Reino Unido - inglês - MHRA (Medicines & Healthcare Products Regulatory Agency)

thornton & ross ltd - magnesium trisilicate; magnesium carbonate light; sodium bicarbonate - oral suspension - 50mg/1ml ; 50mg/1ml ; 50mg/1ml

Namíbia - inglês - Namibia Medicines Regulatory Council

adcock ingram limited - calcium carbonate, light magnesium carbonate , sodium bicarbonate, sodium citrate, alcohol - mixture - each 5 ml mixture contains: calcium carbonate 87 mg, light magnesium carbonate 87 mg, sodium bicarbonate 87 mg, sodium citrate 6

Estados Unidos - inglês - NLM (National Library of Medicine)

mylan institutional llc - sodium phenylacetate (unii: 48n6u1781g) (phenylacetic acid - unii:er5i1w795a), sodium benzoate (unii: oj245fe5eu) (benzoic acid - unii:8skn0b0mim) - sodium phenylacetate 100 mg in 1 ml - sodium phenylacetate and sodium benzoate injection is indicated as adjunctive therapy in pediatric and adult patients for the treatment of acute hyperammonemia and associated encephalopathy in patients with deficiencies in enzymes of the urea cycle. during acute hyperammonemic episodes, arginine supplementation, caloric supplementation, dietary protein restriction, hemodialysis, and other ammonia lowering therapies should be considered [see warnings and precautions (5) ]. none. available data with sodium phenylacetate and sodium benzoate injection use in pregnant women are insufficient to identify a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. animal reproduction studies have not been conducted with sodium phenylacetate and sodium benzoate injection. 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 to 4%, and 15 to 20%, respectively. there are no data on the presence of sodium phenylacetate, sodium benzoate in either human or animal milk, the effects on the breastfed infant, or the effects on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for sodium phenylacetate and sodium benzoate injection and any potential adverse effects on the breastfed infant from sodium phenylacetate and sodium benzoate injection or from the underlying maternal condition. sodium phenylacetate and sodium benzoate injection has been used as a treatment for acute hyperammonemia in pediatric patients including patients in the early neonatal period [see dosage and administration (2) ]. clinical studies of sodium phenylacetate and sodium benzoate injection did not include any patients aged 65 and over to determine whether they respond differently from younger patients. urea cycle disorders are presently diseases of the pediatric and younger adult populations. no pharmacokinetic studies of sodium phenylacetate and sodium benzoate injection have been performed in geriatric patients. in general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and concomitant disease or other drug therapy in this patient population. pharmacokinetic parameters of sodium phenylacetate and sodium benzoate injection were compared in healthy males and females. bioavailability of both benzoate and phenylacetate was slightly higher in females than in males. however, conclusions cannot be drawn due to the limited number of subjects in this study. limited information is available on the metabolism and excretion of sodium phenylacetate and sodium benzoate in patients with impaired hepatic function. however, metabolic conjugation of sodium phenylacetate and sodium benzoate is known to take place in the liver and kidney. therefore, caution should be used in administering sodium phenylacetate and sodium benzoate injection to patients with hepatic insufficiency. the drug metabolites of sodium phenylacetate and sodium benzoate injection (phenylacetylglutamine and hippurate) and subsequently ammonia are primarily excreted by the kidney. therefore, use caution and closely monitor patients with impaired renal function who receive sodium phenylacetate and sodium benzoate injection.

Estados Unidos - inglês - NLM (National Library of Medicine)

trigen laboratories, llc - sodium phenylacetate (unii: 48n6u1781g) (phenylacetic acid - unii:er5i1w795a), sodium benzoate (unii: oj245fe5eu) (benzoic acid - unii:8skn0b0mim) - sodium phenylacetate 100 mg in 1 ml - sodium phenylacetate and sodium benzoate injection, 10%/10% is indicated as adjunctive therapy in pediatric and adult patients for the treatment of acute hyperammonemia and associated encephalopathy in patients with deficiencies in enzymes of the urea cycle. during acute hyperammonemic episodes, arginine supplementation, caloric supplementation, dietary protein restriction, hemodialysis, and other ammonia lowering therapies should be considered [see warnings and precautions (5) ]. none. pregnancy category c. animal reproduction studies have not been conducted with sodium phenylacetate and sodium benzoate injection, 10%/10%. it is not known whether sodium phenylacetate and sodium benzoate injection, 10%/10% can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. thus, sodium phenylacetate and sodium benzoate injection, 10%/10% should be given to a pregnant woman only if clearly needed. it is not known whether sodium phenylacetate, sodium benzoate, or their

Estados Unidos - inglês - NLM (National Library of Medicine)

ailex pharmaceuticals, llc - sodium phenylacetate (unii: 48n6u1781g) (phenylacetic acid - unii:er5i1w795a), sodium benzoate (unii: oj245fe5eu) (benzoic acid - unii:8skn0b0mim) - sodium phenylacetate 100 mg in 1 ml - sodium phenylacetate and sodium benzoate injection, 10%/10% is indicated as adjunctive therapy in pediatric and adult patients for the treatment of acute hyperammonemia and associated encephalopathy in patients with deficiencies in enzymes of the urea cycle. during acute hyperammonemic episodes, arginine supplementation, caloric supplementation, dietary protein restriction, hemodialysis, and other ammonia lowering therapies should be considered [see warnings and precautions (5) ]. none. pregnancy category c. animal reproduction studies have not been conducted with sodium phenylacetate and sodium benzoate injection, 10%/10%. it is not known whether sodium phenylacetate and sodium benzoate injection, 10%/10% can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. thus, sodium phenylacetate and sodium benzoate injection, 10%/10% should be given to a pregnant woman only if clearly needed. it is not known whether sodium phenylacetate, sodium benzoate, or their conjugation p

Estados Unidos - inglês - 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

Estados Unidos - inglês - NLM (National Library of Medicine)

zydus lifesciences limited - omeprazole (unii: kg60484qx9) (omeprazole - unii:kg60484qx9), sodium bicarbonate (unii: 8mdf5v39qo) (bicarbonate ion - unii:hn1zra3q20) - omeprazole, usp .............................................................................acid reducer sodium bicarbonate, usp ………allows absorption of this omeprazole product - treats frequent heartburn (occurs 2 or more days a week) - not intended for immediate relief of heartburn. this drug may take 1 to 4 days for full effect. - trouble or pain swallowing food - vomiting with blood - bloody or black stools these may be signs of a serious condition. see your doctor. - had heartburn over 3 months. this may be a sign of a more serious condition. - heartburn with lightheadedness, sweating or dizziness - chest pain or shoulder pain with shortness of breath; sweating; pain spreading to arms, neck or shoulders; or lightheadedness - frequent chest pain - frequent wheezing, particularly with heartburn - unexplained weight loss - nausea or vomiting - stomach pain - a sodium-restricted diet - your heartburn continues or worsens - you need to take this product for more than 14 days - you need to take more than 1 c

Estados Unidos - inglês - NLM (National Library of Medicine)

zydus pharmaceuticals usa inc. - omeprazole (unii: kg60484qx9) (omeprazole - unii:kg60484qx9), sodium bicarbonate (unii: 8mdf5v39qo) (bicarbonate ion - unii:hn1zra3q20) - omeprazole, usp .............................................................................acid reducer sodium bicarbonate, usp ………allows absorption of this omeprazole product - treats frequent heartburn (occurs 2 or more days a week) - not intended for immediate relief of heartburn. this drug may take 1 to 4 days for full effect. - trouble or pain swallowing food - vomiting with blood - bloody or black stools these may be signs of a serious condition. see your doctor. - had heartburn over 3 months. this may be a sign of a more serious condition. - heartburn with lightheadedness, sweating or dizziness - chest pain or shoulder pain with shortness of breath; sweating; pain spreading to arms, neck or shoulders; or lightheadedness - frequent chest pain - frequent wheezing, particularly with heartburn - unexplained weight loss - nausea or vomiting - stomach pain - a sodium-restricted diet a prescription drug. acid reducers may interact with certain prescription drugs. - your heartburn continues or worsens - you

Malta - inglês - Medicines Authority

bayer limited 1st floor the grange offices the grange brewery road stillorgan co. dublin, a94 h2k7 , ireland - calcium carbonate, magnesium carbonate, heavy - chewable tablet - calcium carbonate 680 mg magnesium carbonate, heavy 80 mg - drugs for acid related disorders

Malta - inglês - Medicines Authority

bayer limited 1st floor the grange offices the grange brewery road stillorgan co. dublin, a94 h2k7 , ireland - calcium carbonate, magnesium carbonate, heavy - chewable tablet - calcium carbonate 680 mg magnesium carbonate, heavy 80 mg - drugs for acid related disorders