United States - English - 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.

United States - English - 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

United States - English - 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

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

baxter healthcare corporation - dextrose monohydrate (unii: lx22yl083g) (anhydrous dextrose - unii:5sl0g7r0ok), sodium chloride (unii: 451w47iq8x) (sodium cation - unii:lyr4m0nh37, chloride ion - unii:q32zn48698) - dextrose and sodium chloride injection is indicated as a source of water, electrolytes and calories. dextrose and sodium chloride injection is contraindicated in patients with: risk summary appropriate administration of dextrose and sodium chloride injection during pregnancy is not expected to cause adverse developmental outcomes, including congenital malformations. animal reproduction studies have not been conducted with dextrose and sodium chloride 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. risk summary sodium is present in human breast milk. there are no data on the effects of dextrose and sodium chloride injection on a breastfed infant or the effects on milk producti

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

laboratorios alfa srl - dextrose monohydrate (unii: lx22yl083g) (anhydrous dextrose - unii:5sl0g7r0ok), sodium chloride (unii: 451w47iq8x) (chloride ion - unii:q32zn48698) - veterinary 5% dextrose in 0.9% sodium chloride, usp is indicated as a source of water, electroytes and calories. solutions containing 5% dextrose in 0.9% sodium chloride injection, usp may be contraindicated in patients with known allergy to corn or corn products. this is a single dose container and does not contain preservatives. if leaks are found, discard solution as sterility may be impaired. use the solution immediately after the bottle is opened, discard the remaining one. discard unused portion. if supplemental medication is desired follow directions below: do not administer simultaneously with blood. do not use it unless solution is clear and seal is intact, the solution containing dextrose may be contraindicated in patients with a known allergy to corn or corn products. preparation and administration check for minute leaks by squeezing the container firmly. if leaks are found, discard solution as sterility may be impaired. suspend container from eyelet support. remove plastic protector from ports area at the bottom of container. hold the bottle in vertical position and inset pyrogen free iv administration set in the outlet port. use aseptic technique. to add medication warning: additives may be incompatible. to add medication before solution administration 1. prepare medication site. 2. using syringe with 19 to 22 gauge needle, puncture inlet port and inject. 3. mix solution and medication thoroughly. return container to in-use position and continue administration. for high density medication such as potassium chloride, squeeze ports while ports are upright and mix thoroughly. to add medication during solution administration 1. close clamp on the set. 2. prepare medication site. 3. using syringe with 19 to 22 gauge needle, puncture inlet port and inject. 4. remove container from iv pole and/or turn to an upright position. 5. mix solution and medication thoroughly. 6. return container to in use position and continue administration. caution: federal law (usa) restricts this drug to use by or on the order of a licensed veterinarian.

Tanzania - English - Tanzania Medicinces & Medical Devices Authority

amanta healthcare limited, india - sodium chloride , dextrose - infusion - glucose anhydrous 5.00 gm + sodium chloride 0.90 gm

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

fresenius kabi usa, llc - dextrose monohydrate (unii: lx22yl083g) (anhydrous dextrose - unii:5sl0g7r0ok), sodium chloride (unii: 451w47iq8x) (sodium cation - unii:lyr4m0nh37, chloride ion - unii:q32zn48698), potassium chloride (unii: 660yq98i10) (potassium cation - unii:295o53k152, chloride ion - unii:q32zn48698) - these solutions are indicated in patients requiring parenteral administration of potassium chloride with minimal carbohydrate calories and sodium chloride. solutions containing potassium chloride are contraindicated in diseases where high potassium levels may be encountered. check flexible container solution composition, lot number, and expiry date. do not remove solution container from its overwrap until immediately before use. use sterile equipment and aseptic technique. flexible plastic container (free flex ® bag) to open - turn solution container over so that the text is face down. using the pre-cut corner tabs, peel open the overwrap and remove solution container. - check the solution container for leaks by squeezing firmly. if leaks are found, or if the seal is not intact, discard the solution. - do not use if the solution is cloudy or a precipitate is present. to add medication - identify white additive port with arrow pointing toward container. - immediately before injecting additives, break off whit

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

fresenius kabi usa, llc - dextrose monohydrate (unii: lx22yl083g) (anhydrous dextrose - unii:5sl0g7r0ok), sodium chloride (unii: 451w47iq8x) (sodium cation - unii:lyr4m0nh37, chloride ion - unii:q32zn48698), potassium chloride (unii: 660yq98i10) (potassium cation - unii:295o53k152, chloride ion - unii:q32zn48698) - these solutions are indicated in patients requiring parenteral administration of potassium chloride with minimal carbohydrate calories and sodium chloride. solutions containing potassium chloride are contraindicated in diseases where high potassium levels may be encountered. check flexible container solution composition, lot number, and expiry date. do not remove solution container from its overwrap until immediately before use. use sterile equipment and aseptic technique. flexible plastic container (free flex ® bag) to open - turn solution container over so that the text is face down. using the pre-cut corner tabs, peel open the overwrap and remove solution container. - check the solution container for leaks by squeezing firmly. if leaks are found, or if the seal is not intact, discard the solution. - do not use if the solution is cloudy or a precipitate is present. to add medication - identify white additive port with arrow pointing toward container. - immediately before injecting additives, break off whi

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

fresenius kabi usa, llc - dextrose monohydrate (unii: lx22yl083g) (anhydrous dextrose - unii:5sl0g7r0ok), sodium chloride (unii: 451w47iq8x) (sodium cation - unii:lyr4m0nh37, chloride ion - unii:q32zn48698), potassium chloride (unii: 660yq98i10) (potassium cation - unii:295o53k152, chloride ion - unii:q32zn48698) - these solutions are indicated in patients requiring parenteral administration of potassium chloride with minimal carbohydrate calories and sodium chloride. solutions containing potassium chloride are contraindicated in diseases where high potassium levels may be encountered. check flexible container solution composition, lot number, and expiry date. do not remove solution container from its overwrap until immediately before use. use sterile equipment and aseptic technique. flexible plastic container (free flex ® bag) to open - turn solution container over so that the text is face down. using the pre-cut corner tabs, peel open the overwrap and remove solution container. - check the solution container for leaks by squeezing firmly. if leaks are found, or if the seal is not intact, discard the solution. - do not use if the solution is cloudy or a precipitate is present. to add medication - identify white additive port with arrow pointing toward container. - immediately before injecting additives, break off whit

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

icu medical inc. - dextrose, unspecified form (unii: iy9xdz35w2) (dextrose, unspecified form - unii:iy9xdz35w2), sodium chloride (unii: 451w47iq8x) (sodium cation - unii:lyr4m0nh37, chloride ion - unii:q32zn48698), sodium acetate anhydrous (unii: nvg71zz7p0) (sodium cation - unii:lyr4m0nh37), sodium gluconate (unii: r6q3791s76) (sodium cation - unii:lyr4m0nh37), potassium chloride (unii: 660yq98i10) (potassium cation - unii:295o53k152), magnesium chloride (unii: 02f3473h9o) (magnesium cation - unii:t6v3lhy838) - normosol-r and 5% dextrose injection is indicated for replacement of acute extracellular fluid volume losses in surgery, trauma, burns or shock. normosol-r and 5% dextrose also can be used as an adjunct to restore a decrease in circulatory volume in patients with moderate blood loss. the solution is not intended to supplant transfusion of whole blood or packed red cells in the presence of uncontrolled hemorrhage or severe reductions of red cell volume. none known.