ADR that result in revision of patient information
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| Canada: New Safety Information: TERAZOL 7 Vaginal Cream 0.4% (terconazole); TERAZOL 3 Dual-Pak - Vaginal Cream 0.8%/Vaginal Ovules 80 mg (terconazole) - Risk of Anaphylaxis and Toxic Epidermal Necrolysis |
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Janssen Inc., in consultation with Health Canada, would like to provide you with important new safety information regarding the risk of anaphylaxis and Toxic Epidermal Necrolysis associated with the use of TERAZOL. TERAZOL 7 Vaginal Cream and TERAZOL 3 Dual-Pak Vaginal Cream/Vaginal Ovules are authorized for the local treatment of vulvovaginal candidiasis (moniliasis). Very rare cases of serious or even life-threatening adverse reactions of anaphylaxis or Toxic Epidermal Necrolysis (TEN) have been reported during treatment with TERAZOL. Anaphylaxis is characterized by swollen face, lips, mouth, tongue or throat, and difficulty swallowing or breathing. TEN is presented with flu-like symptoms, fever, itching of the skin, mouth sores, tender or painful skin rash that spreads and blisters causing the skin to shed over much of the body. The Canadian Product Monograph for TERAZOL has been updated to include this new safety information. Healthcare professionals are advised to counsel patients about the risks of anaphylaxis and TEN with TERAZOL and instruct them to discontinue using the product if signs or symptoms of serious allergic reactions occur.
Please refer to the following website in Health Canada for details:
http://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/../39911a-eng.php
In Hong Kong, the above products are not registered pharmaceutical products.
Ends/ Tuesday, June 10, 2014
Issued at HKT 12:00
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