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Version v8-EN Version v2-FR
Language English French
Date Updated 2021-12-01 2021-09-21
Drug Identification Number 02139537 02139537
Brand name PROTAMINE SULFATE INJECTION, USP PROTAMINE SULFATE INJECTION, USP
Common or Proper name Protamine Sulfate Injection, USP 10 mg/mL SD Vial 25 mL Protamine Sulfate Injection, USP 10 mg/mL SD Vial 25 mL
Company Name FRESENIUS KABI CANADA LTD FRESENIUS KABI CANADA LTD
Ingredients PROTAMINE SULFATE PROTAMINE SULFATE
Strength(s) 10MG 10MG
Dosage form(s) SOLUTION SOLUTION
Route of administration INTRAVENOUS INTRAVENOUS INTRAVENOUS INTRAVENOUS
Packaging size 25 mL 25 mL
ATC code V03AB V03AB
ATC description ALL OTHER THERAPEUTIC PRODUCTS ALL OTHER THERAPEUTIC PRODUCTS
Reason for shortage Disruption of the manufacture of the drug. Disruption of the manufacture of the drug.
Anticipated start date 2021-09-24 2021-09-24
Actual start date 2021-09-24
Estimated end date 2021-12-13 2021-12-13
Actual end date 2021-11-30
Shortage status Resolved Anticipated shortage
Tier 3 Status No No
Company comments Our Protamine Sulfate Injection, USP 10 mg/mL SD Vial 5 mL format is available for substitution:
Health Canada comments