Other safety alerts
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| Canada: Tromboject 1% and 3% (sodium tetradecyl sulfate) with visible particles - Update on the use of medical grade filters |
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Health Canada announces this update to replace the information previously communicated on 17 Jul 2018 regarding the presence of visible and insoluble particles in Tromboject 1% and 3% vials. When the products must be used for reasons of medical necessity, it is recommended to administer Tromboject 1% and 3% with sterile medical grade polyethersulfone (PES) filters of 0.22 micrometer pore size, and 25 or 33 mm diameter.
The affected products are:
- Tromboject 1% Inj 10mg/mL (Code: L0010049)
- Tromboject 3% Inj 30 mg/mL (Code: L0010050 and L0010051)
Tromboject 1% and 3% may contain visible particles that are not soluble. The insoluble particles in the intravenous injection solution may pose a potential serious risk to patients. Potential adverse effects related to the use of injectable products containing particulate matter include phlebitis, pulmonary emboli, and pulmonary granulomas.
Recent investigations conducted by Omega Laboratories Limited confirmed that medical grade filters with the specifications above are acceptable for use with the product in this situation.
Please refer to the following website in Health Canada for details:
http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/../67742a-eng.php
In Hong Kong, the above products are not registered pharmaceutical products. Related news was previously issued by Health Canada, and was posted on the Drug Office website on 18 Jul 2018.
Ends/Thursday, Sep 13, 2018
Issued at HKT 15:00
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