Iracet Oral Solution 100mgml

Χώρα: Μαλαισία

Γλώσσα: Αγγλικά

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

Δραστική ουσία:

LEVETIRACETAM

Διαθέσιμο από:

MEDISPEC (M) SDN.BHD

INN (Διεθνής Όνομα):

LEVETIRACETAM

Μονάδες σε πακέτο:

1 x 50ml BOTTLE

Κατασκευάζεται από:

Square Pharmaceuticals PLC.

Φύλλο οδηγιών χρήσης

IRACET ORAL SOLUTION 100 MG/ML
Levetiracetam (100mg/mL)
1
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
WHAT IS IN THIS LEAFLET
1.
What
_Iracet_
is used for
2.
How
_Iracet_
works
3.
Before you use
_Iracet_
4.
How to use
_Iracet_
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of
_Iracet_
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
11.
Serial Number
WHAT _IRACET_
_ _
IS USED FOR
_Iracet_
is used:
• on its own in adults and adolescents
from 16 years of age with a certain type
of newly diagnosed 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).
_Iracet_
has
been given to you by your doctor to
reduce the number of fits.
• as an add-on to other antiepileptic
medicines to treat:
- partial onset seizures with or without
secondary generalization in adults and
children from 4 years of age with
epilepsy.
- 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
- primary generalized tonic-clonic
seizures (major fits, including loss of
consciousness) in adults and children
from 12 years of age with Idiopathic
Generalized Epilepsy.
HOW _IRACET_
WORKS
_Iracet_
_ _
is an antiepileptic medicine (a
medicine used to treat seizures in
epilepsy).
BEFORE YOU USE _IRACET_
_ _
_When you must not use it _
Do not take Iracet
•
If you are allergic to levetiracetam,
pyrrolidone derivatives or any of the
other ingredients of this medicine.
_Pregnancy and breastfeeding: _
If you are pregnant or breastfeeding,
think you may be pregnant or are
planning to have a baby, ask your doctor
for advice before taking this medicine.
_Iracet_
can be used during pregnancy,
only if after careful assessment i

Αρχείο Π.Χ.Π.

IRACET ORAL SOLUTION 100MG/ML
Each ml solution contains Levetiracetam 100 mg.
PRODUCT DESCRIPTION
An orange color solution having sweet orange flavor with slight bitter
taste; free from any visible foreign particle. The solution is filled
in
transparent PET bottle and sealed with white color PP cap overprinted
with “SQUARE”.
PHARMACODYNAMICS
Pharmacotherapeutic group: antiepileptics, other antiepileptics, ATC
code: N03AX14
Mechanism of action
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.
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 Ca2+ levels by partial inhibition
of N-type Ca2+ currents and by reducing the release of Ca2+ from
intraneuronal stores. In addition, it partially reverses the
reductions in GABA- and glycine-gated currents induced by zinc and
β-carbolines.
Furthermore, levetiracetam 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 analogs 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. 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 in partial and primary
generalised seizures without having a pro-convulsant effect. The
primary
metabolite is inactive.
In man, an activity in both partial and generalized epilepsy
conditions (epileptiform discharge/ photoparoxysmal response) has
confirmed the
broad-spectrum pharmacological profile of levetiracet