Drug Report History

Return to report

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 v6-EN
Language English English
Date Updated 2018-02-07 2018-02-07
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 Resolved
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