The United Kingdom: Braltus (tiotropium): risk of inhalation of capsule if placed in the mouthpiece of the inhaler (English Only) |
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Medicines and Healthcare products Regulatory Agency (MHRA) announces that it has received reports of patients who have inhaled a Braltus capsule from the mouthpiece into the back of the throat, resulting in coughing and risking aspiration or airway obstruction. Patients should be trained to place the Braltus capsule in the correct chamber of the Zonda inhaler
Braltus tiotropium 10 µg per delivered dose inhalation powder is a once-a-day maintenance bronchodilator treatment authorised to relieve symptoms in adults with chronic obstructive pulmonary disease (COPD). The inhalation powder is provided in capsules for inhalation using the Zonda inhaler device. MHRA has received 2 Yellow Card reports of patients who have inhaled a Braltus capsule from the mouthpiece into the back of the throat. Both patients coughed up the capsule and recovered from the event. Health professionals have also observed that some patients have placed the capsule into the mouthpiece during training to use the inhaler device. It is essential that patients know never to place a capsule directly into the mouthpiece. Healthcare professionals are advised: Please refer to the following website in MHRA for details: http://www.gov.uk/drug-safety-update/braltus-tiotropium-risk-of-inhalation-of-capsule-if-placed-in-the-mouthpiece-of-the-inhaler In Hong Kong, the above product is not a registered pharmaceutical product. Ends/Friday, May 25, 2018 轉載自衛生署藥物辦公室網頁http://www.drugoffice.gov.hk/ |