Epilim Intravenous 400mg powder and solvent for solution for injection or infusion

国: アイルランド

言語: 英語

ソース: HPRA (Health Products Regulatory Authority)

有効成分:

Sodium valproate

から入手可能:

Sanofi-Aventis Ireland Limited T/A SANOFI

ATCコード:

N03AG; N03AG01

INN（国際名）:

Sodium valproate

投薬量:

400 milligram(s)

医薬品形態:

Powder and solvent for solution for injection/infusion

処方タイプ:

Product subject to prescription which may not be renewed (A)

治療領域:

Fatty acid derivatives; valproic acid

認証ステータス:

Marketed

承認日:

1998-12-15

情報リーフレット

PACKAGE LEAFLET: INFORMATION FOR THE USER
EPILIM® INTRAVENOUS 400 MG, POWDER AND SOLVENT FOR SOLUTION FOR
INJECTION OR
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.
IS THIS LEAFLET HARD TO SEE OR READ? PHONE [phone] FOR HELP
WARNING
Epilim, sodium valproate can seriously harm an unborn child when taken
during pregnancy.
If you are a female able to have a baby you must use effective method
of birth control
(contraception) without interruptions during your entire treatment
with Epilim. Your doctor
will discuss this with you but you must also follow the advice in
section 2 of this leaflet.
Schedule an urgent appointment with your doctor if you want to become
pregnant or if you
think you are pregnant.
Do not stop taking Epilim unless your doctor tells you to as your
condition may become
worse._ _
OTHER SOURCES OF INFORMATION
For the most up to date patient information leaflet and important
safety information on this product for girls and women of childbearing
potential scan the QR code included in this leaflet and on the carton
label with a smartphone. The same information is also available on the
following URL: qr.epilimandme.ie
Patients should select the electronic patient information leaflet
which
matches the name of their medicine, the name of this medicine is
stated in full at the beginning of this leaflet.
qr.epilimandme.ie
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS
MEDICINE
•
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 signs of illness are the same as yours.
•
If you get any side effects, talk to your doctor or pharmacist. This
includes any
possible side effects not listed in this leaf

製品の特徴

Health Products Regulatory Authority
11 March 2024
CRN00F60S
Page 1 of 17
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
Epilim Intravenous 400mg powder and solvent for solution for injection
or infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 400mg of Sodium Valproate.
The concentration of reconstituted sodium valproate is 100 mg/ml.
Excipients with known effect:
Sodium 55.35 mg (see section 4.4).
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Powder and solvent for solution for injection or infusion.
Colourless Type I glass vial containing a sterile off-white freeze
dried powder (sodium valproate 400mg) and colourless glass
Type I flat-bottomed closed ampoule containing 4ml of Water for
Injections.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
In the treatment of generalised, partial or other epilepsy for
short-term therapy, where oral treatment is not possible.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Epilim Intravenous is for intravenous injection or infusion.
DOSAGE
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. See section
6.6 for instructions on reconstitution of the solution for
injection/infusion.
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.
Epilim Intravenous should not be administered via the same IV line as
other IV additives. The intravenous solution is suitable
for infusion in PVC, polyethylene or glass containers.
Epilim Intravenous may be given by direct slow intravenous