Philippines - English - FDA (Food And Drug Administration)

numen healthcare pvt. ltd.; importer: eon pharmatek, inc.; distributor: eon pharmatek, inc. - iron , folic acid , vitamin b12 , zinc - film-coated tablet - formulation each film-coated tablet contains: iron (equivalent to 400 mg ferrous ascorbate)-60 mg folic acid-1 mg cyanocobalamin (vitamin b2)-15 mcg zinc (equivalent to 9.5 mg zinc oxide)-7.5 mg

Philippines - English - FDA (Food And Drug Administration)

n/a; importer: eon pharmatek, inc.; distributor: eon pharmatek, inc. - multivitamins , zinc - capsule - formulation: each capsule contains: ascorbic acid (vitamin c)-150mg nicotinamide (vitamin b3)-50mg zinc (equivalent to 54.93 mg zinc sulfate monohydrate)-20mg calcium pantothenate-12.5mg thiamine nitrate (vitamin b1)-10mg riboflavin (vitamin b2)-10mg pyridoxine hydrochloride (vitamin b6)-3mg folic acid-1mg cyanocobalamin (vitamin b12)-15mcg

Philippines - English - FDA (Food And Drug Administration)

i-care formulations; importer: eon pharmatek inc.; distributor: eon pharmatek inc. - ascorbic acid , zinc, cholecalciferol (vitamin d3) - softgel capsule - 500 mg/20 mg (equivalent to 54.902 mg zinc sulphate monohydrate)/1000 iu

Philippines - English - FDA (Food And Drug Administration)

n/a; importer: eon pharmatek inc.; distributor: n/a - calcium , zinc , calcitriol - softgel capsule - 200mg (equivalent to 500mg calcium carbonate) / 7.5mg (equivalent to 20.588mg zinc sulfate monohydrate) / 0.25mcg

Philippines - English - FDA (Food And Drug Administration)

i-care formulations; importer: eon pharmatek inc.; distributor: n/a - calcium , zinc , calcitriol - softgel capsule - 200mg (equivalent to 500mg calcium carbonate) / 7.5mg (equivalent to 20.588mg zinc sulfate monohydrate) / 0.25mcg

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

teva pharmaceuticals, inc. - tasimelteon (unii: shs4pu80d9) (tasimelteon - unii:shs4pu80d9) - - tasimelteon capsules are indicated for the treatment of non-24 in adults. none. risk summary available postmarketing case reports with tasimelteon use in pregnant women are not sufficient to evaluate drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. in pregnant rats, no embryofetal developmental toxicity was observed at exposures of 50 mg/kg/day, or up to 24 times higher than the human exposure at the maximum recommended human dose (mrhd) (see data). the estimated background risk of major birth defects and miscarriage for the indicated populations are unknown. 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 in pregnant rats administered tasimelteon at oral doses of 5 mg/kg/day, 50 mg/kg/day, or 500 mg/kg/day during the period of organogenesis, there were no effects on embryofetal development. the highest dose tested is approximately 240 times the mrhd of 20 mg/day, based on mg/m2 body surface area. in pregnant rabbits administered tasimelteon at oral doses of 5 mg/kg/day, 30 mg/kg/day, or 200 mg/kg/day during the period of organogenesis, embryolethality and embryofetal toxicity (reduced fetal body weight and delayed ossification) were observed at the highest dose tested. the highest dose is approximately 200 times the mrhd. oral administration of tasimelteon at 50 mg/kg/day, 150 mg/kg/day, or 450 mg/kg/day to rats throughout organogenesis resulted in persistent reductions in body weight, delayed sexual maturation, and physical development, and neurobehavioral impairment in offspring at the highest dose tested which is approximately 220 times the mrhd based on mg/m2 body surface area. reduced body weight in offspring was also observed at the mid-dose. the no effect dose (noel), (50 mg/kg/day) is approximately 25 times the mrhd based on mg/m2 body surface area. risk summary there are no data on the presence of tasimelteon or its metabolites in human or animal milk, the effects on the breastfed infant, or the effects on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for tasimelteon and any potential adverse effects on the breastfed infant from tasimelteon or from the underlying maternal condition. safety and effectiveness of tasimelteon for the treatment of non-24 in pediatric patients have not been established. juvenile animal toxicity data juvenile rats received oral doses of tasimelteon at 50, 150, or 450 mg/kg from weaning (day 21) through adulthood (day 90). these doses are approximately 12 to 108 times the maximum recommended human dose (mrhd) of 20 mg based on a mg/m2 body surface area. toxicity was observed mainly at the highest dose and included mortality (females only), tremors, unsteady gait, decrease in growth and development compared to controls. the former reflected as decreases in bone growth, bone mineral content, bone ossification, and a delay in attainment of sexual maturation. tasimelteon had no effect on fertility, reproduction, or learning and memory. the no observed adverse effect level (noael) is 150 mg/kg/day, which is approximately 178 times the mrhd based on auc. the risk of adverse reactions may be greater in elderly (>65 years) patients than younger patients because exposure to tasimelteon is increased by approximately 2-fold compared with younger patients. dose adjustment is not necessary in patients with mild or moderate hepatic impairment. tasimelteon has not been studied in patients with severe hepatic impairment (child-pugh class c). therefore, tasimelteon is not recommended for use in patients with severe hepatic impairment [see clinical pharmacology (12.3)] . smoking causes induction of cyp1a2 levels. the exposure of tasimelteon in smokers was lower than in non-smokers and therefore the efficacy of tasimelteon may be reduced in smokers [see clinical pharmacology (12.3)] . tasimelteon is not a controlled substance under the controlled substances act. tasimelteon did not produce any abuse-related signals in animal behavioral studies. rats did not self-administer tasimelteon, suggesting that the drug does not have rewarding properties. there were also no signs or symptoms indicative of abuse potential in clinical studies with tasimelteon. discontinuation of tasimelteon in humans following chronic administration did not produce withdrawal signs. tasimelteon does not appear to produce physical dependence.

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

amneal pharmaceuticals ny llc - tasimelteon (unii: shs4pu80d9) (tasimelteon - unii:shs4pu80d9) - - tasimelteon capsules are indicated for the treatment of non-24-hour in adults. none.  risk summary available postmarketing case reports with tasimelteon use in pregnant women are not sufficient to evaluate drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. in pregnant rats, no embryofetal developmental toxicity was observed at exposures of 50 mg/kg/day, or up to 24 times higher than the human exposure at the maximum recommended human dose (mrhd) (see data). the estimated background risk of major birth defects and miscarriage for the indicated populations are unknown. 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 in pregnant rats administered tasimelteon at oral doses of 5, 50, or 500 mg/kg/day during the period of organogenesis, there were no effects on embryofetal development. the highest dose tested is approximat

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

apotex corp. - tasimelteon (unii: shs4pu80d9) (tasimelteon - unii:shs4pu80d9) - tasimelteon capsules are indicated for the treatment of non-24 in adults. none. risk summary available postmarketing case reports with tasimelteon use in pregnant women are not sufficient to evaluate drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. in pregnant rats, no embryofetal developmental toxicity was observed at exposures of 50 mg/kg/day, or up to 24 times higher than the human exposure at the maximum recommended human dose (mrhd) (see data). the estimated background risk of major birth defects and miscarriage for the indicated populations are unknown. 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 in pregnant rats administered tasimelteon at oral doses of 5, 50, or 500 mg/kg/day during the period of organogenesis, there were no effects on embryofetal development. the highest dose tested is approximately 240 times the mrhd of 20 mg/day, based on mg/m2 body surface area. in pregnant rabbits administered tasimelteon at oral doses of 5, 30, or 200 mg/kg/day during the period of organogenesis, embryolethality and embryofetal toxicity (reduced fetal body weight and delayed ossification) were observed at the highest dose tested. the highest dose is approximately 200 times the mrhd. oral administration of tasimelteon at 50, 150, or 450 mg/kg/day to rats throughout organogenesis resulted in persistent reductions in body weight, delayed sexual maturation, and physical development, and neurobehavioral impairment in offspring at the highest dose tested which is approximately 220 times the mrhd based on mg/m2 body surface area. reduced body weight in offspring was also observed at the mid-dose. the no effect dose (noel), (50 mg/kg/day) is approximately 25 times the mrhd based on mg/m2 body surface area. risk summary there are no data on the presence of tasimelteon or its metabolites in human or animal milk, the effects on the breastfed infant, or the effects on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for tasimelteon and any potential adverse effects on the breastfed infant from tasimelteon or from the underlying maternal condition. safety and effectiveness of tasimelteon capsules for the treatment of non-24 in pediatric patients have not been established. juvenile animal toxicity data juvenile rats received oral doses of tasimelteon at 50, 150, or 450 mg/kg from weaning (day 21) through adulthood (day 90). these doses are approximately 12 to 108 times the maximum recommended human dose (mrhd) of 20 mg based on a mg/m2 body surface area. toxicity was observed mainly at the highest dose and included mortality (females only), tremors, unsteady gait, decrease in growth and development compared to controls. the former reflected as decreases in bone growth, bone mineral content, bone ossification, and a delay in attainment of sexual maturation. tasimelteon had no effect on fertility, reproduction, or learning and memory. the no observed adverse effect level (noael) is 150 mg/kg/day, which is approximately 178 times the mrhd based on auc. the risk of adverse reactions may be greater in elderly (>65 years) patients than younger patients because exposure to tasimelteon is increased by approximately 2-fold compared with younger patients. dose adjustment is not necessary in patients with mild or moderate hepatic impairment. tasimelteon has not been studied in patients with severe hepatic impairment (child-pugh class c). therefore, tasimelteon is not recommended for use in patients with severe hepatic impairment [see clinical pharmacology (12.3)]. smoking causes induction of cyp1a2 levels. the exposure of tasimelteon in smokers was lower than in non-smokers and therefore the efficacy of tasimelteon may be reduced in smokers [see clinical pharmacology (12.3)]. tasimelteon is not a controlled substance under the controlled substances act. tasimelteon did not produce any abuse-related signals in animal behavioral studies. rats did not self-administer tasimelteon, suggesting that the drug does not have rewarding properties. there were also no signs or symptoms indicative of abuse potential in clinical studies with tasimelteon. discontinuation of tasimelteon in humans following chronic administration did not produce withdrawal signs. tasimelteon does not appear to produce physical dependence.

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

intervet australia pty limited - pigeon paramyxovirus-1 strain p201 (inactivated) - unknown - pigeon paramyxovirus-1 strain p201 (inactivated) virus active 0.0 - active constituent

Canada - English - Health Canada

boiron laboratoires - paeonia officinalis - drops - 1dh - paeonia officinalis 1dh - homeopathic products