CLEXANE

Main information

  • Trade name:
  • CLEXANE enoxaparin sodium 60mg/0.6mL injection syringe with automatic safety lock system
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • CLEXANE enoxaparin sodium 60mg/0.6mL injection syringe with automatic safety lock system
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 221719
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

221719

CLEXANE enoxaparin sodium 60mg/0.6mL injection syringe with automatic safety lock system

ARTG entry for

Medicine Registered

Sponsor

Sanofi-Aventis Australia Pty Ltd

Postal Address

Locked Bag 2227,NORTH RYDE BC, NSW, 1670

Australia

ARTG Start Date

10/07/2014

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. CLEXANE enoxaparin sodium 60mg/0.6mL injection syringe with automatic safety lock system

Product Type

Single Medicine Product

Effective date

30/01/2017

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

Prevention of thrombo-embolic disorders of venous origin in patients undergoing orthopaedic and general surgery. Prophylaxis of venous

thromboembolism in medical patients bedridden due to acute illness. Prevention of thrombosis in extra-corporeal circulation during haemodialysis.

Treatment of established deep vein thrombosis. Treatment of unstable angina and non-Q-wave myocardial infarction, administered concurrently with

aspirin. Treatment of acute ST-segment Elevation Myocardial Infarction (STEMI) as an adjunctive to thrombolytic treatment, including patients to be

managed medically or with subsequent Percutaneous Coronary Intervention (PCI).

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Syringe

Not recorded

3 Years

Store below 25

degrees Celsius

Not recorded

Do not Freeze

Pack Size/Poison information

Pack Size

Poison Schedule

1 x 0.6mL prefilled syringe

(S4) Prescription Only Medicine

15 x 0.6mL prefilled syringe

(S4) Prescription Only Medicine

10 x 0.6mL prefilled syringe

(S4) Prescription Only Medicine

6 x 0.6mL prefilled syringe

(S4) Prescription Only Medicine

Components

1. Medicine Component

Dosage Form

Injection, solution

Route of Administration

Subcutaneous

Extracorporeal Circulation - Haemodialysis

Visual Identification

Clear, colourless to pale yellow solution.

Active Ingredients

Enoxaparin sodium

60 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 12:45:14 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

Clexane

®

and Clexane

®

Forte*

enoxaparin sodium

Consumer Medicine Information

What is in this leaflet

This leaflet answers some common

questions about Clexane.

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 using Clexane

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 Clexane is used

for

Clexane is used in a number of

medical conditions. It is used to:

treat blood clots

treat certain types of heart disease

(eg. angina and heart attacks),

when used with aspirin

prevent blood clots forming after

an operation, during

hospitalisation or extended bed

rest or during purification of the

blood by an artificial kidney

(haemodialysis).

Clexane is one of a group of

medicines called low molecular

weight heparins (LMWH). These

medicines work by reducing blood

clotting activity.

Your doctor may have prescribed

Clexane for another reason.

Ask your doctor if you have any

questions about why Clexane has

been prescribed for you.

There is no evidence that Clexane is

addictive.

This medicine is only available with

a doctor's prescription.

Before you are given it

When you must not use it

Do not use Clexane if you have an

allergy to Clexane, heparin or its

derivatives including other

LMWHs. Some signs and

symptoms of an allergic reaction

can include swelling of the face,

lips or tongue, wheezing or

troubled breathing, skin rash,

itching hives, blisters or peeling

skin.

Do not use Clexane if you have, or

have ever had any of the following

medical conditions:

major blood disorders

certain types of stroke

stomach or bowel problems such

as ulcers or ulcerative colitis

bacterial infections in your heart.

Do not give Clexane to a child.

The safety and effectiveness of

Clexane has not been established in

children.

Do not use Clexane after the expiry

date printed on the syringe.

Do not use Clexane if the

packaging is torn or shows signs of

tampering.

If you are not sure whether you

should start using Clexane, talk to

your doctor or pharmacist.

Before you are given it

Tell your doctor or pharmacist if

you have allergies to:

heparin or its derivatives,

including other LMWHs

any other medicines

any other substances, such as

foods, preservatives or dyes.

Tell your doctor or pharmacist if

you have or have had any of the

following medical conditions:

major bleeding disorder or blood

clotting problem, including a

recent stroke or hereditary blood

disorders

bacterial endocarditis,

inflammation of the lining of the

heart caused by bacteria

stomach or bowel problems such

as ulcers or ulcerative colitis

kidney or liver disease

uncontrolled high blood pressure

diabetic related eye disease

recently undergone brain, spinal

or eye surgery

history of spinal surgery or spinal

deformity

an artificial heart valve

obesity

If you have not told your doctor or

pharmacist about any of the above,

CLEXANE

AND CLEXANE

FORTE*

tell them before you start using

Clexane.

Tell your doctor or pharmacist if

you are pregnant or intend to

become pregnant.

Like most LMWHs, Clexane is not

recommended to be used during

pregnancy. If there is a need to

consider Clexane during your

pregnancy, your doctor or pharmacist

will discuss with you the benefits and

risks of using it.

Tell your doctor or pharmacist if

you are breastfeeding or plan to

breastfeed.

Like most LMWHs, Clexane is not

recommended while you are

breastfeeding. If there is a need to

consider Clexane while you are

breastfeeding, your doctor or

pharmacist will discuss with you the

benefits and risks of using it.

Tell your doctor that you are using

Clexane if your doctor is planning

for you to have an anaesthetic

injection in your back (spinal or

epidural injection).

If you have not told your doctor or

pharmacist about any of the above,

tell them before you start using

Clexane.

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.

Some medicines and Clexane may

interfere with each other. These

include:

medicines or substances used to

prevent and treat blood clots

medicines containing aspirin or

salicylates

Dextran 40, a medicine use to

treat shock

medicines used to treat

inflammatory disease, such as

oral non-steroidal anti-

inflammatory medicines or

corticosteroids.

If any of these medicines are used

while using Clexane, careful

monitoring of your blood clotting

factors is required by your doctor.

These medicines may be affected by

Clexane or may affect how well it

works. You may need to use different

amounts of your medicine or you

may need to use different medicines.

Your doctor or pharmacist will

advise you.

Your doctor and pharmacist may

have more information on medicines

to be careful with or avoid while

using Clexane.

How to use it

How much to use

Your doctor will decide what dose

you will receive. This depends on

your condition and other factors,

such as your weight.

For the prevention of blood clots, the

following are the usual doses, which

are administered by injection under

the skin once a day:

moderate risk patients: 20mg

high risk patients: 40mg

For the treatment of blood clots

which have formed in the leg/deep

vein,

the usual dose is 1mg/kg body weight

twice a day or 1.5mg/kg body weight

once a day injected under the skin.

Warfarin sodium therapy is usually

started within 72 hours of Clexane by

your doctor.

For patients that require dialysis,

the usual dose is 1mg/kg into the

tubing of the dialysis machine at the

start of the session. Additional doses

may be given if required.

For treatment of severe heart

attacks,

the usual dose is 30mg injected into a

vein plus 1mg/kg injected under the

skin, followed by 1mg/kg injected

under the skin twice a day.

For treatment of certain other

types of heart disease,

the usual dose is 1 mg/kg injected

under the skin twice a day.

These doses of Clexane may be

changed by your doctor. Your doctor

will decide when and how much

Clexane you will be given.

How to use it

Clexane is usually given by an

injection under the skin or into the

tubing of the dialysis machine. The

recommended site for injection is the

stomach area. A different injection

site should be used for each injection.

Do not rub the injection site after

administration.

It may be given by your doctor, nurse

or yourself. Your doctor will tell you

how you will be given your injection.

Clexane can also be given by an

injection into a vein. This will be

done in hospital by your doctor or

nurse.

Prefilled Syringes

The prefilled syringes are ready for

use. The air bubble in the syringe

should not be expelled.

Graduated Prefilled Syringes

When using the 60mg, 80mg, 100mg,

120mg and 150mg graduated

syringes, the volume to be injected

should be measured precisely

according to the dosage

recommended by your doctor.

Injection Technique

The whole length of the syringe

needle should be introduced

vertically into the thickness of a skin

fold gently held between the

operator's thumb and finger. This

skin fold should be held throughout

the duration of the injection.

Clexane does not contain any

antimicrobial agents, so must be used

once only and any residue discarded.

How long to use it

Your doctor will tell you how long

you will be using Clexane.

CLEXANE

AND CLEXANE

FORTE*

If you use too much

(overdose)

As Clexane is often given to you

under the supervision of your

doctor, it is very unlikely that you

will receive too much. However,

some patients may self-inject

Clexane.

Tell your doctor or nurse or

telephone the Poisons Information

Centre in Australia (13 11 26) or

the National Poisons Information

Centre in NZ (0800 POISON or

0800 764 766), or go to Accident

and Emergency at your nearest

hospital, if you think that you or

anyone else may have injected too

much Clexane.

Do this even if there are no signs of

discomfort or poisoning.

You may need urgent medical

attention.

While you are using it

Things you must do

Use Clexane exactly as your doctor

has prescribed.

If you become pregnant while

using Clexane tell your doctor

immediately.

Tell your doctor if you have an

artificial heart valve.

If you are about to be started on

any new medicine tell your doctor,

dentist or pharmacist that you are

using Clexane.

Tell any other doctors, dentists or

pharmacists who are treating you

that you are using Clexane.

If you plan to have surgery, tell

your doctor or dentist that you are

using Clexane.

Tell your doctor that you are using

Clexane if your doctor is planning

for you to have an anaesthetic

injection in your back (spinal or

epidural injection).

Things you must not do

Do not give Clexane to anyone else,

even if they have the same

condition as you.

Do not use Clexane to treat any

other complaints, unless your

doctor tells you to.

Do not stop using Clexane, or

lower the dosage, without checking

with your doctor or pharmacist.

Do not mix Clexane with other

injections or infusion fluids.

Certain medicines or solutions

contain ingredients that can interact

with Clexane. If you need an

injection of Clexane into a vein, your

doctor or nurse will make sure it is

not mixed with any medicines or

solutions with which it can interact.

Do not inject Clexane into a

muscle.

Things to be careful of

Clexane is not interchangeable

with other low molecular weight

heparins (LMWH) products.

Ask your doctor whether there are

any activities you should avoid

while using Clexane, for example

certain sports.

Sometimes after an injury bleeding

may occur inside your body without

you knowing about it.

Be sure to keep all of your doctor

appointments. Your doctor will

check your progress and may want to

take some blood tests from time to

time.

Side Effects

Tell your doctor or pharmacist as

soon as possible if you do not feel

well while you are using Clexane.

All medicines can have side effects.

Sometimes they are serious, most of

the time they are not. You may need

medical treatment if you get some of

the side effects.

Ask your doctor or pharmacist to

answer any questions you may

have.

Tell your doctor if you notice any

of the following and they worry

you:

Pain, bruising or irritation at the

injection site after Clexane has

been given

hard inflamed nodules at the

injection site

itchy red rash at the injection site

bleeding at the injection site

itchy skin

If any of the following happen, stop

using Clexane and tell your doctor

immediately or go to the

Emergency Department at your

nearest hospital:

painful itchy red/purple rash at

the injection site

difficulty in breathing, symptoms

of hayfever, feeling faint, itching

hives, blisters or other symptoms

of allergy

bleeding (including nose bleeds

or prolonged bleeding from cuts),

bruising more easily than normal,

red or dark brown urine, red or

black bowel motions

numbness (paralysis), problems

with coordination, dizziness,

tiredness, light-headedness,

blurred vision, confusion or

difficulty speaking

severe abdominal, chest pain and

headache

nausea, diarrhoea, fever

swelling of the hands, ankles or

feet

a fine widespread rash, especially

noticeable on your mouth or eyes

or sudden onset of white or blue

colour in fingers or toes

suggesting poor blood supply.

If you need to have had an

anaesthetic injection in your back

(spinal or epidural injection) while

taking Clexane, this should be done

in a hospital. Tell your doctor

immediately if any of the following

CLEXANE

AND CLEXANE

FORTE*

happen after an anaesthetic

injection in your back:

pain in the middle of your back

(midline back pain)

numbness and weakness in your

legs (sensory and motor deficits)

intestinal problems and problems

in passing urine

These are very serious side effects.

You may need urgent medical

attention or hospitalisation. These

side effects are rare.

Other side effects not listed above

may occur in some patients. Tell

your doctor or pharmacist if you

notice anything else that is making

you feel unwell.

Do not be alarmed by this list of

possible side effects. You may not

experience any of them.

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 Clexane in a cool dry place

where the temperature stays below

25°C.

Keep the syringes in the pack until

it is time to use them.

Do not freeze Clexane.

Do not leave Clexane in the car.

Keep Clexane away from direct

sunlight.

Do not store Clexane or any other

medicine in the bathroom, near a

sink or stove or on a windowsill.

Heat, light and dampness can destroy

some medicines.

Keep Clexane where children

cannot reach it.

A locked cupboard at least one and a

half metres above the ground is a

good place to store medicines.

Disposal

If your doctor tells you to stop

using Clexane or you find that the

syringes have passed their expiry

date, ask your doctor or

pharmacist what to do with any

that are left over.

Return any unused medicine to

your pharmacist.

Product description

What it looks like

Clexane is available in the following

range of presentations:

Ready to use Prefilled Syringes:

20mg/0.2mL, 10's

40mg/0.4mL, 10's

Ready to use Prefilled Syringes

with graduated markings:

60mg/0.6mL, 10's

80mg/0.8mL, 10's

100mg/1.0mL, 10's

120mg/0.8mL, 10's

150mg/1.0mL, 10's

Ingredients

Active Ingredient:

Clexane contains enoxaparin sodium.

Inactive Ingredients:

Clexane also contains water for

injections.

Sponsor

Clexane is distributed in Australia

sanofi-aventis australia pty ltd

12-24 Talavera Road

Macquarie Park NSW 2113

Clexane is distributed in New

Zealand by:

sanofi-aventis new zealand limited

Level 8, 56 Cawley Street

Ellerslie, Auckland

This leaflet was prepared in January

2017

Australian Register Numbers:

Pre-filled Syringes

20mg-AUST R 42965

40mg-AUST R 42962

60mg-AUST R 56709

80mg-AUST R 56710

100mg-AUST R 56711

120mg-AUST R 74173

150mg-AUST R 74175

Pre-filled syringes with automatic

safety lock system

20mg-AUST R 221717

40mg-AUST R 221718

60mg-AUST R 221719

80mg-AUST R 221720

100mg-AUST R 221721

120mg-AUST R 221722

150mg-AUST R 221723

Not marketed in New Zealand

Registered Trademark

* Subsequent references to

"CLEXANE" refer to both

CLEXANE and CLEXANE FORTE.

clexane-ccdsv12-cmiv20-jan17

CLEXANE

AND CLEXANE

FORTE*

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EU/3/17/1876 (FGK Representative Service GmbH)

EU/3/17/1876 (FGK Representative Service GmbH)

EU/3/17/1876 (Active substance: Sodium (1R,3R,4R,5S)-3-({2-N-acetylamino-2-deoxy-3-O-[(1S)-1-carboxylato-2-cyclohexylethyl]-beta-D-galactopyranosyl}oxy)-4-({6-deoxy-alpha-L-galactopyranosyl}oxy)-5-ethyl-cyclohexan-1-yl-(38-oxo-2,5,8,11,14,17,20,23,26,29,32,35-dodecaoxa-39-azahentetracontan-41-yl)carboxamide) - Transfer of orphan designation - Commission Decision (2018)2011 of Wed, 28 Mar 2018 European Medicines Agency (EMA) procedure number: EMA/OD/010/17/T/01

Europe -DG Health and Food Safety

21-3-2018

EU/3/16/1711 (Akcea Therapeutics UK Ltd)

EU/3/16/1711 (Akcea Therapeutics UK Ltd)

EU/3/16/1711 (Active substance: Volanesorsen sodium) - Transfer of orphan designation - Commission Decision (2018)1822 of Wed, 21 Mar 2018 European Medicines Agency (EMA) procedure number: EMA/OD/082/16/T/01

Europe -DG Health and Food Safety