LEVETIRACETAM-AFT

Main information

  • Trade name:
  • LEVETIRACETAM-AFT levetiracetam 500 mg/5 mL concentrate solution for infusion vial
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • LEVETIRACETAM-AFT levetiracetam 500 mg/5 mL concentrate solution for infusion vial
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 218280
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

218280

LEVETIRACETAM-AFT levetiracetam 500 mg/5 mL concentrate solution for infusion vial

ARTG entry for

Medicine Registered

Sponsor

AFT Pharmaceuticals Pty Ltd

Postal Address

PO Box 748,North Ryde,Sydney, NSW, 1670

Australia

ARTG Start Date

7/11/2014

Product category

Medicine

Status

Active

Approval area

Drug Safety Evaluation Branch

Conditions

Conditions applicable to all therapeutic goods as specified in the document "Standard Conditions Applying to Registered or Listed Therapeutic Goods

Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.

Conditions applicable to the relevant category and class of therapeutic goods as specified in the document "Standard Conditions Applying to Registered

or Listed Therapeutic Goods Under Section 28 of the Therapeutic Goods Act 1989" effective 1 July 1995.

Products

1. LEVETIRACETAM-AFT levetiracetam 500 mg/5 mL concentrate solution for infusion vial

Product Type

Single Medicine Product

Effective date

8/09/2015

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific 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.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Vial

Glass Type I Clear

24 Months

Store below 25

degrees Celsius

Neither child resistant

closure nor restricted

flow insert

Not recorded

Pack Size/Poison information

Pack Size

Poison Schedule

500mg/5mL 10 vials

(S4) Prescription Only Medicine

Components

1. LEVETIRACETAM-AFT levetiracetam 500 mg/5 mL concentrate solution for infusion vial

Dosage Form

Injection, concentrated

Route of Administration

Intravenous Infusion

Visual Identification

Clear, colourless, sterile solution (500mg/5ml), free from foreign particles,

contained in transparent vial sealed with a rubber stopper and aluminium

flip cap

Active Ingredients

Levetiracetam

10 % w/v

© Commonwealth of Australia.This work is copyright.You are not permitted to re-transmit, distribute or commercialise the material without obtaining prior

written approval from the Commonwealth.Further details can be found at http://www.tga.gov.au/about/website-copyright.htm.

Public Summary

Page 1 of

Produced at 26.11.2017 at 05:10:51 AEDT

This is not an ARTG Certificate document.

The onus is on the reader to verify the current accuracy of the information on the document subsequent to the date shown.

Visit www.tga.gov.au for contact information

Patient Information leaflet

Levetiracetam-AFT

Levetiracetam concentrate solution for IV infusion

What is in this leaflet

This leaflet answers some common questions about Levetiracetam-AFT concentrate solution for IV

infusion (Levetiracetam-AFT 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 Levetiracetam-

AFT 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 in a safe place.

You may need to read it again.

What Levetiracetam-AFT IV 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 are given Levetiracetam-AFT IV

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When you must not be given it

You must not be given Levetiracetam-AFT IV 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

If you are not sure whether you should be given this medicine, talk to your doctor, nurse or

pharmacist.

Before you are given it

Tell your doctor if you have allergies to:

any other medicines, especially barbiturates (such as phenobarbitone) or any other

antiepileptic medicines (such as carbamazepine, lamotrigine or valproate)

any other substances, such as foods, preservatives or dyes.

Tell your doctor if you have or have had any medical conditions, especially the following:

kidney problems

liver problems.

Tell your doctor if you are pregnant or intend to become pregnant.

Levetiracetam-AFT may affect your developing baby if you take it during pregnancy. However, it is

very important to control your seizures while you are pregnant. Your doctor will outline and weigh

up all the risks and benefits of taking Levetiracetam-AFT during pregnancy to help decide whether or

not you should take it.

Tell your doctor if you are breastfeeding or plan to breastfeed.

The active ingredient in Levetiracetam-AFT passes into breast milk and there is a possibility that your

baby may be affected. Your doctor will discuss the risks and benefits of using Levetiracetam-AFT if

you are breastfeeding.

If you have not told your doctor about any of the above, tell them before you are given

Levetiracetam-AFT.

Taking other medicines

Tell your doctor or pharmacist if you are taking any other medicines, including any that you buy

without a prescription from your pharmacy, supermarket or health food shop.

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Levetiracetam-AFT does not interact with the oral contraceptive pill.

However, you may be given Levetiracetam-AFT together with other antiepileptic medicines that do

interact and may affect the effectiveness of your contraceptive. Your doctor may advise you to use

an additional method of contraception if you take Levetiracetam-AFT with other antiepileptic

medicines.

How Levetiracetam-AFT IV is given

How much is given

Your doctor will decide how much Levetiracetam-AFT you will receive. This depends on your age,

your condition and whether or not you are taking any other medicines.

How it is given

Levetiracetam-AFT IV is diluted and given as an infusion (intravenous drip) into a vein.

Levetiracetam-AFT IV must only be given by a doctor, nurse or other trained person.

If you take too much (overdose)

As Levetiracetam-AFT IV is given to you under the supervision of your doctor, it is very unlikely that

you will receive too much.

However, if you experience severe side effects tell your doctor immediately.

Symptoms of an overdose may include feeling drowsy.

Immediately telephone your doctor or the Poisons Information Centre (telephone 13 11 26) for

advice, or go to Accident and Emergency at the nearest hospital, if you think that you or anyone

else may have taken too much Levetiracetam-AFT. Do this even if there are no signs of discomfort

or poisoning.

You may need urgent medical attention.

While you are using Levetiracetam-AFT IV

Things you must do

Tell your doctor immediately if you notice an increase in seizures.

Tell your doctor immediately if you have symptoms of depression or thoughts of harming yourself.

Tell any other doctors, dentists, and pharmacists who are treating you that you are being given

this medicine.

If you are about to be started on any new medicine, tell your doctor, dentist or pharmacist that

you are being given this medicine.

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Before you have any surgery or emergency treatment, tell your doctor or dentist that you are

being given Levetiracetam-AFT.

Tell your doctor if you feel Levetiracetam-AFT is not helping your condition.

Your doctor may need to change your medicine.

If you become pregnant while taking this medicine, tell your doctor.

Be sure to keep all of your doctor’s appointments so that your progress can be checked.

Your doctor will check your progress and may want to take some tests from time to time. This helps

to prevent unwanted side effects.

Stopping Levetiracetam-AFT suddenly may cause unwanted side effects or make your condition

worse.

Things to be careful of

Be careful driving or operating machinery until you know how this medicine affects you. Children

should be careful doing things like riding bicycles or climbing trees.

As with other antiepileptic medicines, Levetiracetam-AFT may cause dizziness or drowsiness in some

people. This is more frequent at the beginning of treatment or after an increase in the dose.

If you are feeling dizzy or drowsy do not drive, operate machinery, or do anything else that could be

dangerous. Children should not ride a bike, climb trees or do anything else that could be dangerous

if they are feeling dizzy or drowsy.

Be careful when drinking alcohol while taking this medicine.

Combining Levetiracetam-AFT and alcohol can make you more drowsy. Your doctor may suggest you

avoid alcohol while you are being treated with Levetiracetam-AFT.

Side effects

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking

Levetiracetam-AFT.

This medicine helps most people with epilepsy, but it may have unwanted side effects in a few

people. All medicines can have side effects. Sometimes they are serious, most of the time they are

not. You may need medical attention if you get some of the side effects.

Do not be alarmed by the following list of side effects. You may not experience any of them.

Ask your doctor or pharmacist to answer any questions you may have.

If you get any side effects, do not stop taking Levetiracetam-AFT without first talking to your

doctor or pharmacist.

Tell your doctor or pharmacist if you notice any of the following and they worry you:

dizziness

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feeling weak

headache

common cold

upset stomach

diarrhoea

feeling tired, drowsy or sleepy.

The above list includes the more common side effects of your medicine. They are usually mild and

short-lived.

Tell your doctor as soon as possible if you notice any of the following:

mood changes such as depression, nervousness, aggression, anger, anxiety, confusion,

hallucination, irritability

feelings of depression

upper respiratory tract infections

weight loss.

The above list includes serious side effects that may require medical attention.

If any of the following happen, tell your doctor immediately or go to Accident and Emergency at

your nearest hospital:

thoughts of harming yourself

more frequent or more severe seizures

shortness of breath

wheezing or difficulty breathing

swelling of the face, lips, mouth, throat or tongue or other parts of the body

rash, itching or hives on the skin.

The above list includes very serious side effects. You may need urgent medical attention or

hospitalisation.

Tell your doctor if you notice anything else that is making you feel unwell.

Other side effects not listed above may happen in some people.

After you have been given Levetiracetam-AFT IV

Storage

Levetiracetam-AFT IV will be stored in the pharmacy or on the ward. The vials are kept in a cool dry

place where the temperature stays below 25°C.

Product description

What it looks like

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Levetiracetam-AFT IV is a clear, colourless solution.

Ingredients

Each vial of Levetiracetam-AFT IV contains 500 mg/5 mL levetiracetam.

It also contains:

sodium acetate

sodium chloride

glacial acetic acid

water for injections

Sponsor

Australia:

AFT Pharmaceuticals Pty Ltd.

Suite 301, 113 Wicks Road

North Ryde

NSW 2113

Levetiracetam-AFT concentrate solution for IV infusion: AUST R 218280

Date of preparation:

August 2015

6 | P a g e

27-7-2018

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Pending EC decision: Kalydeco, ivacaftor, Opinion date: 26-Jul-2018

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Pending EC decision:  Symkevi, tezacaftor / ivacaftor, Opinion date: 26-Jul-2018

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