Brinavess
Maa: Euroopan unioni
Kieli: englanti
Lähde: EMA (European Medicines Agency)
Pakkausseloste
(PIL)
20-02-2024
Valmisteyhteenveto
(SPC)
20-02-2024
Julkisesta arviointikertomuksesta
(PAR)
14-11-2019
Aktiivinen ainesosa:
Vernakalant hydrochloride
Saatavilla:
Correvio
ATC-koodi:
C01BG11
INN (Kansainvälinen yleisnimi):
vernakalant hydrochloride
Terapeuttinen ryhmä:
Cardiac therapy
Terapeuttinen alue:
Atrial Fibrillation
Käyttöaiheet:
Rapid conversion of recent onset atrial fibrillation to sinus rhythm in adults:for non-surgery patients: atrial fibrillation
Tuoteyhteenveto:
Revision: 16
Valtuutuksen tilan:
Authorised
Valtuutus päivämäärä:
2010-09-01
Pakkausseloste
24
B. PACKAGE LEAFLET
25
PACKAGE LEAFLET: INFORMATION FOR THE USER
BRINAVESS 20 MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION
vernakalant hydrochloride
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor.
-
If you get any side effects, talk to your doctor. This includes any
possible side effects not listed
in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What BRINAVESS is and what it is used for
2.
What you need to know before you use BRINAVESS
3.
How to use BRINAVESS
4.
Possible side effects
5.
How to store BRINAVESS
6.
Contents of the pack and other information
1.
WHAT BRINAVESS IS AND WHAT IT IS USED FOR
BRINAVESS contains the active substance vernakalant hydrochloride.
BRINAVESS works by
changing your irregular or fast heart beat to a normal heart beat.
In adults it is used if you have a fast, irregular heart beat called
atrial fibrillation
_ _
which has started
recently, less than or equivalent to 7 days, for non-surgery patients
and less than or equivalent
to 3 days for post-cardiac surgery patients
_._
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE BRINAVESS
DO NOT USE BRINAVESS
•
if you are allergic to vernakalant hydrochloride or any of the other
ingredients of this medicine
(listed in section 6)
•
if you have had new or worsening chest pain (angina) diagnosed by your
doctor as an acute
coronary syndrome in the last 30 days or you have had a heart attack
in the last 30 days
•
if you have a very narrow heart valve, systolic blood pressure less
than 100 mm Hg
or advanced
heart failure with symptoms at minimal exertion or at rest
•
if you have an abnormally slow heart rate or skipped heart beats and
do not have a pacemaker,
or you have conduction disturbance called QT prolongation - which can
be seen on an ECG by
your doctor
•
if you take certain other intravenous medicines (antiarrhythmics Class
I and III) used to
normalis
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Valmisteyhteenveto
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
BRINAVESS 20 mg/ml concentrate for solution for infusion
_ _
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
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) 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.
3.
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
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
_ _
Brinavess is indicated in adults for rapid conversion of recent onset
atrial fibrillation to sinus rhythm
-For non-surgery patients: atrial fibrillation ≤ 7 days duration
-For post-cardiac surgery patients: atrial fibrillation ≤ 3 days
duration
_ _
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
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
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