BRIVANESS Concentrate for solution for infusion Ref.[8656] Active ingredients: Vernakalant

Vernakalant should be administered in a monitored clinical setting appropriate for cardioversion. Only a well-qualified healthcare professional should administer it.

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

There is no relevant use of vernakalant in children and adolescents < 18 years of age for rapid conversion of recent onset atrial fibrillation to sinus rhythm and therefore it should not be used in this population.

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.

One patient who received 3 mg/kg of vernakalant over 5 minutes (instead of the recommended 10 minutes) developed haemodynamically stable wide complex tachycardia which resolved without sequelae.

5 years.

The diluted sterile concentrate is chemically and physically stable for 12 hours at or below 25°C.

From a microbiological point of view, the medicinal product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2°C to 8°C, unless dilution has taken place in controlled and validated aseptic conditions.

This medicinal product does not require any special storage conditions.

For storage conditions after dilution of the medicinal product, see section 6.3.

Single-use glass (Type 1) vials with a chlorobutyl rubber stopper and an aluminium overseal.

Pack size of 1 vial includes either 10 ml or 25 ml of concentrate.

Not all pack sizes may be marketed.

Read all steps before administration.

An infusion pump is the preferred delivery device. However, a syringe pump is acceptable provided that the calculated volume can be accurately given within the specified infusion time.

Preparation of BRINAVESS for infusion

Step 1:

BRINAVESS vials should be visually inspected for particulate matter and discolouration before administration. Any vials exhibiting particulate matter or discolouration should not be used.

Note: BRINAVESS concentrate for solution for infusion ranges from colourless to pale yellow. Variations of colour within this range do not affect potency.

Step 2: Dilution of concentrate

To ensure proper administration, a sufficient amount of BRINAVESS 20 mg/ml should be prepared at the outset of therapy to deliver the initial and second infusion should it be warranted.

Create a solution with a concentration of 4 mg/ml following the dilution guidelines below:

Patients ≤100 kg: 25 ml of BRINAVESS 20 mg/ml is added to 100 ml of diluent.

Patients >100 kg: 30 ml of BRINAVESS 20 mg/ml is added to 120 ml of diluent.

Recommended diluents are sodium chloride 9 mg/ml (0.9%) solution for injection, Lactated Ringers solution for injection, or 5% glucose solution for injection.

Step 3: Inspection of the solution

The diluted sterile solution should be clear, colourless to pale yellow. The solution should be visually re-inspected for particulate matter and discolouration before administering.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.