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

apotheca inc. - topiramate (unii: 0h73wjj391) (topiramate - unii:0h73wjj391) - topiramate 25 mg - topiramate tablets, usp are indicated as initial monotherapy in patients 2 years of age and older with partial onset or primary generalized tonic-clonic seizures. safety and effectiveness in patients who were converted to monotherapy from a previous regimen of other anticonvulsant drugs have not been established in controlled trials [see clinical studies ( 14.1)] . topiramate tablets, usp are indicated as adjunctive therapy for adults and pediatric patients ages 2 to 16 years with partial onset seizures or primary generalized tonic-clonic seizures, and in patients 2 years of age and older with seizures associated with lennox-gastaut syndrome [see clinical studies ( 14.2)] . additional pediatric use information for patients ages 12 to 17 years is approved for janssen pharmaceuticals, inc.’s topamax (topiramate) tablets and sprinkle capsules. however, due to janssen pharmaceuticals, inc.’s marketing exclusivity rights,

United States - English - 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.

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

apotheca inc. - topiramate (unii: 0h73wjj391) (topiramate - unii:0h73wjj391) - topiramate 100 mg - topiramate tablets, usp are indicated as initial monotherapy in patients 2 years of age and older with partial onset or primary generalized tonic-clonic seizures. safety and effectiveness in patients who were converted to monotherapy from a previous regimen of other anticonvulsant drugs have not been established in controlled trials [see clinical studies ( 14.1)] . topiramate tablets, usp are indicated as adjunctive therapy for adults and pediatric patients ages 2 to 16 years with partial onset seizures or primary generalized tonic-clonic seizures, and in patients 2 years of age and older with seizures associated with lennox-gastaut syndrome [see clinical studies ( 14.2)] . additional pediatric use information for patients ages 12 to 17 years is approved for janssen pharmaceuticals, inc.’s topamax (topiramate) tablets and sprinkle capsules. however, due to janssen pharmaceuticals, inc.’s marketing exclusivity rights,

Australia - English - Department of Health (Therapeutic Goods Administration)

coregas pty ltd - carbon dioxide, quantity: 5 % v/v; oxygen, quantity: 95 % v/v - gas, medicinal - excipient ingredients: - ? as a respiratory stimulant after apnoea or after chronic respiratory obstruction has been relieved. ? in clinical situations where carbon dioxide is needed as an anaesthetic supplement. ? use in clinical and physiological investigations.

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

apotheca inc. - topiramate (unii: 0h73wjj391) (topiramate - unii:0h73wjj391) - topiramate 50 mg - topiramate tablets, usp are indicated as initial monotherapy in patients 2 years of age and older with partial onset or primary generalized tonic-clonic seizures. safety and effectiveness in patients who were converted to monotherapy from a previous regimen of other anticonvulsant drugs have not been established in controlled trials [see clinical studies ( 14.1)] . topiramate tablets, usp are indicated as adjunctive therapy for adults and pediatric patients ages 2 to 16 years with partial onset seizures or primary generalized tonic-clonic seizures, and in patients 2 years of age and older with seizures associated with lennox-gastaut syndrome [see clinical studies ( 14.2)] . additional pediatric use information for patients ages 12 to 17 years is approved for janssen pharmaceuticals, inc.’s topamax (topiramate) tablets and sprinkle capsules. however, due to janssen pharmaceuticals, inc.’s marketing exclusivity rights,

Jordan - English - JFDA (Jordan Food & Drug Administration - المؤسسة العامة للغذاء والدواء)

مستودع ادوية شاوي و رشيدات و مسنات - shawi & rushedat drug store - osimertinib mesylate 95.4 milligram - 95.4 milligram

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

turf culture pty ltd - azoxystrobin - dispersible concentrate - azoxystrobin pyrimidine active 95.0 g/l - fungicide - turf - anthracnose - colletotrichum graminicola | brown patch - rhizoctonia solani | grey leaf spot - pyricularia grisea | helminthosporium disease | phytophthora parasitica | pythium spp. | red thread | wilt rootrot or damping off | winter fusarium | bipolaris spp. | damping off seedling | damping-off | drechslera dermatiodia | drechslera spp. | exserohilum spp. | grease spot | helminthosporium disease patch | helminthosporium leaf spot | helminthosporium spot | leaf blight - helminthosporium | pythium blight | pythium root rot | pythium soil fungus | seedling root rot | soil fungi | white helminthosporium

New Zealand - English - Medsafe (Medicines Safety Authority)

crombie and price ltd - ispaghula husk 95.75%{relative} (40 mesh) - powder for oral suspension - 95% w/w - active: ispaghula husk 95.75%{relative} (40 mesh) excipient: citric acid orange flavour 17-1063 sucralose sunset yellow fcf

New Zealand - English - Medsafe (Medicines Safety Authority)

valeant pharmaceuticals new zealand ltd - light liquid paraffin 95%{vol} - bath oil - 95 % - active: light liquid paraffin 95%{vol} excipient: dye green astead praderol iii 82/m purified water terics

New Zealand - English - Medsafe (Medicines Safety Authority)

medic corporation ltd (refer to ebos) - light liquid paraffin 95% - bath oil - 95 % - active: light liquid paraffin 95% excipient: dye green astead praderol iii 82/m purified water terics