day during organogenesis. an increased incidence of resorptions was observed at a dose lower than the maximum recommended dose (1,500 mg/day trientine free base equivalent), based on body surface area. an increased incidence of fetal abnormalities, including hemorrhage and edema, was observed at 2.7 times the maximum recommended dose, based on body surface area. when pregnant rats were treated with trientine and supplemented with copper (concentration of 50 mcg/g in the diet), fetal abnormalities were markedly reduced, indicating that the mechanism of embryo-fetal harm in rats with no copper supplementation was based on copper depletion (primary pharmacology of trientine). in embryo-fetal development studies in mice, trientine dihydrochloride was administered orally at doses up to approximately 2,000 mg/kg/day during organogenesis. a dose-dependent increase in the incidence of abnormal fetuses occurred at all doses. fetal abnormalities included hemorrhages and delayed ossification which were observed starting at 500 mg/kg/day, microcephaly and hydrocephaly starting at 1,000 mg/kg/day, and exencephaly at 2,000 mg/kg/day (the doses were 1.1, 2.1, and 4.3 times the maximum recommended dose, respectively, based on body surface area). the percentage of dams with total resorption was increased at 2,000 mg/kg/day (5.3 times the maximum recommended dose based on body surface area). the mechanism of embryo-fetal harm (e.g. copper depletion) was not determined in this study. risk summary the available published data are inconsistent regarding the detection of trientine in breastmilk. available published literature have not reported drug-associated adverse effects in infants exposed to trientine through breastmilk. there are no data on the effects of trientine on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for cuvrior and any potential adverse effects on the breastfed infant from cuvrior or from the underlying condition. the safety and effectiveness of cuvrior in pediatric patients have not been established. in trial 1, of the total number of cuvrior-treated patients, 1 (4%) was 65 years of age and older [see clinical studies (14)] . clinical studies with trientine did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently from younger adult patients. other reported clinical experience with trientine is insufficient to determine differences in responses between geriatric and younger adult patients. in general, dose selection should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

Թայվան - չինարեն - 衛生福利部食品藥物管理署 (Ministry of Health and Welfare, Food And Drug Administration)

美商美國新美股份有限公司台灣分公司 台北巿仁愛路三段１３６號芙蓉大樓１４樓 (11505604) - penicillamine - 膠囊劑 - penicillamine (6400000500) 250mg - 用於清除患ＷＩＬＳＯＮ氏症之患者體內過剩之銅以及用於治療膀胱氨荃酸尿症（ＣＹＳＴＩＮＵＲＩＡ）

Թայվան - չինարեն - 衛生福利部食品藥物管理署 (Ministry of Health and Welfare, Food And Drug Administration)

施懷哲股份有限公司 台北巿南京東路五段１６號１０Ｆ (12141223) - penicillamine d- - 膠囊劑 - penicillamine d- (6400000501) 0.150gm - 類風濕關節炎、威爾森病（ＷＩＬＳＯＮＳ　ＤＩＳＥＡＳＥ　ＶＩＴＡＬ　ＩＮＤＩＣＡＴＩＯＮ）胱胺酸引起泌尿系統結石、重金屬等中毒（如銅、金、鉛、汞、鈷、鋅）硬皮症、肺間質組織纖維化症

Թայվան - չինարեն - 衛生福利部食品藥物管理署 (Ministry of Health and Welfare, Food And Drug Administration)

創富國際有限公司 台北市信義區忠孝東路五段410號13樓之3 (30015374) - penicillamine d- - 膠囊劑 - penicillamine d- (6400000501) 0.150gm - 類風濕關節炎、威爾森氏病（ＷＩＬＳＯＮＳ　ＤＩＳＥＡＳＥ　ＶＩＴＡＬ　ＩＮＤＩＣＡＴＩＯＮ）、胱胺酸引起泌尿系統結石、重金屬等中毒（如：銅、金、鉛、汞、鈷、鋅）、硬皮症、肺間質組織纖維化症

Թայվան - չինարեն - 衛生福利部食品藥物管理署 (Ministry of Health and Welfare, Food And Drug Administration)

創富國際有限公司 台北市信義區忠孝東路五段410號13樓之3 (30015374) - penicillamine d- - 膠囊劑 - penicillamine d- (6400000501) 0.250gm - 類風濕關節炎、重金屬中毒