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

Țară: Australia

Limbă: engleză

Sursă: Department of Health (Therapeutic Goods Administration)

Ingredient activ:

levetiracetam, Quantity: 100 mg/mL

Disponibil de la:

Arrotex Pharmaceuticals Pty Ltd

INN (nume internaţional):

Levetiracetam

Forma farmaceutică:

Injection, intravenous infusion

Compoziție:

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

Calea de administrare:

Intravenous Infusion

Unități în pachet:

10 x 5mL vials

Tip de prescriptie medicala:

(S4) Prescription Only Medicine

Indicații terapeutice:

Levetiracetam concentrate solution for IV infusion after dilution is an alternative for patients when oral administration is temporarily not feasible. 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).

Rezumat produs:

Visual Identification: A clear, colourless, sterile solution.; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Statutul autorizaţiei:

Licence status A

Data de autorizare:

2015-03-12

Prospect

LEVETIRACETAM APOTEX
SOLUTION FOR INFUSION
_Contains the active ingredient levetiracetam_
CONSUMER MEDICINE INFORMATION
_FOR A COPY OF A LARGE PRINT LEAFLET, PH: 1800 195 055_
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about this medicine. 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 being given this
medicine against the benefits they
expect it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
BEING GIVEN THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT THIS MEDICINE IS
USED FOR
The name of your medicine is
Levetiracetam APOTEX Solution for
Infusion. It contains the active
ingredient levetiracetam.
It 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.
Levetiracetam belongs to a group of
medicines called anti-epileptics.
These medicines are thought to work
by controlling brain chemicals which
send signals to nerves so that seizures
do not happen.
Levetiracetam solution for infusion
may be used alone, or in combination
with other medicines, to treat your
condition.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.
Your doctor may have prescribed this
medicine for another reason.
This medicine is available only with
a doctor's prescription.
There is no evidence that this
medicine is addictive.
This medicine should not be used in
children. The safety and
effectiveness of this medicine has not
been established in patients less than
4 years of age.
BEFORE YOU ARE GIVEN
THIS MEDICINE
_WHEN YOU MUST NOT BE GIVEN_
_IT_
YOU SHOULD NOT BE GIVEN THIS
MEDICINE IF YOU HAVE AN ALLERGY TO:
•
any medicine containing
levetiracetam
•
any of the ingredients listed at the
end of this leaflet.
Some of the symptoms of an allergic
reactio

Caracteristicilor produsului

1
AUSTRALIAN PRODUCT INFORMATION
LEVETIRACETAM IV APOTEX (LEVETIRACETAM)
CONCENTRATE SOLUTION FOR IV INFUSION
1
NAME OF THE MEDICINE
Levetiracetam.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Levetiracetam
concentrate
solution
for
IV
infusion
contains
500 mg
of
levetiracetam
(500 mg/5 mL) as the active ingredient.
One vial of levetiracetam concentrate solution for IV infusion
contains 500 mg of levetiracetam
(500 mg/5 mL).
For the full list of excipients see section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
The concentrated solution for IV infusion is a clear, colourless,
sterile solution.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
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), 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).
Levetiracetam concentrate solution for IV infusion after dilution is
an alternative for patients
when oral administration is temporarily not feasible.
4.2
DOSE AND METHOD OF ADMINISTRATION
Levetiracetam IV APOTEX concentrate solution is intended for IV
infusion.
DOSAGE
Levetiracetam
therapy
can
be
initiated
with
either
intravenous
or
oral
administration.
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 concentrate solution for IV infusion is for intravenous
use only and must be
diluted in at least 100 mL of a compatible diluent and administered as
a