BRINAVESS 20 MGML

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

VERNAKALANT HYDROCHLORIDE

Available from:

TZAMAL BIO-PHARMA LTD

ATC code:

C01BG11

Pharmaceutical form:

CONCENTRATE FOR SOLUTION FOR INFUSION

Composition:

VERNAKALANT HYDROCHLORIDE 20 MG/ML

Administration route:

I.V

Prescription type:

Required

Manufactured by:

CORREVIO INTERNATIONAL SARL, SWITZERLAND

Therapeutic group:

VERNAKALANT

Therapeutic area:

VERNAKALANT

Therapeutic indications:

Rapid conversion of recent onset atrial fibrillation to sinus rhythm in adults who are hemodynamically stable.- For non-surgery patients: atrial fibrillation ≤ 7 days duration- For post-cardiac surgery patients: atrial fibrillation ≤ 3 days duration

Authorization date:

2017-05-31

Patient Information leaflet

דומע
1
ךותמ
1
BPS-Safety update form SPC-01 ךיראת
:
2.11.17
1 םש
םושירה רפסמו תילגנאב רישכתה
BRINAVESS 20 MG/ML
148 28 33391 00 םושירה לעב םש
ויב ל"מצ
-
מ"עב המראפ
!דבלב תורמחהה טורפל דעוימ הז ספוט
תושקובמה תורמחהה
ןולעב קרפ
יחכונ טסקט טסקט
שדח
SPECIAL WARNINGS
AND PRECAUTIONS FOR
USE
Atrial flutter
…
Atrial flutter
… In post-marketing experience very rare
cases of atrial flutter with 1:1
atrioventricular conduction are observed.
INTERACTIOS WITH OTHER
MEDICAMENTS AND
OTHER FORMS OF
INTERACTION
No formal interaction…
Within the
clinical development…
…
No formal interaction
….._ _
BRINAVESS must not be administered in
patients who received intravenous AADs
(class I and III) within 4 hours prior to
vernakalant (see section 4.3).
Within the clinical development…
EFFECTS ON ABILITY TO
DRIVE AND USE
MACHINES
BRINAVESS has a minor to moderate
influence on the ability to drive and use
machines.
ADVERSE EVENTS
Atrial Flutter
… BRINAVESS did not develop
1:1 atrioventricular conduction.
_Atrial Flutter_
_ _
… However, in post-marketing experience
very rare cases of atrial flutter with 1:1
atrioventricular conduction are observed.
Reporting suspected adverse reactions
after authorisation of the medicinal product
is important. It allows continued monitoring
of the benefit/risk balance of the medicinal
product.
Any suspected adverse events should be
reported to the Ministry of Health
according to the National Regulation by
using an online form
http://forms.gov.il/globaldata/getsequence/
getsequence
.aspx?formType=AdversEffectMedic@mo
h.gov.il
In addition, you may report by sending an
e-mail message to safety@tzamal-
medical.co.il
or by visiting the "Contact Us" webpage at:
http://www.tzamal-medical.co.il/69601.html
or by phone: [phone]

Summary of Product characteristics

1
BRINAVESS
® 20 MG/ML
Prescribing information
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 is
equivalent to 181 mg of
vernakalant.
Each 25 ml vial contains 500 mg of vernakalant hydrochloride is
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.
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
_ _
Rapid
conversion
of
recent
onset
atrial
fibrillation
to
sinus
rhythm
in
adults
who
are
hemodynamically stable
-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 by intravenous infusion, in a
monitored clinical setting
appropriate for cardioversion. Only a well-qualified healthcare
professional should administer
BRINAVESS and should frequently monitor the patient for the duration
of the infusion and for
2
at least 15 minutes after the completion of the infusion
for signs and symptoms of a sudd