Hospira

Main information

  • Trade name:
  • Hospira Tranexamic Acid Injection tranexamic acid 1000 mg in 10 mL ampoule
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Hospira Tranexamic Acid Injection tranexamic acid 1000 mg in 10 mL ampoule
    Australia
  • Language:
  • English

Other information

Status

  • Source:
  • Dept. of Health,Therapeutic Goods Administration - Australia
  • Authorization number:
  • 222160
  • Last update:
  • 08-10-2017

Public Assessment Report

Public Summary

Summary for ARTG Entry:

222160

Hospira Tranexamic Acid Injection tranexamic acid 1000 mg in 10 mL ampoule

ARTG entry for

Medicine Registered

Sponsor

Pfizer Australia Pty Ltd

Postal Address

38-42 Wharf Road,WEST RYDE, NSW, 2114

Australia

ARTG Start Date

3/02/2015

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. Hospira Tranexamic Acid Injection tranexamic acid 1000 mg in 10 mL ampoule

Product Type

Single Medicine Product

Effective date

4/08/2015

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

36 Months

Store below 25

degrees Celsius

Not recorded

Protect from Light

Do not Freeze

Pack Size/Poison information

Pack Size

Poison Schedule

1 ampoule per pack

(S4) Prescription Only Medicine

10 ampoules per pack

(S4) Prescription Only Medicine

Components

1. Hospira Tranexamic Acid Injection tranexamic acid 1000 mg in 10 mL ampoule

Dosage Form

Injection, solution

Route of Administration

Intravenous

Visual Identification

Clear, colourless solution in a clear glass ampoule

Active Ingredients

Tranexamic acid

1000 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 12:01:30 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

HOSPIRA™ Tranexamic Acid

Injection

Tranexamic Acid

Consumer Medicine Information

Date of Dispensing

Consumer Name

Pharmacist Name

Consumer Address

Pharmacist Address

What is in this leaflet

This leaflet answers some common

questions about HOSPIRA™

Tranexamic Acid Injection.

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 receiving

HOSPIRA™ Tranexamic Acid

Injection against the benefits they

expect it will have for you.

If you have any concerns about

having this medicine, ask your

doctor or pharmacist.

Keep this leaflet

You may need to read it again.

What HOSPIRA™

Tranexamic Acid

Injection is used for

HOSPIRA™ Tranexamic Acid

Injection is used to reduce bleeding

and the need for blood transfusion

in adults and children undergoing

heart surgery, and adults

undergoing total knee or hip

replacement surgery.

It works by slowing the breakdown

of blood clots.

Ask your doctor if you have any

questions about why this

medicine has been prescribed

for you.

Your doctor may have prescribed it

for another reason.

This medicine is not addictive.

Before you are given

HOSPIRA™

Tranexamic Acid

Injection

When you must not be given

it

You must not be given

HOSPIRA™ Tranexamic Acid

Injection if you

have an allergy to tranexamic

acid

Some of the symptoms of an

allergic reaction may include:

shortness of breath

wheezing or difficulty breathing

swelling of the face, lips, tongue

or other parts of the body

rash, itching or hives on the

skin.

You must not be given it if

you have a problem with colour

vision that developed after you

were born

you have problems associated

with blood clots or stroke.

Before you are given it

Tell your doctor if you have or

have had any of the following

kidney problems

convulsions, fits or seizures.

you, or someone in your family

has ever suffered from stroke or

blood clots

Tell your doctor if you are

pregnant or plan to become

pregnant or are breast-feeding.

Your doctor can discuss with you

the risks and benefits involved.

If you have not told your doctor

about any of the above, tell

him/her before you are given

HOSPIRA™ Tranexamic Acid

Injection.

Taking other medicines

Tell your doctor or pharmacist if

you are taking any other

medicines, including any that

you get without a prescription

from your pharmacy,

supermarket or health food

shop.

Some medicines and HOSPIRA™

Tranexamic Acid Injection may

interfere with each other. These

include:

medicines used to thin the blood

some medicines used to prevent

bleeding.

These medicines may be affected

by HOSPIRA™ Tranexamic Acid

Injection or may affect how well it

works. You may need different

amounts of your medicines, or you

may need to take different

medicines.

Your doctor and pharmacist have

more information on medicines to

be careful with or avoid while taking

this medicine.

HOSPIRA™ Tranexamic Acid Injection CMI

How HOSPIRA™

Tranexamic Acid

Injection is given

Follow all directions given to you

by your doctor or pharmacist

carefully.

They may differ from the

information contained in this leaflet.

HOSPIRA™ Tranexamic Acid

Injection is administered to prevent

blood loss during surgery. It will be

administered by a doctor or nurse

as an injection or infusion (drip) into

a vein.

How much is given

Your doctor will decide what dose

you will receive. This depends on

the type of surgery and other

factors, such as your weight and

how well your kidneys are

functioning. The dosage for

children undergoing heart surgery

may be different to the dose used

in adults.

If you are given too much

(overdose)

As HOSPIRA™ Tranexamic Acid

Injection is given under medical

supervision, it is very unlikely that

you will receive too much.

However, if you experience

severe side effects after being

given this medicine, tell your

doctor immediately.

Symptoms from being given too

much include

dizziness

headache

nausea and vomiting

diarrhoea

low blood pressure

convulsions, fits or seizures.

Immediately telephone your

doctor or the Poisons

Information Centre (telephone 13

11 26 in Australia, or 0800 764

766 in New Zealand) for advice,

or go to Accident and

Emergency at the nearest

hospital, if you think that you

may have received too much

HOSPIRA™ Tranexamic Acid

Injection.

Ask your doctor if you have any

concerns.

While you are using

HOSPIRA™

Tranexamic Acid

Injection

Things you must do

If you are about to be started on

any new medicine, remind your

doctor and pharmacist that you

are being treated with

HOSPIRA™ Tranexamic Acid

Injection.

Tell any other doctors, dentists,

and pharmacists who treat you

that you are being treated with

this medicine.

Things to be careful of

Tranexamic acid may cause

dizziness and therefore may

influence the ability to drive or

use machines.

Be careful driving or operating

machinery until you know how

tranexamic acid affects you.

Side effects

Tell your doctor or pharmacist as

soon as possible if you do not

feel well while you are taking

HOSPIRA™ Tranexamic Acid

Injection.

This medicine helps most people,

but it may have unwanted side

effects in a few people. All

medicines can have side effects.

Sometimes they are serious, most

of the time they are not. You may

need medical attention if you get

some of the side effects.

Do not be alarmed by the

following lists of side effects.

You may not experience any of

them.

Ask your doctor or pharmacist to

answer any questions you may

have.

Tell your doctor or pharmacist if

you notice any of the following

and they worry you:

nausea

vomiting

diarrhoea.

If any of the following happen,

tell your doctor immediately or

go to Accident and Emergency at

your nearest hospital:

irregular, slow or rapid heart

beat

convulsions, fits or seizures

changes in your eye sight

dizziness

heart attack (symptoms of chest

pain which may spread to the

neck and shoulders)

kidney problems where you

pass little or no urine,

drowsiness, nausea, vomiting

and breathlessness

bowel infarction caused by

restricted blood supply to the

bowel. Symptoms include

abdominal pain and diarrhoea

a condition called deep vein

thrombosis (DVT) which is the

formation of blood clots in the

legs. This can sometimes lead

to complications such as blood

clots in your lungs. The

symptoms may include pain and

swelling in the large veins,

usually in your legs, and lung

complications can cause

symptoms of shortness of

breath and chest pain

stroke which can include

collapse, numbness or

weakness of the arms or legs,

headache, dizziness and

confusion, visual disturbance,

difficulty swallowing, slurred

speech and loss of speech

signs of an allergic reaction,

such as rash, itching or hives on

the skin; swelling of the face,

lips, tongue or other parts of the

HOSPIRA™ Tranexamic Acid Injection

body; shortness of breath,

wheezing or difficulty breathing

cardiogenic shock, a serious

heart condition caused by very

low blood pressure. Symptoms

may include rapid, shallow

breathing, cold, clammy skin, a

rapid, weak pulse, dizziness,

weakness and fainting

symptoms of low blood pressure

(dizziness, lightheadedness).

The above list includes very serious

side effects. You may need urgent

medical attention or hospitalisation.

These side effects are rare.

Tell your doctor or pharmacist if

you notice anything that is

making you feel unwell.

Other side effects not listed above

may also occur in some people.

After using HOSPIRA™

Tranexamic Acid

Injection

Storage

HOSPIRA™ Tranexamic Acid

Injection will be stored in the

pharmacy or on the ward. Store

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.

Any unused product should be

discarded .

Product description

What it looks like

HOSPIRA™ Tranexamic Acid

Injection is a clear, colourless

solution available in 5mL and 10mL

clear glass ampoules.

Each 5mL ampoule contains

500mg of tranexamic acid. It is

available in packs of 5 and 10.

Each 10mL ampoule contains

1000mg of tranexamic acid. It is

available in packs of 1 and 10.

Not all pack sizes and

presentations are distributed in

Australia.

Ingredients

HOSPIRA™ Tranexamic Acid

Injection contains

100 mg per mL of tranexamic

acid as the active ingredient

It also contains:

water for injections.

This medicine does not contain

lactose, sucrose, gluten, tartrazine

or any other azo dyes.

Sponsor

HOSPIRA™ Tranexamic Acid

Injection is supplied by:

Australian Sponsor:

Hospira Pty Ltd

ABN 13 107 058 328

Level 3

500 Collins St

Melbourne VIC 3000

Australia

New Zealand Sponsor:

Hospira NZ Limited

58 Richard Pearse Drive

Airport Oaks, Mangere 2022

Auckland

New Zealand

HOSPIRA™ Tranexamic Acid

Injection is available in the following

sizes:

500 mg/5 mL ampoule

AUST R 222159

1,000 mg/10 mL ampoule

AUST R 222160

This leaflet was prepared in

February 2015.

HOSPIRA™ Tranexamic Acid Injection

17-11-2018

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Daptomycin Hospira (Hospira UK Limited)

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5-11-2018

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

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1-11-2018

Taxespira (Hospira UK Limited)

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Taxespira (Active substance: docetaxel) - Centralised - Withdrawal - Commission Decision (2018)7368 of Thu, 01 Nov 2018

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

22-10-2018

Pemetrexed Hospira (Pfizer Europe MA EEIG)

Pemetrexed Hospira (Pfizer Europe MA EEIG)

Pemetrexed Hospira (Active substance: pemetrexed) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6971 of Mon, 22 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/3970/T/14

Europe -DG Health and Food Safety

8-10-2018

Palonosetron Hospira (Pfizer Europe MA EEIG)

Palonosetron Hospira (Pfizer Europe MA EEIG)

Palonosetron Hospira (Active substance: palonosetron) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6606 of Mon, 08 Oct 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4069/T/04

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

Topotecan Hospira (Pfizer Europe MA EEIG)

Topotecan Hospira (Pfizer Europe MA EEIG)

Topotecan Hospira (Active substance: topotecan) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6238 of Mon, 24 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/1192/T/33

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

10-9-2018

Retacrit (Hospira UK Limited)

Retacrit (Hospira UK Limited)

Retacrit (Active substance: epoetin zeta) - Centralised - Yearly update - Commission Decision (2018)5946 of Mon, 10 Sep 2018

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

10-8-2018

Bortezomib Hospira (Pfizer Europe MA EEIG)

Bortezomib Hospira (Pfizer Europe MA EEIG)

Bortezomib Hospira (Active substance: bortezomib) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)5515 of Fri, 10 Aug 2018 European Medicines Agency (EMA) procedure number: EMEA/H/C/4207/T/10

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