JUBLEVET (Levetiracetam Tablets 500mg)

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

LEVETIRACETAM

Boleh didapati daripada:

SYNERRV SDN BHD

INN (Nama Antarabangsa):

LEVETIRACETAM

Unit dalam pakej:

3 x 10 Tablets

Dikeluarkan oleh:

Jubilant Generics Limited

Risalah maklumat

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
JUBLEVET
LEVETIRACETAM TABLETS 500MG
Levetiracetam (500mg)
1
WHAT IS IN THIS LEAFLET
1.
What JUBLEVET is used for
2.
How JUBLEVET works
3.
Before you use JUBLEVET
4.
How to use JUBLEVET
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of product
name
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT IS JUBLEVET USED FOR
JUBLEVET is used to control
epilepsy. Epilepsy is a condition
where you have repeated seizures
(fits). There are many different kinds
of seizures that can be mild or severe
in nature.
JUBLEVET can be used alone or in
combination with other medicines to
treat your condition. Alone,
JUBLEVET is used in treatment of
newly diagnosed epilepsy in patients
from 16 years and older.
JUBLEVET is used in patients who
are already taking other anti-epileptic
medicines:

For treating partial seizures
in adults and children from
4 years of age.

For treating myoclonic
seizures in adults and
adolescents from 12 years
of age with Juvenile
Myoclonic Epilepsy.

For treating primary
generalized tonic-clonic
seizures in adults and
adolescents from 12 years
of age with Idiopathic
Generalized Epilepsy.
HOW JUBLEVET WORKS
JUBLEVET contains the active
ingredient levetiracetam, which
belongs to a group of medicines
called anti-epileptics. It is thought to
control brain chemicals which send
signals to nerves, so that seizures do
not occur.
BEFORE YOU USE JUBLEVET
_-When you must not use it _
Do not use JUBLEVET if you are
allergic to:

Any medicine containing
levetiracetam.

Medicines derived from a
chemical called pyrrolidine
(e.g. piracetam) or any of
the ingredients that are
listed here.
If you are unsure about the use of
JUBLEVET, please consult your
doctor or pharmacist for further
advice.
_Pregnancy and lactation _
Tell your doctor if you are pregnant,
planning to become pregnant or are
currently breast-feeding. Your doctor
will determine if it is alright for you
to take JUBLEVET during
pre

Ciri produk

6401
Last modified: 6. July 2021, 12:30 PM
SITE PACKAGING DEVELOPMENT
SIGN AND DATE
PRODUCTION
SIGN AND DATE
QA
SIGN AND DATE
ITEM CODE: 50000001587
SUPERSEDED ITEM CODE: NA
PHARMA CODE: 6401
SUBSTRATE: 40 GSM BIBLE PAPER
OPEN (LXW): 420 X 240 MM
FOLDED (LXW): 62 X 31 MM
FOIL WIDTH: NA
PRINT REGISTRATION: NA
CARTON (LXWXH): NA
PIL/ MEDICATION GUIDE
LABEL (LXW): NA
COMPONENT: PIL
CLIENT & COUNTRY : SYNERRV SDN. BHD., MALAYSIA
REFERENCE SPEC NO: PS2860
SPECIAL INSTRUCTION (IF ANY): NA
PANTONE:
MARKET: ROW
REASON FOR ARTWORK: NEW
BLISTER (LXW): NA
DIMENSION
BLACK
DIELINE
FOR THE USE OF A REGISTERED MEDICAL PRACTITIONER OR A HOSPITAL OR A
LABORATORY ONLY
JUBLEVET
LEVETIRACETAM TABLETS 500 MG
1.
PRODUCT NAME:
Levetiracetam Tablets 500 mg
2.
NAME AND STRENGTH OF ACTIVE INGREDIENT:
EACH FILM-COATED TABLET CONTAINS:
Levetiracetam Ph.Eur. 500 mg
3.
PRODUCT DESCRIPTION:
LEVETIRACETAM TABLET 500 MG:
Yellow coloured, oblong shaped, film coated tablets, with a scoreline
on one side and debossed with ‘500’ on the
other side of the tablet.
4.
PHARMACODYNAMICS / PHARMACOKINETICS:
PHARMACODYNAMIC PROPERTIES
Levetiracetam induces seizure protection in a broad range of animal
models of partial and primary generalised
seizures without having a pro-convulsant effect. The primary
metabolite is inactive.
In man, an activity in both partial and generalised epilepsy
conditions (epileptiform discharge/ photoparoxysmal
response) has confirmed the broad spectrum pharmacological profile of
levetiracetam.
PHARMACOKINETIC PROPERTIES
Levetiracetam is a highly soluble and permeable compound. The
pharmacokinetic profile is linear with low intra- and
inter-subject variability. There is no modification of the clearance
after repeated administration. There is no evidence
for any relevant gender, race or circadian variability. The
pharmacokinetic profile is comparable in healthy volunteers
and in patients with epilepsy.
Due to its complete and linear absorption, plasma levels can be
predicted from the oral dose of levetiracetam
expressed as mg/kg