Drug Report History
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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 v3-EN | |
---|---|---|
Language | French | English |
Date Updated | 2018-02-08 | 2018-01-25 |
Drug Identification Number | 00865109 | 00865109 |
Brand name | DIANEAL PD4 CAPD SOLUTION WITH 2.5% DEXTROSE AND 2.5MEQ/L CALCIUM | DIANEAL PD4 CAPD SOLUTION WITH 2.5% DEXTROSE AND 2.5MEQ/L CALCIUM |
Common or Proper name | Dianeal, PD4 w/ 2.5% Dextrose & 1.25 mmol/L Calcium | Dianeal, PD4 w/ 2.5% Dextrose & 1.25 mmol/L Calcium |
Company Name | VANTIVE ULC | VANTIVE ULC |
Ingredients | SODIUM LACTATE DEXTROSE MAGNESIUM CHLORIDE CALCIUM CHLORIDE SODIUM CHLORIDE | SODIUM LACTATE DEXTROSE MAGNESIUM CHLORIDE CALCIUM CHLORIDE SODIUM CHLORIDE |
Strength(s) | 448MG 2.5G 5.08MG 18.3MG 538MG | 448MG 2.5G 5.08MG 18.3MG 538MG |
Dosage form(s) | SOLUTION | SOLUTION |
Route of administration | DIALYSIS | DIALYSIS |
Packaging size | 5L | 5L |
ATC code | B05ZA | B05ZA |
ATC description | HEMODIALYTICS AND HEMOFILTRATES | HEMODIALYTICS AND HEMOFILTRATES |
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 | 2018-02-08 | Unknown |
Actual end date | 2018-02-08 | |
Shortage status | Actual shortage | 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 |