Other safety alerts
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| Canada: Tromboject 1% and 3% (sodium tetradecyl sulfate) with visible particles |
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Health Canada announces that vials of Tromboject 1% and 3% may contain visible particles that are not soluble. The affected products are:
- Tromboject 1% Inj 10mg/mL (Sodium Tetradecyl Sulfate) (Code: L0010049)
- Tromboject 3% Inj 30mg/mL (Sodium Tetradecyl Sulfate) (Code: L0010050 and L0010051)
Tromboject 1% and 3% are sclerosing solutions for intravenous treatment of varicose veins. 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.
Healthcare professionals are advised:
- Use the product only when the benefits of Tromboject 1% and 3% therapy outweigh the risk of the treatment for medically necessary interventions or in conditions where there are no therapeutic alternatives for the patient.
- Conserve product only for medically necessary use due to the anticipated drug shortage of all Tromboject formats.
- As a risk mitigation measure, if the product must be used, administer Tromboject 1% and 3% with an in-line, sterile, polyethersulfone (PES) filter of 0.2 micrometer pore size, 13mm diameter.
Investigations related to the manufacture of this product are ongoing.
Please refer to the following website in Health Canada for details:
http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/../67246a-eng.php
In Hong Kong, the above products are not registered pharmaceutical products.
Ends/Wednesday, Jul 18, 2018
Issued at HKT 17:00
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