Belgia - engelsk - AFMPS (Agence Fédérale des Médicaments et des Produits de Santé)

baxter sa-nv - mannitol 15 g/100 ml - solution for infusion - mannitol 150 mg/ml - mannitol

USA - engelsk - NLM (National Library of Medicine)

hf acquisition co llc, dba healthfirst - mannitol (unii: 3owl53l36a) (mannitol - unii:3owl53l36a) - mannitol injection is indicated for the following purposes in adults and pediatric patients. therapeutic use reduction of intracranial pressure and brain mass. reduction of high intraocular pressure. diagnostic use measurement of glomerular filtration rate. mannitol injection is contraindicated in patients with: well established anuria due to severe renal disease. severe pulmonary congestion or frank pulmonary edema. active intracranial bleeding except during craniotomy. severe dehydration. progressive heart failure or pulmonary congestion after institution of mannitol therapy. do not administer to patients with a known hypersensitivity to mannitol. 8.1 pregnancy risk summary there are no well-controlled studies in pregnant women that establish developmental toxicity related to the use of mannitol injection. mannitol crosses the placenta and may cause fluid shifts that could potentially result in adverse effects in the fetus (see data). the available data do not establish the presence or absence of developmental toxicity related to the use of mannitol. there are limited animal data in the published literature. the effects of mannitol on embryo-fetal development have not been evaluated; however, fluid shifts occurred in animal studies in response to maternal infusion of mannitol. mannitol injection should be given to a pregnant woman only if clearly needed. 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. data human data published literature reports the presence of mannitol in amniotic fluid when mannitol is administered to pregnant women during the third trimester of pregnancy. 8.2 lactation risk summary lactation studies have not been conducted with mannitol. it is not known whether this drug is excreted in human milk. mannitol injection should be administered to lactating women only if clearly indicated. studies assessing the effects of mannitol injection in breastfed children have not been performed. studies to assess the effect of mannitol on milk production or excretion have not been performed. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for mannitol and any potential adverse effects on the breastfed child from mannitol or from the underlying maternal condition. 8.5 geriatric use mannitol is known to be substantially excreted by the kidney, and the risk of adverse reactions to this drug may be greater in elderly patients with impaired renal function. evaluate the renal, cardiac and pulmonary status of the patient and correct fluid and electrolyte imbalances prior to administration of mannitol [see warnings and precautions (5)]. 8.6 renal impairment patients with pre-existing renal disease, patients with conditions that put them at high risk for renal failure, or those receiving potentially nephrotoxic drugs or other diuretics, are at increased risk of renal failure with administration of mannitol. evaluate the renal, cardiac and pulmonary status of the patient and correct fluid and electrolyte imbalances prior to administration of mannitol [see warnings and precautions (5)].

USA - engelsk - NLM (National Library of Medicine)

henry schein, inc. - mannitol (unii: 3owl53l36a) (mannitol - unii:3owl53l36a) - mannitol injection is indicated for the reduction of: - intracranial pressure and treatment of cerebral edema. - elevated intraocular pressure. mannitol injection is contraindicated in patients with: - known hypersensitivity to mannitol [see warnings and precautions (5.1)]. - anuria [see warnings and precautions (5.2)]. - severe hypovolemia [see warnings and precautions (5.4)]. - pre-existing severe pulmonary vascular congestion or pulmonary edema [see warnings and precautions (5.5)]. - active intracranial bleeding except during craniotomy. 8.1 pregnancy risk summary the available case report data with mannitol over decades of use have not identified a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. mannitol crosses the placenta and may cause fluid shifts that could potentially result in adverse effects in the fetus (see data).no adverse developmental effects from mannitol were reported in published animal studies; however, fluid shifts occurred in fetal ewes i

Israel - engelsk - Ministry of Health

a.l. medi-market ltd. - mannitol - solution for infusion - mannitol 200 g / 1000 ml - mannitol - mannitol 20% imuna, solution for infusion is indicated for: - the promotion of diuresis, in the prevention and/or treatment of the oliguric phase of acute renal failure before irreversible renal failure becomes established;- the reduction of intracranial pressure and treatment of cerebral edema by reducing brain mass; - the reduction of elevated intraocular pressure when the pressure cannot be lowered by other means, and promoting the urinary excretion of toxic substances.

Sveits - fransk - Swissmedic (Swiss Agency for Therapeutic Products)

b. braun medical ag - mannitolum - solution à diluer pour perfusion - mannitolum 200 mg, aqua ad iniectabile q.s. ad solutionem pro 1 ml. - diurétique en cas d'insuffisance rénale - synthetika

Sveits - fransk - Swissmedic (Swiss Agency for Therapeutic Products)

grosse apotheke dr. g. bichsel ag - mannitolum - solution à diluer pour perfusion - mannitolum 10 g, aqua ad iniectabile q.s. ad solutionem pro 100 ml. - diurétique en cas d'insuffisance rénale - synthetika

Sveits - fransk - Swissmedic (Swiss Agency for Therapeutic Products)

grosse apotheke dr. g. bichsel ag - mannitolum - solution à diluer pour perfusion - mannitolum 20 g, aqua ad iniectabile q.s. ad solutionem pro 100 ml. - diurétique en cas d'insuffisance rénale - synthetika

Canada - fransk - Health Canada

fresenius kabi canada ltd - mannitol - solution - 25% - mannitol 25% - osmotic diuretics

Canada - engelsk - Health Canada

fresenius kabi canada ltd - mannitol - solution - 25% - mannitol 25% - osmotic diuretics

Italia - italiensk - AIFA (Agenzia Italiana del Farmaco)

industria farmaceutica galenica senese s.r.l. - mannitolo - mannitolo