Malaysia - English - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

b.braun medical industries sdn bhd - malic acid; potassium chloride; sodium chloride; magnesium chloride hexahydrate.; calcium chloride dihydrate.; hydroxyethyl starch/hetastarch; sodium acetate trihydrate. -

Malaysia - English - NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

b.braun medical industries sdn bhd - malic acid; potassium chloride; sodium chloride; magnesium chloride hexahydrate.; calcium chloride dihydrate.; hydroxyethyl starch/hetastarch; sodium acetate trihydrate. -

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)

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)

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,

Malta - English - Medicines Authority

b braun melsungen ag carl-braun-strasse 1, d34212 melsungen, germany - calcium chloride, dihydrate, potassium chloride, malic acid, magnesium chloride, hexahydrate, sodium acetate, trihydrate, sodium chloride - solution for infusion - calcium chloride dihydrate 0.37 g/l potassium chloride 0.3 g/l l-malic acid 0.67 g/l magnesium chloride hexahydrate 0.2 g/l sodium acetate trihydrate 3.27 g/l sodium chloride 6.8 g/l - blood substitutes and perfusion solutions

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 States - English - NLM (National Library of Medicine)

cardinal health - potassium chloride (unii: 660yq98i10) (potassium cation - unii:295o53k152) - potassium chloride 1.5 g in 1.74 g

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

ferring pharmaceuticals inc. - sodium picosulfate (unii: lr57574hn8) (deacetylbisacodyl - unii:r09078e41y), magnesium oxide (unii: 3a3u0gi71g) (magnesium cation - unii:t6v3lhy838), anhydrous citric acid (unii: xf417d3psl) (anhydrous citric acid - unii:xf417d3psl) - sodium picosulfate 10 mg in 160 ml - clenpiq is indicated for cleansing of the colon as a preparation for colonoscopy in adults and pediatric patients 9 years of age and older. clenpiq is contraindicated in the following conditions: - patients with severe renal impairment (creatinine clearance less than 30 ml/minute), which may result in accumulation of magnesium [see warnings and precautions (5.3)]. - 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 of the ingredients in clenpiq [see adverse reactions (6.2)]. risk summary there are no data with clenpiq use in pregnant women to determine a drug-associated risk of adverse developmental outcomes. in animal reproduction studies, no adverse developmental effects were observed in pregnant rats when sodium picosulfate, magnesium oxide, and anhydrous citric acid were administered orally at doses 1.2 times the recommended human dose based

Australia - English - APVMA (Australian Pesticides and Veterinary Medicines Authority)

troy laboratories pty ltd - malic acid - unknown - malic acid acid-general active 0.0 - active constituent