Source: European Medicines Agency (EU) Revision Year: 2022 Publisher: Correvio, 15 rue du Bicentenaire, 92800, Puteaux, France
BRINAVESS 20 mg/ml concentrate for solution for infusion.
| Pharmaceutical Form |
|---|
|
Concentrate for solution for infusion (sterile concentrate). Clear and colourless to pale yellow solution with a pH of approximately 5.5. The osmolality of the medicinal product is controlled between the following range: 270-320 mOsmol/kg. |
Each ml of concentrate contains 20 mg of vernakalant hydrochloride which is equivalent to 18.1 mg of vernakalant.
Each 10 ml vial contains 200 mg of vernakalant hydrochloride equivalent to 181 mg of vernakalant.
Each 25 ml vial contains 500 mg of vernakalant hydrochloride equivalent to 452.5 mg of vernakalant.
After dilution the concentration of the solution is 4 mg/ml vernakalant hydrochloride.
Excipient with known effect:
Each vial of 200 mg contains approximately 1.4 mmol (32 mg) sodium.
Each vial of 500 mg contains approximately 3.5 mmol (80 mg) of sodium.
Each ml of the diluted solution contains approximately 3.5 mg of sodium (sodium chloride 9 mg/ml (0.9%) solution for injection), 0.64 mg sodium (5% glucose solution for injection) or 3.2 mg sodium (Lactated Ringers solution for injection).
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Vernakalant |
Vernakalant is an antiarrhythmic medicine that acts preferentially in the atria to prolong atrial refractoriness and to rate-dependently slow impulse conduction. |
| List of Excipients |
|---|
|
Citric acid (E330) |
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.
Correvio, 15 rue du Bicentenaire, 92800, Puteaux, France
EU/1/10/645/001
EU/1/10/645/002
Date of first authorisation: 01 September 2010
Date of latest renewal: 06 September 2015
| Drug | Countries | |
|---|---|---|
| BRINAVESS | Austria, Canada, Cyprus, Estonia, Spain, Finland, Hong Kong, Croatia, Ireland, Israel, Lithuania, Netherlands, Poland, Romania, United Kingdom, South Africa |
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