Malta - English - Medicines Authority

leo pharma a/s industriparken 55, 2750-dk ballerup, denmark - hydrocortisone butyrate - cutaneous emulsion - hydrocortisone butyrate 1 mg/g - corticosteroids, dermatological preparations

Malta - English - Medicines Authority

leo pharma a/s industriparken 55, 2750-dk ballerup, denmark - hydrocortisone butyrate - cutaneous solution - hydrocortisone butyrate 1 mg/g - corticosteroids, dermatological preparations

Armenia - English - Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

temmler italia s.r.l. - hydrocortisone (hydrocortisone 17-butyrate) - emulsion cutaneous - 1mg/g

Malta - English - Medicines Authority

astellas pharma europe b.v. - hydrocortisone butyrate 1 mg/g - cutaneous emulsion

Malta - English - Medicines Authority

astellas pharma europe b.v. - hydrocortisone butyrate 1 mg/g - cutaneous solution

Malta - English - Medicines Authority

astellas pharma europe b.v. - hydrocortisone butyrate 1 mg/g - cream

Malta - English - Medicines Authority

astellas pharma europe b.v. - hydrocortisone butyrate 1 mg/g - cream

South Africa - English - South African Health Products Regulatory Authority (SAHPRA)

adcock ingram limited - ointment - see ingredients - each gram ointment contains hydrocortisone butyrate 1,0 mg

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

bausch health us, llc - hydrocortisone butyrate (unii: 05rmf7ypwn) (hydrocortisone - unii:wi4x0x7bpj) - hydrocortisone butyrate 1 mg in 1 g - locoid lipocream is indicated for: none. pregnancy category c. there are no adequate and well-controlled studies in pregnant women. therefore, locoid lipocream should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. corticosteroids have been shown to be teratogenic in laboratory animals when administered systemically at relatively low dosage levels. some corticosteroids have been shown to be teratogenic after dermal application in laboratory animals. note: the animal multiples of human exposure calculations in this label were based on body surface area comparisons for an adult (i.e., mg/m2 /day dose comparisons) assuming 100% human percutaneous absorption of a maximum topical human dose (mthd) for hydrocortisone butyrate cream (25 g). systemic embryofetal development studies were conducted in rats and rabbits. subcutaneous doses of 0.6, 1.8, and 5.4 mg/kg/day hydrocortisone butyrate were administered to pregnant female rats during gestation days 6 - 17. in the

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

bausch health us, llc - hydrocortisone butyrate (unii: 05rmf7ypwn) (hydrocortisone - unii:wi4x0x7bpj) - hydrocortisone butyrate 1 mg in 1 ml - locoid® lotion is indicated for the topical treatment of mild to moderate atopic dermatitis in patients 3 months of age and older. none. pregnancy   risk summary there are no controlled or large-scale epidemiologic studies with locoid lotion in pregnant women, and available data on hydrocortisone butyrate use in pregnant women have not identified a drug associated risk for major birth defects, miscarriages, or adverse maternal or fetal outcomes. in animal reproduction studies, when administered subcutaneously or topically to pregnant rats, rabbits, and mice, hydrocortisone butyrate induced adverse reproductive and developmental outcomes, including abortion, fetal death, malformation, delayed ossification, decrease in fetal weight, and delay in sexual maturation (see data) . the available data do not allow the calculation of relevant comparisons between the systemic exposure of hydrocortisone butyrate observed in animal studies and the systemic exposure that would be expected in humans after topical use of lo