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Human medicines European public assessment report (EPAR): Brinavess, vernakalant hydrochloride, Date of authorisation: 01/09/2010, Revision: 17, Status: Authorised

Brinavess can only be obtained with a prescription and should be given by a qualified healthcare professional in a setting where the patient’s heart can be properly monitored. The healthcare professional should monitor the patient’s blood pressure and heart rate while the medicine is being given and for at least 15 minutes afterwards.

Brinavess is a solution that is given by infusion (drip) into a vein over a period of 10 minutes. The dose of Brinavess depends on the patient’s body weight. If the heart rhythm has not returned to normal 15 minutes after the end of the first infusion, a second, smaller dose may be given. Patients should not be given more than 5 mg of Brinavess per kg body weight within any 24-hour period, or a maximum of 565 mg in patients weighing more than 113 kg. If the blood pressure or heart rate suddenly decreases the infusion should be stopped immediately. For more information about using Brinavess, see the package leaflet or contact your doctor or pharmacist.

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