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Delflex Neutral pH
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  • FDA PI

Delflex Neutral pH

Generic name: dextrose monohydrate, sodium chloride, sodium lactate, calcium chloride and magnesium chloride
Dosage form: injection, solution
Drug class:Intravenous nutritional products

Medically reviewed by Drugs.com. Last updated on Mar 22, 2022.

Description

DELFLEX® Neutral pH, peritoneal dialysis solutions, (standard, low magnesium and low magnesium/low calcium) are sterile, non-pyrogenic formulations of dextrose and electrolytes in water for injection, USP, for use in peritoneal dialysis. These solutions do not contain antimicrobial agents or additional buffers. In comparison to conventional peritoneal dialysis solutions, DELFLEX® Neutral pH solutions are formulated to lower levels of glucose degradation products and provide a neutral pH of 7.0 ± 0.4, which is closer to the physiologic pH. The osmotic and buffer solutions are stored separately and mixed by the patient prior to use. The stay∙safe® Exchange Set utilizes an easy to use dial designed to eliminate the use of clamps and to prevent touch contamination of internal connection components. Composition, calculated osmolarity, pH and ionic concentrations of the mixed solutions are shown in Table 2.

Dextrose USP is chemically designated D-glucose monohydrate (C6H12O6∙H2O) a hexose sugar freely soluble in water. The structural formula is shown here.

Calcium chloride, USP, is chemically designated calcium chloride dihydrate (CaCl2∙2H2O) white fragments or granules freely soluble in water.

Magnesium chloride, USP, is chemically designated magnesium chloride hexahydrate (MgCl2∙6H2O) colorless flakes or crystals very soluble in water.

Sodium lactate solution, USP, is chemically designated (CH3CH(OH)COONa), a 60% aqueous solution miscible in water.

Sodium chloride, USP, is chemically designated (NaCl), a white, crystalline compound freely soluble in water.

Water for injection, USP, is chemically designated (H2O).

Hydrochloric acid, and sodium hydroxide may be added for pH adjustment. pH is 7.0 ± 0.4.

Exposure to temperatures above 25°C (77°F) during transport and storage will lead to minor losses in moisture content. Higher temperatures lead to greater losses...