Brinavess

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Vernakalant hydrochloride 20 mg/mL Equivalent to 18.1 mg/mL of vernakalant

Available from:

Merck Sharp & Dohme (New Zealand) Limited

INN (International Name):

Vernakalant hydrochloride 20 mg/mL (Equivalent to 18.1 mg/mL of vernakalant)

Dosage:

20 mg/mL

Pharmaceutical form:

Concentrate for infusion

Composition:

Active: Vernakalant hydrochloride 20 mg/mL Equivalent to 18.1 mg/mL of vernakalant Excipient: Citric acid monohydrate Sodium chloride Sodium hydroxide Water for injection

Units in package:

Vial, glass, Type I with 20 mm chlorobutyl rubber stupper and 20 mm Al overseal with plastic flip off cap, 30 mL, 25 mL

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Merck & Cie

Therapeutic indications:

Rapid conversion of recent onset atrial fibrillation to sinus rhythm in adults · For non-surgery patients: atrial fibrillation less than or equal to 7 days duration · For post-cardiac surgery patients: atrial fibrillation less than or equal to 3 days duration

Product summary:

Package - Contents - Shelf Life: Vial, glass, Type I with 20 mm chlorobutyl rubber stupper and 20 mm Al overseal with plastic flip off cap, 30 mL - 25 mL - 36 months from date of manufacture stored at or below 30°C

Authorization date:

2009-11-12