Posology : מינונים

4.2 Posology and method of administration
Vernakalant should be administered by intravenous infusion, in a monitored clinical setting appropriate for cardioversion. Only a well-qualified healthcare professional should administer BRINAVESS and should frequently monitor the patient for the duration of the infusion and for 
at least 15 minutes after the completion of the infusion for signs and symptoms of a sudden decrease in blood pressure or heart rate (see section 4.4).

Posology
Vernakalant is dosed by patient body weight, with a maximum calculated dose based upon 113 kg.
The recommended initial infusion is 3 mg/kg to be infused over a 10-minute period with a maximum initial dose of 339 mg (84.7 ml of 4 mg/ml solution). If conversion to sinus rhythm does not occur within 15 minutes after the end of the initial infusion, a second 10-minute infusion of 2 mg/kg may be administered(maximum second infusion of 226 mg (56.5 ml of 4 mg/ml solution)). Cumulative doses of greater than 5 mg/kg should not be administered within 24 hours.

The initial infusion is administered as a 3 mg/kg dose over 10 minutes.
During this period, the patient should be carefully monitored for any signs or symptoms of a sudden decrease in blood pressure or heart rate. If such signs develop, with or without symptomatic hypotension or bradycardia, the infusion should be stopped immediately.

If conversion to sinus rhythm has not occurred, the patient’s vital signs and cardiac rhythm should be observed for an additional 15 minutes.

If conversion to sinus rhythm did not occur with the initial infusion or within the 15 minute observation period, a 2 mg/kg second infusion should be administered over 10 minutes.

If conversion to sinus rhythm occurs during either the initial or second infusion, that infusion should be continued to completion. If haemodynamically stable atrial flutter is observed after the initial infusion, the second infusion may be administered as patients may convert to sinus rhythm. (See sections 4.4 and 4.8).

Patients with body weight > 113 kg
For patients above 113 kg, vernakalant has a fixed dose. The initial dose is 339 mg (84.7 ml of 4 mg/ml solution). If conversion to sinus rhythm does not occur within 15 minutes after the end of the initial infusion, a second 10-minute infusion of 226 mg (56.5 ml of 4 mg/ml solution) may be administered. Cumulative doses above 565 mg have not been evaluated.

Post-cardiac surgery
No dose adjustment necessary.

Renal impairment
No dose adjustment necessary (see section 5.2).
Hepatic impairment
No dose adjustment necessary (see sections 4.4 and 5.2).

Elderly (≥ 65 years)
No dose adjustment necessary.

Paediatric population
Vernakalant is not indicated for children and adolescents < 18 years of age.
Method of administration
For Intravenous use.
Vernakalant should not be administered as an intravenous push or bolus.

The vials are for single use only and must be diluted prior to administration.

For instructions on dilution of the medicinal product before administration, see section 6.6.