Adrenaline B. Braun 1 mg/ml solution for injection

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Adrenalina B. Braun 1 mg/ml solution for injection

Epinephrine

Read the entire leaflet carefully before you start using this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again. If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you; do not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

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

1. What Adrenalina B. Braun is and what it is used for

Adrenalina B. Braun 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 involuntary and sudden muscle contraction in the airways during acute asthma attacks (sudden sensation 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 (physical measures should be applied first).

2. What you need to know before using Adrenalina B. Braun

Do not use Adrenalina B. Braun:

• If you are allergic to epinephrine (adrenaline), sympathomimetics (medicines that stimulate the central nervous system), or any of the other components of this medicine (listed in section 6).

• If you have:

  • Cardiac dilation, coronary insufficiency, cardiac arrhythmias, or heart failure (impaired heart function).
  • Organic brain lesions, such as cerebral arteriosclerosis (chronic inflammation of cerebral arteries with a tendency toward obstruction).
  • Closed-angle glaucoma (an eye condition characterized by increased intraocular pressure).
  • Arterial hypertension, hyperthyroidism (thyroid gland disorder), or pheochromocytoma (a tumor of the adrenal medulla).
  • During childbirth.

• If you have received general anesthesia with halogenated hydrocarbons (chloroform, trichloroethylene) or cyclopropane, as combination with adrenaline may cause severe arrhythmias (abnormal heart rhythms).

However, in life-threatening situations, there are no absolute contraindications.

Warnings and precautions

Talk to your doctor or pharmacist before using Adrenalina B. Braun.

Inform your doctor of any allergies or medical conditions you currently have or have had, especially if you have or have had cerebrovascular disease (conditions affecting cerebral blood vessels), heart disease (such as angina or myocardial infarction), chronic lung disease, or urinary difficulty due to prostatic hypertrophy (prostate disorder).

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

Repeated administration of local injections may cause necrosis at the injection site due to vasoconstriction (narrowing of blood vessels). Injection sites should be rotated.

If you are diabetic, exercise particular caution due to possible adverse reactions, especially those related to metabolic disturbances, as dosage monitoring is required.

Interference with diagnostic tests

If you are undergoing any diagnostic tests (blood or urine analysis), inform your doctor that you are being treated with adrenaline, as this medicine may alter blood test results for glucose, bilirubin, cholesterol, lactates, uric acid, and insulin. In urine, adrenaline may alter levels of vanillylmandelic acid and catecholamines.

Use in athletes

Athletes are advised that this medicine contains a substance, epinephrine (adrenaline), that may result in a positive doping test. However, the use of epinephrine (adrenaline) is permitted when administered in combination with local anesthetics or in locally acting preparations, such as nasal or ophthalmic formulations.

Use of Adrenalina B. Braun with other medicines

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

Adrenergic blockers (drugs acting on neurons that modify organ and tissue physiology) antagonize some of the effects of adrenaline. They are used therapeutically in cases of adrenaline intoxication.

If this medicine is administered concomitantly with digitalis glycosides (heart medications), cardiac arrhythmias (abnormal heart rhythms) may occur.

If this medicine is administered concomitantly with certain antidepressants or guanethidine (an antihypertensive agent), a marked increase in blood pressure may occur.

If this medicine is administered concomitantly with COMT or MAO inhibitors (medications acting on metabolic systems responsible for adrenaline elimination), the effects of this medicine may be potentiated, to a lesser extent.

Adrenalina B. Braun may reduce the effectiveness of hypoglycemic agents (medications that lower blood sugar).

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

Pregnancy and breastfeeding

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.

If you are pregnant, adrenaline will be administered only if your doctor considers it strictly necessary for your treatment.

This medicine is excreted in breast milk; therefore, breastfeeding should be discontinued or administration of this medicine avoided.

Adrenalina B. Braun contains sodium and sodium metabisulfite

This medicine contains less than 23 mg of sodium (1 mmol) per dose; hence, it is essentially “sodium-free.”

This medicine may cause severe allergic reactions and bronchospasm (sudden sensation of suffocation) because it contains sodium metabisulfite.

3. How to use Adrenalina B. Braun

Follow exactly the instructions for administration of this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again.

The lowest dose that provides 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.

Acute asthma attacks, allergic reactions, and anaphylactic shock.

Use in 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) administered intramuscularly or subcutaneously, with the intramuscular route being faster and more effective. In cases of anaphylactic shock, the intramuscular route should be used, or, in very severe cases, the intravenous route. If necessary, administration may be repeated after 15–20 minutes and subsequently every 4 hours. In severe cases, the dose may be increased up to 1 mg if needed.

The recommended doses for elderly patients are the same as for adults, although special caution should be exercised.

Use in children: The usual dose is 0.01 mg (0.01 ml) per kg of body weight administered intramuscularly or subcutaneously, up to a maximum dose of 0.5 mg (0.5 ml). If necessary, administration may be repeated after 15–20 minutes and subsequently every 4 hours.

Cardiac arrest and cardiopulmonary resuscitation

Use in adults: In the treatment of cardiac arrest and cardiopulmonary resuscitation, the recommended dose of adrenaline is 1 mg administered intravenously, which should be diluted to 1:10,000 and may be repeated as often as necessary every 3–5 minutes.

Use in children: In children, the standard dose is 0.01 mg/kg administered intravenously, which may be repeated every 5 minutes if necessary.

Adrenalina B. Braun will be administered by qualified healthcare personnel.

Adrenalina B. Braun may be administered subcutaneously, intramuscularly, intracardially, or intravenously.

Intracardial administration is only permitted in cases of extreme severity and if the intravenous route is not feasible. The intravenous and intracardial routes may only be used after dilution in water for injectable preparations, 0.9% sodium chloride solution, 5% glucose solution, or 5% glucose in 0.9% sodium chloride solution, in a hospital setting and under cardiac monitoring.

If the intravenous route is not feasible, the intracardial route may be used (using the same diluted solution). However, it should be noted that this route carries significant risks and should only be used if the intravenous route remains persistently inaccessible.

Injection of this medicine into the buttocks should be avoided, as it may lead to gas gangrene (diffuse, rapidly progressing tissue necrosis beneath the skin with gas formation), as well as in peripheral areas of the body such as fingers of the hands and feet, ear lobes, nose, or penis.

If you use more Adrenalina B. Braun than you should:

Adrenaline overdose may cause sudden increases in blood pressure and tachycardia (accelerated heart rate), which may occur following an initial phase of transient bradycardia (abnormally slow heart rate). Potentially fatal arrhythmias (abnormal heart rhythms) may also occur.

The adverse effects of adrenaline are short-lived due to the rapid inactivation of the substance in the body; therefore, treatment of adverse reactions is supportive. To counteract adverse effects on blood pressure and heart rhythm, certain medications such as phentolamine and propranolol may be administered.

In case of overdose or accidental ingestion, contact the Toxicology Information Service (telephone: 91.562 04 20) or consult your doctor or pharmacist. Bring this leaflet with you.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

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

It should be noted that the occurrence and severity of these effects depend on the route of administration, with subcutaneous and intramuscular routes having the lowest incidence compared to intravenous and intracardiac routes.

• Frequent (1/100 to <1/10)

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

Cardiovascular disorders: tachycardia, palpitations, pallor, slight elevation in blood pressure.

These manifestations are not serious and disappear with rest and reassurance of the patient.

• Uncommon (>1/1000 to <1/100)

Cardiovascular disorders (heart and blood vessels): arterial hypertension, which could lead to cerebral haemorrhage or acute cardiac failure with pulmonary oedema (fluid infiltration into the lungs), angina pectoris (even at usual doses in patients with coronary insufficiency), ventricular arrhythmias (abnormal heartbeats), tachycardia (increased heart rate), and ventricular fibrillation (abnormal contraction of the heart), which may be fatal.

Also observed in some cases: difficulty in urination, necrosis at the injection site, metabolic acidosis, and renal failure.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Adrenaline B. Braun

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

No special storage conditions are required. Store in the original container to protect from light.

Do not use this medicine after the expiry date stated on the container after EXP. The expiry date refers to the last day of the month indicated.

The contents of the ampoules must be used immediately after opening. After opening, discard any unused portion of the solution.

Do not use if you observe discoloration or precipitation in the solution.

6. Contents of the container and other information

Composition of Adrenaline B. Braun

The active substance in Adrenaline B. Braun is epinephrine (adrenaline).

Each ml of medicinal product contains 1 mg of epinephrine (adrenaline).

The other components are sodium chloride, sodium metabisulfite (E-223), hydrochloric acid (for pH adjustment), and water for injections.

Appearance of the product and contents of the container

Adrenaline B. Braun is a clear, slightly yellowish aqueous solution supplied in 1 ml glass ampoules. Package sizes:

Boxes of 10 and 100 units.

Marketing Authorization Holder:

Name: B. BRAUN MEDICAL, S.A.

Address: Ctra. de Terrassa, 121.

Rubí (Barcelona) - 08191 - Spain

Manufacturer:

Name: B. BRAUN MEDICAL, S.A.

Address: Ronda de los Olivares, Parcela 11

Polígono Industrial Los Olivares

Jaén (Jaén) – 23009 - Spain

Date of the most recent review of this summary: November 2019

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS): (http://www.aemps.gob.es/)

This information is intended for healthcare professionals only:

Treatment of overdose

To counteract adverse effects on blood pressure and heart rhythm, certain medications such as phentolamine and propranolol may be administered.

If a sudden increase in blood pressure occurs, vasodilator drugs such as nitrites may be given. Angina attacks are treated with sublingual trinitrin, whereas ventricular fibrillation (abnormal heart contraction) requires treatment with an electric defibrillator.