Land: Canada
Sprog: engelsk
Kilde: Health Canada
SODIUM CHLORIDE
CHIEF MEDICAL SUPPLIES LTD
B05XA03
SODIUM CHLORIDE
0.9%
SOLUTION
SODIUM CHLORIDE 0.9%
INTRAVENOUS
2000ML
Ethical
REPLACEMENT PREPARATIONS
Active ingredient group (AIG) number: 0100053002; AHFS:
APPROVED
2017-06-09
Page 1 of 9 PRESCRIBING INFORMATION SODIUM CHLORIDE INJECTION USP (SODIUM CHLORIDE SOLUTION USP) 0.9% Parenteral Electrolyte, Sodium CHIEF MEDICAL SUPPLIES LTD. DATE OF PREPARATION: CALGARY, AB T2E 6J7 JUNE 9, 2017 CANADA SUBMISSION CONTROL #: 196338 Page 2 of 9 Chief Medical Supplies Ltd. SODIUM CHLORIDE INJECTION USP (SODIUM CHLORIDE SOLUTION USP) 0.9% Parenteral Electrolyte, Sodium SUMMARY PRODUCT INFORMATION ROUTE OF ADMINISTRATION DOSAGE FORM/STRENGTH ALL NONMEDICINAL INGREDIENTS Intravenous Solution/0.9% w/v Water for injection, USP DESCRIPTION Each 100 mL of 0.9% SODIUM CHLORIDE INJECTION USP contains: Sodium Chloride USP 0.9 g; Water for Injection USP qs pH: 5.6 (4.5-7.0) Calculated Osmolarity: 308 mOsmol/liter pH adjusted with Hydrochloric Acid NF Concentration of Electrolytes (mEq/liter): Sodium 154 Chloride 154 Sodium Chloride Injection USP is sterile, nonpyrogenic, isotonic and contains no bacteriostatic or antimicrobial agents. The formula of the active ingredient is: INGREDIENT MOLECULAR FORMULA MOLECULAR WEIGHT Sodium Chloride USP NaCI 58.44 Not made with natural rubber latex, PVC, or DEHP. The plastic container is made from a homogenous blend of polypropylene and thermoplastic modifier specifically developed for parenteral drugs. The container is nontoxic and biologically inert. The container is a closed system and is not dependent upon entry of external air during administration. Addition of medication should be accomplished using complete aseptic technique. Refer to the Directions for Use of the container. Page 3 of 9 INDICATIONS AND CLINICAL USE This intravenous solution is indicated for use in adults and pediatric patients as a source of electrolytes and water for hydration. 0.9% Sodium Chloride Injection USP is indicated for extracellular fluid replacement, treatment of metabolic alkalosis in the presence of fluid loss and mild sodium depletion. 0.9% Sodium Chloride Injection USP is also indicated for use as a priming solution in hemodialysis procedures and may be used to initiate and termina Læs hele dokumentet