Prospecto: Information for the user

Adrenalina Bradex 1 mg / ml Injectable Solution

Adrenaline

Read this prospect carefully before you are given this medicine, because it contains important information for you.

-Keep this prospect, as you may need to read it again.

-If you have any questions, consult your doctor, pharmacist or nurse.

-This medicine has been prescribed only for 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 side effects, consult your doctor, pharmacist or nurse, even if they are not listed in this prospect. See section 4.

1.What is Adrenalina Bradex and how is it used

2.What you need to know before you are given Adrenalina Bradex

3.How to administer Adrenalina Bradex

4.Possible side effects

5.Storage of Adrenalina Bradex

6.Contents of the package and additional information

Adrenaline belongs to a class of medications known as adrenergics and dopaminergics.Adrenalina Bradexis used in life-threatening emergencies such as severe allergic reactions or cardiac arrest.

No useAdrenalina Bradex:

•If you are allergic to adrenaline or any of the other components of this medication (listed in section 6).

Advertencias y precauciones

Consult your doctor, pharmacist or nurse before administration if:

•You are an elderly person

•You have heart problems, especially if they affect heart rate or if you experience chest pain

•You have brain problems, e.g., stroke, brain damage or vascular disease

•You have hyperthyroidism, diabetes or glaucoma (high eye pressure)

•You have pheochromocytoma (a tumor in the adrenal gland)

•You have low blood potassium or high blood calcium levels

•You have a prostate gland tumor or kidney disease

•You are in shock or have lost a lot of blood

•You are about to undergo surgery with general anesthesia

•You have high blood pressure

•You have atherosclerosis, which is a narrowing and hardening of the blood vessels (your doctor will inform you)

Speak with your doctor if any of these circumstances apply before receiving this medication.

Uso deAdrenalina Bradex con otros medicamentos

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

A large number of medications can interact with Adrenalina BRADEX, which can significantly alter its effects. These medications include:

•monoamine oxidase inhibitors (MAOIs) such as moclobemide or tricyclic antidepressants such as imipramine, amitriptyline, both used for depression

•cardiac glycosides such as digoxin, used for heart failure

•guanetidine, used for rapid control of blood pressure

•diuretics, such as hydrochlorothiazide, furosemide

•inhaled general anesthetics, such as halothane

•medications to increase or decrease blood pressure, including beta-blockers, such as propranolol, atenolol, bisoprolol, fentolamine

•antidiabetic medications such as insulin or oral hypoglycemics (e.g., glipizide)

•aminophylline and theophylline (medications used to treat asthma)

•corticosteroids (medications used to treat inflammatory conditions of the body such as asthma or arthritis)

•antihistamines (e.g., diphenhydramine), used for allergy treatment

•medications used to treat mental illness such as chlorpromazine, perphenazine or fluphenazine

•medications used to treat hypothyroidism

•oxytocin, used to induce labor at term and to control bleeding after delivery

•any cough or cold remedy (sympathomimetics).

If you are already taking any of these medications, speak with your doctor before receiving Adrenalina Bradex.

Embarazo y lactancia

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medication.

Adrenalina Bradex should not be used during pregnancy or delivery.

Adrenaline is excreted in breast milk. Speak with your doctor before receiving Adrenalina Bradex.

Adrenaline should only be used during pregnancy and breastfeeding if your doctor considers it essential.

Conducción y uso de máquinas

It is unlikely to be applicable, as you will not be in a state to drive or operate machinery.

Consult your doctor before considering this measure.

Adrenalina Bradex contains metabisulfito de sodio and cloruro de sodio

The metabisulfito de sodio (as a preservative) may cause, in isolated cases, allergic reactions (hypersensitivity) and sneezing.

This medication contains less than 1 mmol of sodium (23 mg) per dose (essentially, "sodium-free").

Adrenalina Bradex can be diluted in sodium chloride 0.9%. This fact should be taken into account in patients following a low-sodium diet.

Adrenaline can be injected into a muscle (intramuscularly) or a bone (intraosseously). It must be diluted before injection into a vein. Adrenaline injection should not be used in areas such as the fingers, toes, ears, nose, or penis, as blood flow to these areas may become insufficient.

A healthcare professional will administer it. Your doctor will decide on the most suitable dose and administration route for your specific case, taking into account your age and physical condition.

If you think you have been given more Adrenalina Bradex than you should

This is unlikely, as the injection will be administered by a doctor or a member of the nursing staff.

Possible signs of overdose include restlessness, confusion, pallor, abnormally rapid heart rate at rest (tachycardia), abnormally slow heart rate (bradycardia), irregular heart rate (cardiac arrhythmias), and cardiac arrest.

Consult your doctor if you experience any side effects, so that they can provide you with suitable treatment.

If you have already left the medical center, contact your nearest hospital, doctor, or pharmacist.

If you have any other questions about the use of this product, consult your doctor, pharmacist, or nurse.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

The following side effects have also been reported (unknown frequency):

•headache, dizziness

•sensation of anxiety or fear or restlessness

•tremor

•insomnia, confusion, irritability

•mood or behavior changes

•dry mouth or excessive saliva production

•weakness or sweating

•changes in heart rate and rhythm

•palpitations (rapid or irregular heartbeat), tachycardia (abnormally fast resting heart rate), angina (chest pain of varying intensity)

•high blood pressure

•coldness in the arms or legs

•difficulty breathing

•reduced appetite, nausea, or vomiting

•repeated injections may damage tissues at the injection site and may also cause damage to the extremities, kidneys, and liver

•difficulty urinating, urinary retention

•metabolic acidosis (a blood component imbalance) may occur

•increased tremors and rigidity in patients with a known condition called Parkinson's syndrome

•cerebral hemorrhage

•paralysis of one half of the body

•increased blood sugar levels

•reduced potassium levels in the blood

•pulmonary edema

Reporting side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:www.notificaRAM.es.

By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the box and on the ampoule label after CAD. The expiration date is the last day of the month indicated.

Store below 25°C. Store the ampoules in the outer packaging to protect them from light.

For single use only. If only part of an ampoule is used, the remaining solution must be discarded.

Do not remove the ampoule from the box until ready for use.

After dilution, the ready-to-use solution must be administered as soon as possible but must not, under any circumstances, be stored for more than 24 hours at 2-8°C, 3 hours at 23-27°C if exposed to light, or 6 hours at 23-27°C if protected from light.

Do not use this medication if you observe discoloration, turbidity, or precipitates.

Medications should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the containers and medications that you no longer need. This will help protect the environment.

Composition ofAdrenalina Bradex

•The active principle is adrenaline (epinephrine) in the form of adrenaline tartrate. Each 1ml of this injection solution contains 1mg of adrenaline (epinephrine) in the form of adrenaline tartrate.

•The other components are sodium metabisulphite (E223), sodium chloride, water for injection, hydrochloric acid and sodium hydroxide.

Aspect of the product and content of the package

Adrenalina Bradex is a transparent, colorless and sterile injection solution, in amber-colored type I glass ampoules.

Adrenalina Bradex is available in packs of 5, 10, 25 or 50ampoules.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization:

BRADEX S.A.,

27 Asklipiou street

14568 Kryoneri, Greece,T:+30 2106221801, +30 2106220323,F:+30 2106221802.

Responsible for manufacturing:

DEMO S.A., 21st km National Road Athens-Lamia, 14568 Krioneri, Attiki, Greece,T:+30 210 8161802,F: +30 210 8161587.

This medicine is authorized in the member states of the European Economic Area with the following names:

United Kingdom:Adrenaline 1:1000 (1 mg / ml) Solution for injection

Germany:Epinephrin BRADEX 1 mg / ml Injektionslösung

Hungary: Adrenalin BRADEX 1 mg / ml oldatos injekció

Spain: Adrenalina Bradex 1 mg / ml Solución inyectable

France:ADRENALINE BRADEX 1 mg / mL, solution injectable

Belgium:Adrenaline (tartrate) Bradex 1 mg / ml solution injectable

Adrenaline (tartrate) Bradex 1 mg / ml οplossing voor injectie

Adrenaline (tartrate) Bradex 1 mg / ml Injektionslösung

Luxembourg:ADRENALINE BRADEX 1 mg / mL, solution injectable

Denmark:Adrenalin Bradex1 mg / ml injektionsvæske, opløsning

Sweden:Adrenalin Bradex1 mg / ml injektionsvätska, lösning

Slovakia:Adrenalin Bradex 1 mg / ml, injekcný roztok

Czech Republic:Adrenalin Bradex1 mg / ml injekcní roztok

Last review date of this leaflet: 05/2021

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This information is intended solely for healthcare professionals:

Preparation and handling

Do not use this medicine if you observe discoloration.

Repeated local administration may cause necrosis at the injection sites.

The best site for i.m. injection is the anterolateral part of the middle third of the thigh. The needle used for injection should be long enough to ensure that adrenaline is injected into the muscle. Injections of Adrenalina Bradex 1 mg / ml Solución inyectablein the thighs should be avoided due to the risk of tissue necrosis.

Prolonged administration may induce metabolic acidosis, renal necrosis and resistance to adrenaline or tachyphylaxis.

Adrenaline should be avoided or used with extreme caution in patients who have been anesthetized with halothane or other halogenated anesthetics, due to the risk of inducing ventricular fibrillation.

Adrenaline should not be used with peripheral nerve blocks, including fingers and ear lobes.

Do not mix with other drugs, unless compatibility is known.

Adrenaline should not be used during the second stage of labor.

Intravascular accidental injection may cause cerebral hemorrhage due to sudden increase in blood pressure.

The patient should be monitored as soon as possible (pulse, blood pressure, ECG, pulse oximetry) to evaluate the response to adrenaline.

Incompatibilities

Dilution

For intravenous administration, Adrenalina Bradex 1 mg / ml Solución inyectablemust be diluted to a solution of 0.1 mg / ml (a 1:10 dilution of the contents of the ampoule) with sodium chloride 0.9%.

Dosage and administration

Adrenalina Bradex 1 mg / ml Solución inyectableis for intramuscular or intraosseous administration. For intravenous administration only after dilution.

Anaphylactic shock

The intramuscular (i.m.) route is the preferred route for most people who need to receive adrenaline for the treatment of anaphylactic shock, according to the doses indicated in Table1.

Generally, the recommended dose of adrenaline is 0.01 mg per kilogram of body weight (10micrograms/kg).

In adults, the usual recommended dose of adrenaline is 0.5 mg (500 micrograms).

In children, when the weight is unknown, the following table can be consulted, which shows the recommended doses according to age:

Table 1.Doses of i.m. injection of adrenaline (epinephrine) BP 1 mg / ml for severe anaphylactic reaction

When the patient is in a critical state and there is a real doubt about the sufficiency of circulation and absorption from the i.m. injection site, Adrenalina Bradex 1 mg/ml Solución inyectablemay be administered by intravenous (i.v.) injection.

Adrenaline intravenous should only be administered by experienced individuals in the use and adjustment of vasopressors in their usual clinical practice (see section 4.4 of the SPC). In case of adrenaline intravenous, the dose should be adjusted with 50microgram boluses according to response. This dose can only be administered with a solution of 0.1 mg / ml (i.e. a 1:10ml dilution of the contents of the ampoule). The undiluted adrenaline solution of 1 mg / ml should not be administered by i.v. route. In case of repeated doses of adrenaline, an i.v. infusion of adrenaline with adjustment of the rate according to response in the presence of continuous hemodynamic monitoring is recommended.

Cardiopulmonary resuscitation

Adults

1mg of adrenaline by intravenous or intraosseous route repeated every 3-5minutes until spontaneous circulation is restored. If injected through a peripheral vein, it should be followed by flushing with at least 20ml of liquid and elevation of the limb for 10-20seconds to facilitate the arrival of the drug in the central circulation.

Paediatric population

The recommended intravenous or intraosseous dose of adrenaline in children is 10micrograms/kg. Depending on the weight, this dose may need to be administered with a solution of 0.1 mg / ml (i.e. a 1:10ml dilution of the contents of the ampoule). Further doses of adrenaline may be administered every 3-5minutes. The maximum single dose is 1mg.

Elimination

The unused medicine and all materials that have been in contact with it will be disposed of in accordance with local regulations.

Overdose

Signs

Overdose of Adrenalina Bradex 1 mg / ml Solución inyectablecauses restlessness, confusion, pallor, tachycardia, bradycardia, cardiac arrhythmias and cardiac arrest.

Treatment

The treatment is mainly symptomatic and supportive. A rapid injection of a rapid-acting alpha-adrenergic receptor blocker such as fentolamine, followed by a beta-blocker such as propranolol, has been used to counteract the effects on blood pressure and arrhythmogenic of adrenaline. A rapid-acting vasodilator such as glyceryl trinitrate has also been used.