Land: Canada
Taal: Engels
Bron: Health Canada
DEXTROSE
BAXTER CORPORATION
B05BA03
CARBOHYDRATES
5G
SOLUTION
DEXTROSE 5G
INTRAVENOUS
15G/50G
Ethical
CALORIC AGENTS
Active ingredient group (AIG) number: 0102181006; AHFS:
APPROVED
2019-03-25
Page 1 of 9 PRESCRIBING INFORMATION 5% DEXTROSE INJECTION, USP IN AVIVA PLASTIC CONTAINER Solution for Infusion Intravenous Fluid and Nutrient Replenisher Baxter Corporation Mississauga, Ontario L5N 0C2 Canada Date of Revision: June 11, 2019 Submission Control No: 227512 Baxter and Aviva are Trademarks of Baxter International Inc. Page 2 of 9 5% DEXTROSE INJECTION, USP IN AVIVA PLASTIC CONTAINER SUMMARY PRODUCT INFORMATION 5% Dextrose Injection, USP is a sterile, nonpyrogenic solution for fluid replenishment and caloric supply in single dose containers for intravenous administration. It contains no bacteriostatic or antimicrobial agents or added buffers. The composition, osmolarity and approximate pH of 5% Dextrose Injection, USP are shown in Table 1. TABLE 1. PRODUCT INFORMATION Product Name DIN Package Size Composition (g/L) Osmolarity (mOsmol/L) pH Caloric Content (cal/L) Dextrose Hydrous*, USP 5% Dextrose Injection, USP 00060348 250mL 50 252 3.2 – 6.5 170 * The dextrose is purified from corn and may contain fructose. The flexible AVIVA plastic container is made with non-latex plastic materials specially designed for a wide range of parenteral drugs including those requiring delivery in containers made of polyolefins or polypropylene. For example, the AVIVA container system is compatible with the admixture and administration of paclitaxel. In addition, the AVIVA container system is compatible with the admixture and administration of all drugs deemed compatible with existing polyvinyl chloride container systems. The solution contact materials do not contain PVC, DEHP or other plasticizers. No safety issues of the plastic material were identified in Class VI U.S.Pharmacopeia (USP) testing for plastic containers. The flexible container is a closed system and air is prefilled in the container to facilitate drainage. The container does not require entry of external air during administration. The container has two ports: one is the administration outlet port for attachment of an intravenous administration set and Lees het volledige document