Sodium Valproate 400mg Powder and Solvent for solution for injection/infusion

Country: United Kingdom

Language: English

Source: myHealthbox

Active ingredient:

Sodium Valproate

Available from:

Noridem Enterprises Ltd

ATC code:

N03AG01

INN (International Name):

Sodium Valproate

Dosage:

400mg

Pharmaceutical form:

Powder and Solvent for solution for injection/infusion

Administration route:

intravenous injection or by infusion

Units in package:

packs of 1 glass vial with 1 glass ampoule solvent, 4 glass vials with 4 glass ampoules solvent and 5 glass vials with 5 glass a

Prescription type:

POM - Prescription Only Medicine

Manufactured by:

DEMO S.A.

Therapeutic group:

Anti-epileptics; Fatty acid derivatives

Therapeutic indications:

The treatment of epileptic patients who would normally be maintained on oral sodium valproate and for whom oral therapy is temporarily not possible.

Authorization status:

Authorised

Authorization date:

2015-04-27

Patient Information leaflet

 
PACKAGE LEAFLET: INFORMATION FOR THE USER 

SODIUM VALPROATE 400MG POWDER AND SOLVENT FOR 
SOLUTION FOR INJECTION/INFUSION 
Sodium Valproate 

This medicine is subject to additional monitoring. 
This will allow quick identification of new safety 
information. You can help by reporting any side effects 
you may get. See the end of section 4 for how to report 
side effects.  

IMPORTANT THINGS TO KNOW ABOUT YOUR 
MEDICINE 

Like all medicines Sodium Valproate
_ _
can have unwanted 
effects. It is therefore important that you and your doctor 
weigh up the benefits of treatment against the possible 
unwanted effects, before starting treatment. 

Sodium Valproate
_ _ 
must not be used by women who are 
trying to become pregnant or are pregnant as it can cause 
serious birth defects and developmental problems in the 
child, unless explicitly advised and agreed with your doctor 
to do so. All female patients who are capable of becoming 
pregnant will need to consider this risk and follow the 
advice provided in section 2. Your doctor will discuss this 
with you. 

Please read the rest of this leaflet. It includes other 
important information on the safe and effective use of this 
medicine that might be especially important for you.  

There is a lot of information and it is recommended that 
you show this leaflet to friends and family to help you 
discuss and understand your treatment. This leaflet was 
last updated on 03/2015_._ 
-  Keep this leaflet. You may need to read it again.  
-  If you have any further questions, ask your doctor or 
pharmacist.  
-  This medicine has been prescribed for you only. Do 
not pass it on to others. It may harm them, even if 
their symptoms seem the same as yours.  
-  If you get

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS 
This medicinal product is subject to additional monitoring. This will
allow quick 
identification of new safety information.
Healthcare professionals are asked to report 
any suspected adverse reactions. See section 4.8 for how to
report adverse reactions. 

1 
NAME OF THE MEDICINAL PRODUCT 
Sodium Valproate_ _400mg Powder and Solvent for solution
for injection/infusion. 

2 
QUALITATIVE AND QUANTITATIVE COMPOSITION 
Each vial of freeze-dried powder contains 400mg of
the active substance Sodium 
Valproate. 

Each ampoule of solvent contains 4ml of Water for Injection. 

Each 1 ml of the reconstituted solution contains 95mg of the
active substance Sodium 
Valproate.  

For the full list of excipients, see section 6.1. 

3 PHARMACEUTICAL 
FORM 
Powder and Solvent for solution for injection/infusion. 

The powder is hygroscopic, white or
practically white crystalline.  

The solvent is a clear, colourless solution. 

4 CLINICAL 
PARTICULARS 

4.1 THERAPEUTIC 
INDICATIONS 
The treatment of epileptic patients who would
normally be maintained on oral sodium 
valproate and for whom oral therapy is
temporarily not possible. 

4.2 
POSOLOGY AND METHOD OF ADMINISTRATION 
Sodium Valproate_ _Intravenous may be given by direct slow
intravenous injection or 
by infusion using a separate intravenous line in normal saline,
dextrose 5%, or 
dextrose saline. 

_Posology _
_ _
Monotherapy 

Daily dosage requirements vary according to age and
body weight. 

To reconstitute, inject the solvent provided (4ml) into the
vial, allow to dissolve and 
extract the appropriate dose. Due to displacement of solvent
by sodium valproate the 
concentration of reconstituted sodium valproate is 95mg/ml. 

Each vial of Sodium Valproate Intravenous is for
single dose injection only. It should 
be reconstituted immediately prior�