Keppra

نشرة المعلومات

1
KEPPRA
®
_ _oral solution
(pronounced “KEPP-ruh”)
_ _
_Contains the active ingredient levetiracetam (pronounced "LEE ve tye
RA se tam") _
_ _
CONSUMER MEDICINE INFORMATION
_ _
WHAT IS IN THIS LEAFLET

This leaflet answers some common
questions about Keppra.

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 Keppra
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 KEPPRA IS USED
FOR

Keppra 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.

Keppra 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
Keppra has not been established in
patients less than 4 years of age.

BEFORE YOU TAKE KEPPRA

_WHEN YOU MUST NOT TAKE IT _

DO NOT TAKE KEPPRA 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

اقرأ الوثيقة كاملة

خصائص المنتج

KEPPRA IV PI 18
th
September 2012 (g2012-314)
Page 1 of 22

PRODUCT INFORMATION

KEPPRA
(LEVETIRACETAM)
CONCENTRATE SOLUTION FOR IV INFUSION

NAME OF THE MEDICINE

Non-proprietary name: Levetiracetam

Chemical name: (S)-
α-ethyl-2-oxo-1-pyrrolidineacetamide

Chemical structure:

Molecular formula: C
8
H
14
N
2
O
2

CAS number: 102767-28-2

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.

KEPPRA concentrate solution for IV infusion contains 500 mg of
levetiracetam
(500 mg/5 mL). The excipients are sodium acetate, sodium chloride,
acetic acid- glacial 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 β-
carbolines. 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 bi

اقرأ الوثيقة كاملة

Keppra

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