Krajina: Kanada
Jazyk: angličtina
Zdroj: Health Canada
DEXTROSE; SODIUM CHLORIDE; POTASSIUM CHLORIDE
BAXTER CORPORATION
B05BB02
ELECTROLYTES WITH CARBOHYDRATES
3.3G; 300MG; 300MG
SOLUTION
DEXTROSE 3.3G; SODIUM CHLORIDE 300MG; POTASSIUM CHLORIDE 300MG
INTRAVENOUS
1000ML
Ethical
REPLACEMENT PREPARATIONS
Active ingredient group (AIG) number: 0300097002; AHFS:
APPROVED
2012-12-07
Page 1 of 10 PRESCRIBING INFORMATION 3.3% Dextrose and 0.3% Sodium Chloride Injection 5% Dextrose and 0.2% Sodium Chloride Injection 5% Dextrose and 0.45% Sodium Chloride Injection 5% Dextrose and 0.9% Sodium Chloride Injection 10% Dextrose and 0.9% Sodium Chloride Injection DEXTROSE AND SODIUM CHLORIDE INJECTION, USP Solution for infusion Intravenous Fluid and Nutrient Replenisher In VIAFLEX Plastic Container Baxter Corporation Mississauga, Ontario L5N 0C2 Canada Date of Revision: December 14, 2018 Submission Control No: 221959 Baxter and VIAFLEX are Trademarks of Baxter International Inc. Page 2 of 10 DEXTROSE AND SODIUM CHLORIDE INJECTION, USP IN VIAFLEX PLASTIC CONTAINER SUMMARY PRODUCT INFORMATION Dextrose and Sodium Chloride Injection USP solutions are sterile, nonpyrogenic and contain no bacteriostatic or antimicrobial agents or added buffers. The composition, osmolarity and approximate pH of the individual solutions are shown in TABLE 1. TABLE 1. Size (mL) DIN Composition (g/L) Osmolarity (mOsmol/L) pH Ionic Concentration (mmol/L) Caloric Content (cal/L) * Dextrose Monohyd. Sodium Chloride Sodium Chloride 3.3% Dextrose & 0.3% NaCl 500 00060712 33.0 g 3.0 g 271 3.5 to 6.5 51 51 112 1000 5% Dextrose & 0.2% NaCl 500 00060704 50.0 g 2.0 g 321 3.5 to 6.5 34 34 170 5% Dextrose & 0.45% NaCl 500 00060739 50.0 g 4.5 g 406 3.5 to 6.5 77 77 170 1000 5% Dextrose & 0.9% NaCl 500 00060747 50.0 g 9.0 g 560 3.5 to 6.5 154 154 170 1000 10% Dextrose & 0.9% NaCl 1000 00060755 100.0 g 9.0 g 813 3.5 to 6.5 154 154 340 *The dextrose is purified from corn and may contain fructose. The VIAFLEX plastic container is fabricated from a specially formulated polyvinyl chloride (PL 146 Plastic). Water in a solution in the container can permeate through the plastic wall, but in an insufficient amount to significantly affect the solution. Before the product expires, very small amounts of chemical components of the plastic can be leached into the solution in the container, such as up to 5 parts per million for di-2-ethylhexyl phthalate (D Prečítajte si celý dokument