Ирландия - английски - HPRA (Health Products Regulatory Authority)

infomed fluids srl - meropenem - powder for solution for injection/infusion - 1 gram(s) - meropenem

Ирландия - английски - HPRA (Health Products Regulatory Authority)

infomed fluids srl - meropenem - powder for solution for injection/infusion - 500 milligram(s) - meropenem

Малта - английски - Malta Medicines Authority

infomed fluids srl blvd. theodor pallady 50, sector 3 032266 bucharest , romania - meropenem trihydrate - powder for solution for injection/infusion - meropenem trihydrate 500 mg - antibacterials for systemic use

Малта - английски - Malta Medicines Authority

infomed fluids srl blvd. theodor pallady 50, sector 3 032266 bucharest , romania - meropenem trihydrate - powder for solution for injection/infusion - meropenem trihydrate 1 g - antibacterials for systemic use

Ирландия - английски - HPRA (Health Products Regulatory Authority)

hikma farmacêutica (portugal) s.a. - meropenem trihydrate - powder for solution for injection/infusion - meropenem

Ирландия - английски - HPRA (Health Products Regulatory Authority)

acs dobfar s.p.a. - meropenem - powder for solution for injection/infusion - meropenem

Ирландия - английски - HPRA (Health Products Regulatory Authority)

acs dobfar s.p.a. - meropenem - powder for solution for injection/infusion - meropenem

САЩ - английски - NLM (National Library of Medicine)

oceanside pharmaceuticals - tretinoin (unii: 5688utc01r) (tretinoin - unii:5688utc01r) - tretinoin 1 mg in 1 g - tretinoin gel microsphere is a retinoid indicated for topical application in the treatment of acne vulgaris. none. pregnancy category c there are no adequate and well-controlled studies in pregnant women. tretinoin gel microsphere should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. thirty human cases of temporally associated congenital malformations have been reported during two decades of clinical use of tretinoin products. although no definite pattern of teratogenicity and no causal association has been established from these cases, five of the reports describe the rare birth defect category holoprosencephaly (defects associated with incomplete midline development of the forebrain). the significance of these spontaneous reports in terms of risk to the fetus is not known. for purposes of comparison of the animal exposure to systemic human exposure, the mrhd applied topically is defined as 1 gram of tretinoin gel microsphere, 0.1%, applied daily to a 60 kg person (0.017 mg tretinoin/kg body weight). pregnant rats were treated with tretinoin gel microsphere, 0.1%, at daily dermal doses of 0.5 to 1.0 mg/kg/day tretinoin on gestation days 6-15. alterations were seen in vertebrae and ribs of offspring at 5 to 10 times the mrhd based on the body surface area (bsa) comparison. pregnant new zealand white rabbits were treated with tretinoin gel microsphere, 0.1%, at daily dermal doses of 0.2, 0.5, and 1.0 mg/kg/day tretinoin on gestation days 7-19. doses were administered topically for 24 hours a day while wearing elizabethan collars to prevent ingestion of the drug. increased incidences of certain alterations, including domed head and hydrocephaly, typical of retinoid-induced fetal malformations in this species, were observed at 0.5 and 1.0 mg/kg/day. similar malformations were not observed at 0.2 mg/kg/day, 4 times the mrhd based on bsa comparison. other pregnant rabbits exposed topically for six hours per day to 0.5 or 1.0 mg/kg/day tretinoin while restrained in stocks to prevent ingestion, did not show any malformations at doses up to 19 times (1.0 mg/kg/day) the mrhd based on bsa comparison, but fetal resorptions were increased at 0.5 mg/kg (10 times the mrhd based on bsa comparison). oral tretinoin has been shown to cause malformations in rats, mice, rabbits, hamsters, and nonhuman primates. tretinoin induced fetal malformations in wistar rats when given orally at doses greater than 1 mg/kg/day (10 times the mrhd based on bsa comparison). in the cynomolgus monkey, fetal malformations were reported for doses of 10 mg/kg/day but none were observed at 5 mg/kg/day (95 times the mrhd based on bsa comparison), although increased skeletal variations were observed at all doses. dose-related increases in embryolethality and abortion also were reported. similar results have also been reported in pigtail macaques. in oral peri- and postnatal development studies in rats with tretinoin, decreased survival of neonates and growth retardation were observed at doses in excess of 2 mg/kg/day (19 times the mrhd based on bsa comparison). nonteratogenic effects on fetus oral tretinoin has been shown to be fetotoxic in rats when administered at doses 24 times the mrhd based on bsa comparison. topical tretinoin has been shown to be fetotoxic in rabbits when administered at doses 10 times the mrhd based on bsa comparison. it is not known whether tretinoin and/or its metabolites are excreted in human milk. because many drugs are excreted in human milk, caution should be exercised when tretinoin gel microsphere is administered to a nursing woman. safety and effectiveness in children below the age of 12 have not been established. safety and effectiveness in a geriatric population have not been established. clinical trials of tretinoin gel microsphere, 0.1%, 0.08% and 0.04%, did not include sufficient numbers of subjects aged 65 and over to determine whether they responded differently from younger subjects.

САЩ - английски - NLM (National Library of Medicine)

bausch health us llc - tretinoin (unii: 5688utc01r) (tretinoin - unii:5688utc01r) - tretinoin 1 mg in 1 g - retin-a micro ® is a retinoid indicated for topical application in the treatment of acne vulgaris. none. pregnancy category c there are no adequate and well-controlled studies in pregnant women. retin-a micro should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. thirty human cases of temporally associated congenital malformations have been reported during two decades of clinical use of tretinoin products. although no definite pattern of teratogenicity and no causal association has been established from these cases, five of the reports describe the rare birth defect category holoprosencephaly (defects associated with incomplete midline development of the forebrain). the significance of these spontaneous reports in terms of risk to the fetus is not known. for purposes of comparison of the animal exposure to systemic human exposure, the mrhd applied topically is defined as 1 gram of retin-a micro (tretinoin) gel microsphere, 0.1%, applied daily to a 60 kg person (0.017 mg tretinoin/kg body weight). pregnant rats were treated with retin-a micro (tretinoin) gel microsphere, 0.1%, at daily dermal doses of 0.5 to 1.0 mg/kg/day tretinoin on gestation days 6-15. alterations were seen in vertebrae and ribs of offspring at 5 to 10 times the mrhd based on the body surface area (bsa) comparison. pregnant new zealand white rabbits were treated with retin-a micro (tretinoin) gel microsphere, 0.1%, at daily dermal doses of 0.2, 0.5, and 1.0 mg/kg/day tretinoin on gestation days 7-19. doses were administered topically for 24 hours a day while wearing elizabethan collars to prevent ingestion of the drug. increased incidences of certain alterations, including domed head and hydrocephaly, typical of retinoid-induced fetal malformations in this species, were observed at 0.5 and 1.0 mg/kg/day. similar malformations were not observed at 0.2 mg/kg/day, 4 times the mrhd based on bsa comparison. other pregnant rabbits exposed topically for six hours per day to 0.5 or 1.0 mg/kg/day tretinoin while restrained in stocks to prevent ingestion, did not show any malformations at doses up to 19 times (1.0 mg/kg/day) the mrhd based on bsa comparison, but fetal resorptions were increased at 0.5 mg/kg (10 times the mrhd based on bsa comparison). oral tretinoin has been shown to cause malformations in rats, mice, rabbits, hamsters, and nonhuman primates. tretinoin induced fetal malformations in wistar rats when given orally at doses greater than 1 mg/kg/day (10 times the mrhd based on bsa comparison). in the cynomolgus monkey, fetal malformations were reported for doses of 10 mg/kg/day but none were observed at 5 mg/kg/day (95 times the mrhd based on bsa comparison), although increased skeletal variations were observed at all doses. dose-related increases in embryolethality and abortion also were reported. similar results have also been reported in pigtail macaques. in oral peri- and postnatal development studies in rats with tretinoin, decreased survival of neonates and growth retardation were observed at doses in excess of 2 mg/kg/day (19 times the mrhd based on bsa comparison). nonteratogenic effects on fetus oral tretinoin has been shown to be fetotoxic in rats when administered at doses 24 times the mrhd based on bsa comparison. topical tretinoin has been shown to be fetotoxic in rabbits when administered at doses 10 times the mrhd based on bsa comparison. it is not known whether tretinoin and/or its metabolites are excreted in human milk. because many drugs are excreted in human milk, caution should be exercised when retin-a micro is administered to a nursing woman. safety and effectiveness in children below the age of 12 have not been established. safety and effectiveness in a geriatric population have not been established. clinical trials of retin-a micro (tretinoin) gel microsphere, 0.1% and 0.04%, did not include sufficient numbers of subjects aged 65 and over to determine whether they responded differently from younger subjects.

САЩ - английски - NLM (National Library of Medicine)

spear dermatology products inc - tretinoin (unii: 5688utc01r) (tretinoin - unii:5688utc01r) - tretinoin 1 mg in 1 g - tretinoin gel microsphere , 0.1% and 0.04%, is a retinoid indicated for topical application in the treatment of acne vulgaris. none. there are no adequate and well-controlled studies in pregnant women. tretinoin gel microsphere should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. thirty human cases of temporally associated congenital malformations have been reported during two decades of clinical use of tretinoin gel microsphere , 0.1% and 0.04%. although no definite pattern of teratogenicity and no causal association has been established from these cases, five of the reports describe the rare birth defect category holoprosencephaly (defects associated with incomplete midline development of the forebrain). the significance of these spontaneous reports in terms of risk to the fetus is not known. for purposes of comparison of the animal exposure to systemic human exposure, the maximum recommended human dose (mrhd) applied topically is defined as 1 gram of tre