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 v17-FR | Version v8-FR | |
|---|---|---|
| Language | French | French |
| Date Updated | 2023-06-02 | 2022-03-08 |
| Drug Identification Number | 02139529 | 02139529 |
| Brand name | SODIUM ACETATE INJECTION, USP | SODIUM ACETATE INJECTION, USP |
| Common or Proper name | Sodium Acetate Injection, USP 4 mEq/mL SD Vial 50 mL | Sodium Acetate Injection, USP 4 mEq/mL SD Vial 50 mL |
| Company Name | FRESENIUS KABI CANADA LTD | FRESENIUS KABI CANADA LTD |
| Ingredients | SODIUM ACETATE | SODIUM ACETATE |
| Strength(s) | 328MG | 328MG |
| Dosage form(s) | SOLUTION | SOLUTION |
| Route of administration | INTRAVENOUS INTRAVENOUS | INTRAVENOUS INTRAVENOUS |
| Packaging size | 50 mL | 50 mL |
| ATC code | B05XA | B05XA |
| ATC description | I.V. SOLUTION ADDITIVES | I.V. SOLUTION ADDITIVES |
| Reason for shortage | Other (Please describe in comments) | Other (Please describe in comments) |
| Anticipated start date | ||
| Actual start date | 2023-03-10 | 2021-12-17 |
| Estimated end date | 2023-05-31 | Unknown |
| Actual end date | 2023-05-31 | |
| Shortage status | Resolved | Actual shortage |
| Tier 3 Status | No | No |
| Company comments | Sodium Acetate Injection, USP 4 mEq/mL SD Vial 50 mL will be available at all distribution centres by March 10, 2023. Once available, this product will be placed on allocation. Contract customers will be allocated 100% of historical monthly demand of the 50 mL plus 100% of historical monthly demand of the 100 mL at a 2:1 ratio (2 vials of 50 mL = 1 vial of 100 mL). Please refer to our recent Healthcare Professional Communication “Important Safety Information Sodium Acetate Injection, USP – Potential for the Development of Particulate Matter” dated February 23, 2023, for important guidance relating to use of this product. Please see communication for details. | Fresenius Kabi Canada regrets to advise that due to unforeseen circumstances, we will be encountering a supply interruption, effective immediately, on our Sodium Acetate Injection, USP 4 mEq/mL SD Vial 50 mL and Sodium Acetate Injection, USP 4 mEq/mL Maxivial® 100 mL. |
| Health Canada comments |