LEVETIRACETAM JUNO levetiracetam 500mg/100mL solution for infusion bags

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

levetiracetam

Available from:

Horizon Hospital Healthcare Pty Ltd

INN (International Name):

Levetiracetam

Authorization status:

Registered

Patient Information leaflet

Levetiracetam Juno solution for IV infusion CMI v2.0 October 2018
Page 1 of 4
CONSUMER MEDICINE INFORMATION
LEVETIRACETAM JUNO
_LEVETIRACETAM (PRONOUNCED “LEE VET YE RA SE TAM”) SOLUTION FOR IV
INFUSION _
_ _
WHAT IS IN THIS LEAFLET
This leaflet answers some
common questions about
Levetiracetam Juno solution for
IV infusion.
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 IN A SAFE PLACE.
You may need to read it again.
WHAT LEVETIRACETAM JUNO
SOLUTION FOR IV INFUSION IS
USED FOR
This medicine 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.
This medicine 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 Juno solution for
IV infusion 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.
There is no evidence that this
medicine is addictive.
This medicine is available only
with a doctor’s prescription.
BEFORE YOU ARE GIVEN
LEVETIRACETAM JUNO
SOLUTION FOR IV INFUSION
_ _
_WHEN YOU MUST NOT BE GIVEN IT _
YOU MUST NOT BE GIVEN THIS
MEDICINE IF YOU HAVE AN ALLERGY
TO:
•
Levetiracetam, the active
ingredient(s), or to any of the
other ingredient(s) listed at
the end of this leaflet under
Product Description.
Some of the symptoms of an
allergic reaction may include:
•
shortness of breath;
•
wheezing or difficulty
breathing;
•
swe

Summary of Product characteristics

Levetiracetam Juno solution for IV infusion PI v3 08 October 2018 Page
1 of 28
AUSTRALIAN PRODUCT INFORMATION – LEVETIRACETAM JUNO
(LEVETIRACETAM) SOLUTION FOR IV INFUSION
1
NAME OF THE MEDICINE
Levetiracetam
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Levetiracetam Juno 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 Juno solution for IV infusion is a pre-mixed drug
product solution which is
available in 100 mL bags containing 500 mg levetiracetam.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Levetiracetam Juno solution for IV infusion is an alternative for
patients when oral
administration is temporarily not feasible.
Levetiracetam Juno 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); and
•
add on therapy in the treatment of primary generalized tonic-clonic
seizures in adults
and children from 4 years of age with idiopathic generalized epilepsy
(IGE).
4.2
DOSE AND METHOD OF ADMINISTRATION
Levetiracetam therapy can be initiated with either intravenous or oral
administration.
Alternative preparations will be required for dosages requiring oral
tablets or suspension.
Conversion to or from oral to intravenous can be done directly without
titration. The total
daily dose and frequency of administration should be maintained.
Levetiracetam Juno solution for IV infusion PI v3 08 October 2018 Page
2 of 28
Levetiracetam Juno solution for IV infusion is for intravenous use
only. The ready to use
solution is for single use only. It does not