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

braintree laboratories, inc. - polyethylene glycol 3350 (unii: g2m7p15e5p) (polyethylene glycol 3350 - unii:g2m7p15e5p), sodium sulfate (unii: 0ypr65r21j) (sodium sulfate anhydrous - unii:36kcs0r750), potassium chloride (unii: 660yq98i10) (potassium cation - unii:295o53k152), magnesium sulfate anhydrous (unii: ml30mj2u7i) (magnesium cation - unii:t6v3lhy838), sodium chloride (unii: 451w47iq8x) (chloride ion - unii:q32zn48698) - suflave is indicated for the cleansing of the colon as a preparation for colonoscopy in adults. suflave is contraindicated in the following conditions: - gastrointestinal obstruction or ileus [see warnings and precautions ( 5.6)] - bowel perforation [see warnings and precautions ( 5.6)] - toxic colitis or toxic megacolon - gastric retention - hypersensitivity to any ingredient in suflave  [see warnings and precautions ( 5.8)] risk summary there are no available data on the use of suflave during pregnancy to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. animal reproduction studies have not been conducted with polyethylene glycol 3350, sodium sulfate, potassium chloride, magnesium sulfate, and sodium chloride (suflave). 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 ad

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

potassium 5mmol/500ml) / glucose 10% / calcium gluconate 0.21% / sodium chloride 0.029% / magnesium sulfate 0.025% (magnesium 0.5mmol/500ml) solution for infusion 500ml bottles (special order - glucose monohydrate; calcium gluconate; potassium chloride; magnesium sulfate heptahydrate; sodium chloride - solution for infusion - 115.5gram/1litre ; 2.102gram/1litre ; 746mg/1litre ; 246mg/1litre ; 292mg/1litre

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

novel laboratories, inc. - sodium sulfate (unii: 0ypr65r21j) (sodium sulfate anhydrous - unii:36kcs0r750), potassium sulfate (unii: 1k573lc5tv) (sulfate ion - unii:7is9n8kpmg), magnesium sulfate anhydrous (unii: ml30mj2u7i) (magnesium cation - unii:t6v3lhy838) - sodium sulfate, potassium sulfate and magnesium sulfate oral solution is indicated for cleansing of the colon as a preparation for colonoscopy in adults. - gastrointestinal obstruction - bowel perforation - gastric retention - ileus - toxic colitis or toxic megacolon - known allergies to components of the kit [see description (11)] teratogenic effects: pregnancy category c. animal reproduction studies have not been conducted with sodium sulfate, potassium sulfate and magnesium sulfate oral solution. it is also not known whether sodium sulfate, potassium sulfate and magnesium sulfate oral solution can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. sodium sulfate, potassium sulfate and magnesium sulfate oral solution should be given to a pregnant woman only if clearly needed. it is not known whether this drug is excreted in human milk. because many drugs are excreted in human milk, caution should be exercised when sodium sulfate, potassium sulfate and magnesium

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

affordable pharmaceuticals, llc - sodium sulfate (unii: 0ypr65r21j) (sodium cation - unii:lyr4m0nh37), potassium sulfate (unii: 1k573lc5tv) (potassium cation - unii:295o53k152), magnesium sulfate, unspecified form (unii: de08037sab) (magnesium cation - unii:t6v3lhy838) - sodium sulfate, potassium sulfate and magnesium sulfate oral solution is indicated for cleansing of the colon as a preparation for colonoscopy in adult and pediatric patients 12 years of age and older. sodium sulfate, potassium sulfate and magnesium sulfate oral solution is contraindicated in the following conditions: - gastrointestinal obstruction or ileus  [see warnings and precautions ( 5.6)] - bowel perforation [see warnings and precaution ( 5.6)] - toxic colitis or toxic megacolon - gastric retention - hypersensitivity to any of the ingredients in sodium sulfate, potassium sulfate and magnesium sulfate oral solution risk summary there are no available data on sodium sulfate, potassium sulfate and magnesium sulfate oral solution use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. animal reproductive studies have not been conducted with sodium sulfate,

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

phebra pty ltd - magnesium sulfate heptahydrate, quantity: 500 mg/ml - injection, concentrated - excipient ingredients: water for injections - parenteral administration of magnesium is indicated in the treatment of acute hypomagnesaemia. magnesium salts are also indicated to prevent hypomagnesaemia in patients receiving total parenteral nutrition. magnesium sulphate is also indicated in the prevention and treatment of life-threatening seizures in the treatment of toxemias of pregnancy (pre-eclampsia and eclampsia). for emegency treatment of some arrhythmias such as torsade de pointes and those associated with hypokalemia.

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

potassium 20mmol/1litre) / magnesium sulfate 0.2% (magnesium 8mmol/1litre) / sodium chloride 0.9% infusion 1litre bags (special order - sodium chloride; magnesium sulfate heptahydrate; potassium chloride - solution for infusion - 9mg/1ml ; 2mg/1ml ; 1.5mg/1ml

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

lupin pharmaceuticals, inc. - sodium sulfate (unii: 0ypr65r21j) (sodium sulfate anhydrous - unii:36kcs0r750), potassium sulfate (unii: 1k573lc5tv) (sulfate ion - unii:7is9n8kpmg), magnesium sulfate anhydrous (unii: ml30mj2u7i) (magnesium cation - unii:t6v3lhy838) - sodium sulfate, potassium sulfate and magnesium sulfate oral solution is indicated for cleansing of the colon as a preparation for colonoscopy in adults. - gastrointestinal obstruction - bowel perforation - gastric retention - ileus - toxic colitis or toxic megacolon - known allergies to components of the kit [see description (11)] teratogenic effects: pregnancy category c. animal reproduction studies have not been conducted with sodium sulfate, potassium sulfate and magnesium sulfate oral solution. it is also not known whether sodium sulfate, potassium sulfate and magnesium sulfate oral solution can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. sodium sulfate, potassium sulfate and magnesium sulfate oral solution should be given to a pregnant woman only if clearly needed. it is not known whether this drug is excreted in human milk. because many drugs are excreted in human milk, caution should be exercised when sodium sulfate, potassium sulfate and magnesium sulfate oral solution is administered to a nursing woman. safety and effectiveness in pediatric patients have not been established. of the 375 patients who received sodium sulfate, potassium sulfate and magnesium sulfate oral solution in clinical trials, 94 (25%) were 65 years of age or older, and 25 (7%) were 75 years of age or older. no overall differences in safety or effectiveness of sodium sulfate, potassium sulfate and magnesium sulfate oral solution administered as a split-dose (2-day) regimen were observed between geriatric patients and younger patients. geriatric patients reported more vomiting when sodium sulfate, potassium sulfate and magnesium sulfate oral solution was given as a one-day preparation.

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

braintree laboratories, inc. - sodium sulfate (unii: 0ypr65r21j) (sodium cation - unii:lyr4m0nh37), potassium sulfate (unii: 1k573lc5tv) (potassium cation - unii:295o53k152), magnesium sulfate, unspecified form (unii: de08037sab) (magnesium cation - unii:t6v3lhy838) - sodium sulfate 17.5 g in 1 ml - suprep bowel prep kit is indicated for cleansing of the colon as a preparation for colonoscopy in adult and pediatric patients 12 years of age and older. suprep bowel prep kit is contraindicated in the following conditions: - gastrointestinal obstruction or ileus  [see warnings and precautions ( 5.6)] - bowel perforation [see warnings and precaution ( 5.6)] - toxic colitis or toxic megacolon - gastric retention - hypersensitivity to any of the ingredients in suprep bowel prep kit risk summary there are no available data on suprep bowel prep kit use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. animal reproductive studies have not been conducted with sodium sulfate, potassium sulfate, and magnesium sulfate (suprep bowel prep kit). the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. all pregnancies

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

allergan ltd - potassium sulfate; magnesium sulfate heptahydrate; sodium sulfate anhydrous - oral solution - 17.784mg/1ml ; 18.614mg/1ml ; 99.489mg/1ml

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

phebra pty ltd - magnesium sulfate heptahydrate, quantity: 500 mg/ml - injection, concentrated - excipient ingredients: water for injections - indications as at 01 jan 1991 : parenteral administration of magnesium is indicated in the treatment of acute hypomagnesaemia. magnesium salts are also indicated to prevent hypomagnesaemia in patients receiving total parenteral nutrition. magnesium sulphate is also indicated in the prevention and treatment of life-threatening seizures in the treatment of toxemias of pregnancy (pre-eclampsia and eclampsia). for emegency treatment of some arrhythmias such as torsade de pointes and those associated with hypokalemia.