Sodium Valproate (400mg/4ml) Solution for Inj/Inf 100mg/ml

Țară: Malta

Limbă: engleză

Sursă: Medicines Authority

Ingredient activ:

VALPROATE SODIUM

Disponibil de la:

Wockhardt UK Limited

Codul ATC:

N03AG01

INN (nume internaţional):

VALPROATE SODIUM

Forma farmaceutică:

SOLUTION FOR INFUSION OR INJECTION

Compoziție:

VALPROATE SODIUM 100 mg/ml

Tip de prescriptie medicala:

POM

Zonă Terapeutică:

ANTIEPILEPTICS

Statutul autorizaţiei:

Authorised

Prospect

MPS READ DIRECTION
WOCKHARDT TRAVEL DIRECTION
Pharmacode:
Process Black
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Wockhardt UK Limited
SODIUM VALPROATE INJ 100MG/ML AMP COMMON LEAFLET
105857/6
See uploaded pdf
475 x 150mm
MPI
3
04/08/2017
880758
446
6pt (Main Body) / 7.5pt (Variables)
UK
English
446
MEASURE BAR SHOULD BE 150MM AT 100% SCALE
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WARNING! We cannot accept responsibility for any errors
in this proof after approval. Whilst we take extreme care
at all times to ensure accuracy to our clientʼs brief,
the final responsibility must be taken by our client.
IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING
FULL APPROVAL OF DESIGN AND TEXT.
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PACKAGE LEAFLET INFORMATION FOR THE PATIENT
SODIUM VALPROATE 100MG/ML SOLUTION FOR INJECTION OR INFUSION THIS MEDICINE IS
SUBJECT TO ADDITIONAL
MONITORING.
This will allow quick
identifica
tion 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.
WARNING
Valproate can cause birth defects and problems with early
development of the child if it is given during pregnancy. If you are
a female of childbearing age you should use an effective method
of contraception throughout your treatment.
Your doctor will discuss this with you but you should also follow
the advice in section 2 of this leaflet. Tell your doctor at once if
you become pregnant or think you might be pregnant.
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU.
-
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 personally and you
should not pass it on to others. It may harm them, even if their
symptoms are the same as yours.
-
If you get any side effects, talk to your doctor or p

Caracteristicilor produsului

Page 1 of 18
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 100mg/ml Solution for Injection or Infusion
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of solution contains 100 mg sodium valproate. Each 4 ml
ampoule contains 400 mg
sodium valproate. Each 10 ml ampoule contains 1000 mg sodium
valproate.
_ _
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Solution for Injection or Infusion.
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 injection may be given by
direct slow intravenous injection or by infusion
using a separate intravenous line
in normal saline, dextrose 5%, or dextrose saline.
_DOSAGE _
Dosage requirements vary according to age and body weight.
Each vial of sodium valproate injection is for single dose injection
only. For instructions on
preparation and dilution of sodium valproate injection before
administration see section 6.6.
Sodium valproate injection should not be administered via the same IV
line as other IV
additives. The intravenous solution is suitable for infusion by PVC,
polyethylene or glass
containers.
Patients already satisfactorily treated with oral sodium valproate may
be continued at their
current dosage using continuous or repeated infusion. Other patients
may be given a slow
Page 2 of 18
intravenous injection over 3-5 minutes, usually 400-800mg depending on
body weight (up
to 10mg/kg) followed by continuous or repeated infusion up to a
maximum of 2500mg/day.
Sodium valproate injection should be replaced by oral valproate
t