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 v6-EN | Version v5-FR | |
---|---|---|
Language | English | French |
Date Updated | 2018-02-07 | 2018-02-06 |
Drug Identification Number | 02240806 | 02240806 |
Brand name | EXTRANEAL | EXTRANEAL |
Common or Proper name | Extraneal 7.5% PD2 | Extraneal 7.5% PD2 |
Company Name | BAXTER CORPORATION | BAXTER CORPORATION |
Ingredients | SODIUM LACTATE MAGNESIUM CHLORIDE CALCIUM CHLORIDE SODIUM CHLORIDE ICODEXTRIN | SODIUM LACTATE MAGNESIUM CHLORIDE CALCIUM CHLORIDE SODIUM CHLORIDE ICODEXTRIN |
Strength(s) | 4.48G 51MG 257MG 5.35G 75G | 4.48G 51MG 257MG 5.35G 75G |
Dosage form(s) | SOLUTION | SOLUTION |
Route of administration | INTRAPERITONEAL | INTRAPERITONEAL |
Packaging size | 2.5L | 2.5L |
ATC code | B05D | B05D |
ATC description | PERITONEAL DIALYTICS | PERITONEAL DIALYTICS |
Reason for shortage | Shortage of an inactive ingredient or component. | Shortage of an inactive ingredient or component. |
Anticipated start date | 2018-01-24 | 2018-01-24 |
Actual start date | 2018-01-24 | 2018-01-24 |
Estimated end date | 2018-02-06 | 2018-02-06 |
Actual end date | 2018-02-06 | 2018-02-06 |
Shortage status | Resolved | Actual shortage |
Tier 3 Status | No | No |
Company comments | As we work closely with our Supply Chain Operations to minimize the impact to both renal programs and patients, we are implementing a temporary allocation on the affected codes. Effective immediately, Baxter will be contacting all impacted patients and managing their inventory and shipments on a weekly basis or as required. In doing so, we will be releasing a reduced amount of product supply that is sufficient per patient therapy. Multiple shipments will take place to the patient’s home, and we will minimize substitutions unless clinically required. The manufacturing facility supplying the raw material component has advised that they have identified the root cause of the issue, corrective actions have been taken, and supply of new componentry will be shipped to our Alliston facility later this week. We thus expect to have replacement production occurring in coming days. More definitive timelines will be provided once replacement production occurs and finished goods testing is underway. | As we work closely with our Supply Chain Operations to minimize the impact to both renal programs and patients, we are implementing a temporary allocation on the affected codes. Effective immediately, Baxter will be contacting all impacted patients and managing their inventory and shipments on a weekly basis or as required. In doing so, we will be releasing a reduced amount of product supply that is sufficient per patient therapy. Multiple shipments will take place to the patient’s home, and we will minimize substitutions unless clinically required. The manufacturing facility supplying the raw material component has advised that they have identified the root cause of the issue, corrective actions have been taken, and supply of new componentry will be shipped to our Alliston facility later this week. We thus expect to have replacement production occurring in coming days. More definitive timelines will be provided once replacement production occurs and finished goods testing is underway. |
Health Canada comments |