Quetra 100 mgml oral solution

Country: Malaysia

Bahasa: Inggeris

Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Bahan aktif:

LEVETIRACETAM

Boleh didapati daripada:

EUCOGEN SDN BHD

INN (Nama Antarabangsa):

LEVETIRACETAM

Unit dalam pakej:

150 ml; 150 ml; 300 ml

Dikeluarkan oleh:

Remedica Ltd.

Risalah maklumat

QUETRA 100MG/ML ORAL SOLUTION
Levetiracetam 100mg/mL
1
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
WHAT IS IN THIS LEAFLET
1.
What Quetra is used for
2.
How Quetra works
3.
Before you use Quetra
4.
How to use Quetra
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of Quetra
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT QUETRA IS USED FOR
Quetra is used:
•
on its own in adults and adolescents
from
16
years
of
age
with
newly
diagnosed epilepsy, to treat a certain
form
of
epilepsy.
Epilepsy
is
a
condition
where
the
patients
have
repeated fits (seizures). Levetiracetam
is used for the epilepsy form in which
the fits initially affect only one side of
the brain, but could thereafter extend
to larger areas on both sides of the
brain (partial onset seizures with or
without
secondary
generalization).
Levetiracetam has been given to you
by your doctor to reduce the number
of fits.
•
as
an
add-on
to
other
antiepileptic
medicines to treat:
a).
partial
onset
seizures
with
or
without generalization in adults,
adolescents children and children
from 4 years of age with epilepsy.
b). myoclonic seizures (short, shock-
like jerks of a muscle or group of
muscles)
in
adults
and
adolescents from 12 years of age
with
juvenile
myoclonic
epilepsy.
c). primary generalized tonic-clonic
seizures
(major
fits,
including
loss of consciousness) in adults
and adolescents from 12 years of
age with idiopathic generalized
epilepsy (the type of epilepsy that
is
thought
to
have
a
genetic
cause).
HOW QUETRA WORKS
Quetra
contains
the
active
substance
Levetiracetam.
Levetiracetam
is
an
antiepileptic medicine (a medicine used to
treat seizures in epilepsy).
BEFORE YOU USE QUETRA
-
_When you must not use it _
If
you
are
allergic
to
levetiracetam,
pyrrolidone derivatives or any of the other
ingredients of this medicine.
_Children and adolescents _
Quetra is not indicated in children and
adolescents below 16 years on its own
(monotherapy).
_ _
-
_Before you start to use it _
•
I

Ciri produk

my-pi-quetra-oral-sol-a12 page 1 of 16
PACKAGE INSERT
1. NAME OF THE PRODUCT
Quetra 100 mg/ml oral solution
2. NAME AND STRENGTH OF ACTIVE INGREDIENT
Each ml contains 100 mg levetitacetam.
3. DOSAGE FORM
Oral solution.
Clear, colourless liquid with sweet fruity odour and bitter raspberry
flavour.
4. PHARMACOLOGICAL PROPERTIES
PHARMACODYNAMICS
Pharmacotherapeutic group: Antiepileptics, ATC code: N03AX14
The active substance, levetiracetam, is a pyrrolidone derivative
(S-enantiomer of α-ethyl-
2-oxo-1-pyrrolidine
acetamide),
chemically
unrelated
to
existing
antiepileptic
active
substances.
Mechanism of action
The
mechanism
of
action
of
levetiracetam
still
remains
to
be
fully
elucidated.
Levetiracetam does not alter basic cell characteristics and normal
neurotransmission.
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 binds 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
epilepsy. This finding
suggests that the interaction between levetiracetam and the synaptic
vesicle protein 2A
seems to contribute to the antiepileptic mechanism of action of the
medicinal product.
Pharmacodynamic effects
Levetiracetam induces seizure protection and primary generalised
seizures without having
a pro-convulsant effect. The primary metabolite is inactive.
my-pi-quetra-oral-sol-a12 page 2 of 16
An
activity
in
both
partial
and
generalised
epilepsy
conditions
(epileptiform
discharge/photoparoxysmal response) has confirmed the broad spectrum
pharmacolo