LEVETIRACETAM MEDSURGE levetiracetam 500 mg/5 mL concentrate solution for IV infusion vial

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

levetiracetam, Quantity: 500 mg

Available from:

Medsurge Pharma Pty Ltd

Pharmaceutical form:

Injection, concentrated

Composition:

Excipient Ingredients: sodium chloride; sodium acetate trihydrate; glacial acetic acid; water for injections

Administration route:

Intravenous Infusion

Units in package:

10 x 5 mL vials

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Levetiracetam concentrate solution for IV infusion after dilution is an alternative for patients when oral administration is temporarily not feasible.,Levetiracetam concentrate solution for IV infusion is indicated for:,? Use in epileptic patients aged 4 years and older, initially as add-on therapy, in the treatment of partial onset seizures with or without secondary generalisation.,? Monotherapy in the treatment of partial onset seizures, with or without secondary generalisation, in patients from 16 years of age with newly diagnosed epilepsy.,? Add on therapy in the treatment of myoclonic seizures in adults and adolescents from 12 years of age with Juvenile Myoclonic Epilepsy (JME).,? Add on therapy in the treatment of primary generalised tonic-clonic (PGTC) seizures in adults and children from 4 years of age with idiopathic generalised epilepsy (IGE).

Product summary:

Visual Identification: A clear colourless solution.; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Registered

Authorization date:

2022-03-04

Patient Information leaflet

LEVETIRACETAM MEDSURGE IV
1
LEVETIRACETAM MEDSURGE CONCENTRATE SOLUTION FOR IV INFUSION
Levetiracetam
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 LEVETIRACETAM MEDSURGE IV?
Levetiracetam IV contains the active ingredient levetiracetam.
Levetiracetam IV is used to control epilepsy. Levetiracetam IV
may be used alone, or in combination with other medicines, to treat
your condition.
For more information, see Section 1. Why am I using Levetiracetam IV?
in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE LEVETIRACETAM MEDSURGE IV?
Do not use if you have ever had an allergic reaction to Levetiracetam
IV or any of the ingredients listed at the end of the CMI.
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 use
Levetiracetam IV?
in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may be affected by Levetiracetam IV or may 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 IS LEVETIRACETAM MEDSURGE IV GIVEN?
Your doctor will decide how much Levetiracetam IV you will receive.
This depends on your age, your condition and whether or
not you are taking any other medicines. More instructions can be found
in Section 4. How do I use Levetiracetam IV?
in the full
CMI.
5.
WHAT SHOULD I KNOW WHILE USING LEVETIRACETAM MEDSURGE IV?
THINGS YOU
SHOULD DO
•
Tell your doctor immediately if you notice an increase in seizures.
•
Tell your doctor immediately if you have symptoms of depression or
thoughts of harming yourself.
•
Tell any other doctors, dentists, and pharmacists who are treating you
that you are being given this
medicine.
THINGS TO BE
CAREFUL OF
•
If you are feeling dizzy or drowsy do not drive, operate machinery, o

Summary of Product characteristics

Page 1 of 27
LEVETIRACETAM
PRODUCT INFORMATION
AUSTRALIAN PRODUCT INFORMATION
LEVETIRACETAM MEDSURGE
(LEVETIRACETAM)
CONCENTRATE SOLUTION FOR IV INFUSION
1
NAME OF THE MEDICINE
Levetiracetam
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5 mL of Levetiracetam Medsurge concentrate solution for IV
infusion contains 500 mg
levetiracetam.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Levetiracetam Medsurge concentrate solution for IV infusion is a clear
colourless solution.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Levetiracetam concentrate solution for IV infusion after dilution is
an alternative for patients when
oral administration is temporarily not feasible.
Levetiracetam concentrate solution for IV infusion is indicated for:
•
Use in epileptic patients aged 4 years and older, initially as add-on
therapy, in the
treatment of partial onset seizures with or without secondary
generalisation.
•
Monotherapy in the treatment of partial onset seizures, with or
without secondary
generalisation, in patients from 16 years of age with newly diagnosed
epilepsy.
•
Add on therapy in the treatment of myoclonic seizures in adults and
adolescents from
12 years of age with Juvenile Myoclonic Epilepsy (JME).
•
Add on therapy in the treatment of primary generalised tonic-clonic
(PGTC) seizures in
adults and children from 4 years of age with idiopathic generalised
epilepsy (IGE).
4.2
DOSE AND METHOD OF ADMINISTRATION
DOSAGE
Conversion to or from oral to intravenous can be done directly without
titration. The total daily dose
and frequency of administration should be maintained.
_MONOTHERAPY_
The recommended starting dose is 250 mg twice daily, which should be
increased to an initial
~GE
Page 2 of 27
therapeutic dose of 500 mg twice daily after two weeks. The dose can
be further increased by
250 mg twice daily every two weeks depending upon the clinical
response. The maximum dose is
1,500 mg twice daily.
_ _
_ADD-ON THERAPY_
_Adults (> 18 years of age) and adolescents (ag