hovid-Valproate Liquid 200 mg5 ml

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

SODIUM VALPROATE

Boleh didapati daripada:

HOVID BERHAD

INN (Nama Antarabangsa):

SODIUM VALPROATE

Unit dalam pakej:

300 ml; 100 ml; 300 ml

Dikeluarkan oleh:

HOVID BERHAD

Risalah maklumat

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
HOVID-VALPROATE LIQUID 200MG/5ML
SODIUM VALPROATE (200MG/5ML)
1
WHAT IS IN THIS LEAFLET
1.
What hovid Valproate Liquid is
used for
2.
How hovid Valproate Liquid works
3.
Before you use hovid Valproate
Liquid
4.
How to use hovid Valproate Liquid
5.
While you are using it
6.
Side effects
7.
Storage and disposal of hovid
Valproate Liquid
8.
Product description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
11.
Serial number
WHAT HOVID VALPROATE LIQUID IS USED
FOR
hovid Valproate Liquid is used for the
treatment of generalized (affects the
entire brain) or partial (only affects a
small part of the brain) epilepsy (fits)
with the following pattern of seizures:
•
Absence (a short period of
“blanking out”)
•
Myoclonic (brief, shock-like
jerks of muscles)
•
Tonic-clonic (muscles stiffen,
and jerking movements)
•
Atonic (muscles suddenly lose
strength)
•
Mixed
•
Simple (awareness is retained)
or complex (impairment of
awareness) seizures
•
Secondary generalized seizure
(spread to both sides of the
brain after the initial event)
•
Specific syndromes (Wes,
Lennox-Gastaut)
Hovid Valproate Liquid may also be
used to control bipolar disorder, a
mental condition with mania symptoms
(an elevation of mood).
HOW HOVID VALPROATE LIQUID WORKS
hovid Valproate Liquid contains a
medicine called sodium valproate. This
belongs to a group of medicines called
anticonvulsants or anti-epileptic agents.
It works by controlling brain chemicals
which send signals to nerves so that
seizures do not happen.
BEFORE YOU USE HOVID VALPROATE
LIQUID
WARNING FOR WOMEN AND
GIRLS
Before you start to use it:
This medicine can seriously harm an
unborn baby
Always use effective contraception
during treatment with sodium valproate
If you are thinking about becoming
pregnant, or if you are pregnant, contact
your doctor urgently.
You must CONTINUE taking sodium
valproate unless your doctor tells you to
stop
_- When you must not use it_
Do not take this medicine if:
•

Ciri produk

HOVID VALPROATE LIQUID 200MG / 5ML
VIVAL05-var (MY)
DESCRIPTION
A red, cherry flavoured liquid.
COMPOSITION
Each 5 ml contains Sodium Valproate 200 mg.
PHARMACODYNAMICS
Sodium valproate is an anticonvulsant.
The most likely mode of action for Hovid Valproate Liquid is
potentiation of the inhibitory action of gamma amino-butyric acid
(GABA) through an action on the further synthesis or further
metabolism of GABA.
PHARMACOKINETICS
The half-life of Hovid Valproate Liquid 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 levels.
The reported effective therapeutic range for plasma valproic
acid levels is 40-100 mg/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
Hovid
Valproate Liquid may not be clearly correlated with the total or
free (unbound) plasma valproic acid levels.
INDICATION
Treatment of generalized or partial epilepsy, particularly with
the following patterns of seizures:
•
Absence
•
Myoclonic
•
tonic-clonic
•
atonic
•
mixed
As well as, for partial epilepsy:
•
simple or complex seizures
•
secondary generalized seizures
•
specific syndromes (West, Lennox-Gastaut)
Treatment and prevention of mania associated with bipolar disorder.
CONTRAINDICATIONS
•
Active liver disease
•
History of severe hepatic dysfunction
•
Hypersensitivity to sodium valproate
•
Porphyria
•
Valproate is contraindicated in patients known to have
mitochondrial disorders caused by mutations in the nuclear
gene encoding the mitochondrial enzyme polymerase
γ
(POLG), e.g. Alpers-Huttenlocher Syndrome, and in children
under two years of age who ar