LETRAM OS (Levetiracetam Oral Solution 100mgml)

Država: Malezija

Jezik: engleski

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

Aktivni sastojci:

LEVETIRACETAM

Dostupno od:

UNIMED SDN BHD

INN (International ime):

LEVETIRACETAM

Jedinice u paketu:

1 x 150ML Units; 300ML Units

Proizveden od:

Hetero Labs Limited

Uputa o lijeku

LETRAM (LEVETIRACETAM )
(Levetiracetam Oral Solution)
1
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
WHAT IS IN THIS LEAFLET
1.
What LETRAM is used for
2.
How LETRAM works
3.
Before you use LETRAM
4.
How to take LETRAM
5.
While you are using LETRAM
6.
Side effects
7.
Storage and Disposal of LETRAM
8.
Product Description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of revision
WHAT LETRAM IS USED FOR
LETRAM is indicated as monotherapy in
the
treatment
of
partial
onset
seizures
with or without secondary generalization
in patients from 16 years of age with
newly diagnosed epilepsy.
LETRAM is indicated as adjuctive
theraphy:
•
In the treatment of seizures in adults
and children from 4 years of age with
epilepsy.
• In the treatment of myoclonic seizures
in adults and adolscents from 12 years of
age with Juvenile Myoclonic Epilepsy.
• In the treatment of primary generalized
tonic-clonic
seizures
in
adults
and
children
from
12
years
of
age
with
Idiopathic Generalized Epilepsy.
HOW LETRAM_ _WORKS
LETRAM is an anti-epileptic medicine
(a
medicine
used
to
treat
seizures
in
epilepsy).
BEFORE YOU USE LETRAM
_When you must not use it_
_ _
Do not take LETRAM
:
•
If you are allergic (hypersensitive)
to
LETRAM
_ _
or any of the other
ingredients of
LETRAM.
PREGNANCY AND LACTATION
Pregnancy
Ask your doctor or pharmacist for advice
before taking any medicine.
If you are pregnant or if you think you
may
be
pregnant,
please
inform
your
doctor.
LETRAM
_ _
should
not
be
used
during
pregnancy
unless
clearly
necessary.
The potential risk to your unborn child is
unknown.
LETRAM
_ _
has
shown
unwanted reproductive effects in animal
studies at dose levels higher than you
would need to control your seizures.
Breastfeeding
Breast-feeding
is
not
recommended
during treatment.
-
_Before you start use it_
Take
special
care
with
LETRAM
and
check
with
your
doctor
or
pharmacist
before
using
this
medicine
if
you
are
suffering or have ever suffered from any
of the following conditions or illnesses:
•
If you suffer from kidne

Svojstava lijeka

LETRAM OS
LEVETIRACETAM ORAL SOLUTION 100MG/ML
DESCRIPTION
LETRAM OS (LEVETIRACETAM ORAL SOLUTION 100MG/ML) 150ML PACK SIZE: A
Clear,
colourless grape flavoured liquid filled in 200mL amber coloured glass
bottle.
LETRAM
OS
(LEVETIRACETAM
ORAL
SOLUTION
100MG/ML)
300ML
PACK
SIZE:
A
clear,
colorless grape flavoured liquid filled in 300ml amber coloured glass
bottle with EPE wad.
Each ml contains 100.00mg of Levetiracetam, 1.500mg of Methyl
Parahydroxy Benzoate (as
preservative) and 0.180mg of Propyl Parahydroxy Benzoate (as
preservative).
PHARMACODYNAMICS
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 but appears to be
different from the mechanisms of current antiepileptic medicinal
products.
_Pharmacodynamics effects _
Levetiracetam induces seizure protection in a broad range of animal
models of partial and
primary generalized seizures without having pro-convulsant effect. The
primary metabolite is
inactive.
In man, activity in both partial and generalized epilepsy conditions
(epileptiform discharge/photo
paroxysmal response) has confirmed the broad spectrum of the
preclinical pharmacological
profile.
PHARMACOKINETICS
Levetiracetam is a highly soluble and permeable compound. The
pharmacokinetic profile is
linear
and
time-independent
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 bodyweight. Therefore there is no
need for plasma level
monitoring of levetiracetam.
A significant correlation between saliva and pla