DIMETHYL SULFOXIDE - परिणामों की खोज

gln-dimethyl fumarate capsule (delayed release)

glenmark pharmaceuticals canada inc. - dimethyl fumarate - capsule (delayed release) - 120mg - dimethyl fumarate 120mg - miscellaneous central nervous system agents

कनाडा - अंग्रेज़ी - Health Canada

gln-dimethyl fumarate capsule (delayed release)

glenmark pharmaceuticals canada inc. - dimethyl fumarate - capsule (delayed release) - 240mg - dimethyl fumarate 240mg - miscellaneous central nervous system agents

इसराइल - अंग्रेज़ी - Ministry of Health

dimethyl fumarate medomie 120 mg

medomie pharma ltd, israel - dimethyl fumarate - capsules delayed release - dimethyl fumarate 120 mg - dimetyl fumarate - indicated for the treatment of adult patients with relapsing remitting multiple sclerosis.

इसराइल - अंग्रेज़ी - Ministry of Health

dimethyl fumarate medomie 240 mg

medomie pharma ltd, israel - dimethyl fumarate - capsules delayed release - dimethyl fumarate 240 mg - dimetyl fumarate - indicated for the treatment of adult patients with relapsing remitting multiple sclerosis.

न्यूज़ीलैंड - अंग्रेज़ी - Medsafe (Medicines Safety Authority)

dimethyl fumarate te arai

te arai biofarma limited - dimethyl fumarate 240mg - modified release capsule - 240 mg - active: dimethyl fumarate 240mg excipient: colloidal silicon dioxide crospovidone sheffcoat clear asa 5x00294 sheffcoat white ent tec 5x00273 capsugel green op. c162 magnesium stearate microcrystalline cellulose povidone - indicated in patients with relapsing multiple sclerosis to reduce the frequency of relapses and to delay the progression of disability.

संयुक्त राज्य - अंग्रेज़ी - NLM (National Library of Medicine)

tecfidera- dimethyl fumarate kit tecfidera- dimethyl fumarate capsule

biogen inc. - dimethyl fumarate (unii: fo2303mni2) (monomethyl fumarate - unii:45iub1px8r) - dimethyl fumarate 120 mg - tecfidera is indicated for the treatment of relapsing forms of multiple sclerosis (ms), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. tecfidera is contraindicated in patients with known hypersensitivity to dimethyl fumarate or to any of the excipients of tecfidera. reactions have included anaphylaxis and angioedema [see warnings and precautions (5.1)]. risk summary available data from the tecfidera pregnancy registry, observational studies, and pharmacovigilance with dimethyl fumarate use in pregnant women have not indicated an increased risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. most of the reported exposures to dimethyl fumarate occurred during the first trimester of pregnancy (see data ). in animals, adverse effects on offspring survival, growth, sexual maturation, and neurobehavioral function were observed when dimethyl fumarate (dmf) was administered during pregnancy and lactation at clinically relevant doses (see data ). the background risk of major birth defects and miscarriage for the indicated population is 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 human data in a prospective observational tecfidera pregnancy registry (2013-2022), the rate of major birth defects among 362 live births and stillbirths from women who were exposed to dimethyl fumarate during pregnancy was 3.6% (95% ci: 1.9-6.1). no specific pattern of major birth defects was identified. important potential study limitations include exposure misclassification, no adjustment for confounders, and lack of an internal comparator cohort. animal data in rats administered dmf orally (25, 100, 250 mg/kg/day) throughout organogenesis, embryofetal toxicity (reduced fetal body weight and delayed ossification) were observed at the highest dose tested. this dose also produced evidence of maternal toxicity (reduced body weight). plasma exposure (auc) for monomethyl fumarate (mmf), the major circulating metabolite, at the no-effect dose is approximately three times that in humans at the recommended human dose (rhd) of 480 mg/day. in rabbits administered dmf orally (25, 75, and 150 mg/kg/day) throughout organogenesis, embryolethality and decreased maternal body weight were observed at the highest dose tested. the plasma auc for mmf at the no-effect dose is approximately 5 times that in humans at the rhd. oral administration of dmf (25, 100, and 250 mg/kg/day) to rats throughout organogenesis and lactation resulted in increased lethality, persistent reductions in body weight, delayed sexual maturation (male and female pups), and reduced testicular weight at the highest dose tested. neurobehavioral impairment was observed at all doses. a no-effect dose for developmental toxicity was not identified. the lowest dose tested was associated with plasma auc for mmf lower than that in humans at the rhd. risk summary there are no data on the presence of dmf or mmf in human milk. the effects on the breastfed infant and on milk production are unknown. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for tecfidera and any potential adverse effects on the breastfed infant from the drug or from the underlying maternal condition. safety and effectiveness in pediatric patients have not been established. clinical studies of tecfidera did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently from younger patients.

ऑस्ट्रेलिया - अंग्रेज़ी - Department of Health (Therapeutic Goods Administration)

tecfidera dimethyl fumarate 240 mg modified release capsules blister packs

biogen australia pty ltd - dimethyl fumarate, quantity: 240 mg - capsule, modified release - excipient ingredients: brilliant blue fcf; croscarmellose sodium; methacrylic acid copolymer; polysorbate 80; purified talc; triethyl citrate; gelatin; colloidal anhydrous silica; simethicone; magnesium stearate; sodium lauryl sulfate; titanium dioxide; microcrystalline cellulose; iron oxide yellow; methacrylic acid - ethyl acrylate copolymer (1:1); propylene glycol; ethanol; butan-1-ol; isopropyl alcohol; purified water; shellac; strong ammonia solution; iron oxide black; potassium hydroxide - tecfidera is indicated in patients with relapsing multiple sclerosis to reduce the frequency of relapses and to delay the progression of disability

ऑस्ट्रेलिया - अंग्रेज़ी - Department of Health (Therapeutic Goods Administration)

tecfidera dimethyl fumarate 120 mg modified release capsules blister packs

biogen australia pty ltd - dimethyl fumarate, quantity: 120 mg - capsule, modified release - excipient ingredients: colloidal anhydrous silica; gelatin; methacrylic acid - ethyl acrylate copolymer (1:1); titanium dioxide; croscarmellose sodium; polysorbate 80; simethicone; methacrylic acid copolymer; magnesium stearate; brilliant blue fcf; microcrystalline cellulose; iron oxide yellow; triethyl citrate; sodium lauryl sulfate; purified talc; propylene glycol; ethanol; butan-1-ol; isopropyl alcohol; purified water; shellac; strong ammonia solution; iron oxide black; potassium hydroxide - tecfidera is indicated in patients with relapsing multiple sclerosis to reduce the frequency of relapses and to delay the progression of disability

संयुक्त राज्य - अंग्रेज़ी - NLM (National Library of Medicine)

dimethyl fumarate capsule, delayed release

a-s medication solutions - dimethyl fumarate (unii: fo2303mni2) (monomethyl fumarate - unii:45iub1px8r) - dimethyl fumarate delayed-release capsules are indicated for the treatment of relapsing forms of multiple sclerosis (ms), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. dimethyl fumarate delayed-release capsules are contraindicated in patients with known hypersensitivity to dimethyl fumarate or to any of the excipients of dimethyl fumarate delayed-release capsules. reactions have included anaphylaxis and angioedema [see warnings and precautions ( 5.1)]. risk summary there are no adequate data on the developmental risk associated with the use of dimethyl fumarate delayed-release capsules in pregnant women. in animals, adverse effects on offspring survival, growth, sexual maturation, and neurobehavioral function were observed when dimethyl fumarate (dmf) was administered during pregnancy and lactation at clinically relevant doses [see data] . 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. the background risk of major birth defects and miscarriage for the indicated population is unknown. data animal data in rats administered dmf orally (25, 100, 250 mg/kg/day) throughout organogenesis, embryofetal toxicity (reduced fetal body weight and delayed ossification) were observed at the highest dose tested. this dose also produced evidence of maternal toxicity (reduced body weight). plasma exposure (auc) for monomethyl fumarate (mmf), the major circulating metabolite, at the no-effect dose is approximately three times that in humans at the recommended human dose (rhd) of 480 mg/day. in rabbits administered dmf orally (25, 75, and 150 mg/kg/day) throughout organogenesis, embryolethality and decreased maternal body weight were observed at the highest dose tested. the plasma auc for mmf at the no-effect dose is approximately 5 times that in humans at the rhd. oral administration of dmf (25, 100, and 250 mg/kg/day) to rats throughout organogenesis and lactation resulted in increased lethality, persistent reductions in body weight, delayed sexual maturation (male and female pups), and reduced testicular weight at the highest dose tested. neurobehavioral impairment was observed at all doses. a no-effect dose for developmental toxicity was not identified. the lowest dose tested was associated with plasma auc for mmf lower than that in humans at the rhd. risk summary there are no data on the presence of dmf or mmf in human milk. the effects on the breastfed infant and on milk production are unknown. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for dimethyl fumarate delayed-release capsules and any potential adverse effects on the breastfed infant from the drug or from the underlying maternal condition. safety and effectiveness in pediatric patients have not been established. clinical studies of dimethyl fumarate delayed-release capsules did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently from younger patients.

ऑस्ट्रेलिया - अंग्रेज़ी - APVMA (Australian Pesticides and Veterinary Medicines Authority)

crown 225sl systemic insecticide