BRIVIACT brivaracetam 50mg/5mL injection vial

Land: Ástralía

Tungumál: enska

Heimild: Department of Health (Therapeutic Goods Administration)

Virkt innihaldsefni:

brivaracetam, Quantity: 10 mg/mL

Fáanlegur frá:

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

INN (Alþjóðlegt nafn):

brivaracetam

Lyfjaform:

Injection, solution

Samsetning:

Excipient Ingredients: sodium chloride; sodium acetate trihydrate; glacial acetic acid; water for injections

Stjórnsýsluleið:

Intravenous

Einingar í pakka:

10 x 5 mL vials

Gerð lyfseðils:

(S4) Prescription Only Medicine

Ábendingar:

Briviact solution for injection 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.

Vörulýsing:

Visual Identification: Clear, colourless solution; Container Type: Vial; Container Material: Glass; Container Life Time: 4 Years; Container Temperature: Store below 30 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Leyfisstaða:

Licence status A

Leyfisdagur:

2016-08-04

Upplýsingar fylgiseðill

_May 2016: – Briviact Solution for Injection _
_Reference documents: EU SmPC, Brivaracetam PI _
1
BRIVIACT

solution for injection (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 solution for injection is 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.
If you

Vara einkenni

Briviact Solution for injection PI g2016-263
Page 1
PRODUCT INFORMATION
BRIVIACT (BRIVARACETAM) SOLUTION FOR INJECTION
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 SOLUTION FOR INJECTION
contains the following excipients: sodium acetate
trihydrate, glacial acetic acid, sodium chloride, water for
injections.
PHARMACOLOGY
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 was evaluated in a
randomized, double-blind,
positive-controlled (moxifloxacin 400 mg)- and placebo-controlled
parallel group study of
brivaracetam (150 mg/day and 800 mg/day in two daily intakes) in 184
healthy subjects.
There was no evidence that brivaracetam prolongs the QT interval.
Seizure frequency
A statistically significant correlation has been demonstrated between
brivaracetam plasma
concentration and seizure frequency reduction from baseline in
confirmatory clinical studies
Briviact Solution for injection PI g2016-263
Page 2
in adjunctive treatment of partial onset seizures. The EC50
(brivaracetam plasma
concentration corresponding to 50% of the maximum effect) was
estimated to be 0.57 mg/L.
This plasma concentration is slightly above the median exposure
obtained after brivaracetam
d