LEVETIRACETAM

Main information

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

Documents

Localization

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

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 222092
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

222092

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

ARTG entry for

Medicine Registered

Sponsor

Apotex Pty Ltd

Postal Address

PO Box 280,NORTH RYDE BC, NSW, 1670

Australia

ARTG Start Date

12/03/2015

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

Product Type

Single Medicine Product

Effective date

28/09/2017

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

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).

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Vial

Glass Type I Clear

36 Months

Store below 25

degrees Celsius

Neither child resistant

closure nor restricted

flow insert

Store in Original

Container

Pack Size/Poison information

Pack Size

Poison Schedule

10 x 5mL vials

(S4) Prescription Only Medicine

Components

1. LEVETIRACETAM IV APOTEX levetiracetam 500mg/5mL concentrate solution for IV infusion vial

Dosage Form

Injection, intravenous infusion

Route of Administration

Intravenous Infusion

Visual Identification

A clear, colourless, sterile solution.

Active Ingredients

Levetiracetam

100 mg/mL

© 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 12:07:38 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 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

Read this leaflet carefully before

taking your medicine.

This leaflet answers some common

questions about levetiracetam

solution for infusion. It does not

contain all the available information.

It does not take the place of talking to

your doctor or pharmacist.

The information in this leaflet was

last updated on the date listed on the

last page. More recent information on

this medicine may be available.

Ask your doctor or pharmacist:

if there is anything you do not

understand in this leaflet,

if you are worried about taking

your medicine, or

to obtain the most up-to-date

information.

You can also download the most up

to date leaflet from

www.apotex.com.au.

All medicines have risks and

benefits. Your doctor has weighed

the risks of you using this medicine

against the benefits they expect it

will have for you.

Pharmaceutical companies cannot

give you medical advice or an

individual diagnosis.

Keep this leaflet with your medicine.

You may want 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 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.

How it works

This medicine 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.

There is no evidence that this

medicine is addictive.

Use in children

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 must not be given this

medicine if:

You are hypersensitive to, or

have had an allergic reaction to,

levetiracetam or any of the

ingredients listed at the end of

this leaflet.

Symptoms of an allergic reaction

may include: cough, shortness of

breath, wheezing or difficulty

breathing; swelling of the face,

lips, tongue, throat or other parts

of the body; rash, itching or hives

on the skin; fainting; or hay

fever-like symptoms.

If you think you are having an

allergic reaction, do not take

any more of the medicine and

contact your doctor

immediately or go to the

Accident and Emergency

department at the nearest

hospital.

The expiry date (EXP) printed

on the pack has passed.

The packaging is torn, shows

signs of tampering or it does not

look quite right.

LEVETIRACETAM APOTEX SOLUTION FOR INFUSION

Before you are given it

Before you are given this medicine,

tell your doctor if:

You have allergies to:

any other medicines, especially

barbiturates or any other

antiepileptic medicines.

any other substances, such as

foods, preservatives or dyes.

You have or have had any

medical conditions, especially the

following:

kidney problems

liver problems

depression.

You are currently pregnant or you

plan to become pregnant.

This medicine may affect your

developing baby if you take it

during pregnancy. However, it is

very important to control your

seizures while you are pregnant.

Do not take this medicine whilst

pregnant until you and your

doctor have discussed the risks

and benefits involved.

You are currently breastfeeding

or you plan to breastfeed.

Do not take this medicine whilst

breastfeeding until you and your

doctor have discussed the risks

and benefits involved.

The active ingredient in this

medicine passes into breast milk

and there is a possibility that your

baby may be affected.

You are planning to have surgery

or an anaesthetic.

You are taking or are planning to

take any other medicines. This

includes vitamins and

supplements that are available

from your pharmacy, supermarket

or health food shop.

Some medicines may interact with

levetiracetam. These include other

antiepileptic drugs.

Other medicines may also interact

with this medicine.

How this medicine is

given

How much is given

Your doctor will decide how much of

this medicine you will receive. This

will depend on your age, your

condition and whether you are taking

any other medicines.

How it is given

Levetiracetam solution for infusion is

diluted and given as an infusion

(intravenous drip) into a vein.

Levetiracetam solution for infusion

must only be given by a doctor, nurse

or other trained person.

If you take too much

(overdose)

As levetiracetam solution for

infusion 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, agitation,

aggression or coma.

If you think that you or anyone

else may have been given too much

of this medicine, immediately

telephone your doctor or the

Poisons Information Centre (Tel:

13 11 26 in Australia) for advice.

Alternatively, go to the Accident

and Emergency department at

your nearest hospital.

Do this even if there are no signs of

discomfort or poisoning. You may

need urgent medical attention.

While you are being

given this medicine

Things you must do

Tell your doctor immediately that

you are taking this medicine if:

you are about to be started on any

new medicine

you are pregnant or are planning

to become pregnant

you are breastfeeding or are

planning to breastfeed

you are about to have any blood

tests

you are going to have surgery or

an anaesthetic or are going into

hospital.

Tell your doctor if you feel

levetiracetam solution for infusion

is not helping your condition.

Your doctor may need to change

your medicine.

Your doctor may occasionally do

tests to make sure the medicine is

working and to prevent side effects.

Go to your doctor regularly for a

check-up.

Tell any other doctors, dentists and

pharmacists who are treating you that

you take this medicine.

Stopping levetiracetam solution for

infusion suddenly may cause

unwanted side effects or make your

condition worse.

Things to be careful of

Be careful when driving or

operating machinery until you

know how this medicine affects

you.

As with other antiepileptic

medicines, this medicine 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.

LEVETIRACETAM APOTEX SOLUTION FOR INFUSION

Possible side effects

Tell your doctor as soon as possible

if you do not feel well while you are

taking this medicine or if you have

any questions or concerns.

Do not be alarmed by the following

lists of side effects. You may not

experience any of them. All

medicines can have side effects.

Sometimes they are serious but most

of the time they are not.

Tell your doctor if you notice any

of the following:

dizziness

feeling weak

headache

common cold

upset stomach

diarrhoea

feeling tired, drowsy or sleepy.

Tell your doctor as soon as possible

if you notice any of the following.

These may be serious side effects and

you may need medical attention:

mood changes such as depression,

nervousness, aggression, anger,

anxiety, confusion, hallucination,

irritability

feelings of depression

upper respiratory tract infections

weight loss.

If you experience any of the

following, stop taking your

medicine and contact your doctor

immediately or go to the Accident

and Emergency department at

your nearest hospital.

These are very serious side effects

and you may need urgent medical

attention or hospitalisation:

thoughts of harming yourself

more frequent or more severe

seizures

Other side effects not listed above

may occur in some patients.

Allergic reactions

If you think you are having an

allergic reaction to levetiracetam

solution for infusion, do not take

any more of this medicine and tell

your doctor immediately or go to

the Accident and Emergency

department at your nearest

hospital.

Symptoms of an allergic reaction

may include some or all of the

following:

cough, shortness of breath,

wheezing or difficulty breathing

swelling of the face, lips, tongue,

throat or other parts of the body

rash, itching or hives on the skin

fainting

hay fever-like symptoms.

Storage and disposal

Storage

Levetiracetam solution for infusion

will be stored in the pharmacy or

kept at the hospital. The vials should

be kept in a cool dry place where the

temperature stays below 25°C.

Product description

What Levetiracetam

APOTEX Solution for

Infusion looks like

Levetiracetam concentrate solution is

intended for IV infusion after

dilution. It is a clear, colourless,

sterile solution.

The primary container is a glass vial

closed with a grey rubber stopper and

sealed with an aluminium/

polypropylene flip off cap.

Available in a carton containing 10

vials.

Ingredients

One vial of levertiracetam solution

for infusion contains 500 mg of

levetiracetam (500 mg/5 mL) as the

active ingredient.

It also contains the following inactive

ingredients:

sodium acetate trihydrate

sodium chloride

glacial acetic acid

water for injections

This medicine is gluten-free, lactose-

free, sucrose-free, tartrazine-free and

free of other azo dyes.

Latex free.

Australian Registration

Numbers

Levetiracetam APOTEX Solution for

Injection 500 mg/5 mL.

AUST R 222092

Sponsor

Apotex Pty Ltd

16 Giffnock Avenue

Macquarie Park NSW 2113

APO and APOTEX are registered

trademarks of Apotex Inc.

This leaflet was last updated in

March 2015

LEVETIRACETAM APOTEX SOLUTION FOR INFUSION