COPAXONE

Main information

  • Trade name:
  • COPAXONE glatiramer acetate 40 mg/1 mL solution for injection prefilled syringe
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • COPAXONE glatiramer acetate 40 mg/1 mL solution for injection prefilled syringe
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 218615
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

218615

COPAXONE glatiramer acetate 40 mg/1 mL solution for injection prefilled syringe

ARTG entry for

Medicine Registered

Sponsor

Teva Pharma Australia Pty Ltd

Postal Address

Locked Bag 2053,NORTH RYDE BC, NSW, 1670

Australia

ARTG Start Date

25/02/2015

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. COPAXONE glatiramer acetate 40 mg/1 mL solution for injection prefilled syringe

Product Type

Single Medicine Product

Effective date

2/12/2016

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

Copaxone is indicated for the:

1- Reduction of the frequency of relapses in patients with Relapsing Remitting Multiple Sclerosis.

2-Treatment of patients with a single clinical event suggestive of multiple sclerosis and at least two clinically silent MRI lesions characteristic of multiple

sclerosis, if alternative diagnoses have been excluded.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Syringe

Glass Type I Clear

2 Years

Store at 2 to 8

degrees Celsius

Not recorded

Protect from Light

Refrigerate

Do not Freeze

Pack Size/Poison information

Pack Size

Poison Schedule

12 single pre-filled syringes

(S4) Prescription Only Medicine

Components

1. COPAXONE glatiramer acetate 40 mg/1 mL solution for injection prefilled syringe

Dosage Form

Injection, solution

Route of Administration

Subcutaneous

Visual Identification

A clear, colourless solution for injection, essentially free of visible particles.

Active Ingredients

Glatiramer acetate

40 mg

© 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 04:39:39 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

COPAXONE

40MG/ML

Copaxone

®

40 mg/mL

glatiramer acetate

Consumer Medicine Information (CMI)

What is in this leaflet

This leaflet answers some common

questions about Copaxone 40

mg/mL.

It does not contain all the available

information. It does not take the

place of talking to your doctor and

pharmacist.

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.

If you have any concerns about

using this medicine, ask your

doctor or pharmacist.

Keep this leaflet with the medicine.

You may need to read it again.

What Copaxone 40

mg/mL is used for

Copaxone 40 mg/mL is used for the

management of relapsing forms of

Multiple Sclerosis (MS).

Copaxone may also be used in

patients who, for the first time, have

experienced symptoms and have

MRI changes that indicate a high risk

for development of MS. Your doctor

will rule out any other reasons which

could explain these symptoms before

you are treated.

The cause of MS is not yet known.

MS affects the brain and spinal cord.

In MS, the body's immune system

reacts against its own myelin (the

'insulation' surrounding nerve fibres).

In relapsing forms of MS, people can

have 'exacerbations' from time to

time (eg. blurred vision, weakness in

the legs or arms, or loss of control of

bowel or bladder function). These are

followed by periods of recovery.

Although the exact mechanism of

how Copaxone works in MS is

unknown, it is thought that Copaxone

works by changing the immune

processes that are believed to be

responsible for the disease.

Copaxone has been shown to be

effective in reducing the number of

relapses in patients with relapsing

remitting MS. Although it is not a

cure, patients treated with Copaxone

generally find that they will

experience fewer relapses.

Your doctor, however, may prescribe

Copaxone 40 mg/mL for another

purpose.

Ask your doctor or pharmacist if

you have any questions about why

it has been prescribed for you.

This medicine is only available with

a doctor's prescription.

Before you use it

When you must not use it

Do not use Copaxone if you are

allergic to it or any of the

ingredients listed at the end of this

leaflet.

Some symptoms of an allergic

reaction include skin rash, itching,

shortness of breath or swelling of the

face, lips or tongue, which may cause

difficulty in swallowing or breathing.

Do not give Copaxone to children.

There is no experience with its use in

children under 12 years of age.

Do not use it after the expiry date

(EXP) printed on the pack.

If you use it after the expiry date has

passed, it may not work as well.

Do not use it if the packaging is

damaged or shows signs of

tampering.

Before you start to use it

Tell your doctor or pharmacist if

you have allergies to:

any of the ingredients listed at

the end of this leaflet

any other medicines

any other substances, such as

foods, preservatives or dyes.

Tell your doctor if you are

pregnant or intend to become

pregnant.

Like most medicines of this kind,

Copaxone is not recommended to be

used during pregnancy. You should

discuss with your doctor

contraceptive options. Your doctor

will discuss the risks and benefits of

using it if you are pregnant.

Tell your doctor if you are breast-

feeding or plan to breast-feed.

It is not known whether Copaxone

passes into breast milk. Your doctor

will discuss the risks and benefits of

using it if you are breast-feeding or

planning to breast-feed.

Tell your doctor if you have or

have ever had any medical

conditions, especially the following:

asthma

a history of severe allergic

reactions

COPAXONE

40MG/ML

Tell your doctor if you plan to have

surgery.

If you have not told your doctor

about any of the above, tell them

before you use Copaxone 40

mg/mL.

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 store.

Some medicines may interfere with

the absorption of Copaxone.

These medicines may be affected by

Copaxone, or may affect how well it

works. You may need to use different

amounts of your medicine, or take

different medicines. Your doctor or

pharmacist will advise you.

Your doctor or pharmacist has more

information on medicines to be

careful with or avoid while using

Copaxone 40 mg/mL.

How to use it

Follow all directions given to you

by your doctor, MS education

nurse or pharmacist.

They may differ from the

information contained in this leaflet.

How much to use

The recommended dose of this

medicine is one Copaxone 40 mg/mL

pre-filled syringe (1mL) injected

three times a week and at least 48

hours apart.

Copaxone 40 mg/mL should be

given, if possible, at the same time

and on the same three days each

week (for example, Monday,

Wednesday and Friday) at least 48

hours apart.

Do not change the dose or dosing

schedule or stop using Copaxone

without talking to your doctor.

How to use it

Copaxone 40 mg/mL is given by an

injection into the fatty layer under the

skin (subcutaneous injection).

Many people with MS learn to give

themselves the injection or have it

given by a carer.

Self-injection needs to be taught and

practised. It is important that a

qualified healthcare professional

supervises your first injection.

Your doctor may teach you to self-

inject or arrange for an MS education

nurse to do so.

You may have a friend attend the

injection training session as your

assistant. Especially when you first

start giving yourself injections, your

assistant should be with you.

Talk to your doctor or the MS

Society or telephone 1800 502 802

in Australia for more information.

Patient support kits that include a

self-injection device are available by

telephoning 1800 502 802 in

Australia.

After being taught to self-inject, you

can refer to this leaflet for step-by-

step instructions about how to

prepare and inject Copaxone 40

mg/mL.

The following instructions explain

how to inject Copaxone 40 mg/mL

yourself.

Do not attempt self-injection until

you are confident that you

understand how to inject yourself.

Please read these instructions

carefully.

Before you Inject

Copaxone 40 mg/mL pre-filled

injection is pre-mixed and ready for

you to use.

Make sure that the blister with the

syringe inside is taken out of the

refrigerator for 20 minutes before

you use it.

It is important that the solution is

at room temperature when you

inject it.

If you need to delay your injection,

return the blister to its package in the

refrigerator.

Always inspect Copaxone 40

mg/mL solution in the pre-filled

syringe before you use it. Do not

inject the solution if it is cloudy or

has particles in it.

Gathering the Materials

Gather the following items on a

towel in a well-lit area:

One blister with Copaxone 40

mg/mL pre-filled syringe (at

room temperature - as

described above)

A dry cotton ball

Disposal unit for used syringes

Wash and dry your hands. Do not

touch your hair or skin afterwards.

This will help prevent infection.

Deciding where to Inject

There are seven injection areas on

your body: arms, thighs, back of the

hips and stomach (belly). Within

each injection area there are multiple

injection sites. (Figure 1).

Rotate the injection sites within an

area.

You should not use any site more

than one time a week. Choose a

different site for each injection.

This will reduce the likelihood of

irritation, pain or loss of fatty

tissue (lipoatrophy) at the site of

injection.

Marking a calendar will help you

keep track of the sites you have used

each week.

COPAXONE

40MG/ML

Giving Yourself the Injection

1.

Remove the syringe from its

protective blister by peeling

back the paper label.

2.

Pick up the syringe as you

would a pencil, using the hand

you write with. Remove the

plastic cover from the needle.

3.

Pinch about a 5 cm fold of skin

between thumb and index

finger.

When you inject in the upper

back portions of your arms, it is

not possible to pinch 5 cm of skin

with one hand and inject yourself

with the other hand. Ask your

doctor / nurse for instruction on

how to use these areas.

4.

Insert the needle into the 5 cm

fold of skin. It may help to

steady your hand by resting the

heel of your hand against your

body.

5.

When the needle is all the way

in, release the fold of skin.

6.

Inject the medication by

holding the syringe steady while

pushing down on the plunger

until the syringe is empty. The

injection should take just a few

seconds.

7.

Pull the needle straight out

8.

Press a dry cotton ball on the

injection site for a few seconds,

but do not massage it.

9.

Dispose of the pre-filled syringe

in a safe hard-walled container,

according to your doctor's

instructions and the laws of

your state (if any). Ask your

doctor or pharmacist for advice

if you are in doubt.

Some patients may experience a side-

effect known as the Immediate Post

Injection Reaction (see the

information under the heading 'Side

effects' below).

Proper use of needles and

syringes

Do not reuse the pre-filled syringe.

Each pre-filled syringe should be

used only for one injection.

Ask your doctor or nurse about

obtaining a "sharps container".

After use, place all used syringes

and needles in a hard-walled

plastic container, such as a liquid

laundry detergent container.

It is very important that you keep the

cover of the container tightly shut

and that you store it out of the reach

of children. When the container is

full, check with your doctor or nurse

about proper disposal.

When to use it

Give yourself the injection at the

same time on the same three days

of the week (for example, Monday,

Wednesday and Friday) at least 48

hours apart.

Choose a time when you feel

strongest.

How long to use it

Do not stop using Copaxone

without checking with your doctor

first.

The positive effects of Copaxone are

not seen immediately. They occur

with long-term treatment.

If you forget to use it

If you miss a dose of Copaxone 40

mg/mL, you should take your next

dose as soon as you remember or are

able to take it, then skip the

following day. If possible, you

should return to your regular

administration schedule the

following week.

Do not use a double dose to make

up for forgotten individual doses.

This may increase the chance of you

getting an unwanted side-effect.

If you are not sure what to do, ask

your doctor or pharmacist.

If you have trouble remembering

when to use your medicine, ask

your pharmacist or MS education

nurse for some hints.

It is important not to miss injections

as this can affect the success of your

treatment.

If you use too much

(overdose)

Immediately telephone your doctor

or Poisons Information Centre

(telephone Australia 13 11 26 or

0800 POISON), or go to Accident

and Emergency at your nearest

hospital, if you think that you or

anyone else may have used too

much Copaxone 40 mg/mL.

Do this even if there are no signs of

discomfort or poisoning.

You may need urgent medical

attention.

COPAXONE

40MG/ML

While you are using it

Things you must do

Tell all the doctors, dentists and

pharmacists who are treating you

that you are using Copaxone.

If you are about to be started on

any new medicine, tell your doctor

and pharmacist that you are using

Copaxone 40 mg/mL.

If you plan to have surgery that

needs a general anaesthetic, tell

your doctor or dentist that you are

using this medicine.

If you become pregnant while you

are using this medicine, stop using

it and tell your doctor immediately.

Things you must not do

Do not use more than the

recommended dose unless your

doctor tells you to.

Do not give this medicine to anyone

else, even if they have the same

condition as you.

Side effects

All medicines have some unwanted

side effects. Sometimes they are

serious, but most of the time they are

not. Your doctor has weighed the

risks of using this medicine against

the benefits they expect it will have

for you.

Do not be alarmed by this list of

possible side effects.

You may not experience any of them.

Tell your doctor or pharmacist as

soon as possible if you do not feel

well while you are using Copaxone

40 mg/mL.

It helps most people with MS, but it

may have unwanted side effects in a

few people.

Tell your doctor if you notice any

of the following and they worry

you:

pain, redness, itching,

hardening of the skin or an

infection at the site where you

have injected yourself

nausea (feeling sick)

pain in the joints

sore muscles

feeling of weakness

dizziness

constipation

These side effects were reported by

patients who used Copaxone 20

mg/mL every day and by patients

who use Copaxone 40 mg/mL three

times a week.

Some patients may experience a side-

effect known as the Immediate Post

Injection Reaction. This reaction

consists of the following symptoms:

reddening of the face and/or neck,

chest pain or tightness,

feeling your heart beat quickly

(heart palpitations),

anxiety and difficulty in

breathing.

These are mild side effects of this

medicine and usually are short-lived.

Some patients may experience only

one episode during the treatment

period.

Stop administering Copaxone and

contact your doctor immediately if

the above symptoms are severe.

If any of the following happen, stop

using this medicine and tell your

doctor immediately, or go to

Accident and Emergency at your

nearest hospital:

swelling of the face, lips, mouth

or throat, which may cause

difficultly in swallowing or

breathing

hives

chest pain

trouble breathing

severe pain, redness or swelling

at the injection site that does

not go away.

These are very serious side effects. If

you have them, you may have had a

serious allergic reaction to

Copaxone. You may need urgent

medical attention or hospitalisation.

These side effects are very rare.

Tell your doctor or pharmacist if

you notice anything else that is

making you feel unwell.

Other side effects not listed above

may occur in some patients.

Do not be alarmed by this list of

possible side effects.

You may not experience any of them.

Ask your doctor or pharmacist to

answer any questions you may

have.

After using it

If you have any queries about any

aspect of your medicine, or any

questions regarding the

information in this leaflet, discuss

them with your doctor or

pharmacist.

Storage

Keep Copaxone 40 mg/mL in the

pack until it is time to use it.

Protect from direct light.

The medicine will not keep as well if

taken out of the packaging.

Keep Copaxone 40 mg/mL pre-

filled syringes in the refrigerator at

2°C to 8°C. In the event of

refrigeration being unavailable,

Copaxone 40 mg/mL may be

stored below 25°C on one occasion

for up to one month.

Copaxone 40 mg/mL must not be

frozen. Do not place in the freezer

or freezing compartment of a

refrigerator.

Do not store it or any other

medicine in the bathroom, near a

sink, or on a windowsill.

Do not leave it in the car.

Heat and damp can destroy some

medicines.

COPAXONE

40MG/ML

Keep it where children cannot

reach it.

Disposal

Please read the package insert

carefully for full details, including

self disposal of needles and

syringes after use.

If your doctor tells you to stop

using Copaxone 40 mg/mL, or the

medicine has passed its expiry

date, ask your pharmacist what to

do with any that are left over.

Return any unused medicine to

your pharmacist.

Product description

What it looks like

Copaxone 40 mg/mL is a clear

colourless solution supplied in 1mL

glass single use pre-filled syringes

fitted with a staked 1/2 inch needle.

Copaxone 40 mg/mL is supplied in a

box of 12 blister packed pre-filled

syringes.

Ingredients

Active Ingredient:

Each Copaxone 40 mg/mL pre-filled

syringe contains 40 mg glatiramer

acetate.

Inactive Ingredients:

Each injection also contains:

mannitol

water for injections

Distributor

Copaxone 40 mg/mL is distributed in

Australia by:

Teva Pharma Australia Pty Ltd

Level 2, 37 Epping Road

Macquarie Park 2113

NSW, Australia

Australian Register Number:

AUST R 218615

This leaflet was prepared in

November 2014

Copaxone is a registered trademark

of Teva Pharmaceuticals Industries

Ltd.

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