Estats Units - anglès - NLM (National Library of Medicine)

cardinal health 107, llc - furosemide (unii: 7lxu5n7zo5) (furosemide - unii:7lxu5n7zo5) - furosemide injection is indicated in adults and pediatric patients for the treatment of edema associated with heart failure, cirrhosis of the liver, and renal disease, including the nephrotic syndrome. furosemide injection is indicated as adjunctive therapy in acute pulmonary edema. risk summary available data from published observational studies, case reports, and postmarketing reports, from decades of use, have not demonstrated a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes with furosemide use during pregnancy. untreated congestive heart failure and cirrhosis of the liver can lead to adverse outcomes for the mother and the fetus (see clinical considerations) . in animal reproduction studies, furosemide has been shown to cause unexplained maternal deaths and abortions in rabbits when administered orally during organogenesis at 4 times a human i.v. dose of 80 mg based on body surface area (bsa) and oral bioavailability corrections, presumably secondary to volume depletion (see data) . the estimated background risk for major birth defects and miscarriage for the indicated populations 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 the clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. clinical considerations disease-associated maternal and/or embryo/fetal risk pregnant women with congestive heart failure are at increased risk for pre-term birth. stroke volume and heart rate increase during pregnancy, increasing cardiac output, especially during the first trimester. clinical classification of heart disease may worsen with pregnancy and lead to maternal death and/or stillbirth. closely monitor pregnant patients for destabilization of their heart failure. pregnant women with symptomatic cirrhosis generally have poor outcomes including hepatic failure, variceal hemorrhage, pre-term delivery, fetal growth restriction and maternal death. outcomes are worse with coexisting esophageal varices. pregnant women with cirrhosis of the liver should be carefully monitored and managed accordingly. data animal data the effects of furosemide on embryonic and fetal development and on pregnant dams were studied in mice, rats and rabbits. furosemide caused unexplained maternal deaths and abortions in the rabbit at the lowest dose of 25 mg/kg (approximately 4 times a human i.v. dose of 80 mg based on bsa and oral bioavailability corrections). in another study, a dose of 50 mg/kg (approximately 7 times a human i.v. dose of 80 mg based on bsa and oral bioavailability corrections) also caused maternal deaths and abortions when administered to rabbits between days 12 and 17 of gestation. in a third study, none of the pregnant rabbits survived an oral dose of 100 mg/kg. data from the above studies indicate fetal lethality that can precede maternal deaths. the results of the mouse study and one of the three rabbit studies also showed an increased incidence and severity of hydronephrosis (distention of the renal pelvis and, in some cases, of the ureters) in fetuses of treated dams as compared with the incidence of fetuses from the control group. risk summary the presence of furosemide has been reported in human milk. there are no data on the effects on the breastfed infant or the effects on milk production. doses of furosemide associated with clinically significant diuresis may impair milk production. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for furosemide and any potential adverse effects on the breastfed infant from furosemide or from the underlying maternal condition. published reports indicate that premature infants with post conceptual age (gestational plus postnatal) less than 31 weeks receiving doses exceeding 1 mg/kg/24 hours may develop plasma levels which could be associated with potential toxic effects including ototoxicity [see warnings and precautions (5.3)] . furosemide in the first year of life, especially in patients born pre-term, may precipitate nephrocalcinosis/nephrolithiasis [see warnings and precautions (5.2)] . controlled clinical studies of furosemide 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. in general, dose selection for the elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal or cardiac function, and of concomitant disease or other drug therapy. this drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. because elderly patients are more likely to have decreased renal function, care should be taken in dose selection and it may be useful to monitor renal function [see clinical pharmacology (12.3)] .

Estats Units - anglès - NLM (National Library of Medicine)

cardinal health 107, llc - furosemide (unii: 7lxu5n7zo5) (furosemide - unii:7lxu5n7zo5) - furosemide injection is indicated in adults and pediatric patients for the treatment of edema associated with heart failure, cirrhosis of the liver, and renal disease, including the nephrotic syndrome. furosemide injection is indicated as adjunctive therapy in acute pulmonary edema. risk summary available data from published observational studies, case reports, and postmarketing reports, from decades of use, have not demonstrated a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes with furosemide use during pregnancy. untreated congestive heart failure and cirrhosis of the liver can lead to adverse outcomes for the mother and the fetus (see clinical considerations) . in animal reproduction studies, furosemide has been shown to cause unexplained maternal deaths and abortions in rabbits when administered orally during organogenesis at 4 times a human i.v. dose of 80 mg based on body surface area (bsa) and oral bioavailability corrections, presumably secondary to volume depletion (see data) . the estimated background risk for major birth defects and miscarriage for the indicated populations 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 the clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. clinical considerations disease-associated maternal and/or embryo/fetal risk pregnant women with congestive heart failure are at increased risk for pre-term birth. stroke volume and heart rate increase during pregnancy, increasing cardiac output, especially during the first trimester. clinical classification of heart disease may worsen with pregnancy and lead to maternal death and/or stillbirth. closely monitor pregnant patients for destabilization of their heart failure. pregnant women with symptomatic cirrhosis generally have poor outcomes including hepatic failure, variceal hemorrhage, pre-term delivery, fetal growth restriction and maternal death. outcomes are worse with coexisting esophageal varices. pregnant women with cirrhosis of the liver should be carefully monitored and managed accordingly. data animal data the effects of furosemide on embryonic and fetal development and on pregnant dams were studied in mice, rats and rabbits. furosemide caused unexplained maternal deaths and abortions in the rabbit at the lowest dose of 25 mg/kg (approximately 4 times a human i.v. dose of 80 mg based on bsa and oral bioavailability corrections). in another study, a dose of 50 mg/kg (approximately 7 times a human i.v. dose of 80 mg based on bsa and oral bioavailability corrections) also caused maternal deaths and abortions when administered to rabbits between days 12 and 17 of gestation. in a third study, none of the pregnant rabbits survived an oral dose of 100 mg/kg. data from the above studies indicate fetal lethality that can precede maternal deaths. the results of the mouse study and one of the three rabbit studies also showed an increased incidence and severity of hydronephrosis (distention of the renal pelvis and, in some cases, of the ureters) in fetuses of treated dams as compared with the incidence of fetuses from the control group. risk summary the presence of furosemide has been reported in human milk. there are no data on the effects on the breastfed infant or the effects on milk production. doses of furosemide associated with clinically significant diuresis may impair milk production. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for furosemide and any potential adverse effects on the breastfed infant from furosemide or from the underlying maternal condition. published reports indicate that premature infants with post conceptual age (gestational plus postnatal) less than 31 weeks receiving doses exceeding 1 mg/kg/24 hours may develop plasma levels which could be associated with potential toxic effects including ototoxicity [see warnings and precautions (5.3)] . furosemide in the first year of life, especially in patients born pre-term, may precipitate nephrocalcinosis/nephrolithiasis [see warnings and precautions (5.2)] . controlled clinical studies of furosemide 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. in general, dose selection for the elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal or cardiac function, and of concomitant disease or other drug therapy. this drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. because elderly patients are more likely to have decreased renal function, care should be taken in dose selection and it may be useful to monitor renal function [see clinical pharmacology (12.3)] .

Estats Units - anglès - NLM (National Library of Medicine)

phlow corporation - furosemide (unii: 7lxu5n7zo5) (furosemide - unii:7lxu5n7zo5) - furosemide injection is indicated in adults and pediatric patients for the treatment of edema associated with heart failure, cirrhosis of the liver, and renal disease, including the nephrotic syndrome. furosemide injection is indicated as adjunctive therapy in acute pulmonary edema. - furosemide injection is contraindicated in patients with anuria. - furosemide injection is contraindicated in patients with a history of hypersensitivity to furosemide. risk summary available data from published observational studies, case reports, and postmarketing reports, from decades of use, have not demonstrated a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes with furosemide use during pregnancy. untreated congestive heart failure and cirrhosis of the liver can lead to adverse outcomes for the mother and the fetus (see clinical considerations) . in animal reproduction studies, furosemide has been shown to cause unexplained maternal deaths and abortions in rabbits when administered orally during organogenesis at 4 times a human i.v. dose of 80 mg based on body surface area (bsa) and oral bioavailability corrections, presumably secondary to volume depletion (see data) . the estimated background risk for major birth defects and miscarriage for the indicated populations 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 the clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. clinical considerations disease-associated maternal and/or embryo/fetal risk pregnant women with congestive heart failure are at increased risk for pre-term birth. stroke volume and heart rate increase during pregnancy, increasing cardiac output, especially during the first trimester. clinical classification of heart disease may worsen with pregnancy and lead to maternal death and/or stillbirth. closely monitor pregnant patients for destabilization of their heart failure. pregnant women with symptomatic cirrhosis generally have poor outcomes including hepatic failure, variceal hemorrhage, pre-term delivery, fetal growth restriction and maternal death. outcomes are worse with coexisting esophageal varices. pregnant women with cirrhosis of the liver should be carefully monitored and managed accordingly. data animal data the effects of furosemide on embryonic and fetal development and on pregnant dams were studied in mice, rats and rabbits. furosemide caused unexplained maternal deaths and abortions in the rabbit at the lowest dose of 25 mg/kg (approximately 4 times a human i.v. dose of 80 mg based on bsa and oral bioavailability corrections). in another study, a dose of 50 mg/kg (approximately 7 times a human i.v. dose of 80 mg based on bsa and oral bioavailability corrections) also caused maternal deaths and abortions when administered to rabbits between days 12 and 17 of gestation. in a third study, none of the pregnant rabbits survived an oral dose of 100 mg/kg. data from the above studies indicate fetal lethality that can precede maternal deaths. the results of the mouse study and one of the three rabbit studies also showed an increased incidence and severity of hydronephrosis (distention of the renal pelvis and, in some cases, of the ureters) in fetuses of treated dams as compared with the incidence of fetuses from the control group. risk summary the presence of furosemide has been reported in human milk. there are no data on the effects on the breastfed infant or the effects on milk production. doses of furosemide associated with clinically significant diuresis may impair milk production. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for furosemide and any potential adverse effects on the breastfed infant from furosemide or from the underlying maternal condition. published reports indicate that premature infants with post conceptual age (gestational plus postnatal) less than 31 weeks receiving doses exceeding 1 mg/kg/24 hours may develop plasma levels which could be associated with potential toxic effects including ototoxicity [see warnings and precautions (5.3)] . furosemide in the first year of life, especially in patients born pre-term, may precipitate nephrocalcinosis/nephrolithiasis [see warnings and precautions (5.2)] . controlled clinical studies of furosemide 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. in general, dose selection for the elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal or cardiac function, and of concomitant disease or other drug therapy. this drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. because elderly patients are more likely to have decreased renal function, care should be taken in dose selection and it may be useful to monitor renal function [see clinical pharmacology (12.3)] .

Unió Europea - anglès - EMA (European Medicines Agency)

baxalta innovations gmbh - pegaspargase - precursor cell lymphoblastic leukemia-lymphoma - antineoplastic agents, - oncaspar is indicated as a component of antineoplastic combination therapy in acute lymphoblastic leukaemia (all) in paediatric patients from birth to 18 years, and adult patients.,

Israel - anglès - Ministry of Health

novartis israel ltd - onasemnogene abeparvovec - suspension - onasemnogene abeparvovec 2 x 10^13 vg / 1 ml - onasemnogene abeparvovec - zolgensma is indicated for the treatment of:- patients with 5q spinal muscular atrophy (sma) with a bi-allelic mutation in the smn1 gene and a clinical diagnosis of sma type 1, or- patients with 5q sma with a bi-allelic mutation in the smn1 gene and up to 3 copies of the smn2 gene.

Austràlia - anglès - APVMA (Australian Pesticides and Veterinary Medicines Authority)

nutrien ag solutions limited - atrazine - water dispersible granule - atrazine triazine active 900.0 g/kg - herbicide - broom millet - dryland | broom millet - irrigated | canola - tt only - post sowing, pre emer | canola-triazine tolerant only-pos - african star grass | amaranth or amaranthus | annual grass weed - suppression | annual ground cherry | annual ryegrass | annual ryegrass - suppression | barley grass | barley grass - suppression | barnyard grass or water grass | barnyard or water grass | bellvine | black bindweed | blackberry nightshade | bladder ketmia | blue heliotrope or blue top | broadleaf weeds | broadleaf weeds and grasses | brome grass | brome grass - suppression | budda or butter pea | burr | caltrop or yellow vine | capeweed | charlock | chinese burr | clover | cobbler's pegs | common sida | common thornapple | corn gromwell, ironweed or sheepweed | crowsfoot grass | dock | dwarf marigold | early spring grass | fat hen | feathertop | flannel weed - sida cordifolia | fumitory | gambia pea | geranium | giant or black pigweed | giant sensitive plant | green summer grass | ivy leaf speedwell | london rocket | loosestrife | lovegrass | medic | mintweed | mossman river or burr grass | mouse-ear chickweed | mustard | noogoora burr | paddy

Austràlia - anglès - APVMA (Australian Pesticides and Veterinary Medicines Authority)

ezycrop pty ltd - clopyralid present as the potassium salt - water soluble granules - clopyralid present as the potassium salt pyridine active 750.0 g/kg - herbicide - canola - clearfield | canola - post emergence | canola - post sowing/pre-emergence | canola (prior to sowing) | canola-triazine - californian thistle | capeweed | capeweed - pre emergence | common cotula or carrot weed | cotulas | creeping/russian knapweed,hardhead | lucerne | nodding thistle | prickly lettuce | saffron thistle | scotch thistle | skeleton weed | slender, shore or sheep thistle | soldier thistle | sow or milk thistle | spear or black thistle | st barnaby's thistle | stemless thistle | subterranean clover | variegated thistle | vetches | volunteer chickpea | volunteer cotton - conventional | volunteer faba bean | volunteer field pea | volunteer lentil | volunteer lucerne - seedling | volunteer lupin | volunteer medic | volunteer safflower | volunteer subterranean clover | volunteer vetch or tares | bird's eye | blessed thistle | bull thistle | cabbage thistle | canada thistle | carduus marianus | common lucerne | common sowthistle | cotton thistle | creeping thistle | false star thistle | field pea | hairy vetch | hardhead thistle | heraldic thistle | holy thistle | lady's thistle | lentil | milk thistle | musk thistle |

Austràlia - anglès - APVMA (Australian Pesticides and Veterinary Medicines Authority)

redox limited - simazine - water dispersible granule - simazine triazine active 900.0 g/kg - herbicide - aerodrome - weed control | almond | apple | asparagus | berry fruit | canola - tt only - post sowing, pre emer | canola(tt varie - amaranth or amaranthus | amaranthus - pre emergence | annual or wimmera ryegrass | annual or wimmera ryegrass - suppression | annual ryegrass | annual ryegrass - suppression | annual thistle | barley grass | barley grass - suppression | barnyard or water grass | bindy-eye | black bindweed - suppression | blue-green algae - phormidium spp. | brome grass | brome grass - suppression | capeweed | cereal - self-sown | charlock | chickweed | clover | common sowthistle - suppression | corn gromwell, ironweed or sheepweed | creeping oxalis | deadnettle | dock | dock - suppression | doublegee - suppression | fat hen | fumitory | geranium | indian hedge mustard | ivy leaf speedwell | lesser swinecress or bittercress | london rocket | medic | mustard | native geranium | nettle | paradoxa grass | paradoxa grass - suppression | paterson's curse | potato or yellow weed | potato weed - seedling | powell's amaranth or powell's slim | prickly lettuce | purple goosefoot | radish | redroot or redroot amaranth | redshank | ryegr

Austràlia - anglès - APVMA (Australian Pesticides and Veterinary Medicines Authority)

pct holdings pty ltd - bifenthrin; n-methyl-2-pyrrolidone; liquid hydrocarbon - emulsifiable concentrate - bifenthrin pyrethroid active 100.0 g/l; n-methyl-2-pyrrolidone solvent other 50.0 g/l; liquid hydrocarbon solvent other 562.0 g/l - insecticide - commercial area - general | commercial building/structure - external | domestic and/or public area | domestic building/structure - ant | cockroach | flea | fly | mosquito | paper nest wasp | spider | subterranean termite - c. acinaciformes | tick - except paralysis tick | adult mosquitoes | argentine ant | ctenocephalides spp. | ground fleas | large cockroach | papernest wasps | pharaoh ant | small cockroach

Austràlia - anglès - APVMA (Australian Pesticides and Veterinary Medicines Authority)

pct holdings pty ltd - chlorpyrifos; liquid hydrocarbon - emulsifiable concentrate - chlorpyrifos organophosphorus active 500.0 g/l; liquid hydrocarbon solvent other 488.0 g/l - insecticide - apple | asparagus | banana | bean | beetroot | broccoli | brussels sprouts | buildings - around | cabbage | canola | capsicum or - african black beetle | ant | argentine ant | argentine stem weevil | australian plague locust | banana scab moth | banana weevil borer | black beetle | blackheaded pasture cockchafer | bloodworm - chironomus spp. | blue oat or pea mite | bluegreen aphid | brown pasture looper | cabbage aphid | cabbage cluster caterpillar | cabbage moth | cabbage white butterfly | california red scale | caterpillar | cluster caterpillar | cockroach infestation - heavy/residual | cockroach infestation - light | common armyworm - mythimna convecta | corn aphid | corn earworm | cotton aphid | cricket | cutworm | cutworm in young plants | false wireworm - celibe spp. | flea - outdoors only | funnel ant | grapevine moth | grapevine scale | green peach aphid | green vegetable bug | hide or skin beetle | lawn armyworm | light brown apple moth | lucerne flea | lucerne leafhopper | migratory locust | mosquito | mosquito larva | native budworm or bollworm | pasture webworm | pea aphid | pineapple mealy bug | redlegged earth mite | san j