Австралия - английский - APVMA (Australian Pesticides and Veterinary Medicines Authority)

4 farmers australia pty ltd - metsulfuron-methyl - water dispersible granule - metsulfuron-methyl urea-sulfonyl active 600.0 g/kg - herbicide - barley | cereal rye | commercial area - general | flood plain | industrial land or area | natural pasture (native) | pasture ren - african turnip weed | alligator weed | amsinckia | annual clovers | apple box | australian or native blackthorn | ball mustard | bellyache bush | bitou bush or boneseed | black bindweed | blackberry | blakely's red gum or gum | boggabri weed | bracken | bridal creeper | calomba daisy | cape tulip | capeweed | charlock | chickweed | chicory | crofton weed | cutleaf mignonette | darling pea | deadnettle | denseflower fumitory | dock | erodium spp. | erodium, crowfoot or storksbill | fennel | furze or gorse | golden dodder | great mullein | gum - peppermint | hare's-ear or treacle mustard | hawthorn | indian hedge mustard | inkweed | japanese sunflower | kangaroo thorn | lantana - lantana camara | lincoln weed, sand rocket or mustard | lupins | mallee catchfly | medic | messmate stringybark | mimosa pigra | mistflower or creeping crofton weed | new zealand spinach | noogoora burr | onion or guildford grass | parthenium weed | paterson's curse | prickly lettuce | privet | ragwort | red pigweed | rough poppy | rub

Австралия - английский - APVMA (Australian Pesticides and Veterinary Medicines Authority)

imtrade australia pty ltd - diclofop-methyl; liquid hydrocarbon - emulsifiable concentrate - diclofop-methyl phenoxy acids-propionics active 375.0 g/l; liquid hydrocarbon solvent other 531.4 g/l - herbicide - barley | buffalo grass lawn or turf | canola oilseed crop | carpet grass lawn or turf | cereal rye | common couch lawn or turf | - annual or wimmera ryegrass | common barb grass | crowsfoot grass | wild or black oat | crab grass | rigid ryegrass | spring oat | wimmera ryegrass

Ирландия - английский - HPRA (Health Products Regulatory Authority)

pco manufacturing ltd. - progesterone - vaginal gel - 8 percent weight/weight - progesterone

Австралия - английский - APVMA (Australian Pesticides and Veterinary Medicines Authority)

imtrade australia pty ltd - carfentrazone-ethyl; n-methyl-2-pyrrolidone; liquid hydrocarbon - emulsifiable concentrate - carfentrazone-ethyl ungrouped active 240.0 g/l; n-methyl-2-pyrrolidone solvent other 20.0 g/l; liquid hydrocarbon solvent other 685.0 g/l - herbicide

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

biogen inc. - dimethyl fumarate (unii: fo2303mni2) (monomethyl fumarate - unii:45iub1px8r) - dimethyl fumarate 120 mg - tecfidera 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. tecfidera is contraindicated in patients with known hypersensitivity to dimethyl fumarate or to any of the excipients of tecfidera. reactions have included anaphylaxis and angioedema [see warnings and precautions (5.1)]. risk summary available data from the tecfidera pregnancy registry, observational studies, and pharmacovigilance with dimethyl fumarate use in pregnant women have not indicated an increased risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. most of the reported exposures to dimethyl fumarate occurred during the first trimester of pregnancy (see data ). 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 ). the background risk of major birth defects and miscarriage for the indicated population is unknown. all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. 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. data human data in a prospective observational tecfidera pregnancy registry (2013-2022), the rate of major birth defects among 362 live births and stillbirths from women who were exposed to dimethyl fumarate during pregnancy was 3.6% (95% ci: 1.9-6.1). no specific pattern of major birth defects was identified. important potential study limitations include exposure misclassification, no adjustment for confounders, and lack of an internal comparator cohort. 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 tecfidera 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 tecfidera did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently from younger patients.

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

american regent, inc. - methylene blue (unii: t42p99266k) (methylene blue cation - unii:zmz79891zh) - methylene blue 5 mg in 1 ml - provayblue is indicated for the treatment of pediatric and adult patients with acquired methemoglobinemia. provayblue is contraindicated in the following conditions: - severe hypersensitivity reactions to methylene blue or any other thiazine dye [see warnings and precautions (5.2)] . - patients with glucose-6-phosphate dehydrogenase deficiency (g6pd) due to the risk of hemolytic anemia [see warnings and precautions (5.3, 5.4)]. risk summary provayblue may cause fetal harm when administered to a pregnant woman. intra-amniotic injection of pregnant women with a methylene blue class product during the second trimester was associated with neonatal intestinal atresia and fetal death. methylene blue produced adverse developmental outcomes in rats and rabbits when administered orally during organogenesis at doses at least 32 and 16 times, respectively, the clinical dose of 1 mg/kg (see data) . advise pregnant women of the potential risk to a fetus. in the u.s. general population, the estimated background risks of major birth defects and miscarriage in clinically recognized pregnancies are 2-4% and 15-20%, respectively. clinical considerations fetal/neonatal adverse reactions intra-amniotic injection of a methylene blue class product hours to days prior to birth can result hyperbilirubinemia, hemolytic anemia, skin staining, methemoglobinemia, respiratory distress and photosensitivity in the newborn. following administration of provayblue to a pregnant woman at term, observe the newborn for these adverse reactions and institute supportive care. data animal data methylene blue was administered orally to pregnant rats at doses of 50 to 350 mg/kg/day, during the period of organogenesis. maternal and embryofetal toxicities were observed at all doses of methylene blue and were most evident at the 200 and 350 mg/kg/day doses. maternal toxicity consisted of increased spleen weight. embryo-fetal toxicities included reduced fetal weight, post-implantation loss, edema, and malformations including enlarged lateral ventricles. the dose of 200 mg/kg (1200 mg/m2 ) in rats is approximately 32 times a clinical dose of 1 mg/kg based on body surface area. methylene blue was administered orally to pregnant rabbits at doses of 50, 100, or 150 mg/kg/day, during the period of organogenesis. maternal death was observed at the methylene blue dose of 100 mg/kg. embryofetal toxicities included spontaneous abortion at all dose levels and a malformation (umbilical hernia) at the 100 and 150 mg/kg/day doses. the dose of 50 mg/kg (600 mg/m2 ) in rabbits is approximately 16 times a clinical dose of 1 mg/kg based on body surface area. risk summary there is no information regarding the presence of methylene blue in human milk, the effects on the breastfed infant, or the effects on milk production. because of the potential for serious adverse reactions including genotoxicity, discontinue breast-feeding during and for up to 8 days after treatment with provayblue [see clinical pharmacology (12.3)] . the safety and effectiveness of provayblue for the treatment of acquired methemoglobinemia have been established in pediatric patients. use of provayblue is supported by two retrospective case series that included 2 pediatric patients treated with provayblue and 12 treated with another methylene blue class product. the case series included pediatric patients in the following age groups: 3 neonates (less than 1 month), 4 infants (1 month up to less than 2 years), 4 children (2 years up to less than 12 years), and 3 adolescents (12 years to less than 17 years). the efficacy outcomes were consistent across pediatric and adult patients in both case series [see clinical studies (14)]. clinical studies of provayblue did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. other reported clinical experience has not identified differences in responses between the elderly and younger patients. provayblue is known to be substantially excreted by the kidney, so the risk of adverse reactions to this drug may be greater in patients with impaired renal function. because elderly patients are more likely to have decreased renal function, treatment of methemoglobinemia in these patients should use the lowest number of doses needed to achieve a response [see dosage and administration (2)] . methylene blue concentrations increased in subjects with renal impairment (egfr 15 to 89 ml/min/1.73m2 ) significantly [see clinical pharmacology (12.3)] . adjust provayblue dosage in patients with moderate or severe renal impairment (egfr 15 to 59 ml/min/1.73 m2 ) [see dosage and administration (2.2)] . no dose adjustment is recommended in patients with mild renal impairment (egfr 60 – 89 ml/min/1.73 m2 ). methylene blue is extensively metabolized in the liver. monitor patients with any hepatic impairment for toxicities and potential drug interactions for an extended period of time following treatment with provayblue.

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

columbia laboratories, inc. - progesterone (unii: 4g7ds2q64y) (progesterone - unii:4g7ds2q64y) - progesterone 45 mg in 1.125 g - crinone® 8% is indicated for progesterone supplementation or replacement as part of an assisted reproductive technology ("art") treatment for infertile women with progesterone deficiency. crinone® 4% is indicated for the treatment of secondary amenorrhea. crinone® 8% is indicated for use in women who have failed to respond to treatment with crinone® 4%. crinone® should not be used in individuals with any of the following conditions: - known sensitivity to crinone® (progesterone or any of the other ingredients) - undiagnosed vaginal bleeding - liver dysfunction or disease - known or suspected malignancy of the breast or genital organs - missed abortion - active thrombophlebitis or thromboembolic disorders, or a history of hormone-associated thrombophlebitis or thromboembolic disorders crinone® progesterone gel 8% ndc 55056-0818-5 15 single-use prefilled applicators each applicator contains 1.45 g of gel and delivers 1.125 g of gel containing 90 mg progesterone. for vaginal use only columbia la

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

columbia laboratories - progesterone (unii: 4g7ds2q64y) (progesterone - unii:4g7ds2q64y) - progesterone 45 mg in 1.125 g - prochieve® 8% is indicated for progesterone supplementation or replacement as part of an assisted reproductive technology ("art") treatment for infertile women with progesterone deficiency. prochieve® 4% is indicated for the treatment of secondary amenorrhea. prochieve® 8% is indicated for use in women who have failed to respond to treatment with prochieve® 4%. prochieve® should not be used in individuals with any of the following conditions: - known sensitivity to prochieve® (progesterone or any of the other ingredients) - undiagnosed vaginal bleeding - liver dysfunction or disease - known or suspected malignancy of the breast or genital organs - missed abortion - active thrombophlebitis or thromboembolic disorders, or a history of hormone-associated thrombophlebitis or thromboembolic disorders prochieve® 4% (progesterone gel) ndc 55056-0406-1 6 single-use prefilled applicators each applicator contains 1.45g of gel and delivers 1.125g of gel containing 45mg progesterone. for vaginal u

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

mylan institutional llc - dimethyl sulfoxide (unii: yow8v9698h) (dimethyl sulfoxide - unii:yow8v9698h) - dimethyl sulfoxide 0.54 g in 1 ml - rimso-50® (dimethyl sulfoxide) is indicated for the symptomatic relief of patients with interstitial cystitis. rimso-50® has not been approved as being safe and effective for any other indication. there is no clinical evidence of effectiveness of dimethyl sulfoxide in the treatment of bacterial infections of the urinary tract. none known. none known.

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

accord-uk ltd - methyldopa (anhydrous) - oral tablet - 125mg