Соединенные Штаты - английский - NLM (National Library of Medicine)

bora pharmaceutical laboratories inc. - 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. 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.

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

galderma australia pty ltd - methyl aminolevulinate hydrochloride, quantity: 200 mg/g (equivalent: methyl aminolevulinate, qty 160 mg/g) - cream - excipient ingredients: self-emulsifying glyceryl monostearate; cetostearyl alcohol; peg-40 stearate; methyl hydroxybenzoate; propyl hydroxybenzoate; disodium edetate; glycerol; white soft paraffin; cholesterol; isopropyl myristate; arachis oil; almond oil; oleyl alcohol; purified water - treatment of thin or non-hyperkeratotic and non-pigmented actinic keratoses on the face and scalp when other registered therapies are unacceptable. primary treatment of superficial and/or nodular basal cell carcinoma where surgery is considered inappropriate. treatment of biopsy-proven squamous cell carcinoma in situ (bowen's disease), where surgery is considered inappropriate. lumexia is indicated in adults above 18 years of age.

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

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

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

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

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

galderma australia pty ltd - methyl aminolevulinate hydrochloride, quantity: 200 mg/g (equivalent: methyl aminolevulinate, qty 160 mg/g) - cream - excipient ingredients: self-emulsifying glyceryl monostearate; cetostearyl alcohol; peg-40 stearate; methyl hydroxybenzoate; propyl hydroxybenzoate; disodium edetate; glycerol; white soft paraffin; cholesterol; isopropyl myristate; arachis oil; almond oil; oleyl alcohol; purified water - treatment of thin or non-hyperkeratotic and non-pigmented actinic keratoses on the face and scalp when other registered therapies are unacceptable. primary treatment of superficial and/or nodular basal cell carcinoma where surgery is considered inappropriate. treatment of biopsy-proven squamous cell carcinoma in situ (bowen's disease), where surgery is considered inappropriate. metvix is indicated in adults above 18 years of age.

Великобритания - английский - MHRA (Medicines & Healthcare Products Regulatory Agency)

ennogen pharma ltd - methyldopa (anhydrous) - oral tablet - 250mg

Великобритания - английский - MHRA (Medicines & Healthcare Products Regulatory Agency)

ennogen pharma ltd - methyldopa (anhydrous) - oral tablet - 500mg

Великобритания - английский - MHRA (Medicines & Healthcare Products Regulatory Agency)

ennogen pharma ltd - methyldopa (anhydrous) - oral tablet - 125mg

Соединенные Штаты - английский - NLM (National Library of Medicine)

rebel distributors corp - methyldopa (unii: 56lh93261y) (methyldopa - unii:56lh93261y) - 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.

Канада - английский - Health Canada

sanis health inc - progesterone - capsule - 100mg - progesterone 100mg - progestins