SODIUM VALPROATE WOCKHARDT 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:

5, 1, 10

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Sodium Valproate Wockhardt 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

SODIUM VALPROATE WOCKHARDT CMI V 3.0
1
V3.0
SODIUM VALPROATE WOCKHARDT
_Sodium Valproate _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Sodium Valproate
Wockhardt.
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 Sodium Valproate
Wockhardt 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 SODIUM
VALPROATE WOCKHARDT
IS USED FOR
Sodium Valproate Wockhardt 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.
Sodium Valproate Wockhardt
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.
Sodium Valproate Wockhardt may
also be used to control mania, a
mental condition with episodes of
overactivity, elation or irritability.
Sodium Valproate Wockhardt may
be used alone or in combination
with other medicines to treat your
condition.
Sodium Valproate Wockhardt 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 Sodium Valproate
Wockhardt for another reason.
Ask your doctor if you have any
questions about why it has been
prescribed for you.
There is no evidence that Sodium
Valproate Wockhardt 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 SODIUM
VALPROATE WOCKHARDT IF YOU HAVE
OR HAVE HAD ANY OF THE FOLLOWING
MEDICAL CONDITIONS:
•
liver disease (hepatic

Summary of Product characteristics

SODIUM VALPROATE WOCKHARDT V4.1
Version 4.1
Page 1 of 29
Australian Product Information – SODIUM VALPROATE WOCKHARDT
(SODIUM VALPROATE) SOLUTION FOR INJECTION
1
NAME OF THE MEDICINE
Sodium Valproate
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
SODIUM VALPROATE WOCKHARDT 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
SODIUM VALPROATE WOCKHARDT 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
SODIUM VALPROATE WOCKHARDT 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.
SODIUM VALPROATE WOCKHARDT 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.
SODIUM VALPROATE WOCKHARDT should be replaced by oral sodium valproate
therapy
(available from other brands) as soon as practicable.
Each ampoule of SODIUM VALPROATE WOCKHARDT 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.
SODIUM
VALPROATE
WOCKHARDT is intended for use in one patient on one occasion only, any
unused portion
should be discarded. NEVER ADMINISTER SODIUM VALPROATE WOCKHARDT OTHER
THAN BY THE