Европска Унија - Енглески - EMA (European Medicines Agency)

teva gmbh - dimethyl fumarate - multiple sclerosis, relapsing-remitting; multiple sclerosis - immunosuppressants - dimethyl fumarate teva is indicated for the treatment of adult and paediatric patients aged 13 years and older with relapsing remitting multiple sclerosis (rrms).

Европска Унија - Енглески - EMA (European Medicines Agency)

accord healthcare s.l.u. - dimethyl fumarate - multiple sclerosis, relapsing-remitting; multiple sclerosis - immunosuppressants - dimethyl fumarate accord is indicated for the treatment of adult and paediatric patients aged 13 years and older with relapsing remitting multiple sclerosis (rrms).

Сједињене Америчке Државе - Енглески - NLM (National Library of Medicine)

novel laboratories, inc. - polyethylene glycol 3350 (unii: g2m7p15e5p) (polyethylene glycol 3350 - unii:g2m7p15e5p), sodium chloride (unii: 451w47iq8x) (chloride ion - unii:q32zn48698), sodium bicarbonate (unii: 8mdf5v39qo) (sodium cation - unii:lyr4m0nh37), potassium chloride (unii: 660yq98i10) (potassium cation - unii:295o53k152), sodium sulfate anhydrous (unii: 36kcs0r750) (sulfate ion - unii:7is9n8kpmg) - polyethylene glycol 3350 240 g in 278.26 g - peg-3350 (240 g) and electrolytes for oral solution, usp with flavor pack is indicated for bowel cleansing prior to colonoscopy or barium enema x-ray examination. peg-3350 (240 g) and electrolytes for oral solution with flavor pack is contraindicated in patients known to be hypersensitive to any of the components. peg-3350 (240 g) and electrolytes for oral solution with flavor pack is contraindicated in patients with ileus, gastrointestinal obstruction, gastric retention, bowel perforation, toxic colitis or toxic megacolon.

Сједињене Америчке Државе - Енглески - NLM (National Library of Medicine)

carilion materials management - methyldopa (unii: 56lh93261y) (methyldopa anhydrous - unii:m4r0h12f6m) - methyldopa anhydrous 250 mg - hypertension. methyldopa is contraindicated in patients: - with active hepatic disease, such as acute hepatitis and active cirrhosis. - with liver disorders previously associated with methyldopa therapy (see ). warnings - with hypersensitivity to any component of this product. - on therapy with monoamine oxidase (mao) inhibitors.

Сједињене Америчке Државе - Енглески - NLM (National Library of Medicine)

martin ekwealor pharmaceuticals, inc. - polyethylene glycol 3350 (unii: g2m7p15e5p) (polyethylene glycol 3350 - unii:g2m7p15e5p) - polyethylene glycol 3350 17 g in 17 g - for the treatment of occasional constipation. this product should be used for 2 weeks or less as directed by a physician. polyethylene glycol 3350 nf is contraindicated in patients with known or suspected bowel obstruction and patients known to be allergic to polyethylene glycol.

Аустралија - Енглески - Department of Health (Therapeutic Goods Administration)

sandoz pty ltd - dimethyl fumarate, quantity: 120 mg - capsule, modified release - excipient ingredients: ethanol; iron oxide black; purified water; iron oxide yellow; gelatin; propylene glycol; triethyl citrate; purified talc; strong ammonia solution; butan-1-ol; shellac; methacrylic acid - ethyl acrylate copolymer (1:1); croscarmellose sodium; methacrylic acid copolymer; isopropyl alcohol; glyceryl monostearate 40-55 per cent; colloidal anhydrous silica; brilliant blue fcf; sodium stearylfumarate; polysorbate 80; titanium dioxide - dimethyl fumarate sandoz is indicated in patients with relapsing multiple sclerosis to reduce the frequency of relapses and to delay the progression of disability.

Аустралија - Енглески - Department of Health (Therapeutic Goods Administration)

sandoz pty ltd - dimethyl fumarate, quantity: 240 mg - capsule, modified release - excipient ingredients: colloidal anhydrous silica; glyceryl monostearate 40-55 per cent; gelatin; shellac; isopropyl alcohol; purified talc; propylene glycol; triethyl citrate; titanium dioxide; methacrylic acid - ethyl acrylate copolymer (1:1); croscarmellose sodium; butan-1-ol; methacrylic acid copolymer; iron oxide black; ethanol; sodium stearylfumarate; purified water; iron oxide yellow; brilliant blue fcf; polysorbate 80; strong ammonia solution - dimethyl fumarate sandoz is indicated in patients with relapsing multiple sclerosis to reduce the frequency of relapses and to delay the progression of disability.

Израел - Енглески - Ministry of Health

taro international ltd, israel - dimethyl fumarate - gastro resistant hard capsule - dimethyl fumarate 120 mg - dimethyl fumarate - dimethyl fumarate taro is indicated for the treatment of adult patients with relapsing remitting multiple sclerosis.

Израел - Енглески - Ministry of Health

taro international ltd, israel - dimethyl fumarate - gastro resistant hard capsule - dimethyl fumarate 240 mg - dimethyl fumarate - dimethyl fumarate taro is indicated for the treatment of adult patients with relapsing remitting multiple sclerosis.

Сједињене Америчке Државе - Енглески - NLM (National Library of Medicine)

solco healthcare us, llc - 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 2-4% and 15-20%, respectively. the background risk of major birth defects and miscarriage for the indicated population is unknown. 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.