Malta - English - Medicines Authority

demo s.a. pharmaceutical industry 21st km national road athens - lamia 14568 krioneri, greece - sodium chloride - solution for injection - sodium chloride 9 mg/ml - blood substitutes and perfusion solutions

Bahrain - English - الهيئة الوطنية لتنظيم المهن والخدمات الصحية، مملكة البحرين

gulf pharmacy - dextrose monohydrate 55gm/l, sodium chloride 2gm/l - iv infusion

Philippines - English - FDA (Food And Drug Administration)

nueva sunshine phils., inc.; distributor: nueva sunshine phils., inc. - 5% dextrose in 0.9% sodium chloride - solution for iv infusion - each 100 ml contains: dextrose monohydrate 5 g sodium chloride 900 mg

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

terumo bct ltd - dextrose monohydrate (unii: lx22yl083g) (anhydrous dextrose - unii:5sl0g7r0ok), sodium citrate, unspecified form (unii: 1q73q2julr) (anhydrous citric acid - unii:xf417d3psl), sodium chloride (unii: 451w47iq8x) (chloride ion - unii:q32zn48698), sodium phosphate, monobasic, monohydrate (unii: 593yog76rn) (phosphate ion - unii:nk08v8k8hr), citric acid monohydrate (unii: 2968phw8qp) (anhydrous citric acid - unii:xf417d3psl), adenine (unii: jac85a2161) (adenine - unii:jac85a2161) - dextrose monohydrate 1.1 g in 100 ml - intended for use only with trima and trima accel automated red blood cell apheresis devices and atreus whole blood processing system. see operator's manuals for additional information and complete usage instructions. sterile. non-pyrogenic. do not use unless the solution is clear and the container is intact. rx only. single use container.

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

cardinal health - dextrose monohydrate (unii: lx22yl083g) (anhydrous dextrose - unii:5sl0g7r0ok) - dextrose monohydrate 50 g in 1000 ml - dextrose injection, usp is indicated as a source of water and calories. solutions containing dextrose may be contraindicated in patients with known allergy to corn or corn products.

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), sodium lactate (unii: tu7hw0w0qt) (sodium cation - unii:lyr4m0nh37, lactic acid - unii:33x04xa5at), potassium chloride (unii: 660yq98i10) (potassium cation - unii:295o53k152, chloride ion - unii:q32zn48698), calcium chloride (unii: m4i0d6vv5m) (calcium cation - unii:2m83c4r6zb, chloride ion - unii:q32zn48698) - dextrose monohydrate 5 g in 100 ml - lactated ringer’s and 5% dextrose injection, usp is indicated as a source of water, electrolytes and calories or as an alkalinizing agent. lactated ringer’s and 5% dextrose injection, usp is contraindicated in: patients with a known hypersensitivity to sodium lactate (see warnings ).

United States - English - 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.

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

international medication systems, limited - dextrose monohydrate (unii: lx22yl083g) (anhydrous dextrose - unii:5sl0g7r0ok) - dextrose monohydrate 500 mg in 1 ml - 50% dextrose injection is indicated in the treatment of insulin hypoglycemia (hyperinsulinemia or insulin shock) to restore blood glucose levels. the solution is also indicated, after dilution, for intravenous infusion as a source of carbohydrate calories in patients whose oral intake is restricted or inadequate to maintain nutritional requirements. slow infusion of hypertonic solutions is essential to ensure proper utilization of dextrose and avoid production of hyperglycemia. a concentrated dextrose solution should not be used when intracranial or intraspinal hemorrhage is present, nor in the presence of delirium tremens if the patient is already dehydrated. dextrose injection without electrolytes should not be administered simultaneously with blood through the same infusion set because of the possibility that pseudoagglutination of red cells may occur.

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

baxter healthcare corporation - dextrose monohydrate (unii: lx22yl083g) (anhydrous dextrose - unii:5sl0g7r0ok) - dextrose monohydrate 50 g in 1000 ml - dextrose injection is indicated as source of water and calories. the use of dextrose injection is contraindicated in patients with: risk summary appropriate administration of dextrose injection during pregnancy is not expected to cause adverse developmental outcomes, including congenital malformations. animal reproduction studies have not been conducted with injectable dextrose solutions. 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 there are no data on the presence of dextrose in human milk, the effects on a breastfed infant, or the effects on milk production. the lack of clinical data during lactation precludes a clear determination of the risk of dextrose injection to an infant during lactation; therefore, the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for dextrose injection and any potential adverse effects on the breastfed infant from dextrose injection or from the underlying maternal condition. the safety profile of dextrose injection in pediatric patients is similar to adults. neonates, especially premature infants with low birth weight, are at increased risk of developing hypo- or hyperglycemia and therefore need close monitoring during treatment with intravenous glucose infusions to ensure adequate glycemic control in order to avoid potential long-term adverse effects. closely monitor plasma electrolyte concentrations in pediatric patients who may have impaired ability to regulate fluids and electrolytes. in very low birth weight infants, excessive or rapid administration of dextrose injection may result in increased serum osmolality and risk of intracerebral hemorrhage. children (including neonates and older children) are at increased risk of developing hyponatremia as well as for developing hyponatremic encephalopathy [see warnings and precautions (5.4)] . clinical studies of dextrose injection did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. elderly patients are at increased risk of developing hyponatremia as well as for developing hyponatremic encephalopathy [see warnings and precautions (5.4)] . other reported clinical experience has not identified differences in responses between the elderly and younger 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 of concomitant disease or other drug therapy. dextrose is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and it may be useful to monitor renal function.

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

baxter healthcare corporation - dextrose monohydrate (unii: lx22yl083g) (anhydrous dextrose - unii:5sl0g7r0ok) - dextrose monohydrate 5 g in 100 ml - dextrose injection is indicated as source of water and calories and may also be used as diluent for reconstitution of a powdered or liquid (up to 10 ml) drug product packaged in a vial with a 20 mm closure. the use of dextrose injection is contraindicated in patients with: risk summary appropriate administration of dextrose injection during pregnancy is not expected to cause adverse developmental outcomes, including congenital malformations. animal reproduction studies have not been conducted with injectable dextrose solutions. 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 there are no data on the presence of dextrose in human milk, the effects on a breastfed infant, or t