Amerikas Savienotās Valstis - angļu - NLM (National Library of Medicine)

shield tx (uk) ltd - ferric maltol (unii: ma10qyf1z0) (ferric cation - unii:91o4lml611) - accrufer is indicated for the treatment of iron deficiency in adults. accrufer is contraindicated in patients with a history of: - hypersensitivity to the active substance or to any of the excipients [see description ( 11)] . reactions could include shock, clinically significant hypotension, loss of consciousness, and/or collapse. - hemochromatosis and other iron overload syndromes [see warnings and precautions ( 5.1)] . use may result in iron overdose [see overdosage ( 10)]. - receiving repeated blood transfusions. use may result in iron overload [see warnings and precautions ( 5.2) and overdosage ( 10)]. risk summary accrufer is not absorbed systemically as an intact complex following oral administration, and maternal use is not expected to result in fetal exposure to the drug [see clinical pharmacology ( 12.3)] . in animal reproduction studies, oral administration of ferric or ferrous compounds to gravid cd1-mice and wistar-rats during organogenesis at doses 13 to 32 times the recommended human dose resulted in no adverse developmental outcomes. an overdose of iron in pregnant women may carry a risk for spontaneous abortion, gestational diabetes and fetal malformation. in animal reproduction studies, oral administration of maltol to pregnant crl: cobs-cd (sd) br rats during organogenesis at doses 6 times the recommended human dose resulted in no adverse developmental outcomes. the estimated 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. clinical considerations disease-associated maternal and/or embryo/fetal risk untreated iron deficiency anemia (ida) in pregnancy is associated with adverse maternal outcomes such as post-partum anemia. adverse pregnancy outcomes associated with ida include increased risk for preterm delivery and low birth weight. data animal data in embryofetal development studies in mice and rats, pregnant animals received oral doses of ferric or ferrous compounds (ferrous sulfate or ferric sodium pyrophosphate) of up to 160 mg/kg/day in mice, or up to 200 mg/kg/day in rats, during the period of organogenesis. administration of ferric or ferrous compounds at doses 13 times (in mice) or 32 times (in rats) the recommended human dose resulted in no maternal toxicity and no adverse developmental outcomes. in a multigeneration reproductive and developmental study in rats, pregnant animals received oral doses of maltol of 100, 200, and 400 mg/kg/day, during the period of organogenesis. administration of maltol at doses 6 times the recommended human dose resulted in no maternal toxicity and no adverse developmental outcomes. risk summary there are no data on the presence of accrufer in human milk, the effects on the breastfed child, or the effects on milk production. accrufer is not absorbed systemically as an intact complex by the mother following oral administration, and breastfeeding is not expected to result in exposure of the child to accrufer. safety and effectiveness of accrufer have not been established in pediatric patients. of the 295 patients in the randomized trials of accrufer, 39% of patients were aged 65 and older, while 23% were aged 75 and older. no overall differences in safety or effectiveness were observed between these patients and younger patients.

Austrālija - angļu - APVMA (Australian Pesticides and Veterinary Medicines Authority)

hextar chemicals pty ltd - msma - soluble concentrate - msma mineral-arsenic active 720.0 g/l - herbicide - control of prickly pear | cotton | couch and bent grass turf or lawn | non-crop area - general | sugar cane | inter-row sprayin - barnyard or water grass | bathurst burr | caltrop or yellow vine | columbus grass | common prickly pear | devil's rope or chain link cactus | green summer grass | indian fig | itch grass | johnson grass | noogoora burr | nutgrass | paspalum | perennial pigweed | smooth tree or drooping prickly pear | spiny burrgrass or gentle annie | summer grass | summer or crab grass | vasey grass | wheel cactus | annual summer grass | barnyard grass | bindy-eye | bullhead | bull's head | caltrop burr | cathead | cat's-head | cenchrus incertus | cenchrus longispinus | cockleburr | devils rope pear | giant paspalum | goat's-head | green summergrass | neverdie | pigweed | puncture vine | red pigweed | sweet summer grass | tribulus maximus | tribulus micrococcus | tribulus terrestris | victorian nutgrass | xanthium chinense | xanthium pungens | xanthium strumarium

Īrija - angļu - HPRA (Health Products Regulatory Authority)

may & baker limited - sodium aurothiomalate - solution for injection - 10mg/0.5 m millilitre

Īrija - angļu - HPRA (Health Products Regulatory Authority)

may & baker limited - sodium aurothiomalate - solution for injection - 20 mg/0.5 millilitre

Īrija - angļu - HPRA (Health Products Regulatory Authority)

may & baker limited - sodium aurothiomalate - solution for injection - 50mg/0.5 millilitre

Austrālija - angļu - APVMA (Australian Pesticides and Veterinary Medicines Authority)

boehringer ingelheim animal health australia pty. ltd. - melarsomine dihydrochloride - injection - melarsomine dihydrochloride ungrouped active 50.0 mg/vi - parasiticides - dog - not pregnant - heartworm

Īrija - angļu - HPRA (Health Products Regulatory Authority)

may & baker limited - sodium aurothiomalate - solution for injection - 20 mg/0.5 millilitre

Īrija - angļu - HPRA (Health Products Regulatory Authority)

may & baker limited - sodium aurothiomalate - solution for injection - 10mg/0.5 m millilitre

Īrija - angļu - HPRA (Health Products Regulatory Authority)

may & baker limited - sodium aurothiomalate - solution for injection - 50mg/0.5 millilitre

Lielbritānija - angļu - MHRA (Medicines & Healthcare Products Regulatory Agency)

esteve pharmaceuticals ltd - ferrous sulfate dried; folic acid - modified-release capsule - 150mg ; 500microgram