Drug Report History
Below you will find the report version history. When a report is updated, a new version of the report is created. The report history allows you to see the changes between versions. You can select two versions of the report to compare. The fields that were changed between versions will be highlighted in yellow.
The translation of reports creates two separate versions which is why some reports may not seem to have any differences. In this case, only the language field below will be highlighted in yellow.
| Version v4-FR | Version v2-FR | |
|---|---|---|
| Language | French | French |
| Date Updated | 2022-09-12 | 2022-08-04 |
| Drug Identification Number | 02139537 | 02139537 |
| Brand name | PROTAMINE SULFATE INJECTION, USP | PROTAMINE SULFATE INJECTION, USP |
| Common or Proper name | PROTAMINE SULFATE INJECTION, USP | PROTAMINE SULFATE INJECTION, USP |
| 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 | ||
| Actual start date | 2022-08-01 | 2022-08-01 |
| Estimated end date | 2022-09-12 | 2022-09-12 |
| Actual end date | 2022-09-07 | |
| Shortage status | Resolved | Actual shortage |
| Tier 3 Status | No | No |
| Company comments | Fresenius Kabi Canada regrets to advise that due to a production delay, we will be encountering a supply interruption on our Protamine Sulfate Injection, USP 10 mg/mL SD Vial 25 mL effective August 1, 2022 until September 12, 2022. Effective August 1, 2022 until August 31, 2022, allocations for our Protamine Sulfate Injection, USP 10 mg/mL SD Vial 5 mL will be increased. Contract customers will be allocated 100% of historical monthly demand of 5 mL plus 40% of historical monthly demand of 25 mL. No coverage of the 25mL will be available in September. | Fresenius Kabi Canada regrets to advise that due to a production delay, we will be encountering a supply interruption on our Protamine Sulfate Injection, USP 10 mg/mL SD Vial 25 mL effective August 1, 2022 until September 12, 2022. Effective August 1, 2022 until August 31, 2022, allocations for our Protamine Sulfate Injection, USP 10 mg/mL SD Vial 5 mL will be increased. Contract customers will be allocated 100% of historical monthly demand of 5 mL plus 40% of historical monthly demand of 25 mL. No coverage of the 25mL will be available in September. |
| Health Canada comments |