Unival Syrup 200mg5ml

Страна: Малайзія

мова: англійська

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

Активний інгредієнт:

SODIUM VALPROATE

Доступна з:

MEDIDATA SDN BHD

ІПН (Міжнародна Ім'я):

SODIUM VALPROATE

Одиниць в упаковці:

100ml1Units mL

Виробник:

United Pharmaceutical Company Mfg. Co. Ltd.

інформаційний буклет

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
_ _
UNIVAL SYRUP 200MG/5ML
UNIVAL ENTERIC COATED TABLET 200MG
Sodium Valproate
WHAT IS IN THIS LEAFLET?
1.
What UNIVAL is used for
2.
How UNIVAL works
3.
Before you use UNIVAL
4.
How to use UNIVAL
5.
While you are using it
6.
Side effects
7.
Storage
and
disposal
of
UNIVAL
8.
Product description
9.
Manufacturer and Product
Registration Holder
10.
Date of Revision
WHAT UNIVAL IS USED FOR
GENERALIZED SEIZURES:
Petit mal which includes:
-
Absence.
-
Myoclonic-astatic (Lennox).
-
Blitz-Nick-Salaam
(BNS)
syndrome.
Grand mal.
Grand mal and petit mal.
PARTIAL (FOCAL) SEIZURES:
Motor (Jackson, adversions).
Psychomotor.
HOW UNIVAL WORKS
sodium
valproate
is
an
anti-
epileptic and anticonvulsive agent.
By
inhibiting
aminobutyrate
aminotransferase
activity,
Valproate increases the level of y-
aminobutyric acid (GABA) in the
CNS.
GABA
inhibits
pre-
and
post-synaptic
discharges.
Valproate
contains
no
nitrogen
atom
thus
differing
completely
from the structure of the commonly
used anticonvulsive agents.
BEFORE YOU USE UNIVAL
-
_When you must not use it _
Do not take sodium valproate if:
•
You are allergic (hypersensitive)
to sodium valproate or any of
the
orher
ingredients
of
UNIVAL.
•
You have liver problems or you
or your family have a history of
live problems.
•
You have a rare illness
known
as porphyria (a type of blood
disorders).
•
You
are
pregnant,
unless
nothing else works for you.
Do not use this medicine if any
of the above apply to you. If you
are not sure, talk to your doctor
or pharmacist.
- _Before you start to use it _
A small number of people being
treated with sodium valproate
have had thoughts of harming or
killing themselves. If at any time
you
have
these
thoughts,
immediately contact your doctor.
Check with your doctor before
taking this medicine if:
•
You
have
diabetes.
This
medicine
may affect the result
of urine tests.
•
You have kidney problems.
•
You have a ‘urea cycle disorder’
where too much ammonia builds
up in the body
•
You
have
a

Характеристики продукта

UNIVAL
SYRUP 200MG/5ML
Sodium valproate
NAME AND STRENGTH OF ACTIVE INGREDIENT
Sodium Valproate 200mg/5ml
PRODUCT DESCRIPTION
Pink, slightly viscous syrup with cherry flavor.
PHARMACODYNAMIC
-
Sodium valproate is an anticonvulsant.
-
The most likely mode of action for sodiu m valproate is potentiation
of the
inhibitory action of gamma amino-butyric acid (GABA) through an action
on the
further synthesis or further metabolism of GABA.
-
In certain in-vitro studies it was reported that sodium valproate
could stimulate HIV
replication but studies on peripheral blood mononuclear cells fro m
HIV-infected
subjects show that sodium valproate does not have a
mitogen-like effect on
inducing HIV replication. Indeed the effect of sodiu m valproate on
HIV replication
ex-vivo is highly variable, modest in quantity, appears to be
unrelated to the dose
and has not been documented in man.
PHARMACOKINETICS
-
The reported effective therapeutic range for plasma valproic acid
levels is 40-
100mg/litre (278-694 micromol/litre). This reported range may depend
on time of
sampling and presence of co-medication.
-
The percentage of free (unbound) drug is usually between 6% and 15% of
the total
plasma
levels.
An
increased
incidence
of
adverse
effects
may
occur
with
plasma levels above the effective therapeutic range.
-
The pharmacological (or therapeutic) effects of sodium valproate may
not be
clearly correlated with the total or free (unbound) plasma valproic
acid levels.
-
The major pathway of sodium valproate biotransformation is
glucuronidation (~
40%), mainly via UGT1 A6, UGT1A9 and UGT2B7.
-
The half-life of sodium valproate is usually reported to be within the
range 8-20
hours. It is usually shorter in children.
-
In patients with severe renal insufficiency it may be necessary to
alter dosage in
accordance with free plasma valproic acid levels.
INDICATION
In the treatment of generalized or partial epilepsy, particularly with
the following
patterns of seizures : - Absence - Myoclonic - Tonic-clonic - Atonic -
Mixed
As well as, for pa