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 v5-FR | Version v2-EN | |
|---|---|---|
| Language | French | English |
| Date Updated | 2024-11-20 | 2024-11-20 |
| Drug Identification Number | 02386925 | 02386925 |
| Brand name | SAG-M | SAG-M |
| Common or Proper name | SAG-M Solution (Saline, Adenine, Glucose, Mannitol Red Blood Cell Preservative Solution) | SAG-M Solution (Saline, Adenine, Glucose, Mannitol Red Blood Cell Preservative Solution) |
| Company Name | HAEMONETICS CORPORATION | HAEMONETICS CORPORATION |
| Ingredients | MANNITOL DEXTROSE ADENINE SODIUM CHLORIDE | MANNITOL DEXTROSE ADENINE SODIUM CHLORIDE |
| Strength(s) | 0.525% 0.9% 0.0169% 0.877% | 0.525% 0.9% 0.0169% 0.877% |
| Dosage form(s) | SOLUTION | SOLUTION |
| Route of administration | 0-UNASSIGNED 0-UNASSIGNED | 0-UNASSIGNED 0-UNASSIGNED |
| Packaging sizes (GTIN) | (See additional packaging sizes) | (See additional packaging sizes) |
| Additional packaging sizes | 350mL | 350mL |
| ATC code | V07AC | V07AC |
| ATC description | ALL OTHER NON-THERAPEUTIC PRODUCTS | ALL OTHER NON-THERAPEUTIC PRODUCTS |
| Reason for shortage | Disruption of the manufacture of the drug. | Disruption of the manufacture of the drug. |
| Anticipated start date | 2024-07-19 | 2024-07-19 |
| Actual start date | 2024-07-19 | 2024-07-19 |
| Estimated end date | 2024-09-01 | 2024-09-01 |
| Actual end date | 2024-09-03 | 2024-09-03 |
| Shortage status | Resolved | Resolved |
| Tier 3 Status | No | No |
| Company comments | Haemonetics was notified of the following product shortage on 19 July 2024. The cause of the shortage was a manufacturing disruption due to a delay in receipt of raw material which contributed to a delay in scheduling/ manufacturing the finished product. In addition, the manufacturing facility was under a planned summer shutdown (3 weeks) whereby production of the solution was delayed. Due to the on-line Drug Shortages Canada Reporting website being inaccessible on 19 July 2024, Haemonetics submitted the shortage notification to Health Canada on 19 July 2024 via email ([email protected]). A commitment was made that once access to the reporting site was provided; this shortage report would be retroactively submitted via the shortage website. | Haemonetics was notified of the following product shortage on 19 July 2024. The cause of the shortage was a manufacturing disruption due to a delay in receipt of raw material which contributed to a delay in scheduling/ manufacturing the finished product. In addition, the manufacturing facility was under a planned summer shutdown (3 weeks) whereby production of the solution was delayed. Due to the on-line Drug Shortages Canada Reporting website being inaccessible on 19 July 2024, Haemonetics submitted the shortage notification to Health Canada on 19 July 2024 via email ([email protected]). A commitment was made that once access to the reporting site was provided; this shortage report would be retroactively submitted via the shortage website. |
| Health Canada comments |