BRIVIACT brivaracetam 10mg/mL oral solution bottle

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

brivaracetam, Quantity: 10 mg/mL

Available from:

UCB Australia Pty Ltd T/A UCB Pharma Division of UCB Australia

INN (International Name):

brivaracetam

Pharmaceutical form:

Oral Liquid, solution

Composition:

Excipient Ingredients: sodium citrate dihydrate; purified water; methyl hydroxybenzoate; citric acid; glycerol; carmellose sodium; sorbitol solution (70 per cent) (crystallising); sucralose; Flavour

Administration route:

Oral

Units in package:

1 x 300 mL bottle with oral dosing syringe and adaptor

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Briviact oral solution is indicated as add-on therapy in the treatment of partial onset seizures with or without secondary generalisation in patients from 4 years of age with epilepsy

Product summary:

Visual Identification: Slightly viscous, clear colourless to yellowish liquid; Container Type: Bottle; Container Material: Glass Type III Coloured; Container Life Time: 4 Years; Container Temperature: Store below 30 degrees Celsius; Container Closure: Child resistant closure

Authorization status:

Licence status A

Authorization date:

2016-08-04

Patient Information leaflet

_May 2016: – Briviact Tablets& Oral Solution _
_Reference documents: EU SmPC, Brivaracetam PI _
1
BRIVIACT

_ _tablets & oral solution (pronounced "BREE-vee-act")
_Contains the active ingredient brivaracetam (pronounced
"BREE-va-RA-se-tam")_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Briviact.
It does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking Briviact
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE
MEDICINE.
You may need to read it again.
WHAT BRIVIACT IS USED
FOR
Briviact tablets and oral solution are
used in combination with other
medicines to control epilepsy.
Epilepsy is a condition where you
have repeated seizures. There are
many different types of seizures,
ranging from mild to severe.
This medicine belongs to a group of
medicines called antiepileptics.
These medicines are thought to
work by controlling brain chemicals
which send signals to nerves so
that seizures do not happen.
Your doctor may have prescribed
this medicine for another reason.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS
MEDICINE HAS BEEN PRESCRIBED
FOR YOU.
There is no evidence that Briviact is
addictive.
This medicine is available only with
a doctor’s prescription.
Briviact is not recommended for
use in children under the age of 16
years as its safety and
effectiveness has not been
established in this age group.
BEFORE YOU TAKE
BRIVIACT
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE BRIVIACT IF YOU HAVE
AN ALLERGY TO:

any of the ingredients listed at
the end of this leaflet.
Some of the symptoms of an
allergic reaction may include:

shortness of breath

wheezing or difficulty breathing

swelling of the face, lips, tongue
or other parts of the body

rash, itching or hives on the
skin

Summary of Product characteristics

Briviact Tablets & OS PI g2016-263
Page 1
PRODUCT INFORMATION
BRIVIACT (BRIVARACETAM) FILM-COATED TABLETS AND ORAL SOLUTION
NAME OF THE MEDICINE
Non-proprietary name: Brivaracetam
Chemical name: (2
_S_
)-2-[(4
_R_
)-2-oxo-4-propyltetrahydro-1H-pyrrol-1-yl]butanamide
Chemical structure:
Molecular formula: C
11
H
20
N
2
O
2
MW: 212.29
CAS number: [357336-20-0]
DESCRIPTION
The active ingredient brivaracetam is a white to off-white crystalline
powder. It is very
soluble in water, buffer (pH 1.2, 4.5 and 7.4), ethanol, methanol, and
glacial acetic acid. It is
freely soluble in acetonitrile and acetone and soluble in toluene. It
is very slightly soluble in
n-hexane.
_ _
BRIVIACT FILM-COATED TABLETS
contain the following excipients: croscarmellose sodium,
lactose, betadex, lactose anhydrous, magnesium stearate and the
proprietary film coating
agents specified below:
10 mg tablets: Opadry II complete film coating system 85F18422 White
(ARTG No: 11376)
25 mg tablets: Opadry II complete film coating system 85F275014 Grey
(ARTG No: 110507)
50 mg tablets: Opadry II complete film coating system 85F38197 (ARTG
No: Yellow
110509)
75 mg tablets: Opadry
II
complete
film
coating
system
85F200021
Purple
(ARTG
No:
110513)
100 mg tablets: Opadry II complete film coating system 85F270000 Tan
(ARTG No: 110508)
BRIVIACT ORAL SOLUTION
contains the following excipients: sodium citrate, citric acid
anhydrous, methyl hydroxybenzoate, carmellose sodium, sucralose,
sorbitol solution (70
percent)(crystallising), glycerol, Raspberry Flavour 7557-A (ARTG No:
110532) and purified
water.
PHARMACOLOGY
Briviact Tablets & OS PI g2016-263
Page 2
MECHANISM OF ACTION
Brivaracetam displays a high and selective affinity for synaptic
vesicle protein 2A (SV2A) in
the brain. Binding to SV2A is considered to be the primary mechanism
for brivaracetam
anticonvulsant activity, however, the precise mechanism by which
brivaracetam exerts is
anticonvulsant activity has not been fully elucidated.
Effects on QT interval
The effect of brivaracetam on QTc prolongation