Consumer medicine information

What is in this leaflet

This leaflet answers some common questions about Tranexamic Acid Juno. It does not contain all the available information and 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 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 and the need for 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 is an 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, 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.

Tell your doctor if you have or have ever suffered from convulsion, fits or seizures before you start taking Tranexamic Acid Juno. Convulsions, fits or seizures have been reported with Tranexamic Acid Juno treatment.

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 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 to 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 Solution for Injection will be administered under medical supervision to reduce blood loss during cardiac surgery or during your knee or 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 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 too 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. You may need urgent medical attention.

Have Tranexamic Acid Juno or this leaflet available to 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.

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.

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 Juno. 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:

• sudden signs of allergy such as rash, itching or hives on the skin, swelling of the face, lips, tongue or other parts of the body, shortness of breath, wheezing or difficulty breathing
• 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
• 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 Juno 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 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 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. Protect from light. Do not freeze.

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

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 of:

• 5 x 5 mL and 10 x 5 mL 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
42 Kelso Street,
Cremorne,
VIC 3121
Australia

Pharmacovigilance & Medical Enquiries Phone: 1800 620 076

Australian Registration Number

AUST R 222348

AUST R 222350

This leaflet was prepared in October 2022.

Published by MIMS December 2022

1 Name of Medicine

Tranexamic acid.

2 Qualitative and Quantitative Composition

Each 5 mL ampoule of Tranexamic Acid Juno solution for injection contains 500 mg tranexamic acid.
Each 10 mL ampoule of Tranexamic Acid Juno solution for injection contains 1000 mg tranexamic acid.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Tranexamic Acid Juno solution for injection is a sterile, clear, colourless solution practically free of visible particles.

4 Clinical Particulars

4.9 Overdose

Overdose data are limited. There is one report of overdosage in which a seventeen year old ingested 37 g of tranexamic acid and after receiving treatment with gastric lavage, mild intoxication was reported.
Symptoms of overdose may include dizziness, headache, nausea, vomiting, diarrhoea, orthostatic symptoms, hypotension and convulsions.
There is no known antidote for tranexamic acid overdose. In the event of overdose, the patient should be treated symptomatically and supportive measures should be instituted as required.
Activated charcoal may reduce absorption of tranexamic acid if given within one or two hours after ingestion. In patients who are not fully conscious or have impaired gag reflex, consideration should be given to administering activated charcoal via a nasogastric tube once the airway is protected.
In addition to this, monitor vital signs to detect a possible hypotensive episode. Monitor fluid and electrolyte status in patients with severe vomiting or diarrhoea and administer IV fluids and replace electrolytes as necessary. Monitor urine output and maintain adequate diuresis. Monitor for clinical evidence of thromboembolic complications (e.g. chest pain, shortness of breath, flank pain, extremity pain). Because there is a risk of thrombosis in predisposed individuals, anticoagulant therapy should be considered in these patients.
In symptomatic patients, support respiratory and cardiac function. Monitor blood count, renal function, pulse oximetry and/or blood gases and obtain a chest X-ray. Obtain an ECG and institute continuous cardiac monitoring.
For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).

5 Pharmacological Properties

5.3 Preclinical Safety Data

Genotoxicity. Tranexamic acid was not mutagenic in B. subtilis and had no chromosomal effects in Chinese hamster cells. The incidence of chromosomal breakage was increased at 3 g/kg in rat bone marrow. No lethal mutagenicity was detected in a dominant lethal test at 100 mg/kg and 3 g/kg. The weight of evidence in a limited range of mutagenicity tests suggests that tranexamic acid is not mutagenic.
Carcinogenicity. A dietary carcinogenicity study in Shermann-Wyckoff rats showed an increase in the incidence of biliary hyperplasia, cholangioma and adenocarcinoma of the liver at high doses.
However, these findings have not been reproduced in a number of other lifetime studies in either SD or CDF1 mice. A possible treatment related increase in the incidence of leukaemia was noted in mice receiving dietary tranexamic acid at doses equivalent to up to 5 g/kg/day for 20 months.

6 Pharmaceutical Particulars

6.7 Physicochemical Properties

Tranexamic acid is a white crystalline powder. It is freely soluble in water and in glacial acetic acid, practically insoluble in methanol, ethanol, acetone, diethyl ether and benzene.
pKa: 4.3 and 10.6.
The pH is 6.5 to 8.0.
Chemical name. Trans-4-aminomethylcyclohexane-carboxylic acid.
Chemical structure.
https://stagingapi.mims.com/au/public/v2/images/fullchemgif/CSTRAACI.gif CAS number. 1197-18-8.
Molecular weight. 157.2 g/mol.
Molecular formula. C₈H₁₅NO₂.

7 Medicine Schedule (Poisons Standard)

Prescription only Medicine (S4).

Summary Table of Changes

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