ADRENALINE LEVEL 1mg/ml INJECTABLE SOLUTION PRE-FILLED SYRINGE

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Adrenaline Level 1 mg/ml solution for injection

Epinephrine

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack:

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

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

Adrenaline Level belongs to a group of medicines called cardiac stimulants, excluding cardiac glycosides: adrenergic and dopaminergic agents. It is indicated in the following cases:

• Treatment of sudden and involuntary contraction of the airways in acute asthma attacks (sudden feeling of suffocation).
• Rapid relief of allergic reactions to drugs or other substances.
• Emergency treatment of shock due to an allergic reaction.
• Cardiac arrest and cardiopulmonary resuscitation (first physical measures must be applied).

2. What you need to know before you use Adrenaline Level

Do not use Adrenaline Level

• If you are allergic (hypersensitive) to adrenaline, to sympathomimetics (medicines that stimulate the central nervous system) or to any of the other components of this medicine (listed in section 6).
• If you have cardiac dilation, coronary insufficiency, cardiac arrhythmias, or cardiac failure (heart function failure).
• If you have organic brain damage, such as cerebral arteriosclerosis (chronic inflammation of the brain arteries with a tendency to obstruction).
• If you have angle-closure glaucoma (eye condition characterized by increased intraocular pressure).
• If you have arterial hypertension, hyperthyroidism (thyroid gland disorder), or pheochromocytoma (tumor of the adrenal medulla).
• At the time of delivery.
• If you have received general anesthesia with halogenated hydrocarbons (chloroform, trichloroethylene) or cyclopropane, as the combination with adrenaline could cause severe arrhythmias (heart rhythm alteration).

However, in situations of extreme severity, there are no absolute contraindications.

Warnings and precautions

Consult your doctor or pharmacist before starting to use Adrenaline Level.

Be especially careful with Adrenaline Level

If you have or have had cerebrovascular insufficiency (condition of the blood vessels in the brain), heart disease (such as angina pectoris or myocardial infarction), chronic pulmonary disease, or difficulty urinating due to prostatic hypertrophy (prostate disorder).

If you are taking any other medicine that may cause potassium loss, such as corticosteroids (medicines used for their anti-inflammatory and immunosuppressive properties), diuretics (facilitate urination), aminophylline (medicine used to facilitate breathing), or theophylline (anti-asthmatic, facilitates urination), your potassium levels in the blood should be monitored.

If you are diabetic, you should be especially careful due to possible adverse reactions that may appear, especially those related to metabolic alterations, as the dose should be monitored.

This medicine can be used in elderly patients, but special caution is recommended.

Repeated administration of local injections may cause necrosis at the injection site due to vascular vasoconstriction (contraction of blood vessels). The injection points should be alternated.

Adrenaline should be diluted before injection for intravenous and intracardiac use (see section 3). In cases of extreme urgency, such as cardiopulmonary resuscitation (CPR) and cardiac arrest, where the medicine cannot be diluted and it is considered essential to administer it intravenously directly from the pre-filled syringe, without dilution, through a catheter, it is necessary to know the compatibility of the pre-filled syringe with the anti-reflux valve to avoid administration problems due to possible blockages of the syringe with components of the anti-reflux valve housed in the catheter. In case of incompatibility, use an adequate adapter between the syringe and the anti-reflux valve. There have been reports of cases where the medicine could not be administered due to these compatibility problems, with the consequent risk to the patient.

Consult your doctor, even if any of the above circumstances have occurred to you at any time.

Other medicines and Adrenaline Level

Tell your doctor or pharmacist if you are using, have recently used, or may need to use any other medicine.

Adrenergic blockers (drugs that act at the level of neurons and modify the physiology of organs and tissues) antagonize some of the effects of adrenaline. They are used as therapy in the case of adrenaline poisoning.

If this medicine is administered together with digitalis glycosides (heart medicines), cardiac arrhythmias (heart rhythm alteration) may appear.

If this medicine is administered together with certain antidepressants or guanidine (antihypertensive agent), a sharp increase in blood pressure may occur.

If this medicine is administered together with COMT or MAO inhibitors (medicines that act on metabolic systems responsible for eliminating adrenaline), to a lesser extent, the effects of this medicine may be enhanced.

Adrenaline Level may reduce the effectiveness of hypoglycemic agents (medicines that decrease blood sugar).

Interference with analytical tests

If you are going to have any analytical test (blood test, urine test), inform your doctor that you are being treated with adrenaline, as this medicine may alter the results in blood sugar, bilirubin, cholesterol, lactates, uric acid, and insulin. In urine, adrenaline may alter the results of vanilmandelic acid and catecholamines.

Pregnancy and lactation

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Consult your doctor or pharmacist before using any medicine.

If you are pregnant, you will receive adrenaline only if your doctor considers it absolutely necessary for your treatment.

This medicine is excreted in breast milk, so breastfeeding should be suspended or the administration of this medicine avoided.

Driving and using machines

This is not applicable in the context of treatment with this medicine.

Adrenaline Level contains sodium bisulfite (E-222) and sodium (in the form of sodium bisulfite and sodium chloride).

This medicine contains sodium bisulfite (E-222). It can rarely cause severe hypersensitivity reactions and bronchospasm (sudden feeling of suffocation)

This medicine contains less than 1 mmol of sodium (23 mg) per 1 ml, i.e., it is essentially "sodium-free".

Use in athletes

This medicine contains adrenaline, which can produce a positive result in doping tests.

The use of adrenaline is not prohibited when administered in combination with local anesthetics or in preparations for local use, such as nasal or ophthalmic use.

3. How to use Adrenaline Level

Adrenaline Level will be administered by qualified healthcare personnel in the case of intravenous or intracardiac administration.

Adrenaline Level can be administered subcutaneously, intramuscularly, or intravenously. Only in cases of extreme severity and if the intravenous route is not feasible can it be administered intracardially. The intravenous and intracardiac routes can only be used after dilution in water for injection, sodium chloride 0.9% solution, glucose 5% solution, or glucose 5% in sodium chloride 0.9% solution, always in a hospital setting and under cardiac monitoring.

In cases of extreme urgency, such as cardiopulmonary resuscitation (CPR) and cardiac arrest, where the medicine cannot be diluted and it is considered essential to administer it intravenously directly from the pre-filled syringe, without dilution, through a catheter, it is necessary to know the compatibility of the pre-filled syringe with the anti-reflux valve to avoid administration problems due to possible blockages of the syringe with components of the anti-reflux valve housed in the catheter. In case of incompatibility, use an adequate adapter between the syringe and the anti-reflux valve. There have been reports of cases where the medicine could not be administered due to these compatibility problems, with the consequent risk to the patient.

The smallest dose that produces relief should be used. After prolonged use, it may be necessary to increase the dose due to the development of resistance to the action of adrenaline.

It should be avoided to inject this medicine intramuscularly in the buttocks, as it can produce gas gangrene (rapid and diffuse gangrene of the tissue under the skin with gas production) and in peripheral areas of the body, such as fingers, toes, earlobe, nose, or penis.

Acute asthma attacks, allergic reactions, and anaphylactic shock

• Adults: The usual dose for the treatment of acute asthma attacks and allergic reactions is 0.3-0.5 mg (0.3-0.5 ml) intramuscularly or subcutaneously, with the intramuscular route being faster and more effective. If necessary, the administration can be repeated at 15-20 minute intervals and subsequently every 4 hours. In the case of anaphylactic shock, the intramuscular route should be used, or in very severe cases, the intravenous route, if the intravenous route is used, adrenaline should be administered in the hospital. In severe cases, the dose can be increased up to 1 mg if necessary.

• Children: The usual dose is 0.01 mg (0.01 ml) per kilogram of body weight intramuscularly or subcutaneously, up to a maximum dose of 0.5 mg (0.5 ml). If necessary, the administration can be repeated at 15-20 minute intervals and subsequently every 4 hours.

It cannot be administered in children with a weight below 20 kg, as the minimum volume that allows dosing with the syringe is 0.2 ml.

In elderly patients, the indicated doses are the same as for adults, although with special caution.

Cardiac arrest and cardiopulmonary resuscitation

In the treatment of cardiac arrest and cardiopulmonary resuscitation, the recommended dose of adrenaline is 1 mg intravenously, which should be administered after dilution to 1:10,000 and can be repeated as many times as necessary every 3-5 minutes.

In children, the standard dose is 0.01 mg/kg intravenously, which can be repeated every 5 minutes if necessary.

It cannot be administered in children with a weight below 20 kg, as the minimum volume that allows dosing with the syringe is 0.2 ml.

In case the intravenous route is not feasible, the intracardiac route can be used (using the same diluted solution). However, it should be taken into account that this route presents significant risks and should only be used in case the intravenous route is persistently inaccessible.

Guidelines for correct administration

Unscrew the removable part of the protective sleeve (1) located on the cone of the syringe and screw the needle (2) in its place. Expel the air and the syringe will be ready for use.

This syringe should be used once and destroyed. Shared use constitutes a risk of infection.

To avoid degradation by light or oxidation, it is recommended to use the product immediately after dilution.

If you use more Adrenaline Level than you should

Adrenaline overdose can cause sudden increases in blood pressure and tachycardia (acceleration of heart rate), which can occur after a first phase of transient bradycardia (abnormal slowness of heart rate). Potentially fatal arrhythmias (heart rhythm alteration) may also appear.

The duration of the adverse effects of adrenaline is brief due to its rapid inactivation in the body, so the treatment of adverse reactions is supportive. To correct the adverse effects on blood pressure and heart rate, some medicines such as phentolamine and propranolol can be administered. If a sudden increase in blood pressure occurs, vasodilator medicines such as nitrites can be administered. Angina attacks are treated with sublingual trinitrine, while in case of ventricular fibrillation (abnormal heart contraction), an electric defibrillator should be used.

In case of overdose or accidental injection, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20 (indicating the medicine and the amount injected).

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

It should be taken into account that the appearance and severity of these effects depend on the route of administration, with the subcutaneous and intramuscular routes being those with the lowest incidence compared to the intravenous and intracardiac routes.

• Frequent (>1/100, <1/10)

Nervous system disorders: fear, anxiety, pulsating headache, difficulty breathing, sweating, and nausea, vomiting, tremors, and dizziness.

Cardiovascular disorders: tachycardia, palpitations, pallor, elevation (discrete) of blood pressure.

These manifestations are not serious and disappear with rest and patient tranquilization.

• Uncommon (>1/1000, <1/100)

Cardiovascular disorders (heart and blood vessels): arterial hypertension, which could lead to cerebral hemorrhage or acute cardiac failure with pulmonary edema (fluid infiltration in the lungs), angina pectoris (even with common doses in patients with coronary insufficiency), ventricular arrhythmias (heart rhythm alteration), tachycardia (acceleration of heart rate), and ventricular fibrillation (abnormal heart contraction), which can be fatal.

Difficulty in urination, necrosis at the injection site, metabolic acidosis, and renal failure have also been observed in some cases.

If you think any of the side effects you are suffering from is serious, or if you notice any side effect not mentioned in this leaflet, tell your doctor or pharmacist.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist, even if it is possible side effects not listed in this leaflet. You can also report them directly through the Spanish Medicines and Health Products Agency (AEMPS) https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Adrenaline Level

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

Do not use this medicine after the expiration date that appears on the packaging after EXP. The expiration date is the last day of the month indicated.

No special storage conditions are required. Store in the original packaging.

Adrenaline Level should be used immediately after opening the syringe. Discard any remaining portion.

Do not use Adrenaline Level if you observe that the solution has a coloration or sedimentation.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE collection point in your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Adrenaline Level

• The active ingredient is epinephrine (adrenaline). Each milliliter of solution contains 1 milligram of epinephrine.
• The other components are sodium chloride, sodium bisulfite (E-222), chlorobutanol, hydrochloric acid (for pH adjustment), and water for injection.

Appearance of the product and packaging contents

Adrenaline Level is a clear, slightly yellowish aqueous solution presented in pre-filled glass syringes of Type I with a capacity of 1 milliliter.

Packaging sizes: Boxes of 1 or 50 units.

Marketing authorization holder and manufacturer

Marketing authorization holder:

LABORATORIOS ERN, S.A.

Perú, 228 - 08020 Barcelona, Spain.

Manufacturer:

LABORATORIOS ERN, S.A.

Gorgs Lladó, 188

08210 Barberá del Vallés, Barcelona, Spain.

Date of the last revision of this leaflet: July 2022

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.