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

camber pharmaceuticals, 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 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.

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)

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.

Australia - English - APVMA (Australian Pesticides and Veterinary Medicines Authority)

4 farmers australia pty ltd - ethyl and methyl esters of vegetable oil - emulsifiable concentrate - ethyl and methyl esters of vegetable oil oil-plant active 700.0 g/l - adjuvant - defoliant additive | desiccant additive | fungicide additive | herbicide additive | insecticide additive | activator | additive - carrier - anti-evaporant | tank mixing | wetting agent (use as directed) | additive | adjuvant | agricultural chemical | evaporant | herbicide | herbicide application | improve penetrating properties | insecticide application | minimise antagonism | spray tank | wetter

Australia - English - APVMA (Australian Pesticides and Veterinary Medicines Authority)

loveland products inc - methyl esters of vegetable oil - emulsifiable concentrate - methyl esters of vegetable oil oil-plant active 630.0 g/l - adjuvant

Australia - English - APVMA (Australian Pesticides and Veterinary Medicines Authority)

australis crop protection pty ltd - ethyl and methyl esters of fatty acids - emulsifiable concentrate - ethyl and methyl esters of fatty acids acid-fatty active 704.0 g/l - adjuvant - defoliant additive | desiccant additive | herbicide additive | insecticide additive | activator | additive | penetrant | post em - wetting agent (use as directed) | improve penetrating properties

Australia - English - APVMA (Australian Pesticides and Veterinary Medicines Authority)

syngenta australia pty ltd - methyl esters of canola oil fatty acids; liquid hydrocarbon - emulsifiable concentrate - methyl esters of canola oil fatty acids ester active 440.0 g/l; liquid hydrocarbon solvent other 222.0 g/l - adjuvant - agricultural chemical additive | herbicide additive | activator | penetrant | post emergent herbicide | spray activator | spread - tank mixing | additive | agricultural chemical | herbicide | minimise antagonism | spray tank

Australia - English - Department of Health (Therapeutic Goods Administration)

phebra pty ltd - methylene blue, quantity: 50 mg - injection, solution - excipient ingredients: water for injections; hydrochloric acid; sodium hydroxide - methylene blue injection usp is indicated: for the treatment of drug-induced methaemoglobinaemia; for the treatment of idiopathic methaemoglobinaemia (in which structural abnormality of haemoglobin is not present); as a bacteriological strain as a dye in diagnostic procedures such as fistula detection; for the delineation of certain body tissues during surgery.

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

akorn - methylene blue (unii: t42p99266k) (methylene blue cation - unii:zmz79891zh) - methylene blue 10 mg in 1 ml - drug-induced methemoglobinemia. methylene blue can cause fetal harm when administered to a pregnant woman. an association exists between the use of methylene blue in amniocentesis and atresia of the ileum and jejunum, ileal occlusions and other adverse effects in the neonate. (2, 3) methylene blue is contraindicated in women who are or may become pregnant. if this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus. intraspinal and subcutaneous injections are contraindicated. methylene blue is contraindicated in patients with a known hypersensitivity to the drug.

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

bryant ranch prepack - progesterone (unii: 4g7ds2q64y) (progesterone - unii:4g7ds2q64y) - progesterone 200 mg - progesterone capsules are indicated for use in the prevention of endometrial hyperplasia in nonhysterectomized postmenopausal women who are receiving conjugated estrogens tablets. they are also indicated for use in secondary amenorrhea. progesterone capsules should not be used in women with any of the following conditions: 1. progesterone capsules should not be used in patients with known hypersensitivity to its ingredients. progesterone capsules contain peanut oil and should never be used by patients allergic to peanuts. 2. undiagnosed abnormal genital bleeding. 3. known, suspected, or history of breast cancer. 4. active deep vein thrombosis, pulmonary embolism or history of these conditions. 5. active arterial thromboembolic disease (for example, stroke and myocardial infarction), or a history of these conditions. 6. known liver dysfunction or disease. 7. known or suspected pregnancy.