TRANEXAMIC

Main information

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

Documents

Localization

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

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 222350
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

222350

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

ARTG entry for

Medicine Registered

Sponsor

Juno Pharmaceuticals Pty Ltd

Postal Address

Level 2 6 Bond Street,South Yarra, VIC, 3141

Australia

ARTG Start Date

2/03/2015

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

Product Type

Single Medicine Product

Effective date

17/08/2016

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

Protect from Light

Do not Freeze

Pack Size/Poison information

Pack Size

Poison Schedule

(S4) Prescription Only Medicine

(S4) Prescription Only Medicine

Components

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

Dosage Form

Injection, solution

Route of Administration

Intravenous

Visual Identification

It is a sterile, clear, colourless solution, practically free from visible particles.

Active Ingredients

Tranexamic acid

500 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 11:31:48 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

Doc ID #

3.JU.M.1.0

Page 1 of 3

Tranexamic Acid Juno

Tranexamic Acid Solution for Injection

Consumer Medicine Information

What is in this leaflet

This

leaflet

answers

some

common

questions

about

Tranexamic Acid Juno. It does

contain

available

information and it does not take

place

talking

your

doctor or pharmacist.

medicines

have

risks

benefits.

Your

doctor

weighed the risks of you being

treated

with

Tranexamic

Acid

Juno against the benefits it is

expected to have for you.

Please read this leaflet carefully

and follow the instructions given

to you by your doctor and the

advice contained in this leaflet.

If

you

have

any

concerns

about being treated with this

medicine, ask your doctor or

pharmacist.

Keep this leaflet.

You may need to read it again.

What Tranexamic Acid

Juno is used for

Tranexamic Acid Juno Solution

for Injection is used to reduce

bleeding

need

transfusion of blood in patients

undergoing heart surgery, total

knee replacement and total hip

replacement surgery.

How Tranexamic Acid

Juno works

Tranexamic Acid Juno contains

tranexamic

acid.

Tranexamic

acid

antifibrinolytic

that

works by slowing the processes

that cause bleeding.

Before

treatment

with

Tranexamic Acid Juno

When Tranexamic Acid Juno

must not be used

Tranexamic Acid Juno must not

be used if you:

have an allergy to tranexamic

acid or any of the ingredients

listed at the end of this leaflet.

are being treated for stroke

are being treated for blood

clots in your legs, lungs or

anywhere else in your body.

have a problem with colour

vision

that

developed

after

you were born.

Do not use Tranexamic Acid

Juno

after

the

expiry

date

(EXP) printed on the pack.

Medicine taken after the expiry

date has passed may not work

as well.

Do not use Tranexamic Acid

Juno if the packaging is torn

or shows signs of tampering.

Do not use Tranexamic Acid

Juno

to

treat

any

other

complaint unless your doctor

tells you to.

Before

treatment

with

Tranexamic Acid Juno

Tell your doctor if you have

any of the following:

you,

someone

your

family,

ever

suffered

from blood clots

severe bruising

kidney

disease

with

without blood in the urine

are pregnant or think you

may be pregnant

breastfeeding

plan to breastfeed

irregular

periods

reason is not known.

Tell your doctor if you have

or have ever suffered from

convulsion, fits or seizures

before

you

start

taking

Tranexamic Acid Juno.

Convulsions,

fits

seizures

have

been

reported

with

Tranexamic

Acid

Juno

treatment.

Tell your doctor if you have

allergies to:

any other medicines

any other substances,

such

foods,

preservatives or dyes.

If

you

have

not

told

your

doctor

about

any

of

these

things,

tell

him/

her

before

you

start

treatment

with

Tranexamic Acid Juno.

Do not give this medicine to

anyone else even if they have

the same condition as you.

Taking other medicines

Tell

your

doctor

about

any

other

medicines

you

are

taking

including

medicines

that

you

buy

without

a

prescription, in a pharmacy,

supermarket

or

health

food

shop.

Some medicines may interfere

with Tranexamic Acid Juno.

These include:

other

medicines

used

prevent bleeding

medicines used to thin the

blood.

These

medicines

may

affect the way Tranexamic

Acid Juno works.

Treatment

with

Tranexamic Acid Juno

Tranexamic

Acid

Juno

Solution for Injection

Cardiac Surgery and Total

Knee

or

Total

Hip

Replacement Surgery

Tranexamic Acid Juno CMI

Juno Pharmaceuticals Pty Ltd

Doc ID #

3.JU.M.1.0

Page 2 of 3

Tranexamic Acid Juno Solution

for Injection will be administered

under

medical

supervision

reduce

blood

loss

during

cardiac surgery or during your

knee

replacement

surgery.

Your doctor will determine the

dose

that

will

given,

based on your weight. The dose

used

children

undergoing

heart surgery may be different to

dose

used

adult

heart

surgery.

dose

vary

depending on whether you

suffer

from

diseases

relating to the kidneys.

If you take or are given too

much

Tranexamic

Acid

Juno (overdose)

Tranexamic

Acid

Juno

Solution for Injection

will be

administered

under

medical

supervision so an overdose is

unlikely.

Symptoms

from

taking

much or being given too much

Tranexamic Acid Juno include:

dizziness

headache

nausea

diarrhoea

low blood pressure

convulsions, fits or seizures.

Immediately telephone your

doctor

or

Poisons

Information Centre for advice

(in Australia telephone 13 11

26, in New Zealand telephone

0800 POISON (0800 764 766)

or

go

to

Accident

&

Emergency at your nearest

hospital if you think you or

anyone else has taken too

much Tranexamic Acid Juno,

even if there are no signs of

discomfort or poisoning.

need

urgent

medical attention.

Have Tranexamic Acid Juno or

this

leaflet

available

give

details if needed.

Keep telephone numbers for

these places handy.

While you being treated

with

Tranexamic

Acid

Juno

Things you must do

Tell

any

other

doctors,

dentists and pharmacists that

you

are

being

treated

with

Tranexamic Acid Juno.

If

you

start

on

any

new

medicine,

tell

your

doctor,

dentist or pharmacist that you

being

treated

with

Tranexamic Acid Juno.

Side effects

Tell

your

pharmacist

or

doctor as soon as possible if

you do not feel well while you

being

treated

with

Tranexamic Acid Juno.

medicines

have

side

effects.

Sometimes

they

serious, most of the 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

more

common

side effects of Tranexamic Acid

Juno. Mostly these are mild and

short-lived.

Following cardiac surgery, total

knee

replacement

total

replacement

surgery,

tell

your

doctor or nurse immediately if

experience

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

consciousness,

fainting,

rapid, shallow breathing, cold

clammy skin and weakness

stroke.

symptoms

stroke

numbness

weakness of the arms or legs,

headache,

dizziness

confusion, visual disturbance,

difficulty swallowing, slurred

speech and loss of speech

kidney problems where you

pass

little

urine,

drowsiness,

nausea,

vomiting and breathlessness

difficulty breathing

a condition called deep vein

thrombosis

(DVT).

symptoms of DVT are pain

swelling

large

veins, usually in your legs.

lead

complications such as blood

clots in your lungs

bowel infarction caused by a

restriction of blood supply to

bowels.

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

blood

pressure

from

rapid

administration

Tranexamic

Acid

Juno

Solution for Injection.

These

serious

side

effects. You may need urgent

medical attention.

These side effects are rare.

Other

side

effects

listed

above

occur

some

patients.

Tranexamic Acid Juno CMI

Juno Pharmaceuticals Pty Ltd

Doc ID #

3.JU.M.1.0

Page 3 of 3

Tell your doctor if you notice

any other side effects while

being treated with Tranexamic

Acid Juno.

Do not be alarmed by this list

of possible side effects.

You may not experience any of

them.

After

treatment

with

Tranexamic Acid Juno

Storage

Tranexamic Acid Juno Solution

Injection

will

normally

stored

hospital.

undiluted

product

should

stored

cool,

place

where the temperature stays

below 25°C. Protect from light.

Do not freeze..

This product does not contain

antimicrobial agents. It is for

single use in one patient only.

storage

diluted

solution is necessary, it should

be stored at

2°C-8°C for a maximum of 24

hours.

unused

solution

should be discarded.

Disposal

If your doctor or pharmacist

tells

you

to

stop

taking

Tranexamic Acid Juno or the

medicine

has

passed

the

expiry

date,

ask

your

pharmacist what to do with

any medicine that is left over.

Remember: this medicine is

for

you.

Never

give

it

to

someone else even if they

have the same condition as

you.

Product Description

What it looks like

Tranexamic Acid Juno Solution

for Injection is a sterile clear and

colourless

solution,

practically

free from visible particules.

Ingredients

Tranexamic Acid Juno Solution

for Injection each contains 100

mg/mL tranexamic acid.

The inactive ingredient is

Sterile Water for Injections.

Pack sizes

Tranexamic Acid Juno Solution

for Injection is available in packs

ampoules each containing 500

mg tranexamic acid and Water

for Injections to 5 mL .

1 x 10 mL and 10 x 10 mL

ampoules each containing 1000

mg tranexamic acid and Water

for Injections to 10 mL.

If you want to know more

If you have any questions about

your treatment with Tranexamic

Acid Juno, ask your doctor or

pharmacist.

Supplier

Juno Pharmaceuticals Pty Ltd

Level 2,

6 Bond Street.

South Yarra,

VIC 3141

Australia

Australian Registration Number

AUST R 222348

AUST R 222350

This leaflet was prepared in July

2016.

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Safety advisory - diabetic ketoacidosis and surgical procedures

Therapeutic Goods Administration - Australia

5-11-2018

EU/3/18/2070 (Accelsiors CRO and Consultancy Services Ltd)

EU/3/18/2070 (Accelsiors CRO and Consultancy Services Ltd)

EU/3/18/2070 (Active substance: (6aR,10aR)-3-(1,1-dimethylheptyl)-delta8-tetrahydro-cannabinol-9-carboxylic acid) - Orphan designation - Commission Decision (2018)7271 of Mon, 05 Nov 2018 European Medicines Agency (EMA) procedure number: EMA/OD/114/18

Europe -DG Health and Food Safety

30-10-2018

EU/3/18/2076 (Orphan Europe S.A.R.L.)

EU/3/18/2076 (Orphan Europe S.A.R.L.)

EU/3/18/2076 (Active substance: Glycine, L-alanine, L-arginine, L-aspartic acid, L-cysteine, L-cystine, L-glutamic acid, L-histidine, L-lysine monohydrate, L-methionine, L-phenylalanine, L-proline, L-serine, L-threonine, L-tryptophan, L-tyrosine, taurine) - Orphan designation - Commission Decision (2018)7277 of Tue, 30 Oct 2018 European Medicines Agency (EMA) procedure number: EMA/OD/100/18

Europe -DG Health and Food Safety

29-10-2018

Clopidogrel/Acetylsalicylic acid Zentiva (Sanofi-Aventis groupe)

Clopidogrel/Acetylsalicylic acid Zentiva (Sanofi-Aventis groupe)

Clopidogrel/Acetylsalicylic acid Zentiva (Active substance: clopidogrel / acetylsalicylic acid) - Centralised - 2-Monthly update - Commission Decision (2018)7249 of Mon, 29 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/1144/WS1433/0051

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

29-5-2018

EU/3/10/826 (Eurocept International B.V.)

EU/3/10/826 (Eurocept International B.V.)

EU/3/10/826 (Active substance: Para-aminosalicylic acid) - Transfer of orphan designation - Commission Decision (2018)3396 of Tue, 29 May 2018 European Medicines Agency (EMA) procedure number: EMA/OD/072/10/T/02

Europe -DG Health and Food Safety