VALWOK sodium valproate 1000 mg/10 mL solution for injection ampoule

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

sodium valproate, Quantity: 1000 mg

Available from:

Wockhardt Bio Pty Ltd

INN (International Name):

Sodium valproate

Pharmaceutical form:

Injection, solution

Composition:

Excipient Ingredients: dibasic sodium phosphate dodecahydrate; monobasic sodium phosphate dihydrate; phosphoric acid; sodium hydroxide; water for injections

Administration route:

Intravenous, Intravenous Infusion

Units in package:

1, 5, 10

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

VALWOK is used for the treatment of patients with epilepsy or mania, who would normally be maintained on oral sodium valproate, and for whom oral therapy is temporarily not possible.

Product summary:

Visual Identification: Clear colourless solution; Container Type: Ampoule; Container Material: Glass Type I Clear; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2017-06-02

Patient Information leaflet

VALWOK
1
V2.0
VALWOK
_Sodium Valproate _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about VALWOK.
It does not contain all of the
available information.
It does not take the place of talking
to your doctor or pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of using VALWOK
against the benefits it is expected to
have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE
MEDICINE.
You may need to read it again.
WHAT VALWOK IS
USED FOR
VALWOK is a medicine used to for
the treatment of epilepsy in adults
and children.
Epilepsy is a condition where you
have repeated seizures (fits). There
are many different types of seizures,
ranging from mild to severe.
VALWOK belongs to a group of
medicines called anticonvulsants.
These medicines are thought to
work by controlling brain chemicals
which send signals to nerves so that
seizures do not happen.
VALWOK may also be used to
control mania, a mental condition
with episodes of overactivity,
elation or irritability.
VALWOK may be used alone or in
combination with other medicines
to treat your condition.
VALWOK may be used short-term
in place of oral sodium valproate
tablets or liquid when the medicine
cannot be given by mouth.
Your doctor, however, may have
prescribed VALWOK for another
reason.
Ask your doctor if you have any
questions about why it has been
prescribed for you.
There is no evidence that
VALWOK is addictive.
This medicine is available only with
a doctor's prescription.
BEFORE YOU ARE GIVEN
IT
_WHEN YOU MUST NOT RECEIVE _
_IT _
YOU SHOULD NOT RECEIVE
VALWOK IF YOU HAVE OR HAVE
HAD ANY OF THE FOLLOWING MEDICAL
CONDITIONS:

liver disease (hepatic
dysfunction) or severe hepatitis.

a family history of hepatitis,
especially when caused by
medicines. Medicines used in
the treatment of epilepsy,
including VALWOK may have
adverse effects on the liver and
the kidneys.

a urea cycle disorder or a family
history

Summary of Product characteristics

VALWOK V4.1
Version 4.1
Page 1 of 29
Australian Product Information –VALWOK (SODIUM VALPROATE)
SOLUTION FOR INJECTION
1
NAME OF THE MEDICINE
Sodium Valproate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
VALWOK solution for injection is available in ampoules containing the
active ingredient
sodium valproate 100 mg/mL.
Each 4 mL ampoule contains 400 mg sodium valproate and each 10 mL
ampoule contains
1000 mg sodium valproate.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Is a clear and colourless solution for injection in a Type I glass
ampoule.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
VALWOK is used for the treatment of patients with epilepsy or mania,
who would normally
be maintained on oral sodium valproate, and for whom oral therapy is
temporarily not
possible.
4.2
D
OSE AND METHOD OF ADMINISTRATION
VALWOK may be given by direct slow intravenous injection or by slow
intravenous infusion
in 0.9% NaCL (normal saline), 5% glucose solution or glucose saline,
using a separate
intravenous line. The recommended concentration of the intravenous
infusion solution is 4
mg/mL, with 8 mg/mL being the maximum concentration.
VALWOK should not be administered at the same time as other
intravenous additives via
the same IV line. The intravenous solution is suitable for infusion by
PVC, polyethylene or
glass containers.
VALWOK should be replaced by oral sodium valproate therapy (available
from other brands)
as soon as practicable.
Each ampoule of VALWOK is for single dose injection only. To reduce
microbiological
hazard, use as soon as practicable after dilution. If storage is
necessary hold at 2 to 8ºC for
not more than 24 hours. VALWOK is intended for use in one patient on
one occasion only,
any unused portion should be discarded. NEVER ADMINISTER VALWOK OTHER
THAN
BY THE INTRAVENOUS ROUTE (see Section 4.3 CONTRAINDICATIONS).
Monotherapy
Daily dosage requirements vary according to age and body weight.
VALWOK V4.1
Version 4.1
Page 2 of 29
Adults
Patients already satisfac