Australia - English - APVMA (Australian Pesticides and Veterinary Medicines Authority)

wsd agribusiness pty ltd - triclabendazole - oral solution/suspension - triclabendazole triazole active 100.0 g/l - parasiticides - cattle | goat | sheep | beef | billy | bos indicus | bos taurus | bovine | buck | buffalo | bull | bullock | calf | capra hircus - liver fluke

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

bluebay shandong co.,ltd - triclabendazole (unii: 4784c8e03o) (triclabendazole - unii:4784c8e03o) -

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

novartis pharmaceuticals corporation - triclabendazole (unii: 4784c8e03o) (triclabendazole - unii:4784c8e03o) - egaten® is indicated for the treatment of fascioliasis in patients 6 years of age and older. egaten is contraindicated in patients with known hypersensitivity to triclabendazole and/or to other benzimidazole derivatives or to any of the excipients in egaten. risk summary there are no available data on egaten use in pregnant women to inform a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. reproductive studies in animals (rat and rabbits) have not shown a risk of increased fetal abnormalities with exposure to triclabendazole during organogenesis at doses approximately 0.3 to 1.6 times the maximum recommended human dose (mrhd) of 20 mg/kg based on body surface area comparison (see data) . the estimated background risk of major birth defects and miscarriage for the indicated population are 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%-4% and 15%-20%, respectively. data animal data embryo-fetal developmental toxicity studies revealed no malformations in rats and rabbits at doses up to 200 mg/kg/day and 20 mg/kg/day, respectively (approximately 1.6 times and 0.3 times the mrhd based on body surface area comparison, respectively). the animals were treated orally during organogenesis, starting on day 6 of the pregnancy until day 15 in rats and day 18 in rabbits. maternal toxicity was noted at doses greater than or equal to 100 mg/kg/day in rats and 10 mg/kg/day in rabbits, which was associated with lower fetus weights and delayed ossification. these findings were considered indicative of delayed physiological growth that was secondary to maternal toxicity. no increase in malformation or other abnormalities was observed at any dose level in either species. risk summary there are no data on the presence of triclabendazole in human milk, the effects on the breastfed infant, or the effects on milk production. published animal data indicate that triclabendazole is detected in goat milk when administered as a single dose to one lactating animal. when a drug is present in animal milk, it is likely that the drug will be present in human milk. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for egaten and any potential adverse effects on the breastfed infant from egaten or from the underlying maternal condition. safety and effectiveness of egaten has been established in pediatric patients aged 6 years and older. safety and effectiveness of egaten in pediatric patients below the age of 6 years have not been established. clinical studies of egaten did not include sufficient numbers of patients aged 65 and over to determine whether the elderly respond differently from younger patients. in general, dose selection for an elderly patient should be cautious, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy. egaten has not been studied in patients with renal impairment. egaten has not been studied in patients with hepatic impairment.

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

ax pharmaceutical corp - triclabendazole (unii: 4784c8e03o) (triclabendazole - unii:4784c8e03o) -

Australia - English - APVMA (Australian Pesticides and Veterinary Medicines Authority)

elanco australasia pty ltd - triclabendazole - oral solution/suspension - triclabendazole triazole active 240.0 g/l - parasiticides - cattle | beef | bos indicus | bos taurus | bovine | buffalo | bull | bullock | calf | cow | dairy cow | heifer | steer - liver fluke

Australia - English - APVMA (Australian Pesticides and Veterinary Medicines Authority)

virbac (australia) pty ltd - triclabendazole - unknown - triclabendazole triazole active 0.0 - active constituent

Australia - English - APVMA (Australian Pesticides and Veterinary Medicines Authority)

boehringer ingelheim animal health australia pty. ltd. - triclabendazole - unknown - triclabendazole triazole active 0.0 - active constituent

Australia - English - APVMA (Australian Pesticides and Veterinary Medicines Authority)

elanco australasia pty ltd - triclabendazole - unknown - triclabendazole triazole active 0.0 - active constituent

Australia - English - APVMA (Australian Pesticides and Veterinary Medicines Authority)

elanco australasia pty ltd - triclabendazole - oral solution/suspension - triclabendazole triazole active 240.0 g/l - parasiticides - cattle - beef | bovine | bullocks | bulls | calves | cows | feedlot cattle | growers | heifer speyed | heifers (meat only) | pod - liver fluke - see label

Australia - English - APVMA (Australian Pesticides and Veterinary Medicines Authority)

apvma permit - triclabendazole - unspecified class