Adrenaline Aguettant

Package leaflet: Information for the patient

Adrenaline Aguettant 1 mg/10 ml (1:10,000) injection solution in pre-filled syringe

(hereinafter referred to as "injectable adrenaline" in this package leaflet)

Adrenaline

Read this leaflet carefully before using this medicine as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

1. What Adrenaline injectable is and what it is used for
2. What you need to know before using Adrenaline injectable
3. How to use Adrenaline injectable
4. Possible side effects
5. How to store Adrenaline injectable
6. Contents of the pack and other information

1. What Adrenaline Injectable is and what it is used for

Adrenaline injectable belongs to a group of medicines called adrenergic and
dopaminergic agents.
This medicine is used for:

• Treatment of cardiac arrest (sudden loss of heart function, breathing, and consciousness),
• Treatment of acute anaphylaxis in adults (severe shock or collapse caused by a severe allergic reaction).

2. What you need to know before using Injectable Adrenaline

Injectable Adrenaline must not be administered:

• if you are allergic (hypersensitive) to any of the other components of this medicine (listed in section 6) when an alternative formulation of Adrenaline or an alternative vasoconstrictor is available.

Warnings and precautions
Injectable Adrenaline is intended for emergency treatment. After administration, continuous medical supervision is required.
For athletes: the use of this drug without therapeutic need constitutes doping and may result in a positive anti-doping test.
Precautions for use
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The risk of adverse effects increases if you:

• have a medical history of hyperthyroidism (a thyroid disorder),
• have severe renal insufficiency,
• suffer from hypercalcemia (increased calcium concentration in the blood),
• suffer from hypokalemia (decreased potassium concentration in the blood),
• have diabetes mellitus,
• have heart disease or arterial hypertension,
• have cerebral damage or cerebral arterial hardening,
• have glaucoma (increased pressure in the eye),
• have prostate disorders,
• are an elderly patient,
• are pregnant.

Other medicines and Injectable Adrenaline
Inform your doctor if you are currently using, have recently used, or might use any other medicines.
Medicines that may interact with Injectable Adrenaline include:

• volatile halogenated anesthetics (gases used during anesthesia);
• certain antidepressants;
• medicines used to treat high blood pressure or heart problems;
• medicines used to treat diabetes.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor, pharmacist, or nurse before using this medicine.
Driving and using machines
The use of Injectable Adrenaline does not affect the ability to drive or operate machinery.
Injectable Adrenaline contains sodium
This medicine contains 35.4 mg of sodium (a key component of table salt) per pre-filled syringe. This corresponds to 1.77% of the maximum daily recommended dietary intake for an adult.

3. How to use Injectable Adrenaline

Injectable Adrenaline is administered by a doctor, nurse, or paramedical staff.
They will decide the correct dosage and when and how it should be administered.
In case of potentially fatal allergic reactions (acute anaphylaxis):
Adults will receive a dose of 0.05 mg (0.5 ml of Adrenaline 1:10,000 solution)
repeatedly until the desired effect is achieved.
In case of cardiac arrest:
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Adults: 1 mg (10 ml of Adrenaline 1:10,000 solution) is administered intravenously or into a bone every 3–5 minutes until the heart starts beating.
Children above 5 kg: 10 micrograms/kg (0.1 ml/kg of Adrenaline 1:10,000 solution) is administered intravenously or into a bone every 3–5 minutes until the heart starts beating.
This medicine is not indicated for administration at doses lower than 0.5 ml and therefore must not be used in neonates and children with body weight below 5 kg.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects have been reported:

• anxiety;
• dyspnoea (difficulty in breathing);
• nervousness;
• fear;
• sweating;
• palpitations (irregular or rapid heartbeat);
• tachycardia (increased heart rate);
• pallor;
• tremors;
• weakness;
• dizziness;
• headache;
• nausea;
• vomiting;
• cold sensation in extremities;
• hallucinations;
• syncope (fainting);
• hyperglycaemia (high blood sugar levels);
• hypokalaemia (low blood potassium levels);
• metabolic acidosis (increased blood acidity);
• mydriasis (dilation of the pupil).

With high doses or in patients sensitive to adrenaline, the adverse effects are:

• cardiac arrhythmia (irregular heartbeat/cardiac arrest),
• hypertension (with risk of cerebral haemorrhage),
• vasoconstriction (narrowing of blood vessels, e.g. skin, extremities or kidneys),
• acute angina attacks,
• risk of acute myocardial infarction.

Repeated local injections may cause necrosis (tissue damage) at the injection sites due to vasoconstriction (narrowing of blood vessels).
In all cases, after administration of Injectable Adrenaline medical supervision is required.
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Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse.
You can also report side effects directly via the national reporting system at the website
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Injectable Adrenaline

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label. The expiry date refers to the last day of that month. The doctor or nurse will check the expiry date.
Store in the aluminium pouch to protect the medicine from light and oxygen.
Do not store above 25°C.
Do not open the aluminium pouch until the time of use.
After opening, the medicine must be used immediately.
Do not freeze.
Do not use sharp instruments to open the pouch.
Injectable adrenaline must not be administered if it has been partially used or shows any signs of visible damage.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What Adrenaline Injectable contains
The active substance is adrenaline tartrate:
Each ml of injectable solution contains 0.1 mg of adrenaline (as adrenaline tartrate).
Each 10 ml pre-filled syringe contains 1 mg of adrenaline (as adrenaline tartrate).
The other components are sodium chloride, hydrochloric acid, sodium hydroxide and water for
injections.

Description of the appearance of Adrenaline Injectable and contents of the pack
Adrenaline Injectable is a clear, colourless solution contained in a 10 ml polypropylene pre-filled syringe. Each syringe is individually packaged in a transparent blister, placed inside an aluminium pouch.
Pre-filled syringes are available in packs of 1 and 10 syringes.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder:
Laboratoire Aguettant
1, rue Alexander Fleming
69007 LYON
FRANCE

Manufacturer:
Laboratoire Aguettant
1, rue Alexander Fleming
69007 LYON
FRANCE
Laboratoire Aguettant
Lieu Dit Chantecaille
07340 Champagne
FRANCE

More detailed information on this medicinal product is available on the website of the Italian Medicines Agency (Agenzia italiana del farmaco).

The following information is intended exclusively for healthcare professionals:
Intravenous adrenaline must be administered only by personnel experienced in the use and titration of vasoconstrictors in routine clinical practice.

Cardiopulmonary resuscitation:
10 ml of adrenaline 1:10,000 solution (1 mg) by intravenous or intraosseous route, repeated every 3–5 minutes until return of spontaneous circulation.
Endotracheal administration should only be used as a last resort when no other route is available, at a dose of 20–25 ml of 1:10,000 solution (2–2.5 mg).
In cardiac arrest occurring during cardiac surgery, adrenaline should be administered intravenously with extreme caution at doses of 0.5 or 1 ml of 1:10,000 solution (50 or 100 micrograms), titrated to the effective dose.

Acute anaphylaxis
Titrate using 0.5 ml of 1:10,000 solution (0.05 mg) as an intravenous bolus according to response.
Adrenaline Aguettant 1 mg/10 ml (1:10,000) solution for injection in pre-filled syringe is not indicated for intramuscular use in acute anaphylaxis. For intramuscular administration, a 1 mg/ml (1:1000) solution must be used.

Paediatric population
This medicinal product is not indicated for administration at doses below 0.5 ml and therefore should not be used in neonates and children with body weight below 5 kg.

Cardiac arrest in children:
Intravenous or intraosseous administration (only in children above 5 kg): 0.1 ml/kg of adrenaline 1:10,000 solution (10 micrograms/kg), up to a maximum single dose of 10 ml of 1:10,000 solution (1 mg), repeated every 3–5 minutes until return of spontaneous circulation.
Endotracheal administration (for any weight) should only be used as a last resort when no other route is available, at a dose of 1 ml/kg of 1:10,000 solution (100 micrograms/kg), up to a maximum single dose of 25 ml of 1:10,000 solution (2.5 mg).

Strictly follow the procedure below:
The pre-filled syringe is for single use only. Dispose of the syringe after use. Do not reuse.
The product should be inspected visually for particulate matter and discoloration prior to administration. Use only clear, colourless solution free from particles or precipitate.
The product must not be used if the aluminium pouch or blister is opened or if the tamper-evident seal on the syringe (plastic ring at the base of the cap) is broken.

1. Open the aluminium pouch by hand, using the perforations.
   Do not use sharp instruments to open the pouch.
2. Remove the pre-filled syringe from the sterile blister.
3. Push the plunger to release the cap. The sterilization process may cause the cap to adhere to the syringe barrel.
4. Rotate the terminal cap to break the seal. Do not touch the exposed luer connector to avoid contamination.

5. Check that the syringe seal has been completely removed. If not, close the cap and rotate it again.
6. Expel air by gently pushing the plunger.
7. Connect the syringe to the vascular access device or needle.
   Push the plunger to inject the required volume.
   Any unused product and waste material must be disposed of in accordance with local regulations.