САЩ - английски - NLM (National Library of Medicine)

sola pharmaceuticals, 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 capsule are contraindicated in patients with known hypersensitivity to dimethyl fumarate or to any of the excipients of dimethyl fumarate delayed-release capsule. 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. 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.

Нова Зеландия - английски - Medsafe (Medicines Safety Authority)

fresenius kabi new zealand limited - water for injection 100%{vol} - solution for injection - active: water for injection 100%{vol} - water for injection bp is used to dissolve or dilute substances or preparations for parenteral administration. water for injection bp may also be used as an irrigating solution for small wounds or during minor surgical procedures.

Австралия - английски - Department of Health (Therapeutic Goods Administration)

roche products pty ltd - methoxy polyethylene glycol-epoetin beta, quantity: 0.05 mg - injection, solution - excipient ingredients: sodium sulfate; monobasic sodium phosphate monohydrate; poloxamer; methionine; mannitol; water for injections - mircera is indicated for the treatment of anaemia associated with chronic kidney disease (ckd).

Австралия - английски - Department of Health (Therapeutic Goods Administration)

roche products pty ltd - methoxy polyethylene glycol-epoetin beta, quantity: 0.03 mg - injection, solution - excipient ingredients: mannitol; sodium sulfate; poloxamer; methionine; monobasic sodium phosphate monohydrate; water for injections - mircera is indicated for the treatment of anaemia associated with chronic kidney disease (ckd).

Австралия - английски - Department of Health (Therapeutic Goods Administration)

roche products pty ltd - methoxy polyethylene glycol-epoetin beta, quantity: 0.12 mg - injection, solution - excipient ingredients: sodium sulfate; monobasic sodium phosphate monohydrate; poloxamer; methionine; mannitol; water for injections - mircera is indicated for the treatment of anaemia associated with chronic kidney disease (ckd).

Австралия - английски - Department of Health (Therapeutic Goods Administration)

roche products pty ltd - methoxy polyethylene glycol-epoetin beta, quantity: 0.1 mg - injection, solution - excipient ingredients: sodium sulfate; poloxamer; monobasic sodium phosphate monohydrate; mannitol; methionine; water for injections - mircera is indicated for the treatment of anaemia associated with chronic kidney disease (ckd).

Австралия - английски - Department of Health (Therapeutic Goods Administration)

roche products pty ltd - methoxy polyethylene glycol-epoetin beta, quantity: 0.2 mg - injection, solution - excipient ingredients: poloxamer; sodium sulfate; methionine; mannitol; monobasic sodium phosphate monohydrate; water for injections - mircera is indicated for the treatment of anaemia associated with chronic kidney disease (ckd).

Австралия - английски - Department of Health (Therapeutic Goods Administration)

roche products pty ltd - methoxy polyethylene glycol-epoetin beta, quantity: 0.36 mg - injection, solution - excipient ingredients: monobasic sodium phosphate monohydrate; sodium sulfate; poloxamer; mannitol; methionine; water for injections - mircera is indicated for the treatment of anaemia associated with chronic kidney disease (ckd).

Австралия - английски - Department of Health (Therapeutic Goods Administration)

roche products pty ltd - methoxy polyethylene glycol-epoetin beta, quantity: 0.075 mg - injection, solution - excipient ingredients: mannitol; methionine; monobasic sodium phosphate monohydrate; poloxamer; sodium sulfate; water for injections - mircera is indicated for the treatment of anaemia associated with chronic kidney disease (ckd).

САЩ - английски - NLM (National Library of Medicine)

zydus pharmaceuticals usa inc. - dimethyl fumarate (unii: fo2303mni2) (monomethyl fumarate - unii:45iub1px8r) - dimethyl fumarate 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. dimethyl fumarate is 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 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%, respect