June 2015 June 2015
Safety Related Changes
Coralan (ivabradine) is now indicated in the symptomatic treatment of chronic stable angina due to atherosclerotic coronary artery disease in patients with normal sinus rhythm and heart rate at or above 70 bpm, who are unable to tolerate or have a contraindication to the use of beta-blockers, OR in combination with atenolol 50 mg once daily when angina is inadequately controlled.
Flutiform (fluticasone propionate and eformoterol fumarate dehydrate) inhaler is now indicated for the regular maintenance treatment of asthma where the use of a combination product (an inhaled corticosteroid and a long‑acting ß2‑agonist) is appropriate. This includes patients not adequately controlled with inhaled corticosteroids and inhaled short-acting ß2‑agonist on an ‘as required’ basis.
Herceptin (trastuzumab (rch)) is now indicated for the treatment of HER2‑positive early breast cancer following surgery, and in association with chemotherapy and, if applicable, radiotherapy.
Zinnat (cefuroxime) is now indicated in acute exacerbations of chronic bronchitis, or acute bronchitis.
Coralan (ivabradine) is now contraindicated in combination with verapamil or diltiazem which are moderate CYP3A4 inhibitors with heart rate reducing properties.
Coralan (ivabradine) is now contraindicated in those with a resting heart rate below 70 bpm prior to treatment.
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