Țară: Canada
Limbă: engleză
Sursă: Health Canada
SODIUM CHLORIDE; CALCIUM CHLORIDE; POTASSIUM CHLORIDE
BAXTER CORPORATION
B05BB01
ELECTROLYTES
860MG; 33MG; 30MG
LIQUID
SODIUM CHLORIDE 860MG; CALCIUM CHLORIDE 33MG; POTASSIUM CHLORIDE 30MG
INTRAVENOUS
1000ML
Ethical
REPLACEMENT PREPARATIONS
Active ingredient group (AIG) number: 0300137001; AHFS:
CANCELLED POST MARKET
2016-07-15
Page 1 of 5 PRESCRIBING INFORMATION RINGER’S INJECTION, USP IN VIAFLEX PLASTIC CONTAINER Parenteral Replenisher Baxter Corporation Mississauga, Ontario L5N 0C2 Canada Date of Revision: November 17, 2014 Submission Control No: 177995 Baxter and Viaflex are Trademarks of Baxter International Inc. Page 2 of 5 RINGER’S INJECTION, USP IN VIAFLEX PLASTIC CONTAINER SUMMARY PRODUCT INFORMATION Ringer’s Injection, USP is a sterile, nonpyrogenic solution and contains no bacteriostatic or antimicrobial agents or added buffers. The composition, osmolarity and approx. pH of Ringer’s Injection, USP is shown in Table 1. Table 1 DIN Size (mL) Composition (g/L) Osmolarity (mOsmol/L) pH Ionic Concentration (mmol/L) Caloric Content (kcal/L) Sodium Chloride, USP Calcium Chloride Dihydrate, USP Potassium Chloride, USP Sodium Potassium Calcium Chloride Ringer’s Injection, USP 00060925 1000 8.60 0.33 0.30 310 5.0 – 7.5 147 4 2.24 156 0 The Viaflex plastic container is fabricated from a specially formulated polyvinyl chloride (PL 146 Plastic). The amount of water that can permeate from inside the container into the overwrap is insufficient to affect the solution significantly. Solutions in contact with the plastic container can leach out certain of its chemical components in very small amounts within the expiration period, e.g. di-2-ethylhexyl phthalate (DEHP), up to 5 parts per million. However, the safety of the plastic has been confirmed in tests in animals according to USP biological tests for plastic containers as well as by tissue culture toxicity studies. Normal physiologic isotonicity range is approximately 280-310 mOsmol/L. Administration of substantially hypotonic solutions may cause hemolysis and administration of substantially hypertonic solutions may cause vein damage. ACTIONS Ringer’s Injection, USP is a source of water for hydration and provides electrolytes. It is capable of inducing diuresis depending on the clinical conditions of the patient. Solutions which are polyelectrolytic have value in maintaining Citiți documentul complet