LEVETIRACETAM GH Oral levetiracetam 100 mg/mL amber glass bottle

Ország: Ausztrália

Nyelv: angol

Forrás: Department of Health (Therapeutic Goods Administration)

Aktív összetevők:

levetiracetam, Quantity: 100 mg/mL

Beszerezhető a:

Southern Cross Pharma Pty Ltd

INN (nemzetközi neve):

Levetiracetam

Gyógyszerészeti forma:

Solution

Összetétel:

Excipient Ingredients: propyl hydroxybenzoate; purified water; ammonium glycyrrhizinate; acesulfame potassium; methyl hydroxybenzoate; sodium citrate dihydrate; glycerol; citric acid monohydrate; maltitol; Flavour

Az alkalmazás módja:

Oral

db csomag:

300 mL amber glass bottle

Recept típusa:

(S4) Prescription Only Medicine

Terápiás javallatok:

LEVETIRACETAM GH Oral Solution 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)

Termék összefoglaló:

Visual Identification: Clear and colourless solution; Container Type: Bottle; Container Material: Glass Type III Coloured; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius

Engedélyezési státusz:

Licence status A

Engedély dátuma:

2016-04-08

Betegtájékoztató

LEVETIRACETAM GH ORAL SOLUTION/APRIL 2020/CMI-00
1
LEVETIRACETAM GH Oral Solution
_contains the active ingredient levetiracetam _
CONSUMER MEDICINE INFORMATION
What is in this leaflet
This leaflet answers some common
questions about LEVETIRACETAM
GH.
It does not contain all of the
available information. It does not
take the place of talking to your
doctor or pharmacist.
All medicines have benefits and
risks. Your doctor has weighed the
risks of you taking LEVETIRACETAM
GH against the benefits they
expect it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, TALK TO YOUR
DOCTOR OR PHARMACIST.
Keep this leaflet with your
medicine. You may need to read it
again.
What LEVETIRACETAM GH
is used for
LEVETIRACETAM GH is used to
control epilepsy.
Epilepsy is a condition where you
have repeated seizures (fits).
There are many different types of
seizures, ranging from mild to
severe.
LEVETIRACETAM GH 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 GH may be used
alone, or in combination with other
medicines, to treat your condition.
Your doctor may have prescribed
LEVETIRACETAM GH in addition to
your current therapy.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY
LEVETIRACETAM GH HAS BEEN
PRESCRIBED FOR YOU.
The safety and effectiveness of
LEVETIRACETAM GH have not been
established in patients less than 4
years of age.
LEVETIRACETAM GH is available
only with a doctor's prescription.
There is no evidence that
LEVETIRACETAM GH is addictive.
Before you take
LEVETIRACETAM GH
_WHEN YOU MUST NOT TAKE IT _
DO NOT TAKE LEVETIRACETAM GH IF
YOU HAVE AN ALLERGY TO
LEVETIRACETAM OR ANY OF THE
INGREDIENTS LISTED AT THE END OF
THIS LEAFLET.
Symptoms of an allergic reaction
may include:
•
shortness of breath, wheezing or
difficulty breathing
•
swelling of the face, lips, tongue
or other parts of the body
•
rash, itching or hives on the skin.
LEVETIRACETAM GH SO

Termékjellemzők

AUSTRALIAN PRODUCT INFORMATION – LEVETIRACETAM GH
(LEVETIRACETAM) ORAL SOLUTION
1
NAME OF THE MEDICINE
Levetiracetam
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Levetiracetam GH oral solution contains 100 mg/mL levetiracetam as the
active ingredient.
List of excipients with known effects: propyl hydroxybenzoate, methyl
hydroxybenzoate, and maltitol.
For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
Clear and colourless solution.
4
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Levetiracetam GH solution 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
Levetiracetam GH solution is intended for oral administration.
DOSAGE
Levetiracetam therapy can be initiated with either intravenous
1
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.
1
Levetiracetam solution for injection is available in various brands.
Levetiracetam GH v0.2
Page 2 of 27
(levetiracetam) oral solution
The oral solution may be diluted in a glass of water and may be taken
with or without food. After oral
administration the bitter taste of levetiracetam may be experienced.
The daily dose is administered in
two equally divided doses.
MONOTHERAPY
The recommended starting dose is 250 mg twice daily which should be
increased to an initi