LEVETIRACETAM SANDOZ 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:

Sandoz Pty Ltd

INN (International Name):

Levetiracetam

Pharmaceutical form:

Injection, concentrated

Composition:

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

Administration route:

Intravenous Infusion

Units in package:

10 vials, 1 vial

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Levetiracetam Sandoz concentrate solution for IV infusion after dilution is an alternative for patients when oral administration is temporarily not feasible.,Levetiracetam Sandoz 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 JME. ? Add on therapy in the treatment of PGTC seizures in adults and children from 4 years of age with IGE.

Product summary:

Visual Identification: Clear, colourless solution.; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Registered

Authorization date:

2013-02-05

Patient Information leaflet

LEVETIRACETAM SANDOZ
®
_Levetiracetam concentrate solution for IV infusion_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Levetiracetam
Sandoz Concentrate for IV Infusion
(Levetiracetam Sandoz IV).
It does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you taking this medicine
against the benefits they expect it
will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET.
You may need to read it again.
WHAT LEVETIRACETAM
SANDOZ IV IS USED FOR
Levetiracetam Sandoz IV is used to
control epilepsy.
Epilepsy is a condition where you
have repeated seizures. There are
many different types of seizures,
ranging from mild to severe.
It contains the active ingredient,
levetiracetam which belongs to a
group of medicines called
antiepileptics. These medicines are
thought to work by controlling brain
chemicals which send signals to
nerves so that seizures do not
happen.
Levetiracetam Sandoz IV may be
used alone, or in combination with
other medicines, to treat your
condition.
Your doctor may have prescribed this
medicine in addition to your current
therapy.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed it
for another reason.
There is no evidence that this
medicine is addictive.
This medicine is available only with
a doctor's prescription.
The safety and effectiveness of
Levetiracetam Sandoz IV has not
been established in patients less than
4 years of age.
BEFORE YOU ARE GIVEN
LEVETIRACETAM SANDOZ
IV
_WHEN YOU MUST NOT BE GIVEN_
_IT_
YOU MUST NOT BE GIVEN THIS
MEDICINE IF YOU HAVE AN ALLERGY TO:
•
levetiracetam, the active
ingredient, or to any of the other
ingredients listed at the end of
this leaflet under Product
Description
•
any other similar medicines.
Some of the symptoms of an aller

Summary of Product characteristics

210809-Levetiracetam Sandoz-pi
Page 1 of 26
AUSTRALIAN PRODUCT INFORMATION
LEVETIRACETAM SANDOZ
® (LEVETIRACETAM) CONCENTRATE
SOLUTION FOR IV INFUSION
1
NAME OF THE MEDICINE
Levetiracetam
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 5 mL of Levetiracetam Sandoz 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 Sandoz concentrate solution for IV infusion is a clear
colourless solution.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
Levetiracetam Sandoz concentrate solution for IV infusion after
dilution is an alternative for
patients when oral administration is temporarily not feasible.
Levetiracetam Sandoz 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 generalized tonic-clonic
(PGTC) seizures
in adults and children from 4 years of age with idiopathic generalized
epilepsy (IGE).
4.2
D
OSE 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
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 (aged 12 to