Australië - Engels - Department of Health (Therapeutic Goods Administration)

stokes family balloon trust - pyridoxine hydrochloride, quantity: 6.08 mg/g (equivalent: pyridoxine, qty 5 mg/g) - powder - excipient ingredients: citric acid; potassium chloride; glycine; glucose monohydrate; colloidal anhydrous silica; siraitia grosvenorii; sodium citrate dihydrate; flavour - decrease/reduce/relieve morning sickness

Ierland - Engels - HPRA (Health Products Regulatory Authority)

zoetis ireland limited - sodium chloride, potassium chloride, sodium bicarbonate, citric acid, aminoacetic acid, lactose monohydrate ph.eur. - tablets effervescent - unknown - electrolyte solutions - bovine - electrolytes

Malta - Engels - Medicines Authority

pfizer hellas s.a. 243 messoghion ave., neo psychiko 15451, athens, greece - zoledronic acid, monohydrate - concentrate for solution for infusion - zoledronic acid monohydrate 4 mg - drugs for treatment of bone diseases

Verenigde Staten - Engels - 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.

Verenigde Staten - Engels - NLM (National Library of Medicine)

baxter healthcare corporation - potassium chloride (unii: 660yq98i10) (potassium cation - unii:295o53k152, chloride ion - unii:q32zn48698), dextrose monohydrate (unii: lx22yl083g) (anhydrous dextrose - unii:5sl0g7r0ok), sodium chloride (unii: 451w47iq8x) (sodium cation - unii:lyr4m0nh37, chloride ion - unii:q32zn48698) - potassium chloride 150 mg in 100 ml - potassium chloride in dextrose and sodium chloride injection is indicated as a source of water, electrolytes and calories. potassium chloride in dextrose and sodium chloride injection is contraindicated in patients with: risk summary appropriate administration of potassium chloride in dextrose sodium chloride injection during pregnancy is not expected to cause adverse developmental outcomes, including congenital malformations. animal reproduction studies have not been conducted with potassium chloride in dextrose 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 and potassium are present in human breast milk. there are no data on the effects

Verenigde Staten - Engels - NLM (National Library of Medicine)

b. braun medical inc. - sodium chloride (unii: 451w47iq8x) (sodium cation - unii:lyr4m0nh37, chloride ion - unii:q32zn48698), potassium chloride (unii: 660yq98i10) (potassium cation - unii:295o53k152, chloride ion - unii:q32zn48698) - sodium chloride 0.9 g in 100 ml - potassium chloride in 0.9% sodium chloride injection is indicated for use in adults and pediatric patients as a source of electrolytes and water for hydration. potassium chloride in 0.9% sodium chloride injection is contraindicated in clinical conditions where additives of sodium, potassium or chloride could be clinically detrimental.

Verenigde Staten - Engels - 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

Verenigde Staten - Engels - NLM (National Library of Medicine)

baxter healthcare corporation - potassium chloride (unii: 660yq98i10) (potassium cation - unii:295o53k152, chloride ion - unii:q32zn48698), dextrose monohydrate (unii: lx22yl083g) (anhydrous dextrose - unii:5sl0g7r0ok) - potassium chloride 150 mg in 100 ml - potassium chloride in dextrose injection is indicated as a source of water, electrolytes and calories. potassium chloride in dextrose injection is contraindicated in patients with: risk summary appropriate administration of potassium chloride in dextrose injection during pregnancy is not expected to cause adverse developmental outcomes, including congenital malformations. animal reproduction studies have not been conducted with potassium chloride in dextrose 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 potassium is present in human breast milk. there are no data on the effects of potassium chloride in dextrose injection on a breastfed infant or the effects on

Verenigde Staten - Engels - NLM (National Library of Medicine)

hospira, inc. - sodium phosphate, monobasic, monohydrate (unii: 593yog76rn) (phosphate ion - unii:nk08v8k8hr, sodium cation - unii:lyr4m0nh37), sodium phosphate, dibasic, anhydrous (unii: 22ado53m6f) (phosphate ion - unii:nk08v8k8hr, sodium cation - unii:lyr4m0nh37) - sodium phosphate, monobasic, monohydrate 276 mg in 1 ml - sodium phosphates injection, usp, 3 mm p/ml is indicated as a source of phosphorus, for addition to large volume intravenous fluids, to prevent or correct hypophosphatemia in patients with restricted or no oral intake. it is also useful as an additive for preparing specific parenteral fluid formulas when the needs of the patient cannot be met by standard electrolyte or nutrient solutions. the concomitant amount of sodium (na+ 4 meq/ml) must be calculated into total electrolyte dose of such prepared solutions. sodium phosphate is contraindicated in diseases where high phosphorus or low calcium levels may be encountered, and in patients with hypernatremia.

Australië - Engels - Department of Health (Therapeutic Goods Administration)

link medical products pty ltd t/a link pharmaceuticals - adrenaline (epinephrine) acid tartrate, quantity: 182 microgram/ml (equivalent: adrenaline (epinephrine), qty 100 microgram/ml) - injection, solution - excipient ingredients: citric acid monohydrate; sodium metabisulfite; sodium chloride; sodium citrate dihydrate; water for injections; dilute hydrochloric acid - adrenaline 1:10,000 is used as an adjunct in the management of cardiac arrest.