Epilim Intravenous 400mg powder and solvent for solution for injection vials

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Sodium valproate

Available from:

Sanofi

ATC code:

N03AG01

INN (International Name):

Sodium valproate

Dosage:

400mg

Pharmaceutical form:

Powder and solvent for solution for injection

Administration route:

Intravenous

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 04080100; GTIN: 5013417101128

Patient Information leaflet

_I_
PACKAGE LEAFLET: INFORMATION FOR THE USER
EPILIM® 400MG POWDER AND SOLVENT FOR SOLUTION
FOR INJECTION/INFUSION
sodium valproate
I AM PREGNANT AND I AM USING EPILIM INJECTION
Do not stop taking Epilim Injection unless your doctor tells you to as
your condition may
become worse.
Schedule an urgent appointment with your doctor if you are pregnant or
think you might be
pregnant. Your doctor will advise you further.
Babies born to mothers who have been on valproate are at serious risk
of birth defects and
problems with development which can be seriously debilitating. You
will be referred to a
specialist experienced in the management of epilepsy so that
alternative treatment
options can be evaluated.
In the exceptional circumstances when Epilim Injection is the only
available treatment
option during pregnancy, you will be monitored very closely both for
the management
of your underlying condition and to check how your unborn child is
developing. You
and your partner should receive counselling and support regarding the
valproate
exposed pregnancy.
Ask your doctor about taking folic acid. Folic acid can lower the
general risk of _spina bifida_
and early miscarriage that exists with all pregnancies. However, it is
unlikely that it will
reduce the risk of birth defects associated with valproate use.
KEY MESSAGES:
• Schedule an urgent appointment with your doctor if you are
pregnant or think you
might be pregnant.
• Do not stop taking Epilim Injection unless your doctor tells you
to.
• Make sure you are referred to a specialist experienced in the
treatment of epilepsy to
evaluate the need for alternative treatment options.
• You must get thorough counselling on the risks of Epilim Injection
during pregnancy,
including malformations and developmental effects in children.
• Make sure you are referred to a specialist for prenatal monitoring
in order to detect
possible occurrences of malformations.
MAKE SURE YOU READ THE PATIENT GUIDE THAT YOU WILL RECEIVE FROM YOUR
DOCTOR. YOUR
DOCTOR WILL DISCUSS THE ANNUAL RIS

Summary of Product characteristics

OBJECT 1
EPILIM 400MG POWDER AND SOLVENT FOR SOLUTION
FOR INJECTION/INFUSION
Summary of Product Characteristics Updated 11-May-2018 | SANOFI
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
Epilim 400mg Powder and Solvent for solution for injection/infusion
2. Qualitative and quantitative composition
Each vial of freeze-dried powder contains 400 mg of the active
substance Sodium Valproate.
Each ampoule of solvent contains 4 ml of Water for Injection.
For 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
Epilim 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.
_Dosage_
Daily dosage requirements vary according to age and body weight.
To reconstitute, inject the solvent provided (4 ml) 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 95 mg/ml.
Each vial of Epilim Intravenous is for single dose injection only. It
should be reconstituted immediately
prior to use and infusion solutions containing it used within 24
hours. Any unused portion should be
discarded (see section 6.6).
Epilim Intravenous should not be administered via the same IV line as
other IV additives. The
intravenous solution is suitable for infusion by PVC, polyethylen