Country: Malaysia
Language: English
Source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
Sodium Chloride USP; DEXTROSE, HYDROUS, USP; Magnesium Chloride USP; Calcium chloride USP; Sodium Lactate USP
BAXTER HEALTHCARE (MALAYSIA) SDN. BHD.
Sodium Chloride USP; DEXTROSE, HYDROUS, USP; Magnesium Chloride USP; Calcium chloride USP; Sodium Lactate USP
5000ml mL; 2500ml mL; 2500ml mL; 2000ml mL
BAXTER HEALTHCARE SA, SINGAPORE BRANCH
1. NAME OF THE MEDICINAL PRODUCT Baxter Dianeal PD-2 Peritoneal Dialysis Solution with 1.5% Dextrose Baxter Dianeal PD-2 Peritoneal Dialysis Solution with 2.5% Dextrose Baxter Dianeal PD-2 Peritoneal Dialysis Solution with 4.25% Dextrose Baxter Dianeal Low Calcium (2.5 mEq/l) Peritoneal Dialysis Solution with 1.5% Dextrose Baxter Dianeal Low Calcium (2.5 mEq/l) Peritoneal Dialysis Solution with 2.5% Dextrose Baxter Dianeal Low Calcium (2.5 mEq/l) Peritoneal Dialysis Solution with 4.25% Dextrose 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Composition/100 mL Osmolarlty (mOsmollL) (calc) pH Ionic Concentration (mEq/L) Dextrose, Hydrous, USP Sodium Chloride, USP (NaCI) Sodium Lactate (C 3 1-1,11a0 0 ) Calcium Chloride, USP (CaCl 2 2H 2 0) Magnesium Chloride. USP (MgC1 2 6H 2 0) Sodium Calcium Magnesium Chloride Lactate DIANEAL PD-2 Peritoneal Dialy sis Solution with 1.5% Dextrose 1.5 g 538 mg 448 mg 25.7 mg 5.08 mg 346 5.2 (4.0 to 6.5) 132 3.5 0.5 96 40 DIANEAL PD-2 Peritoneal Dialysis Solution with 2.5% Dextrose 2.5 g 538 mg 448 mg 25.7 mg 5.08 mg 396 5.2 14.0 to 6.5) 132 3.5 0.5 96 40 DIANEAL PD-2 Peritoneal Dialysis Solution with 4.25% Dextrose 4.25 g 538 mg 448 mg 25.7 mg 5.08 mg 485 5.2 (4.0 to 6.5) 132 3.5 0.5 96 40 DIANEAL Low Calcium 12.5 mEq/L) Peritoneal Dialysis Solution with 1.5% Dextrose 1.5 g 538 mg 448 mg 18.3 mg 5.08 mg 344 5.2 (4,010 6.5) 132 2.5 0.5 95 40 DIANEAL Low Calcium 12.5 mEett) Peritoneal Dialysis Solution with 2.5% Dextrose 2.5 g 538 mg 448 mg 18.3 mg 5.08 mg 395 5.2 (4.0 to 6.5) 132 2.5 0.5 95 40 DIANEAL Low Calcium 12.5 mEqIL) Peritoneal Dialysis Solution with 4.25% Dextrose 4.25 g 538 mg 448 mg 18.3 mg 5.08 mg 483 5.2 (4.0 to 6.5) 132 2.5 0.5 95 40 3. PHARMACEUTICAL FORM AND PRODUCT DESCRIPTION Solution for peritoneal dialysis. Baxter DIANEAL peritoneal dialysis solutions are sterile, clear, colourless and nonpyrogenic. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS AMBUFLEX: Peritoneal dialysis is indicated for patients in acute or chronic renal failure when nondialytic medical th Read the complete document