Epilim IV

Land: Nieuw-Zeeland

Taal: Engels

Bron: Medsafe (Medicines Safety Authority)

Werkstoffen:

Sodium valproate 400mg

Beschikbaar vanaf:

Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics

INN (Algemene Internationale Benaming):

Sodium valproate 400 mg

Dosering:

100 mg/mL

farmaceutische vorm:

Powder for injection with diluent

Samenstelling:

Active: Sodium valproate 400mg Excipient: Water for injection

Eenheden in pakket:

Ampoule, 4 mL

klasse:

Prescription

Prescription-type:

Prescription

Geproduceerd door:

Sanofi Chimie

therapeutische indicaties:

Epilim IV: The treatment of patients with epilepsy or bipolar disorder, who would normally be maintained on oral sodium valproate, and for whom oral therapy is temporarily not possible.

Product samenvatting:

Package - Contents - Shelf Life: Ampoule, - 4 mL - 36 months from date of manufacture stored at or below 30°C - Combination pack, 1 x (powder + diluent) - 400 mg - 36 months from date of manufacture stored at or below 30°C 24 hours opened stored at 2° to 8°C (Refrigerate, do not freeze) - Vial, glass, - 400 mg - 36 months from date of manufacture stored at or below 30°C

Autorisatie datum:

1989-09-06

Bijsluiter

Epilim IV®
1
EPILIM
® IV
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1.
WHY AM I USING EPILIM IV?
Epilim IV contains the active ingredient sodium valproate. Epilim IV
is used to treat epilepsy in adults and children and bipolar
disorder in adults.
For more information, see Section 1. Why am I being given Epilim IV?
in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE EPILIM IV?
You should not be given Epilim IV if you have ever had an allergic
reaction to Epilim IV or any of the ingredients listed at the end
of the CMI.
EPILIM IV CAN SERIOUSLY HARM AN UNBORN CHILD WHEN TAKEN DURING
PREGNANCY. IF YOU ARE A FEMALE ABLE TO HAVE A BABY, YOU MUST
USE AN EFFECTIVE METHOD OF BIRTH CONTROL (CONTRACEPTION) DURING YOUR
ENTIRE TREATMENT WITH EPILIM IV. SCHEDULE AN URGENT
APPOINTMENT WITH YOUR DOCTOR IF YOU WANT TO BECOME PREGNANT OR IF YOU
THINK YOU BECAME PREGNANT. DO NOT STOP TAKING EPILIM
IV UNLESS YOUR DOCTOR TELLS YOU TO, AS IT MAY BE DANGEROUS FOR YOU.
RISK OF NEURODEVELOPMENT DISORDERS IN CHILDREN BORN TO MEN
TREATED WITH VALPROATE CANNOT BE EXCLUDED. ENSURE THAT YOUR DOCTOR HAS
ADVISED YOU OF THE RISKS, ALTERNATIVE TREATMENT
OPTIONS, OR IF REMAINING ON EPILIM IV THE NEED FOR EFFECTIVE
CONTRACEPTION.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY
OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME
PREGNANT OR ARE BREASTFEEDING.
For more information, see Section 2. What should I know before I am
given Epilim IV? in the full CMI and read the patient guide
available electronically through QR code on the carton
(www.sanofi.com.au/valproate)
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Epilim IV and affect how it works.
A list of these medicines is in Section 3. What if I am taking other
medicines? in the full CMI.
4.
HOW AM I GIVEN EPILIM IV?
•
Your doctor will tell you how much to take. This may depend on your
age, your condition and whet

Productkenmerken

epilim-ccdsv38-dsv28-24nov23
Page 1
NEW ZEALAND DATA SHEET
1
PRODUCT NAME
Epilim 100 crushable tablet, 100 mg
Epilim EC modified release tablet, 200 mg
Epilim EC modified release tablet, 500 mg
Epilim Syrup, 200 mg/5 mL
Epilim Liquid oral solution (sugar free), 200mg/5mL
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Epilim 100 Crushable Tablets contain 100 mg sodium valproate.
Epilim EC Modified Release Tablets contain 200 mg sodium valproate.
Epilim EC Modified Release Tablets contain 500 mg sodium valproate.
Epilim Syrup, each 5 mL of syrup contains 200 mg sodium valproate.
Excipients of known
effects: sucrose, saccharin sodium and sorbitol.
Epilim Liquid Oral Solution (sugar free), each 5mL of liquid contains
200 mg sodium valproate.
Excipients of known effects: saccharin sodium, sorbitol solution (70%)
(non-crystallising),
sodium methyl hydroxybenzoate and sodium propyl hydroxybenzoate.
For the full list of excipients, see Section 6.1 List of Excipients.
3
PHARMACEUTICAL FORM
Crushable tablet, 100 mg (white, scored).
Modified release tablet, 200 mg (lilac, enteric-coated).
Modified release tablet, 500 mg (lilac enteric-coated).
Syrup, 200 mg/5 mL (red, cherry flavoured).
Oral solution sugar free liquid, 200 mg/5 mL (red, cherry flavoured)
epilim-ccdsv38-dsv28-24nov23
Page 2
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
_EPILEPSY _
Primary generalised epilepsy (petit mal absences, various forms of
myoclonic epilepsy and tonic-
clonic grand mal seizures). Partial (focal) epilepsy either alone or
as adjuvant therapy. In women
of child bearing potential effective contraception must also be
prescribed.
_BIPOLAR DISORDER _
For the treatment of manic episodes, maintenance and prophylactic
treatment of bipolar disorder
when other treatments have failed. In women of child bearing potential
effective contraception
must also be prescribed. The safety and efficacy of sodium valproate
for the treatment of manic
episodes in bipolar disorder have not been evaluated in patients aged
less than 18 years.
4.2
DOSE AND METHOD