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

baxter healthcare pty ltd - icodextrin, quantity: 75 g/l; sodium chloride, quantity: 5.4 g/l; sodium lactate, quantity: 4.5 g/l; calcium chloride dihydrate, quantity: 257 mg/l; magnesium chloride hexahydrate, quantity: 51 mg/l - solution, dialysis - excipient ingredients: water for injections; sodium hydroxide; hydrochloric acid - indicated as "an alternative osmotic agent in dialysis solution for the long dwell exchange in patients treated with peritoneal dialysis."

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

baxter healthcare pty ltd - icodextrin, quantity: 75 g/l; sodium chloride, quantity: 5.4 g/l; sodium lactate, quantity: 4.5 g/l; calcium chloride dihydrate, quantity: 257 mg/l; magnesium chloride hexahydrate, quantity: 51 mg/l - solution, dialysis - excipient ingredients: water for injections; sodium hydroxide; hydrochloric acid - indicated as "an alternative osmotic agent in dialysis solution for the long dwell exchange in patients treated with peritoneal dialysis."

Israel - English - Ministry of Health

baxter healthcare distribution ltd., israel - calcium chloride dihydrate; icodextrin; magnesium chloride hexahydrate; sodium (s) - lactate; sodium chloride - solution for peritoneal dialysis - icodextrin 75 g/l; magnesium chloride hexahydrate 0.051 g/l; calcium chloride dihydrate 0.257 g/l; sodium (s) - lactate 4.5 g/l; sodium chloride 5.4 g/l - dextran - dextran - once daily replacement of a single glucose exchange as part of continuous ambulatory peritoneal dialysis (capd) or automated peritoneal dialysis (apd) in the treatment of chronic renal failure.

Ireland - English - HPRA (Health Products Regulatory Authority)

baxter healthcare limited - icodextrin, sodium chloride, calcium chloride dihydrate, magnesium chloride hexahydrate, sodium (s)-lactate solution - soln for peritoneal dialysis - per cent - isotonic solutions - peritoneal dialytics, isotonic solutions - it is recommended as a once daily replacement for a single glucose exchange as part of a continuous ambulatory peritoneal dialysis (capd) or automated peritoneal dialysis (apd) regimen for the treatment of chronic renal failure, particularly for patients who have lost ultrafiltration on glucose solutions, because it can extend time on capd therapy in such patients.

Singapore - English - HSA (Health Sciences Authority)

vantive pte. ltd. - calcium chloride dihydrate; icodextrin; magnesium chloride hexahydrate; sodium chloride; sodium lactate - solution, sterile - 257 mg/l - calcium chloride dihydrate 257 mg/l; icodextrin 75 g/l; magnesium chloride hexahydrate 50.8 mg/l; sodium chloride 5.38 g/l; sodium lactate 4.48 g/l

Malta - English - Medicines Authority

baxter healthcare limited caxton way, thetford, norfolk ip24 3se, united kingdom - icodextrin - solution for peritoneal dialysis - icodextrin 7.5 % (w/v) - blood substitutes and perfusion solutions

Canada - English - Health Canada

baxter corporation - sodium chloride; sodium lactate; calcium chloride; magnesium chloride; icodextrin - solution - 5.35g; 4.48g; 257mg; 51mg; 75g - sodium chloride 5.35g; sodium lactate 4.48g; calcium chloride 257mg; magnesium chloride 51mg; icodextrin 75g - hemodialysis solution

New Zealand - English - Medsafe (Medicines Safety Authority)

vantive limited - calcium chloride dihydrate 257 mg/l; icodextrin 75 g/l; magnesium chloride hexahydrate 51 mg/l; sodium chloride 5.4 g/l; sodium lactate 4.5 g/l - dialysis solution - 7.5% w/v - active: calcium chloride dihydrate 257 mg/l icodextrin 75 g/l magnesium chloride hexahydrate 51 mg/l sodium chloride 5.4 g/l sodium lactate 4.5 g/l excipient: hydrochloric acid sodium hydroxide water for injection

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

fresenius kabi norge as - magnesium sulfate heptahydrate (unii: sk47b8698t) (magnesium cation - unii:t6v3lhy838) - magnesium sulfate heptahydrate 80 mg in 1 ml - magnesium sulfate in water for injection is indicated for the prevention and control of seizures in pre-eclampsia and eclampsia, respectively.  when used judiciously it effectively prevents and controls the convulsions of eclampsia without producing deleterious depression of the central nervous system of the mother or infant.  however, other effective drugs are available for this purpose. intravenous magnesium should not be given to mothers with toxemia of pregnancy during the two hours preceding delivery.

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

wg critical care, llc - magnesium sulfate heptahydrate (unii: sk47b8698t) (magnesium cation - unii:t6v3lhy838) - magnesium sulfate heptahydrate 1 g in 100 ml - magnesium sulfate in 5% dextrose injection, usp is indicated for: magnesium sulfate in 5% dextrose injection is contraindicated in patients: risk summary magnesium sulfate in 5% dextrose injection is indicated in pregnant women for the prevention of eclampsia in women with preeclampsia and the treatment of seizures and prevention of recurrent seizures in women with eclampsia. fetal, neonatal, and maternal risks are discussed throughout the labeling. clinical considerations labor or delivery: magnesium sulfate in 5% dextrose injection is not approved for the treatment of pre-term labor. administration of magnesium sulfate in 5% dextrose injection to pregnant women longer than 5 to 7 days may lead to hypocalcemia and bone abnormalities in the developing fetus, including skeletal demineralization and osteopenia [see warnings and precautions (5.1)] . the use of intravenous magnesium in pregnant women increases human milk magnesium concentrations only slightly and oral absorption of magnesium by the infant is poor. the effect of intravenous magnesium on milk production is unknown. the developmental and health benefits to the neonate of breastfeeding should be considered along with the mother's clinical need for magnesium sulfate in 5% dextrose injection and any potential adverse effects on the breastfed infant from magnesium sulfate in 5% dextrose injection or from the underlying maternal condition. the safety and effectiveness of magnesium sulfate in 5% dextrose injection have been established for the prevention of eclampsia in adolescents with preeclampsia and the treatment of seizures and prevention of recurrent seizures in adolescents with eclampsia. dosing recommendation in pregnant adolescent patients are the same as for pregnant adult patients [see dosage and administration (2.2)] . magnesium is excreted solely by the kidneys. patients with severe renal impairment (urine output less than 100 ml per 4 hours) are at greater risk for increased magnesium concentrations that may lead to magnesium toxicity [see warnings and precautions (5.2) and clinical pharmacology (12.3)] . in patients with severe renal impairment, dosage reduction is recommended and the maximum recommended dosage is lower than patients with normal renal function [see dosage and administration (2.3)] .