Australia - English - 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.

United States - English - 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.

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

b. braun medical inc. - hydroxyethyl starch 130/0.4 (unii: 1gvo236s58) (hydroxyethyl starch 130/0.4 - unii:1gvo236s58), sodium chloride (unii: 451w47iq8x) (sodium cation - unii:lyr4m0nh37, chloride ion - unii:q32zn48698) - hydroxyethyl starch 130/0.4 6 g in 100 ml - 6% hydroxyethyl starch 130/0.4 in 0.9% sodium chloride injection is indicated for the treatment and prophylaxis of hypovolemia in adults and children. it is not a substitute for red blood cells or coagulation factors in plasma. - do not use hydroxyethyl starch (hes) products, including 6% hydroxyethyl starch 130/0.4 in 0.9% sodium chloride injection, in critically ill adult patients, including patients with sepsis, due to increased risk of mortality and renal replacement therapy (rrt).  - do not use hes products, including 6% hydroxyethyl starch 130/0.4 in 0.9% sodium chloride injection, in patients with severe liver disease. - do not use hes products, including 6% hydroxyethyl starch 130/0.4 in 0.9% sodium chloride injection, in patients with known hypersensitivity to hydroxyethyl starch [see general warnings and precautions (5.1) ] - do not use hes products in clinical conditions with volume overload.  - do not use hes products in patients with pre-existing coagulation or bleeding disorders.  - do not use h

Israel - English - Ministry of Health

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

Israel - English - Ministry of Health

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

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

vifor (international) inc. - methoxy polyethylene glycol-epoetin beta (unii: lr3uxn0193) (methoxy polyethylene glycol-epoetin beta - unii:lr3uxn0193) - methoxy polyethylene glycol-epoetin beta 30 ug in 0.3 ml - mircera is indicated for the treatment of anemia associated with chronic kidney disease (ckd) in: limitations of use mircera is not indicated and is not recommended: mircera has not been shown to improve symptoms, physical functioning, or health-related quality of life. mircera is contraindicated in patients with: risk summary available data from a small number of published case reports and postmarketing experience with mircera use in pregnancy are insufficient to identify a drug associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. chronic kidney disease is associated with maternal and embryo-fetal risks (see clinical considerations) . in animal reproduction studies, administration of methoxy polyethylene glycol-epoetin beta to rats and rabbits during pregnancy and lactation adversely affected offspring at doses 17-fold and greater than the recommended human dose (see data) . the estimated background risk of major birth defects and miscarriage for the indicated populatio

Singapore - English - HSA (Health Sciences Authority)

link healthcare singapore pte ltd - methylnaltrexone bromide - injection, solution - 12mg/0.6ml - methylnaltrexone bromide 12mg/0.6ml

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

swedish orphan biovitrum ltd - methylnaltrexone bromide - solution for injection - 20mg/1ml

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

rebel distributors corp - 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.

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

strides pharma science limited - polyethylene glycol 3350 (unii: g2m7p15e5p) (polyethylene glycol 3350 - unii:g2m7p15e5p), sodium sulfate anhydrous (unii: 36kcs0r750) (sodium sulfate anhydrous - unii:36kcs0r750), sodium bicarbonate (unii: 8mdf5v39qo) (sodium cation - unii:lyr4m0nh37, bicarbonate ion - unii:hn1zra3q20), sodium chloride (unii: 451w47iq8x) (sodium cation - unii:lyr4m0nh37, chloride ion - unii:q32zn48698), potassium chlorate (unii: h35ks68ee7) (potassium cation - unii:295o53k152, chlorate ion - unii:08z8093742) - polyethylene glycol 3350 and electrolytes for oral solution is indicated for bowel cleansing prior to colonoscopy and barium enema x-ray examination in adults polyethylene glycol 3350 and electrolytes for oral solution, is contraindicated in the following conditions: -   gastrointestinal (gi) obstruction [see warnings and precautions (5.6)] -   bowel perforation [see warnings and precautions (5.6)] -   toxic colitis or toxic megacolon -   gastric retention -   ileus -   hypersensitivity to any component of polyethylene glycol 3350 and electrolytes for oral solution [see warnings and precautions (5.8)] animal reproduction studies have not been conducted with polyethylene glycol 3350 and electrolytes for oral solution. it is also not known whether polyethylene glycol 3350 and electrolytes for oral solution, can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. polyethylene glycol 3350 and electrolytes for oral solution, should be given to a pregnant woman only if clearl