Levetiracetam SUN levetiracetam 500mg/5mL concentrated injection vials

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

levetiracetam, Quantity: 100 mg/mL

Available from:

Sun Pharma ANZ Pty Ltd

INN (International Name):

Levetiracetam

Pharmaceutical form:

Injection, concentrated

Composition:

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

Administration route:

Intravenous Infusion

Units in package:

10

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Levetiracetam (film-coated tablets and oral solution) is indicated for:,? use in epileptic patients aged 4 years and older, initially as add on therapy, in the treatment of partial onset seizures with or without secondary generalisation, ? monotherapy in the treatment of partial onset seizures, with or without secondary generalisation, in patients from 16 years of age with newly diagnosed epilepsy. ? add on therapy in the treatment of myoclonic seizures in adults and adolescents from 12 years of age with Juvenile Myoclonic Epilepsy (JME),and ? add on therapy in the treatment of primary generalized tonic-clonic seizures in adults and children from 4 years of age with idiopathic generalized epilepsy (IGE).,Levetiracetam SUN concentrated injection after dilution is an alternative for patients when oral administration is temporarily not feasible.

Product summary:

Visual Identification: Clear colorless without visible particulate solution in 5ml colorless tubular glass vial with grey rubber stopper sealed with white flip off Alu seal; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2013-12-02

Patient Information leaflet

LEVETIRACETAM SUN
concentrated injection
500 mg/5 mL
_Contains the active ingredient levetiracetam _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This
leaflet
answers
some
common
questions
about
Levetiracetam
SUN
concentrated injection.
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
Levetiracetam
SUN
against
the
benefits
they
expect it will have for you.
IF
YOU
HAVE
ANY
CONCERNS
ABOUT
BEING
GIVEN
THIS
MEDICINE, ASK YOUR DOCTOR
OR PHARMACIST.
KEEP THIS LEAFLET IN A SAFE
PLACE.
You may need to read it
again.
WHAT LEVETIRACETAM
SUN IS USED FOR
Levetiracetam SUN is used 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.
Levetiracetam SUN may be
used alone, or in combination
with other medicines, to treat
your condition.
Your
doctor
may
have
prescribed
this
medicine
in
addition
to
your
current
therapy.
ASK YOUR DOCTOR IF YOU HAVE
ANY
QUESTIONS
ABOUT
WHY
THIS
MEDICINE
HAS
BEEN
PRESCRIBED FOR YOU.
There is no evidence that this
medicine is addictive.
This
medicine
is
available
only
with
a
doctor’s
prescription.
The safety and effectiveness
of
Levetiracetam
SUN
has
not
been
established
in
patients less than 4 years of
age.
BEFORE
YOU
ARE
GIVEN
LEVETIRACETAM SUN
_ _
_WHEN YOU MUST NOT BE _
_GIVEN IT _
_ _
YOU
MUST
NOT
BE
GIVEN
LEVETIRACETAM SUN 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 ARE NOT SURE WHETHER
YO

Summary of Product characteristics

Page 1 of 24
Version 3
PRODUCT INFORMATION
LEVETIRACETAM SUN
500 mg/ 5 mL concentrated injection
NAME OF THE MEDICINE
Levetiracetam SUN concentrated injection contains the active substance
levetiracetam; a pure
enantiomer,
with
chemical
name
(
_S_
)-α-ethyl-2-oxo-1-pyrrolidineacetamide,
formula
C
8
H
14
N
2
O
2
,
_CAS-102767-28-2_
and structure indicated below:
DESCRIPTION
Levetiracetam is a white to off-white powder with a faint odour and a
bitter taste. It is very
soluble in water (104 g/100mL). It is freely soluble in chloroform
(65.3 g/100mL) and in
methanol
(53.6
g/100mL),
soluble
in
ethanol
(16.5
g/100mL),
sparingly
soluble
in
acetonitrile (5.7 g/100mL) and practically insoluble in n-hexane.
Levetiracetam SUN concentrated injection contains 500 mg of
levetiracetam(500 mg/5 mL).
The excipients are sodium acetate trihydrate, sodium chloride, glacial
acetic acid and water
for injections.
PHARMACOLOGY
MECHANISM OF ACTION
The precise mechanism of action by which levetiracetam induces seizure
protection still
remains to be fully elucidated, but appears to be unrelated to the
mechanisms of current anti-
epileptic drugs.
_In vitro _
and
_in vivo _
experiments suggest that levetiracetam does not alter
basic cell characteristics and normal neurotransmission.
_In vitro_
studies show that levetiracetam affects intraneuronal Ca
2+
levels by partial inhibition
of N-type Ca
2+
currents and by reducing the release of Ca
2+
from intraneuronal stores. In
addition, it partially reverses the reductions in GABA- and
glycine-gated currents induced by
zinc and βcarbolines. Furthermore, levetiracetam has been shown in
_in vitro_
studies to bind to
a specific site in rodent brain tissue. This binding site is the
synaptic vesicle protein 2A,
believed to be involved in vesicle fusion and neurotransmitter
exocytosis. Levetiracetam and
related analogues show a rank order of affinity for binding to the
synaptic vesicle protein 2A
which correlates with the potency of their anti-seizure protection in
the mouse audiogenic
model of epilep