LEVETIRACETAM-AFT levetiracetam 100 mg/mL oral solution bottle

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Buy It Now

Patient Information leaflet (PIL)

26-05-2021

Summary of Product characteristics (SPC)

26-05-2021

Public Assessment Report (PAR)

26-11-2017

Active ingredient:

levetiracetam, Quantity: 10 % w/v

Available from:

AFT Pharmaceuticals Pty Ltd

INN (International Name):

Levetiracetam

Pharmaceutical form:

Oral Liquid, solution

Composition:

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

Administration route:

Oral

Units in package:

300mL

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

LEVETIRACETAM-AFT 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),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-AFT concentrate solution for IV infusion after dilution is an alternative for patients when oral administration is temporarily not feasible.

Product summary:

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

Authorization status:

Licence status A

Authorization date:

2014-11-07

Patient Information leaflet

1 | P a g e
Levetiracetam-AFT
®
_LEVETIRACETAM ORAL SOLUTION_
_ _
WHAT IS IN THIS LEAFLET
This leaflet answers some common questions about Levetiracetam-AFT.
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 Levetiracetam-
AFT 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 WITH THE MEDICINE.
You may need to read it again.
WHAT LEVETIRACETAM-AFT IS USED FOR
Levetiracetam-AFT 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-AFT 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.
The safety and effectiveness of Levetiracetam-AFT has not been
established in patients less than 4
years of age.
BEFORE YOU TAKE LEVETIRACETAM-AFT
CMI Oral
Pg. 1
2 | P a g e
_WHEN YOU MUST NOT TAKE IT_
_ _
DO NOT TAKE LEVETIRACETAM-AFT IF YOU HAVE AN ALLERGY TO:
•
any of the ingredients listed at the end of this leaflet.
Some of the 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-AFT ORAL SOLUTION CONTAINS MALTITOL. Maltitol may cause
diarrohea or have a laxative

Read the complete document

Summary of Product characteristics

1
AUSTRALIAN PRODUCT INFORMATION
LEVETIRACETAM-AFT 500 MG/5 ML CONCENTRATE SOLUTION FOR
INFUSION (LEVETIRACETAM)
LEVETIRACETAM-AFT 100MG/ML ORAL SOLUTION (LEVETIRACETAM)
1
NAME OF THE MEDICINE
Levetiracetam
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Levetiracetam is a white to off-white powder with a faint odour and a
bitter taste. It is very soluble in
water (104 g/100mL). It is freely soluble in chloroform (65.3 g/100mL)
and in methanol (53.6 g/100mL),
soluble in ethanol (16.5 g/100mL), sparingly soluble in acetonitrile
(5.7 g/100mL) and
practically
insoluble in n-hexane.
Each mL of LEVETIRACETAM-AFT oral solution contains 100 mg of
levetiracetam (100 mg/mL).
Each 5 mL of LEVETIRACETAM-AFT concentrate solution for IV infusion
contains 500 mg of
levetiracetam (500 mg/ 5 mL).
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
LEVETIRACETAM-AFT 100 mg/mL oral solution is a clear, colourless
solution.
LEVETIRACETAM-AFT 500 mg/ 5 ml concentrate solution for infusion is a
clear, colourless, sterile
solution.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
LEVETIRACETAM-AFT 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).
Product information - clean
1.3.1.1 Pg. 1
2
•
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-AFT 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
_DOSAGE_
Conversion to

Read the complete document