Consumer medicine information

What is in this leaflet

This leaflet answers some of the common questions people ask about Adrenaline Aguettant 1:10,000. It does not contain all the information that is known about Adrenaline Aguettant 1:10,000.

It does not take the place of talking to your doctor or pharmacist.

All medicines have risks and benefits. Your doctor will have weighed the risks of you using Adrenaline Aguettant 1:10,000 against the benefits they expect it will have for you.

If you have any concerns about using this medicine, ask your doctor or pharmacist.

Keep this leaflet with the medicine. You may need to read it again.

What Adrenaline Aguettant 1:10,000 is used for

Adrenaline Aguettant 1:10,000 is usually only given in cases of extreme emergency.

Adrenaline Aguettant 1:10,000 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.

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.

Adrenaline Aguettant 1:10,000 is not addictive.

Before you are given Adrenaline Aguettant 1:10,000

When you must not use it

Adrenaline Aguettant 1:10,000 is an emergency life-saving product.

However, it should be given with care if you have an allergy to:

• Adrenaline
• or any other ingredients listed at the end of the 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

Do not use Adrenaline Aguettant 1:10,000 if:

• you are pregnant unless your doctor says so.
  Your doctor will discuss the possible risks and benefits of using Adrenaline Aguettant 1:10,000 during pregnancy.
• you are in labour.
  Adrenaline Aguettant 1:10,000 can stop the contractions in the womb during labour.

Do not use Adrenaline Aguettant 1:10,000 after the use-by (expiry) date printed on the pack or if the packaging is torn or shows signs of tampering. If it has expired or is damaged, return it to your pharmacist for disposal.

If you are not sure whether you should start using this medicine, talk to your doctor.

Before you start to use it

Tell your doctor if you have allergies to any other medicines, foods, preservatives or dyes.

Tell your doctor if you have or have had any of the following medical conditions:

• heart problems
• angina or chest pains
• high blood pressure
• irregular heart rate
• high pressure in the eyes (glaucoma)
• diabetes
• brain damage
• over active thyroid gland
• lung disease
• stroke
• phaeochromocytoma (rare tumour of the adrenal gland)

Tell your doctor if you are breastfeeding. Adrenaline Aguettant 1:10,000 passes into breastmilk and there is a possibility that your baby may be affected. Your doctor can discuss with you the risks and benefits of using it during breastfeeding.

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 Adrenaline Aguettant 1:10,000 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
• medicines which affect potassium levels such as diuretics, theophylline
• medicines used for high blood pressure or heart conditions
• medicines to treat high blood sugar
• general anaesthetics

These medicines may be affected by Adrenaline Aguettant 1:10,000 or may affect how well it works. You may need different amounts of your medicines, or you may need to use different medicines.

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

If you have not told your doctor about any of these things, tell them before you are given any Adrenaline Aguettant 1:10,000.

How to give Adrenaline Aguettant 1:10,000

How to use it

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

If you have to give Adrenaline Aguettant 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 Aguettant 1:10,000 should not be given into the buttocks.

Children will be given a lower dose of Adrenaline Aguettant 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 Aguettant 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 take too much (overdose)

The doctor or nurse giving you Adrenaline Aguettant 1:10, 000 will be experienced in its use, so it is extremely unlikely that you will be given too much. However, if you experience any side effects after being given Adrenaline Aguettant 1:10,000, tell your doctor or nurse immediately.

If you have to give Adrenaline Aguettant 1:10,000, make sure you give it exactly as directed. This will make it unlikely that too much will be given.

Immediately telephone your doctor or the Poisons Information Centre (Australiaon 131 126) for advice, or go to Accident and Emergency at the nearest hospital, if you think that you or anyone else may have taken too much Adrenaline Aguettant 1:10,000. Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention.

Symptoms of overdose may include feeling unwell, flushing or abnormal heart beats, and headaches.

While you are using Adrenaline Aguettant 1:10,000

Things you must not do

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

Side effects

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are being given Adrenaline Aguettant 1:10,000.

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.

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:

• fear, anxiety, confusion
• tenseness
• restlessness
• headache
• tremor
• weakness
• dizziness
• cold hands and feet
• nausea and vomiting
• difficulty passing urine

These side effects are usually mild.

Tell your doctor immediately or go to Accident and Emergency at your nearest hospital if you notice any of the following:

• difficulty in breathing
• whiteness, swelling, pain or loss of feeling at the site of injection
• convulsions, fits or seizures
• abnormal heart beat or palpitations

These are all serious side effects. You may need urgent medical attention

Serious side effects are rare.

Tell your doctor or pharmacist if you notice anything else that is making you feel unwell. Other side effects not listed above may also occur in some people.

After using Adrenaline Aguettant 1:10,000

Storage

If you are storing Adrenaline Aguettant 1:10,000 at home, they should be stored in the original pack in a cool dark place where the temperature stays below 25ºC.

Do not store it or any other medicine in the bathroom or near a sink. Do not leave it on a window sill or in the car. Heat and dampness can destroy some medicines.

Keep it where children cannot reach it. A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.

Disposal

If your doctor tells you to stop using Adrenaline Aguettant 1:10,000 or the expiry date has passed, ask your pharmacist what to do with any medicine that is left over.

Product description

What it looks like

Adrenaline Aguettant 1:10,000 is a clear, colourless solution.

Adrenaline Aguettant 1:10,000 1mg/10mL contains Adrenaline (Epinephrine) acid tartrate as the active ingredient, plus

• Sodium chloride
• Hydrochloric acid and sodium hydroxide for pH adjustment
• Water for Injections.

Adrenaline Aguettant 1:10,000 is available as 1mg/10mL in packs of 1 or 10 pre-filled syringes

Adrenaline is known as epinephrine in the USA.

Sponsor

Australian Sponsor:

Juno Pharmaceuticals Pty Ltd
15-17 Chapel Street
Cremorne VIC 3121

This leaflet was prepared on 15 December 2023

Australian Registration Number
1mg/10mL 282377

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