Quốc gia: Canada
Ngôn ngữ: Tiếng Anh
Nguồn: Health Canada
DEXTROSE; CALCIUM CHLORIDE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM BICARBONATE; SODIUM LACTATE
BAXTER CORPORATION
B05ZA
HEMODIALYTICS, CONCENTRATES
30.3G; 0.245G; 0.068G; 19.95G; 9.29G; 6.73G
SOLUTION
DEXTROSE 30.3G; CALCIUM CHLORIDE 0.245G; MAGNESIUM CHLORIDE 0.068G; SODIUM CHLORIDE 19.95G; SODIUM BICARBONATE 9.29G; SODIUM LACTATE 6.73G
HAEMODIALYSIS (INTRAPERITONEAL)
3.75L(A)-1.25L(B)
Ethical
HEMODIALYSIS SOLUTION
Active ingredient group (AIG) number: 0649302009; AHFS:
MARKETED
2013-02-06
Page 1 of 19 PRESCRIBING INFORMATION PHYSIONEAL 40 GLUCOSE 1.36% PHYSIONEAL 40 GLUCOSE 2.27% PHYSIONEAL 40 GLUCOSE 3.86% IN CLEAR-FLEX PLASTIC CONTAINER Solution for Peritoneal Dialysis Baxter Corporation Mississauga, Ontario L5N 0C2 Canada Date of Revision: August 23, 2016 Submission Control No: 195541 Baxter and Physioneal are trademarks of Baxter International Inc. Page 2 of 19 PRESCRIBING INFORMATION DIRECTIONS FOR USE FOR HEALTH PROFESSIONALS NAME OF THE MEDICINAL PRODUCT PHYSIONEAL 40 Glucose 1.36% w/v/13.6 mg/mL, CLEAR-FLEX, Solution for Peritoneal Dialysis, Mfr. Std . PHYSIONEAL 40 Glucose 2.27% w/v/22.7 mg/mL, CLEAR-FLEX, Solution for Peritoneal Dialysis, Mfr. Std. PHYSIONEAL 40 Glucose 3.86% w/v/38.6 mg/mL, CLEAR-FLEX, Solution for Peritoneal Dialysis, Mfr. Std. Page 3 of 19 QUALITATIVE AND QUANTITATIVE COMPOSITION FORMULA BEFORE MIXING: PHYSIONEAL 40 GLUCOSE CHAMBER “A”(GLUCOSE BAG) CONTAINS: 1.36% 2.27% 3.86% Glucose Monohydrate 20.0 g/L 33.3 g/L 56.6 g/L Equivalent to Anhydrous Glucose 18.2 g/L 30.3 g/L 51.5 g/L Calcium Chloride Dihydrate 0.245 g/L 0.245 g/L 0.245 g/L Magnesium Chloride Hexahydrate 0.068 g/L 0.068 g/L 0.068 g/L CHAMBER “B”(BUFFER BAG) CONTAINS: 1.36% 2.27% 3.86% Sodium Chloride 19.95 g/L 19.95 g/L 19.95 g/L Sodium Bicarbonate 9.29 g/L 9.29 g/L 9.29 g/L Sodium (S)-Lactate 6.73 g/L 6.73 g/L 6.73 g/L FORMULA AFTER MIXING: THE MIXED SOLUTION CONTAINS: 1.36% 2.27% 3.86% Glucose monohydrate 15.0 g/L 25.0 g/L 42.5 g/L Equivalent to Anhydrous Glucose 13.6 g/L 22.7 g/L 38.6 g/L Sodium Chloride 5.38 g/L 5.38 g/L 5.38 g/L Calcium Chloride Dihydrate 0.184 g/L 0.184 g/L 0.184 g/L Magnesium Chloride Hexahydrate 0.051 g/L 0.051 g/L 0.051 g/L Sodium Bicarbonate 2.10 g/L 2.10 g/L 2.10 g/L Sodium (S)-Lactate 1.68 g/L 1.68 g/L 1.68 g/L 1000 mL of final solution after mixing corresponds to 750 mL of chamber A and 250 mL of chamber B. COMPOSITION OF THE FINAL SOLUTION (MMOL/L) AFTER MIXING: 1.36% 2.27% 3.86% Anhydrous Glucose (C 6 H 12 O 6 ) 75.5 126 214 Sodium (Na + ) 132 132 132 Calcium (Ca ++ Đọc toàn bộ tài liệu