국가: 캐나다
언어: 영어
출처: Health Canada
DEXTROSE
BAXTER CORPORATION
B05BA03
CARBOHYDRATES
70G
SOLUTION
DEXTROSE 70G
INTRAVENOUS
500/1000/2000/3000ML
Ethical
CALORIC AGENTS
Active ingredient group (AIG) number: 0102181015; AHFS:
APPROVED
1999-03-05
Page 1 of 14 PRESCRIBING INFORMATION 50% DEXTROSE INJECTION, USP 70% DEXTROSE INJECTION, USP IN PHARMACY BULK PACK IV Fluid and Nutrient Replenisher Baxter Corporation Mississauga, Ontario L5N 0C2 Canada Date of Revision: November 21, 2018 Submission Control No: 220929 Baxter and Viaflex are trademarks of Baxter International Inc . Page 2 of 14 50% DEXTROSE INJECTION, USP/ 70% DEXTROSE INJECTION, USP NOT FOR DIRECT INFUSION IN PHARMACY BULK PACK SUMMARY PRODUCT INFORMATION 50% Dextrose Injection, USP and 70% Dextrose Injection, USP are sterile, nonpyrogenic, hypertonic solutions for fluid replenishment and caloric supply in a Pharmacy Bulk Package. A Pharmacy Bulk Package is a container of sterile preparation for parenteral use that contains many single doses. The contents are intended for use in a pharmacy admixture program and are restricted to the preparation of admixtures for intravenous infusion. They contain no antimicrobial agents. Composition, osmolarity, pH, and caloric content are shown in Table 1. TABLE 1. PRODUCT INFORMATION. *** DEX USP G/L OSMOLARITY (MOSMOL/L) *KCAL /L **KJ/ L PH CODE VOLUM E 50% DEXTROSE INJ USP 500 2520 1710 7147.8 4.0 2B0256 2000 mL 70% DEXTROSE INJ USP 700 3530 2380 9948.4 4.0 2B0296 2000 mL 70% DEXTROSE INJ USP 700 3530 2380 9948.4 4.0 JB0297 3000 mL * Dex = 3.4 kcal/g ** 1 kcal = 4.18 kJ *** the dextrose is purified from corn and may contain fructose . The structural formula of Dextrose Hydrous, USP is: Page 3 of 14 The VIAFLEX plastic container is fabricated from a specially formulated polyvinyl chloride (PL 146 Plastic) with di-2-ethylhexyl phthalate (DEHP) as a plasticizer. Exposure to temperatures above 25˚C during transport and storage will lead to minor losses in moisture content. Higher temperatures lead to greater losses. It is unlikely that these minor losses will lead to clinically significant changes within the expiration period. The amount of water that can permeate from inside the container into the overwrap is insufficient to affect the solution significantly. 전체 문서 읽기