BRINAVESS Concentrate for Solution for Infusion 20mg/ml

Țară: Singapore

Limbă: engleză

Sursă: HSA (Health Sciences Authority)

Ingredient activ:

Vernakalant 18.1mg/ml equivalent Vernakalant hydrochloride

Disponibil de la:

ZUELLIG PHARMA PTE. LTD.

Codul ATC:

C01BG11

Dozare:

20mg/ml

Forma farmaceutică:

INFUSION, SOLUTION CONCENTRATE

Calea de administrare:

INTRAVENOUS

Tip de prescriptie medicala:

Prescription Only

Produs de:

hameln pharmaceuticals GmbH

Data de autorizare:

2012-09-13

Prospect

 
BRINAVESS 

SG-MK6621-IV-032012 
(Vernakalant, MSD) 

 1 

LOCAL PRODUCT CIRCULAR

CONCENTRATE FOR SOLUTION FOR INFUSION 
BRINAVESS 
(VERNAKALANT, MSD) _ _

I.  THERAPEUTIC CLASS

BRINAVESS
*
 is an antiarrhythmic drug with relative atrial selectivity. 

BRINAVESS is supplied as Concentrate for Solution for Infusion
(sterile concentrate). It is a 
clear and colorless to pale yellow solution with a pH of approximately
5.5.  
The molecule is a synthetic enantiomerically pure new chemical entity
and is chemically 
described as 3-Pyrrolidinol,
1-[(1_R_,2_R_)-2-[2-(3,4-dimethoxyphenyl)ethoxy]cyclohexyl]-, 
hydrochloride, (3_R_)- [ or alternately as
(1_R_,2_R_)-2-[(3_R_)-hydroxypyrrolidinyl]-1-(3,4-
dimethoxyphenethoxy)cyclohexane monohydrochloride ] 
Its empirical formula is C
20
H
31
NO
4
·HCl and its structural formula is shown below
.

Vernakalant hydrochloride is a crystalline, white to beige powder with
a relative molecular 
mass of 385.93 g/mol. It is soluble (276 – 496 mg/mL) in aqueous
solutions throughout the pH 
range of 1.0 to 13.0. 

III.  COMPOSITION 
_ _
_IIIA.  ACTIVE INGREDIENTS_

Each ml of concentrate contains 20 mg of vernakalant
hydrochloride which is equivalent to 
18.1 mg of vernakalant free base. 

_IIIB.  INACTIVE INGREDIENTS_

Citric acid E330 
Sodium chloride  
Water for injection  

  Copyright 
© 2009 MERCK & CO., INC.  
II.  CHEMISTRY

O
OMe
OMe
HCl
N
OH
_R_
_R_
_R_

BRINAVESS 

SG-MK6621-IV-032012 
(Vernakalant, MSD) 

2
Sodium hydroxide E524 (for pH-adjustment)  

IV.  CLINICAL PHARMACOLOGY 

_IVA.  MECHANISM OF ACTION _

Mechanism of Action: Vernakalant is an
antiarrhythmic medicine that acts preferentially in�