Prospecto: information for the patient

Adrenalina Aguettant 0.1 mg/ml, injectable solution in pre-filled syringe

(From now on “Injectable Adrenaline”)

Epinephrine

Read this prospectus carefully before starting to use this medication, as it contains important information for you.

• Keep this prospectus, as you may need to read it again.
• If you have any doubts, consult your doctor, pharmacist, or nurse.
• This medication has been prescribed only to you, and you must not give it to other people even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this prospectus. See section4.

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

2.What you need to know before starting to use Injectable Adrenaline

3.How to use Injectable Adrenaline

4.Possible adverse effects

5.Storage of Injectable Adrenaline

6. Contents of the package and additional information

Injectable Epinephrinebelongs to a group of medications called adrenergic and dopaminergic agents.

This medication is used for:

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

Do not administer Adrenaline injectable

- if you areallergic (hypersensitive) to any of the components of this medication (listed in section6), when an alternative presentation of adrenaline or an alternative vasopressor is available.

Warnings and precautions

Adrenaline injectableis indicated for emergency treatment. Continuous medical supervision is required after administration.

Precautions for use

The risk of adverse effects increases if you:

• have a medical history of hyperthyroidism (thyroid gland disease);
• have severe renal insufficiency;
• are suffering from hypercalcemia (elevated calcium concentration in the blood);
• are suffering from hypokalemia (decreased potassium concentration in the blood);
• have diabetes mellitus;
• have cardiovascular disease or hypertension;
• have cerebral damage or cerebral artery hardening;
• have glaucoma (increased eye pressure);
• have prostate disorders;
• are an elderly patient;
• are pregnant.

Use in athletes

It is reported to athletes that this medication contains adrenaline, which may produce a positive result in doping control tests

Use of Adrenaline injectable with other medications

Inform your doctor if you are taking, have taken recently, or may need to take any other medication.

Medications that may interact with Adrenaline injectable include:

• volatile halogenated anesthetics (gas used during anesthesia);
• certain antidepressants;
• medications to treat hypertension, heart disease;
• medications to treat diabetes.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, or intend to become pregnant, consult your doctor or pharmacist before receiving this medication.

Driving and operating machinery

ReceivingAdrenaline injectabledoes not affect your ability to drive or operate machinery.

Adrenaline injectable contains sodium

This medication contains 35.4 mg of sodium (main component of table salt/for cooking) in each syringe. This is equivalent to 1.77% of the maximum daily sodium intake recommended for an adult.

Adrenaline injectable will be administered byyour doctor, nurse or healthcare assistant. They will have to decide the correct amount for you, as well as when and how it should be administered.

In case of potentially fatal allergic reactions (acute anaphylaxis):

Toadultsa dose of 0.05mg (0.5ml of the 1:10,000 adrenaline solution) will be administered as many times as necessary until the desired response is obtained.

In case of cardiac arrest:

Adults:1mg (10ml of the 1:10,000 adrenaline solution) will be administered in a vein or in a bone every 3-5minutes until the heart starts functioning.

Children over 5 kg:10micrograms/kg (0.1ml/kg of the 1:10,000 adrenaline solution) will be administered in a vein or in a bone every 3-5minutes until the heart starts functioning.

This medication is not suitable for administering a dose less than 0.5 ml and therefore should not be used in newborns or children with a body weight of less than 5 kg.

Like all medications, this medication may produce adverse effects, although not everyone will experience them.

The following adverse effects have been reported:

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

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

• cardiac arrhythmia (irregular heartbeat/heart stop);
• hypertension (high blood pressure with risk of cerebral hemorrhage);
• vasoconstriction (narrowing of blood vessels, for example, in the skin of the extremities or kidneys);
• acute angina pectoris;
• risk of acute myocardial infarction.

Repeated local injections may produce necrosis (tissue damage) at the injection sites, resulting from vascular constriction (narrowing of blood vessels).

Medical supervision is necessary after administration of Adrenaline injectable in all cases.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use:www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication

Keep this medication out of the sight and reach of children.

Do not receive this medication after the expiration date that appears on the label. The expiration date is the last day of the month indicated. Your doctor or nurse will verify this.

Store in the aluminum bag to protect it from light and oxygen.

Do not store at a temperature above25°C.

Do not open the aluminum bag until you are about to use it.

After opening the bag, the product must be used immediately.

Do not freeze.

Do not use sharp objects to open the bag.

Do not receiveInjectable Epinephrineif it has been partially used or shows visible signs of deterioration.

Medicines should not be disposed of through the drains or in the trash. Deposit the containers and unused medicines at the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and unused medicines. By doing so, you will help protect the environment.

Composition of Adrenaline Injectable

The active ingredient is epinephrine (adrenaline):

Each ml of injectable solution contains 0.1mg of epinephrine (adrenaline), in the form of adrenaline tartrate.

Each preloaded syringe of 10ml contains 1mg of epinephrine (adrenaline), in the form of adrenaline tartrate.

The other components are sodium chloride, hydrochloric acid, sodium hydroxide, and water for injectable preparations.

Appearance of the product and contents of the package

Adrenaline injectableis a colorless transparent solution in a preloaded syringe of 10ml polipropylene, individually packaged in a transparent blister and wrapped in an aluminum bag.

The preloaded syringes are available in packs of 1 and 10syringes.

Only some package sizes may be marketed.

Marketing Authorization Holder:

Laboratoire Aguettant

1, rue Alexander Fleming

69007 LYON

FRANCE

Responsible for Manufacturing:

Laboratoire Aguettant

1, rue Alexander Fleming

69007 LYON

FRANCE

Laboratoire Aguettant

Lieu Dit Chantecaille

07340 Champagne

FRANCE

Local Representative:

AGUETTANT IBERICA

C/ Baldini Reixac, 4-8, Torre I, 4º08028, Barcelona-Spain

Last review date of this leaflet:July 2024

For detailed and updated information on this medicine, please visit the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/.

This information is intended solely for healthcare professionals:

Adrenaline intravenous should only be administered by individuals with experience in the use and dosage adjustment of vasopressors in their usual clinical practice.

Cardiopulmonary resuscitation:

10ml of solution 1:10,000 (1mg), by intravenous or intraosseous route, repeated every 3-5minutes until spontaneous circulation returns.

The use of endotracheal should only be used as a last resort if no other route of administration is accessible, at a dose of 20to 25ml of solution 1:10,000 (2 to 2.5mg).

In cardiac arrest after cardiac surgery, adrenaline should be administered intravenously in doses of 0.5ml or 1 ml of solution 1:10,000 (50 or 100 micrograms) with great caution and adjusting the dose until the desired effect is achieved.

Acute anaphylaxis:

Adjust the dose using intravenous boluses of 0.5ml of solution 1:10,000 (0.05 mg) according to the response.

Adrenaline 0.1mg/ml (1:10,000) injectable solution in preloaded syringe is not recommended for intramuscular use in cases of acute anaphylaxis. For intramuscular administration, a solution of 1mg/ml (1:1000) should be used.

Pediatric population:

This medicine is not suitable for administering a dose less than 0.5 ml and should not be used by intravenous or intraosseous route in newborns and children with a body weight less than 5 kg.

Cardiac arrest in children:

Intravenous or intraosseous route (only for children over 5kg): 0.1ml/kg of solution 1:10,000 (10micrograms/kg) up to a maximum single dose of 10ml of solution 1:10,000 (1mg), repeated every 3-5minutes until spontaneous circulation returns.

The use of endotracheal (in any weight range) should only be used as a last resort if no other route of administration is accessible, at a dose of 1ml/kg of solution 1:10000 (100micrograms/kg) up to a maximum single dose of 25ml of solution 1:10,000 (2.5mg).

Follow this protocol strictly:

The preloaded syringe is intended for a single patient. Dispose of the syringe after use.Do not reuse.

The product should be visually inspected to detect particles and color changes before administration. Only use the transparent, colorless, and particle-free solution.

The product should not be used if the bag or blister has been opened or if the safety cap of the syringe (plastic cap at the base of the tip) is broken.

1. Open the aluminum bag with your hand using only the perforations.

Do not use sharp objects to open the bag.

1. Remove the preloaded syringe from the sterile blister.

3)Push the plunger to release the stopper.The sterilization process may have caused the stopper to stick to the syringe body.

1. Remove the tip cap to break the safety.Do not touch the exposed Luer connection to avoid contamination.

1. Check that the safety cap of the syringehas been completely removed. If not, replace the cap and turn it again.

1. Push the plunger gently to remove the air.

7)Connect the syringe to the vascular access device or needle.

Push the plunger to inject the required volume.

The disposal of unused medication and all materials that have come into contact with it will be carried out in accordance with local regulations.