SUMMARY CMI

ADENOSINE VIATRIS

Consumer Medicine Information (CMI) summary

The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist.

1. Why am I using ADENOSINE VIATRIS?

ADENOSINE VIATRIS contains the active ingredient adenosine. ADENOSINE VIATRIS is used as an aid to doctors to understand how your heart is working. Adenosine is a type of medicine used to treat a condition where the heart beats too rapidly.

For more information, see Section 1. Why am I using ADENOSINE VIATRIS? in the full CMI.

2. What should I know before I use ADENOSINE VIATRIS?

Do not use if you have ever had an allergic reaction to ADENOSINE VIATRIS or any of the ingredients listed at the end of the CMI.

Talk to your doctor if you have any other medical conditions, take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding.

For more information, see Section 2. What should I know before I use ADENOSINE VIATRIS? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with ADENOSINE VIATRIS and affect how it works.

A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.

4. How do I use ADENOSINE VIATRIS?

• ADENOSINE VIATRIS will only be given to you in hospital by a trained healthcare professional.
• ADENOSINE VIATRIS will be given to you as a rapid injection over a couple of seconds.

More instructions can be found in Section 4. How do I use ADENOSINE VIATRIS? in the full CMI.

5. What should I know while using ADENOSINE VIATRIS?

For more information, see Section 5. What should I know while using ADENOSINE VIATRIS? in the full CMI.

6. Are there any side effects?

There are a number of side effects associated with this medicine. It is important to be aware of them so that you can identify any symptoms if they occur (see the full CMI for more details).

For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.

FULL CMI

ADENOSINE VIATRIS

Active ingredient(s): adenosine

Consumer Medicine Information (CMI)

This leaflet provides important information about using ADENOSINE VIATRIS. You should also speak to your doctor or pharmacist if you would like further information or if you have any concerns or questions about using ADENOSINE VIATRIS.

Where to find information in this leaflet:

1. Why am I using ADENOSINE VIATRIS?
2. What should I know before I use ADENOSINE VIATRIS?
3. What if I am taking other medicines?
4. How do I use ADENOSINE VIATRIS?
5. What should I know while using ADENOSINE VIATRIS?
6. Are there any side effects?
7. Product details

1. Why am I using ADENOSINE VIATRIS?

ADENOSINE VIATRIS contains the active ingredient adenosine.

ADENOSINE VIATRIS is used to treat a condition called paroxysmal supraventricular tachycardia (including a condition called Wolff-Parkinson-White syndrome). This is when the heart beats too rapidly. If left untreated, this condition can be life threatening.

ADENOSINE VIATRIS is also used as an aid to doctors to understand how your heart is working.

ADENOSINE VIATRIS works by slowing down the electrical impulses that control heart rhythm. This allows the heart rhythm to return to normal.

ADENOSINE VIATRIS is only given in hospitals. It is given to you as an injection. The effect of this medicine only lasts for a couple of minutes.

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 use.

There is no evidence this medicine is addictive.

This medicine is available only with a doctor's prescription.

2. What should I know before I use ADENOSINE VIATRIS?

Warnings

Do not use ADENOSINE VIATRIS if:

• you are allergic to adenosine, or any of the ingredients listed at the end of this leaflet. 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 have asthma
• you have some other problems with your heart or heart rhythm
• you have severe low blood pressure

Check with your doctor if you:

• have allergies to:
  - theophylline or aminophylline
  - dipyridamole
  - carbamazepine
  - any other medicines, foods, preservatives or dyes
• have or have had any of the following medical conditions:
  - a history of heart problems including problems with your blood pressure
  - you have had a heart transplant within the last 12 months
  - a history of epilepsy or seizures
  - a lung disease, such as bronchitis or emphysema
• eat or drink large amounts of food or drinks containing caffeine (e.g. coffee, tea, chocolate or cola)

These could affect how well adenosine works.

During treatment, you may be at risk of developing certain side effects. It is important you understand these risks and how to monitor for them. See additional information under Section 6. Are there any side effects?

Pregnancy and breastfeeding

Check with your doctor if you are pregnant or intend to become pregnant.

Like most medicines of this kind, ADENOSINE VIATRIS is not recommended to be used during pregnancy. Your doctor or pharmacist will discuss the risks and benefits of being given it if you are pregnant.

Talk to your doctor if you are breastfeeding or intend to breastfeed.

It is not known whether ADENOSINE VIATRIS passes into breast milk. Your doctor will discuss the benefits and possible risks of using adenosine during pregnancy or breastfeeding.

3. What if I am taking other medicines?

Tell your doctor or pharmacist if you are taking any other medicines, including any medicines, vitamins or supplements that you buy without a prescription from your pharmacy, supermarket or health food shop.

Some medicines may interfere with adenosine. These include:

• medicines used to help relieve breathing problems, such as theophylline or aminophylline
• dipyridamole, a medicine used for people who have had a stroke
• carbamazepine, a medicine used to treat epilepsy and seizures

These medicines may be affected by adenosine or may affect how well it works. You may need to use different amounts of your medicine or take different medicines. Your doctor or pharmacist will advise you.

Your doctor has more information on medicines to be careful with or avoid while using this medicine.

Check with your doctor or pharmacist if you are not sure about what medicines, vitamins or supplements you are taking and if these affect ADENOSINE VIATRIS.

4. How do I use ADENOSINE VIATRIS?

How much is given

• Your doctor will decide what dose of ADENOSINE VIATRIS you will receive. This depends on your condition. Usually you will only need one or several doses a few minutes apart.
• Adults: One injection (3mg). If the first injection does not slow down your heart rate within 1 or 2 minutes, one (6 mg) or two (12 mg) doses may be given.
• Children: There is not enough evidence to recommend the use of this medicine for children.

How it is given

• Do not eat or drink food or drinks containing caffeine (e.g. coffee, tea, chocolate or cola) for at least 12 hours before you receive your injection.
• ADENOSINE VIATRIS will be given to you in a hospital by a trained healthcare professional.
• ADENOSINE VIATRIS is given by injection either directly into a vein or via an intravenous (I.V.) line.

If you receive too much (overdose)

As this medicine is given to you under the supervision of your doctor, it is very unlikely that you will be given too much.

However, if you experience any unexpected or worrying side effects after being given ADENOSINE VIATRIS and think you have received too much of ADENOSINE VIATRIS, you should immediately:

• phone the Poisons Information Centre
  (Australia telephone 13 11 26) for advice, or
• contact your doctor, or
• go to the Emergency Department at your nearest hospital.

5. What should I know while using ADENOSINE VIATRIS?

Things you should not do

• Do not eat or drink food or drinks containing caffeine (e.g. coffee, tea, chocolate or cola) for at least 12 hours before you receive your injection.

After being given ADENOSINE VIATRIS

• If you have any queries about any aspects of your medicine, or any questions regarding this leaflet, discuss them with your doctor, nurse or pharmacist.

Looking after your medicine

• Do not refrigerate.
• Store below 25°C.
• ADENOSINE VIATRIS is stored in the pharmacy or on the ward.

6. Are there any side effects?

All medicines can have side effects. If you do experience any side effects, most of them are minor and temporary. However, some side effects may need medical attention.

Do not be alarmed by this list of side effects. You may not experience any of them.

Tell your doctor or nurse as soon as possible if you do not feel well during or after treatment with adenosine.

This medicine helps most people who are treated with it, but it may have unwanted side effects in some people.

See the information below and, if you need to, ask your doctor or pharmacist if you have any further questions about side effects.

Less serious side effects

Serious side effects

Tell your doctor or pharmacist if you notice anything else that may be making you feel unwell, even if you think the problems are not connected with this medicine and are not referred to in this leaflet.

Other side effects not listed here may occur in some people.

Reporting side effects

After you have received medical advice for any side effects you experience, you can report side effects to the Therapeutic Goods Administration online at www.tga.gov.au/reporting-problems. By reporting side effects, you can help provide more information on the safety of this medicine.

Always make sure you speak to your doctor or pharmacist before you decide to stop taking any of your medicines.

7. Product details

This medicine is only available with a doctor's prescription.

What ADENOSINE VIATRIS contains

Do not take this medicine if you are allergic to any of these ingredients.

What ADENOSINE VIATRIS looks like

ADENOSINE VIATRIS is a clear, colourless, sterile solution in a glass vial. (AUST R 152014).

Available in packs of 6 x 2mL.

Who distributes ADENOSINE VIATRIS

Alphapharm Pty Ltd trading as Viatris
Level 1, 30 The Bond
30-34 Hickson Road
Millers Point NSW 2000
www.viatris.com.au
Phone: 1800 274 276

This leaflet was prepared in January 2023.

ADENOSINE VIATRIS_cmi\Jan23/00

Published by MIMS March 2023

1 Name of Medicine

Adenosine.

2 Qualitative and Quantitative Composition

Adenosine Viatris is a sterile solution for intravenous injection (rapid bolus), available in clear glass vials and pre-filled syringes.
Each vial or pre-filled syringe contains 6 mg adenosine in 2 mL solution.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Solution for injection.
Clear colourless solution free from visible particles.

4 Clinical Particulars

4.1 Therapeutic Indications

Therapeutic indications.

Diagnostic indications.

4.2 Dose and Method of Administration

Adenosine Viatris should be used only in hospitals with monitoring and cardiorespiratory resuscitation equipment available for immediate use. It should be administered by rapid intravenous bolus injection according to the ascending dosage schedule below. To be certain the solution reaches the systemic circulation, administer either directly into a vein or into an IV line. If administered into an IV line it should be injected as proximally as possible, and followed by a rapid saline flush.
Adenosine Viatris should only be used when facilities exist for cardiac monitoring. Patients who develop high level AV block at a particular dose should not be given further dosage increments.
Adenosine Viatris is for use in one patient only. Discard any remaining contents.

Therapeutic dose.

Initial dose.

Second dose.

Third dose.

Diagnostic dose.

4.3 Contraindications

Adenosine Viatris is contraindicated in patients suffering from:
known hypersensitivity to adenosine;
sick sinus syndrome, second or third degree AV block (except in patients with a functioning artificial pacemaker);
chronic obstructive lung disease (such as asthma);
long QT syndrome;
severe hypotension;
decompensated states of heart failure.

4.4 Special Warnings and Precautions for Use

Adenosine is intended for use by doctors familiar with the product (see Section 4.2 Dose and Method of Administration) in a hospital setting with monitoring and cardiorespiratory resuscitation equipment available for immediate use if necessary.
The occurrence of angina, severe bradycardia, severe hypotension, respiratory failure (potentially fatal), or asystole/ cardiac arrest (potentially fatal), should lead to immediate discontinuation of administration.
In patients with a history of convulsions/ seizures, the administration of adenosine should be carefully monitored.
As dipyridamole is a known inhibitor of adenosine uptake, it may potentiate the action of adenosine administration. If the use of adenosine bolus injection (Adenosine Viatris) is judged to be essential, dipyridamole should be discontinued 24 hours beforehand, or the dose of adenosine should be significantly reduced.
Adenosine should be given as a rapid intravenous bolus injection. Adenosine is ineffective in the management of supraventricular tachycardias when given as an infusion, rather than a bolus. This is most probably due to the different effect on sinus rate and atrioventricular nodal conduction.

Hypotension.

Atrial fibrillation.

Bradycardia.

Heart block and myocardial infarction.

Arrhythmias at time of conversion.

Post heart transplantation.

Bronchoconstriction.

Use in the elderly.

Paediatric use.

Effects on laboratory tests.

4.5 Interactions with Other Medicines and Other Forms of Interactions

Intravenous adenosine has been administered effectively in the presence of other cardioactive drugs, such as digitalis, quinidine, beta-adrenergic blocking agents, calcium channel blocking agents, and angiotensin converting enzyme inhibitors, without any change in the adverse reaction profile.
Adenosine may interact with drugs that tend to impair cardiac conduction. Aminophylline, theophylline and other xanthines are competitive adenosine antagonists and should be avoided for 24 hours prior to the administration of adenosine.
Food and drinks containing xanthines e.g. tea, coffee, chocolate and cola should be avoided for at least 12 hours prior to the administration of adenosine.
Nucleoside transport inhibitors such as dipyridamole inhibit adenosine cellular uptake and metabolism, and potentiate the action of adenosine. In one study dipyridamole was shown to produce a four-fold increase in adenosine activity. If the use of adenosine bolus injection (Adenosine Viatris) is judged to be essential, dipyridamole should be discontinued 24 hours beforehand, or the dose of adenosine should be significantly reduced.
Carbamazepine has been reported to increase the degree of heart block produced by other agents. As the primary effect of adenosine is to decrease conduction through the AV node, higher degrees of heart block may be produced in the presence of carbamazepine.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

4.7 Effects on Ability to Drive and Use Machines

The effects of this medicine on a person's ability to drive and use machines were not assessed as part of its registration.

4.8 Adverse Effects (Undesirable Effects)

The following adverse reactions were reported with adenosine rapid intravenous bolus injection. These adverse reactions have been classified using standard terminology and are categorised by body system. They are listed in order of decreasing frequency according to the following definitions.
Very common: ≥ 1/10 (10%); common: ≥ 1/100 (1%) and < 1/10 (10%); uncommon: ≥ 1/1,000 (0.1%) and < 1/100 (1%); rare: ≥ 1/10,000 (0.01%) and < 1/1,000 (0.1%); very rare: < 1/10,000 (0.01%); not known: (cannot be estimated from available data).

Cardiovascular system.

Respiratory system.

Central nervous system.

Gastrointestinal system.

Other.

Post-marketing experience.

Reporting suspected adverse effects.

4.9 Overdose

As the half-life of adenosine is very short (less than 10 seconds), adverse effects are generally rapidly self-limiting.
Treatment of any prolonged adverse effects should be individualised and be directed toward the specific symptoms. Methylxanthines, such as caffeine and theophylline, and aminophylline are competitive antagonists of adenosine. Intravenous aminophylline or theophylline may be needed.
For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Haemodynamics.

Clinical trials.

5.2 Pharmacokinetic Properties

Intravenously administered adenosine is removed from the circulation very rapidly. Following an intravenous bolus, adenosine is taken up by erythrocytes and vascular endothelial cells. The half-life of intravenous adenosine is estimated to be less than 10 seconds. Adenosine enters the body pool and is primarily metabolised to inosine and adenosine monophosphate (AMP).

Hepatic or renal failure.

5.3 Preclinical Safety Data

Genotoxicity.

Carcinogenicity.

6 Pharmaceutical Particulars

6.1 List of Excipients

Sodium chloride, water for injections.

6.2 Incompatibilities

Incompatibilities were either not assessed or not identified as part of the registration of this medicine.

6.3 Shelf Life

In Australia, information on the shelf life can be found on the public summary of the Australian Register of Therapeutic Goods (ARTG). The expiry date can be found on the packaging.

6.4 Special Precautions for Storage

Adenosine Viatris 6 mg/2 mL glass vials.

Adenosine Viatris 6 mg/2 mL pre-filled syringes.

6.5 Nature and Contents of Container

Adenosine Viatris 6 mg/2 mL glass vial.

Adenosine Viatris 6 mg/2 mL pre-filled syringe.

Australian register of therapeutic goods (ARTG).

6.6 Special Precautions for Disposal

In Australia, any unused medicine or waste material should be disposed of in accordance with local requirements.

6.7 Physicochemical Properties

Adenosine is a white, crystalline powder slightly soluble in water, soluble in hot water, practically insoluble in alcohol and in methylene chloride.
The pH is between 4.5 and 7.5.

Chemical structure.

CAS number.

7 Medicine Schedule (Poisons Standard)

S4 (Prescription Only Medicine).

Summary Table of Changes