TRANEXAMIC

Main information

  • Trade name:
  • TRANEXAMIC ACID LINK 500 mg/ 5 mL tranexamic acid solution for injection ampoule
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • TRANEXAMIC ACID LINK 500 mg/ 5 mL tranexamic acid solution for injection ampoule
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 214485
  • Last update:
  • 09-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

214485

TRANEXAMIC ACID LINK 500 mg/ 5 mL tranexamic acid solution for injection ampoule

ARTG entry for

Medicine Registered

Sponsor

Luminarie Pty Ltd

Postal Address

40 Roxburgh Crescent,STANHOPE GARDENS, NSW, 2768

Australia

ARTG Start Date

5/08/2014

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. TRANEXAMIC ACID LINK 500 mg/ 5 mL tranexamic acid solution for injection ampoule

Product Type

Single Medicine Product

Effective date

14/09/2015

Warnings

See Product Information and Consumer Medicine Information for this product

Standard Indications

Specific Indications

Adults,For the reduction of peri± and post-operative blood loss and the need for blood transfusion in patients undergoing cardiac surgery or total knee

arthroplasty or total hip arthroplasty.,Paediatrics,For the reduction of peri± and post-operative blood loss and the need for blood transfusion in patients

undergoing cardiac surgery.

Additional Product information

Container information

Type

Material

Life Time

Temperature

Closure

Conditions

Ampoule

Glass Type I Clear

24 Months

Store below 25

degrees Celsius

Not recorded

Do not Freeze

Protect from Light

Pack Size/Poison information

Pack Size

Poison Schedule

5 x 5 mL Ampoules

(S4) Prescription Only Medicine

Components

1. TRANEXAMIC ACID LINK 500 mg/ 5 mL tranexamic acid solution for injection ampoule

Dosage Form

Injection, solution

Route of Administration

Intravenous

Visual Identification

Clear, colorless solution for injection.

Active Ingredients

Tranexamic acid

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 09:39:09 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

Link Medical Products Pty Ltd

Version 02

TRANEXAMIC ACID LINK

(tran-x-amic acid link)

Tranexamic acid solution for injection

Consumer Medicine Information

WHAT IS IN THIS

LEAFLET

Please read this leaflet

carefully before you are

given TRANEXAMIC

ACID LINK injection. This

leaflet answers some

common questions about

TRANEXAMIC ACID

LINK.

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

having an administration of

TRANEXAMIC ACID

LINK against the expected

benefits it will have for you.

If you have any concerns

about the administration of

this medicine, ask your

doctor or pharmacist.

Keep this leaflet you may need

to read it again.

WHAT TRANEXAMIC

ACID LINK

IS USED

FOR

TRANEXAMIC ACID LINK

is used to reduce bleeding and

the need for

transfusion of blood in patients

undergoing heart surgery, total

knee replacement and total hip

replacement surgery.

HOW TRANEXAMIC

ACID LINK WORKS

TRANEXAMIC ACID LINK

contains tranexamic acid.

Tranexamic acid is an

antifibrinolytic that works by

slowing the processes that cause

bleeding.

BEFORE RECEIVING

TRANEXAMIC ACID

LINK

When you must not have

an administration of it

Do not have an

administration of

TRANEXAMIC ACID LINK

if you have an allergy to

TRANEXAMIC ACID LINK

or any of the ingredients

listed at the end of this leaflet.

Do not have an

administration of

TRANEXAMIC ACID LINK

if you are being treated for a

stroke.

Do not have an

administration of

TRANEXAMIC ACID

LINK if you are being

treated for blood clots in

your legs, lungs or anywhere

else in your body.

Do not have an

administration of

TRANEXAMIC ACID

LINK if you have a problem

with colour vision that

developed after you were

born.

Before you are

administered it

You must tell your doctor

before he/her administers

TRANEXAMIC ACID

LINK if you have any of the

following:

you, or someone in your

family, has ever suffered

from blood clots

severe bruising

kidney disease with or

without blood in the urine

are pregnant or think you may

be pregnant

are breastfeeding or plan to

breastfeed

irregular periods and the

reason is not known.

Convulsions, fits or seizures

have been reported with

TRANEXAMIC ACID

LINK treatment.

Tell your doctor if you have

or have ever suffered from

convulsion, fits or seizures

before you are

administered

TRANEXAMIC ACID

LINK.

Tell your doctor if you

have allergies to:

any other medicines

any other substances,

such as foods,

preservatives or dyes.

If you have not told your

doctor about any of these

things, tell him/ her before

they administer

TRANEXAMIC ACID

LINK.

Taking other medicines

Tell your doctor about any

other medicines you are

taking including medicines

that you buy without a

Link Medical Products Pty Ltd

Version 02

prescription, in a

pharmacy, supermarket or

health food shop.

Some medicines may interfere

with TRANEXAMIC ACID

LINK. These include:

other medicines used to

prevent bleeding

medicines used to thin the

blood

These medicines may

affect the way

TRANEXAMIC ACID

LINK works.

HOW

TRANEXAMIC

ACID LINK IS

ADMINISTERED

Cardiac Surgery and

Total Knee or Total Hip

Replacement Surgery

Your doctor will determine

the dose that you will be

given, based on your weight.

The dose used in children

undergoing heart surgery may

be different to the dose used

in adult heart surgery. The

dose may vary depending on

whether you suffer from

diseases relating to the

kidneys.

If you are given too much

(overdose)

Immediately telephone your

doctor or Poisons

Information Centre for

advice (in Australia

telephone 13

11 26, or go to Accident &

Emergency at your nearest

hospital if you think you or

anyone else has been

administered too much

TRANEXAMIC ACID

LINK, even if there are no

signs of discomfort or

poisoning.

You may need urgent

medical attention.

Have TRANEXAMIC

ACID LINK or this

leaflet available to give

details if needed.

Keep telephone numbers

for these places handy.

If you are administered too

much TRANEXAMIC

ACID LINK you may have

the following symptoms:

dizziness

headache

nausea

diarrhoea

low blood pressure

convulsions, fits or

seizures.

WHILE YOU ARE

BEING

ADMINISTERED

TRANEXAMIC ACID

LINK

Things you must do

Tell any other doctors,

dentists and pharmacists

who are treating you that

you have been

administered

TRANEXAMIC ACID

LINK.

If you start on any new

medicine, tell your

doctor, dentist or

pharmacist that you have

been administered

TRANEXAMIC ACID

LINK.

SIDE EFFECTS

Tell your pharmacist or

doctor as soon as possible

if you do not feel well

after you are

administered

TRANEXAMIC ACID

LINK.

All medicines can have side

effects. Sometimes they are

serious,

most

time

they are not. You may need

medical treatment if you get

some of the side effects.

Tell your doctor, nurse or

pharmacist if you notice

any of the following and

they worry you:

nausea

vomiting

diarrhoea

These are the more common

side effects of

TRANEXAMIC ACID LINK.

Mostly these are mild and

short-lived.

Following cardiac surgery,

total knee replacement or total

hip replacement surgery, tell

your doctor or nurse

immediately if you experience

any of the following

irregular and often rapid

heart beat

heart attack

slow or irregular heart

beat

cardiogenic shock caused

by very low blood

pressure. The symptoms

are dizziness and light

headedness, rapid, weak

pulse, white skin,

sweating, restlessness,

loss of consciousness,

fainting, rapid, shallow

breathing, cold clammy

skin and weakness.

stroke. The symptoms of

stroke are numbness or

weakness of the arms or

legs, headache, dizziness

and confusion, visual

disturbance, difficulty

swallowing, slurred

speech and loss of speech.

Link Medical Products Pty Ltd

Version 02

kidney problems where

you pass little or no urine,

drowsiness, nausea,

vomiting and

breathlessness

difficulty breathing

a condition called deep

vein thrombosis (DVT).

The symptoms of DVT

are pain and swelling in

the large veins, usually in

your legs. DVT may lead

to complications such as

blood clots in your lungs

bowel infarction caused

by a restriction of blood

supply to the bowels.

You may experience

severe abdominal pains

and may pass bloody

stools.

These are serious side

effects. You may need

urgent medical attention.

Tell your doctor

immediately or go to

Accident and Emergency at

your nearest hospital if you

notice any of the following:

unexpected pain

unexpected swelling in

your legs or arms

giddiness or dizziness

allergic skin reactions

changes in your eyesight

convulsions, fits or

seizures

low blood pressure from

rapid administration of

TRANEXAMIC ACID

LINK Solution for

Injection.

These may be serious side

effects. You may need

urgent medical attention.

These side effects are rare.

Other side effects not listed

above may occur in some

patients.

Tell your doctor if you

notice any other side

effects after administration

of TRANEXAMIC ACID

LINK.

Do not be alarmed by this

list of possible side effects.

You may not experience any

of them.

AFTER

ADMINISTRATION OF

TRANEXAMIC ACID

LINK

Storage

TRANEXAMIC ACID

LINK Solution for

Injection will normally be

stored in a hospital. The

undiluted product should

be stored in a cool, dry

place where the

temperature stays below

25°C. Do not freeze.

Protect from light.

This product does not

contain antimicrobial

agents. It is for single use

in one patient only.

If storage of the diluted

solution is necessary, it

should be stored at

2°C-8°C for a maximum of

24 hours. Any unused

solution should be discarded.

Disposal

The hospital will normally

dispose of unused or

expired TRANEXAMIC

ACID LINK.

PRODUCT

DESCRIPTION

What it looks like

TRANEXAMIC ACID

LINK Solution for Injection

is a clear and colourless

solution.

Ingredients

The active ingredient in

TRANEXAMIC ACID

LINK is tranexamic acid.

TRANEXAMIC ACID

LINK ampoules each

contains 100 mg/mL

tranexamic acid.

The inactive ingredient is

Sterile Water for

Injections.

Pack sizes

TRANEXAMIC ACID

LINK Solution for Injection

is available in packs of

5 x 5 mL ampoules each

containing 500 mg

tranexamic acid and 5 mL

Water for Injections.

If you want to know

more

If you have any questions

about your treatment with

TRANEXAMIC ACID

LINK, ask your doctor or

pharmacist.

Supplier

In Australia by

Link Medical Products Pty

5 Apollo Street

Warriewood NSW 2102

Australian Register

Number

Solution for Injection

500 mg/5 mL ampoule -

AUST R 214485

This leaflet was last updated

in August 2014.

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Europe -DG Health and Food Safety

29-10-2018

DuoPlavin (Sanofi Clir SNC)

DuoPlavin (Sanofi Clir SNC)

DuoPlavin (Active substance: clopidogrel / acetylsalicylic acid) - Centralised - 2-Monthly update - Commission Decision (2018)7255 of Mon, 29 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/1143/WS/1433/0050

Europe -DG Health and Food Safety

2-10-2018

Zoledronic acid Actavis (Actavis Group PTC ehf.)

Zoledronic acid Actavis (Actavis Group PTC ehf.)

Zoledronic acid Actavis (Active substance: zoledronic acid) - Centralised - Yearly update - Commission Decision (2018)6488 of Tue, 02 Oct 2018

Europe -DG Health and Food Safety

2-10-2018

EU/3/16/1786 (Voisin Consulting S.A.R.L.)

EU/3/16/1786 (Voisin Consulting S.A.R.L.)

EU/3/16/1786 (Active substance: Recombinant adeno-associated viral vector serotype 2 carrying the gene for the human aromatic L-amino acid decarboxylase protein) - Transfer of orphan designation - Commission Decision (2018)6427 of Tue, 02 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/183/16/T/02

Europe -DG Health and Food Safety

2-10-2018

Zoledronic acid Mylan (Mylan S.A.S.)

Zoledronic acid Mylan (Mylan S.A.S.)

Zoledronic acid Mylan (Active substance: zoledronic acid) - Centralised - Yearly update - Commission Decision (2018)6486 of Tue, 02 Oct 2018

Europe -DG Health and Food Safety

2-10-2018

Zoledronic acid Teva (Teva B.V.)

Zoledronic acid Teva (Teva B.V.)

Zoledronic acid Teva (Active substance: zoledronic acid) - Centralised - Yearly update - Commission Decision (2018)6466 of Tue, 02 Oct 2018

Europe -DG Health and Food Safety

1-10-2018

EU/3/16/1762 (Pharma Gateway AB)

EU/3/16/1762 (Pharma Gateway AB)

EU/3/16/1762 (Active substance: Synthetic 15-amino-acid macrocyclic peptide acylated with a polyethyleneglycol palmitoylated linker) - Transfer of orphan designation - Commission Decision (2018)6399 of Mon, 01 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/107/16/T/01

Europe -DG Health and Food Safety

24-9-2018

Zoledronic acid Hospira (Pfizer Europe MA EEIG)

Zoledronic acid Hospira (Pfizer Europe MA EEIG)

Zoledronic acid Hospira (Active substance: zoledronic acid) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6243 of Mon, 24 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2365/T/33

Europe -DG Health and Food Safety

28-8-2018

EU/3/18/2056 (Nogra Pharma Limited)

EU/3/18/2056 (Nogra Pharma Limited)

EU/3/18/2056 (Active substance: (S)-(-)-3-(4-aminophenyl)-2-methoxypropanoic acid) - Orphan designation - Commission Decision (2018)5728 of Tue, 28 Aug 2018 European Medicines Agency (EMA) procedure number: EMA/OD/075/18

Europe -DG Health and Food Safety

6-8-2018

Zoledronic acid Accord (Accord Healthcare Limited)

Zoledronic acid Accord (Accord Healthcare Limited)

Zoledronic acid Accord (Active substance: zoledronic acid) - Centralised - Yearly update - Commission Decision (2018)5386 of Mon, 06 Aug 2018

Europe -DG Health and Food Safety

1-8-2018

Ucedane (Lucane Pharma)

Ucedane (Lucane Pharma)

Ucedane (Active substance: carglumic acid) - Centralised - Yearly update - Commission Decision (2018)5230 of Wed, 01 Aug 2018

Europe -DG Health and Food Safety

27-7-2018

EU/3/17/1932 (Millendo Therapeutics SAS)

EU/3/17/1932 (Millendo Therapeutics SAS)

EU/3/17/1932 (Active substance: Synthetic cyclic 8 amino acid analogue of human unacylated ghrelin) - Transfer of orphan designation - Commission Decision (2018)5049 of Fri, 27 Jul 2018 European Medicines Agency (EMA) procedure number: EMA/OD/066/17/T/01

Europe -DG Health and Food Safety

11-7-2018

Vantavo (Merck Sharp and Dohme B.V.)

Vantavo (Merck Sharp and Dohme B.V.)

Vantavo (Active substance: alendronic acid / colecalciferol) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)4511 of Wed, 11 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/1180/T/30

Europe -DG Health and Food Safety

3-7-2018

Granupas (Eurocept International B.V.)

Granupas (Eurocept International B.V.)

Granupas (Active substance: Para-aminosalicylic acid) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018) 4256 of Tue, 03 Jul 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/2709/T/25

Europe -DG Health and Food Safety

27-6-2018

EU/3/11/849 (Merck Sharp and Dohme B.V.)

EU/3/11/849 (Merck Sharp and Dohme B.V.)

EU/3/11/849 (Active substance: (S)-{8-fluoro-2-2[4-(3-methoxyphenyl)-1-piperazinyl]-3-[2-methoxy-5-(trifluoromethyl)-phenyl]-3,4-dihydro-4-quinazolinyl} acetic acid) - Transfer of orphan designation - Commission Decision (2018)4102 of Wed, 27 Jun 2018 European Medicines Agency (EMA) procedure number: EMA/OD/090/10/T/02

Europe -DG Health and Food Safety

19-6-2018

Dany's BienenWohl (Dany Bienenwohl GmbH)

Dany's BienenWohl (Dany Bienenwohl GmbH)

Dany's BienenWohl (Active substance: oxalic acid dihydrate) - Centralised - Authorisation - Commission Decision (2018)3892 of Tue, 19 Jun 2018 European Medicines Agency (EMA) procedure number: EMEA/V/C/4667

Europe -DG Health and Food Safety

4-6-2018

Chenodeoxycholic acid Leadiant (Leadiant GmbH)

Chenodeoxycholic acid Leadiant (Leadiant GmbH)

Chenodeoxycholic acid Leadiant (Active substance: chenodeoxycholic acid) - Centralised - Yearly update - Commission Decision (2018)3627 of Mon, 04 Jun 2018

Europe -DG Health and Food Safety

1-6-2018

Valproate

Valproate

Valproate (Active substance: medicinal products containing substances related to valproate (sodium valproate, valproic acid, valproate semisodium, valpromide, valproate magnesium)) - Community Referrals - Art 31 - Commission Decision (2018)3623 of Fri, 01 Jun 2018 European Medicines Agency (EMA) procedure number: EMEA/H/A-31/1454

Europe -DG Health and Food Safety

29-5-2018

EU/3/14/1400 (Orphan Europe S.A.R.L.)

EU/3/14/1400 (Orphan Europe S.A.R.L.)

EU/3/14/1400 (Active substance: (1S,4R,5R,7S)-3,4-dibenzyl-2-oxo-6,8-dioxa-3-azabyciclo[3.2.1]octane-7-carboxylic acid-L-lysine) - Transfer of orphan designation - Commission Decision (2018)3402 of Tue, 29 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/185/14/T/01

Europe -DG Health and Food Safety