SUMMARY CMI

Adrenaline Juno 1:10,000

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 Adrenaline Juno 1:10,000?

Adrenaline Juno 1:10,000 contains the active ingredient adrenaline (epinephrine) (as acid tartrate). In some countries adrenaline is known as epinephrine. Adrenaline Juno 1:10,000 is usually only given in cases of extreme emergency. It may be used following a heart attack, or to make the heart beat if it has stopped. In heart conditions it can help to restart the heart and stimulates it to beat more strongly.

For more information, see Section 1. Why am I using Adrenaline Juno 1:10,000? in the full CMI.

2. What should I know before I use Adrenaline Juno 1:10,000?

Adrenaline is an emergency life saving product. However, tell your doctor if you have ever had an allergic reaction to adrenaline 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 Adrenaline Juno 1:10,000? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with adrenaline 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 Adrenaline Juno 1:10,000?

• Adrenaline Juno 1:10,000 will normally be given to you by a doctor, paramedic or specially trained nurse.
• The injection will be given directly into the vein (intravenously).

More instructions can be found in Section 4. How do I use Adrenaline Juno 1:10,000? in the full CMI.

5. What should I know while using Adrenaline Juno 1:10,000?

For more information, see Section 5. What should I know while using Adrenaline Juno 1:10,000? in the full CMI.

6. Are there any side effects?

Side effects may include fear, anxiety, confusion, tenseness, restlessness, headache, tremor, weakness, dizziness, cold hands and feet, nausea and vomiting, difficulty passing urine, fast or noticeable heart beat, chest pain, injection site reactions, difficulty breathing.

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

Adrenaline Juno 1:10,000

Active ingredient(s): adrenaline (epinephrine) (as acid tartrate)

Consumer Medicine Information (CMI)

This leaflet provides important information about using Adrenaline Juno 1:10,000. 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 this medicine.

Where to find information in this leaflet:

1. Why am I using Adrenaline Juno 1:10,000?
2. What should I know before I use Adrenaline Juno 1:10,000?
3. What if I am taking other medicines?
4. How do I use Adrenaline Juno 1:10,000?
5. What should I know while using Adrenaline Juno 1:10,000?
6. Are there any side effects?
7. Product details

1. Why am I using Adrenaline Juno 1:10,000?

Adrenaline Juno 1:10,000 contains the active ingredient adrenaline (epinephrine) (as acid tartrate).

Adrenaline Juno 1:10,000 is usually only given in cases of extreme emergency. It may be used following a heart attack, or to make the heart beat if it has stopped. In heart conditions it can help to restart the heart and stimulates it to beat more strongly.

2. What should I know before I use Adrenaline Juno 1:10,000?

Warnings

Adrenaline Juno 1:10,000 is an emergency life-saving product. If possible, tell your doctor if:

• You are allergic to adrenaline, or any of the ingredients listed at the end of this leaflet.
• You have a history of medical conditions such as high blood pressure, heart conditions (ischemic heart disease, problems with the heart rhythm), diabetes mellitus, thyroid conditions, narrow angle glaucoma (high pressure in the eyes), brain damage, Phaeochromocytoma (a rare tumor of the adrenal gland).

Check with your doctor if you:

• Have any other medical conditions such as heart or vascular conditions, diabetes, lung problems, thyroid problems, prostate problems or parkinsonian syndrome.
• Take any medicines for any other condition.

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. Adrenaline should not be used in labor, as it can inhibit contractions.

Talk to your doctor if you are breastfeeding or intend to breastfeed. Adrenaline passes into breastmilk.

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 and adrenaline may interfere with each other. These include:

• some medicines used to treat coughs and colds
• medicines used to treat depression such as monoamine oxidase inhibitors
• some antihistamines
• thyroid hormones
• medicines which affect potassium levels such as diuretics, corticosteroids, theophylline
• medicines used for high blood pressure or heart conditions
• medicines to treat high blood sugar
• general anaesthetics

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

4. How do I use Adrenaline Juno 1:10,000?

How much to use

Adrenaline Juno 1:10,000 will normally be given to you by your doctor or by a specially trained nurse.

If you have to give Adrenaline Juno 1:10,000, your doctor will have told you what dose to use. Follow all directions given to you by your doctor carefully.

This may differ from the information contained in this leaflet.

The injection will be given straight into the vein. Adrenaline Juno 1:10,000 should not be given into the buttocks.

Children will be given a lower dose of Adrenaline Juno 1:10,000 depending on their weight.

This medicine is for injection only. If you will be giving yourself or anybody else injections make sure you know how to give them. Ask your doctor if you are unsure. If you have to use Adrenaline Juno 1:10,000 in an emergency tell your doctor immediately, or go to Accident and Emergency at your nearest hospital. You may need further medical treatment

If you use too much Adrenaline Juno 1:10,000

The doctor or nurse giving you Adrenaline Juno 1:10, 000 will be experienced in its use, so it is extremely unlikely that you will be given too much.

However, if you think that you have used too much Adrenaline Juno 1:10,000, you may need urgent medical attention.

You should immediately:

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

You should do this even if there are no signs of discomfort or poisoning.

5. What should I know while using Adrenaline Juno 1:10,000?

Things you should not do

Do not use Adrenaline Juno 1:10,000 to treat any other complaints unless your doctor tells you to.

Driving or using machines

Be careful before you drive or use any machines or tools until you know how adrenaline affects you.

Adrenaline Juno 1:10,000 may cause side effects such as disorientation, confusion or dizziness in some people.

Looking after your medicine

This medicine will generally be stored in the pharmacy or on the ward.

If you are storing Adrenaline Juno 1:10,000 at home, it should be stored in the original pack in a cool dark place where the temperature stays below 25°C. Follow the instructions in the carton on how to take care of your medicine properly.

Store it in a cool dry place away from moisture, heat or sunlight; for example, do not store it:

• in the bathroom or near a sink, or
• in the car or on window sills.

Keep it where young children cannot reach it.

Getting rid of any unwanted medicine

If you no longer need to use this medicine or it is out of date, take it to any pharmacy for safe disposal.

Do not use this medicine after the expiry date.

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.

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.

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 Adrenaline Juno 1:10,000 contains

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

What Adrenaline Juno 1:10,000 looks like

Adrenaline Juno 1:10,000 is a clear, colourless solution in packs of 10 pre-filled syringes. … (Aust R 282377).

Who distributes Adrenaline Juno 1:10,000

Juno Pharmaceuticals Pty Ltd
15-17 Chapel Street
Cremorne VIC 3121
www.junopharm.com.au

This leaflet was prepared in December 2024.

Published by MIMS February 2025

1 Name of Medicine

Adrenaline (epinephrine) acid tartrate.

2 Qualitative and Quantitative Composition

Each prefilled syringe contains adrenaline (epinephrine) acid tartrate equivalent to 1 mg adrenaline in 10 mL solution. Each prefilled syringe also contains 90 mg of sodium chloride and water for injections. The pH of the solution is adjusted between 3.0 and 3.4 with hydrochloric acid and/or sodium hydroxide.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Adrenaline Juno 1:10,000 is a clear, colourless, practically free from visible particles, sterile and pyrogen-free solution for injection in a 10 mL polypropylene pre-filled syringe. Adrenaline Juno 1:10,000 injection contains no antimicrobial agent. It should be used only once and any residue discarded. It is a clear, colourless solution and should not be used if it is coloured.

4 Clinical Particulars

4.1 Therapeutic Indications

Adrenaline Juno 1:10,000 is used as an adjunct in the management of cardiac arrest.

4.2 Dose and Method of Administration

Adrenaline (epinephrine) injection contains no antimicrobial agent. It should be used only once and any residue discarded. Adrenaline (epinephrine) injection should not be used if it is coloured.

Cardiac arrest.

Adults.

Children.

4.3 Contraindications

Known hypersensitivity to sympathomimetic amines.
Shock (other than anaphylactic shock).
Cardiac dilatation and coronary insufficiency.
Hypertension.
Ischaemic heart disease.
Arrhythmias.
Cerebral arteriosclerosis.
Diabetes mellitus.
Hyperthyroidism.
Narrow angle (congestive) glaucoma.
Organic brain damage.
Phaeochromocytoma.
During general anaesthesia with halogenated hydrocarbons or cyclopropane.
With local anaesthesia in fingers, toes, ears, nose or genitalia - there is a danger of vasoconstriction producing sloughing of tissues in these areas.
Labour - it may delay the second stage by inhibiting spontaneous or oxytocin-induced contractions of the pregnant human uterus.
Conditions in which vasopressor drugs may be contraindicated e.g. thyrotoxicosis.
In obstetrics when maternal blood pressure is in excess of 130/80 mmHg.
(Also see Section 4.5 Interactions with Other Medicines and Other Forms of Interactions.)

4.4 Special Warnings and Precautions for Use

Other beta-agonist sympathomimetics.

Disease states.

General anaesthesia.

Diabetic patients.

Circulatory support.

Gangrene.

Use in the elderly.

Paediatric use.

Effects on laboratory tests.

4.5 Interactions with Other Medicines and Other Forms of Interactions

Other sympathomimetic agents.

Rapidly acting vasodilators.

General anaesthetics.

Cardiovascular drugs.

Antihypertensive therapy.

Alpha blockers.

Beta blockers.

CNS and other drugs.

Drugs causing potassium loss.

Hypoglycaemic agents.

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 this registration.

4.8 Adverse Effects (Undesirable Effects)

Adrenaline (epinephrine) may cause reactions such as fear, anxiety, tenseness, restlessness, disorientation, impaired memory, confusion, irritability, hallucinations and psychotic states.
Headache, weakness, dizziness, anorexia, nausea and vomiting and difficulty in micturition with urinary retention may also occur.
Muscle tremor and hypokalaemia, psychomotor agitation, pallor, respiratory difficulty, hyperglycaemia, sweating, hypersalivation, cold extremities and insomnia have also been reported.
Palpitations, tachycardia (sometimes with anginal pain) and cardiac arrhythmias may also occur along with hypertension which in some instances may induce reflex bradycardia as can vasodilation with flushing and hypotension. Ventricular fibrillation may occur and severe hypertension may lead to cerebral haemorrhage and pulmonary oedema.
Overdosage or inadvertent IV injection of usual subcutaneous doses of adrenaline (epinephrine) may cause hypertension. Cerebrovascular or other haemorrhage and hemiplegia may result, especially in geriatric patients. Inadvertent IV injection of adrenaline (epinephrine) has also been reported to have caused convulsions, metabolic acidosis, and renal failure with anuria.
Repeated injections of adrenaline (epinephrine) can cause necrosis as a result of vascular constriction at the injection site. Prolonged use or overdosage of adrenaline (epinephrine) can result in severe metabolic acidosis.
Pulmonary oedema has been associated with excessive parenteral administration of adrenaline (epinephrine) and following topical aerosol application.
Gas gangrene which can be fatal has been reported following intramuscular injection of adrenaline (epinephrine)into the buttock or thigh. This appears to have been due to clostridium organisms on the skin being deposited into muscle tissue during injection, with the vasoconstrictor properties of adrenaline (epinephrine) enhancing the effects of the infection (see Section 4.2 Dose and Method of Administration).
High doses may result in ventricular arrhythmias.
Rigidity and tremor may be exacerbated in patients with Parkinsonism.
Syncopal episodes have been reported in children.
Psychiatric disorders may be exacerbated.

Reporting suspected adverse effects.

4.9 Overdose

Symptoms.

Treatment.

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Clinical trials.

5.2 Pharmacokinetic Properties

Parenterally administered adrenaline (epinephrine) has a rapid onset and short duration of action. The circulating drug is metabolised by the liver and other tissues. The majority is taken up and metabolised by sympathetic nerve endings. Adrenaline (epinephrine) is excreted in the urine, mainly in the form of metabolites.
Adrenaline (epinephrine) crosses the placenta but not the blood-brain barrier. It is also distributed into breast milk. (See Section 4.6 Fertility, Pregnancy and Lactation).

5.3 Preclinical Safety Data

Genotoxicity.

Carcinogenicity.

6 Pharmaceutical Particulars

6.1 List of Excipients

Sodium chloride, water for injections, hydrochloric acid and/or sodium hydroxide.

6.2 Incompatibilities

Adrenaline (epinephrine) is incompatible with oxidising agents, alkalis, copper, zinc, iron, silver and other metals.
Adrenaline (epinephrine) has been reported to be incompatible with solutions containing the following: aminophylline, ampicillin sodium, amylobarbitone sodium, ascorbic acid, benzylpenicillin potassium, calcium chloride, calcium gluconate, cephalothin sodium, chloramphenicol sodium succinate, chlortetracycline hydrochloride, corticotrophin, diazepam, digitoxin, ergometrine maleate, erythromycin gluceptate, frusemide, hyaluronidase, hydrocortisone sodium succinate, methicillin sodium, nitrofurantoin, noradrenaline acid tartrate, novobiocin sodium, pentobarbitone sodium, procaine, prochlorperazine edisylate, promazine hydrochloride, sodium bicarbonate, sulfadiazine sodium, suxamethonium chloride, tetracycline hydrochloride, vancomycin hydrochloride, vitamin B complex with ascorbic acid, warfarin sodium.
This list is not intended to be comprehensive. Refer to standard texts for further information.

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

Stored below 25°C. Store in the aluminium pouch and blister to protect from light and oxygen. Do not open the Aluminium pouch and blister until use. After opening of the pouch the product must be used immediately. Do not freeze.

6.5 Nature and Contents of Container

Adrenaline Juno 1:10,000 is available as 1 mg/10 mL (1:10,000) 10 mL. Prefilled syringe in a pack of 1 or 10.

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

Chemical name: (1R)-1-(3, 4- Dihydroxyphenyl)-2- (methylamino) ethanol hydrogen (2R, 3R)-2,3- dihydroxybutanedioate.

Chemical structure.

CAS number.

7 Medicine Schedule (Poisons Standard)

Unscheduled.

Summary Table of Changes