ADRENALINE BRADEX 1 mg/ml INJECTABLE SOLUTION

Introduction

Package Leaflet: Information for the User

Adrenaline Bradex 1 mg/ml Solution for Injection

Adrenaline

Read all of this leaflet carefully before you are given 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, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

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

Adrenaline belongs to a class of medicines called adrenergic and dopaminergic agents. Adrenaline Bradex is used in life-threatening emergencies such as severe allergic reactions or cardiac arrest.

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

Do not useAdrenaline Bradex:

• if you are allergic to adrenaline or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Talk to your doctor, pharmacist or nurse before you are given Adrenaline Bradex if:

• you are elderly
• you have heart problems, especially if they affect your heart rate or if you have chest pain
• you have brain problems, e.g. stroke, brain damage or blood vessel disease
• you have hyperthyroidism, diabetes or glaucoma (high pressure in the eye)
• you have a phaeochromocytoma (a tumour in the adrenal gland)
• you have low blood potassium levels or high blood calcium levels
• you have a tumour in the prostate gland or kidney disease
• you are in shock or have lost a lot of blood
• you are going to have a surgical operation with general anaesthesia
• you have high blood pressure
• you have atherosclerosis, which is a narrowing and hardening of the blood vessels (your doctor will tell you if you have this)

Talk to your doctor if any of these apply to you before you are given this medicine.

Using Adrenaline Bradex with other medicines

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

A large number of medicines can interact with Adrenaline Bradex which can significantly alter its effects. These medicines include:

• monoamine oxidase inhibitors (MAOIs) such as moclobemide or tricyclic antidepressants such as imipramine, amitriptiline, both used for depression
• cardiac glycosides such as digoxin, used for heart failure
• guanethidine, used for rapid control of blood pressure
• diuretics, such as hydrochlorothiazide, furosemide
• inhalational general anaesthetics, such as halothane
• medicines to increase or decrease blood pressure, including beta-blockers, such as propranolol, atenolol, bisoprolol, phentolamine
• antidiabetics such as insulin or oral hypoglycaemics (e.g. glipizide)
• aminophylline and theophylline (medicines used to treat asthma)
• corticosteroids (medicines used to treat inflammatory conditions of the body such as asthma or arthritis)
• antihistamines (e.g. diphenhydramine), used to treat allergies
• medicines used to treat mental illness such as chlorpromazine, periciazine or fluphenazine
• medicines used to treat hypothyroidism
• oxytocin, used to induce labour at term and to control bleeding after childbirth
• any cough or cold remedy (sympathomimetics).

If you are already taking any of these medicines, talk to your doctor before you are given Adrenaline Bradex.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.

Adrenaline Bradex should not be used during pregnancy or childbirth.

Adrenaline is excreted in breast milk. If you are breast-feeding, talk to your doctor before you are given Adrenaline Bradex.

Adrenaline should only be used during pregnancy and breast-feeding if your doctor thinks it is essential.

Driving and using machines

It is unlikely to be relevant, as you will not be well enough to drive or use machinery.

Talk to your doctor before considering such action.

Adrenaline Bradex contains sodium metabisulphite and sodium chloride

Sodium metabisulphite (as a preservative) may rarely cause allergic reactions (hypersensitivity) and wheezing.

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

Adrenaline Bradex may be diluted with sodium chloride 0.9%. This should be taken into account in patients on a low sodium diet.

3. How Adrenaline Bradex is given

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

It will be given by a trained healthcare professional. Your doctor will decide the most suitable dose and method of administration for your particular case, depending on your age and physical condition.

If you think you have been given too much Adrenaline Bradex

This is unlikely, as the injection will be given by a doctor or a nurse.

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

Talk to your doctor if you experience any side effects, so that they can give you appropriate treatment.

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

If you have any further questions on the use of this product, ask your doctor, pharmacist or nurse.

4. Possible side effects

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

The following side effects have also been reported (frequency not known):

• headache, dizziness
• feeling of anxiety or fear or apprehension
• tremor
• insomnia, confusion, irritability
• change in mood or behaviour
• dry mouth or excessive saliva production
• weakness or sweating
• changes in heart rate and speed
• palpitations (fast or irregular heartbeat), tachycardia (abnormally fast heart rate at rest), angina (chest pain of varying severity)
• high blood pressure
• coldness in the arms or legs
• breathing difficulties
• reduced appetite, nausea or vomiting
• repeated injections can damage the tissues at the injection site and can also cause damage to the limbs, kidneys and liver
• difficulty urinating, urinary retention
• metabolic acidosis (an imbalance in certain components of the blood) may occur
• increased tremor and rigidity in patients with Parkinson's syndrome
• cerebral haemorrhage
• paralysis of one half of the body
• increased blood sugar levels
• reduced blood potassium levels
• pulmonary oedema

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Pharmacovigilance System for Human Use: www.notificaRAM.es.

By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storing Adrenaline Bradex

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

Do not use this medicine after the expiry date which is stated on the carton and on the label of the ampoule after EXP. The expiry date is the last day of the month stated.

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 should be discarded.

Do not remove the ampoule from the carton until you are ready to use it.

After dilution, the solution should be used as soon as possible but should not 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 medicine if you notice discolouration, turbidity or precipitates.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Adrenaline Bradex contains

• The active substance is adrenaline (epinephrine) as adrenaline tartrate. Each 1 ml of this solution for injection contains 1 mg of adrenaline (epinephrine) as adrenaline tartrate.
• The other ingredients are sodium metabisulphite (E223), sodium chloride, water for injections, hydrochloric acid and sodium hydroxide.

Appearance and packaging

Adrenaline Bradex is a clear, colourless and sterile solution for injection, in amber glass ampoules of type I.

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

Marketing authorisation holder and manufacturer

Marketing authorisation holder:

BRADEX S.A.,

27 Asklipiou street

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

Manufacturer:

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

This medicine is authorised in the Member States of the European Economic Area under 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 oplossing voor injectie

Adrenaline (tartrate) Bradex 1 mg/ml Injektionslösung

Luxembourg: ADRENALINE BRADEX 1 mg/mL, solution injectable

Denmark: Adrenalin Bradex 1 mg/ml injektionsvæske, opløsning

Sweden: Adrenalin Bradex 1 mg/ml injektionsvätska, lösning

Slovakia: Adrenalin Bradex 1 mg/ml, injekčný roztok

Czech Republic: Adrenalin Bradex 1 mg/ml injekční roztok

Date of last revision of this leaflet: 05/2021

-----------------------------------------------------------------------------------------------------------------

This information is intended for healthcare professionals only:

Preparation and handling

Do not use this medicine if you notice discolouration.

Repeated local administration may cause necrosis at the injection site.

The best site for i.m. injection is the anterolateral aspect of the middle third of the thigh. The needle used for injection must be long enough to ensure that the adrenaline is injected into the muscle. Intramuscular injections of Adrenaline Bradex 1 mg/ml Solution for injection should be avoided in the thighs 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 caution in patients who have been anaesthetized with halothane or other halogenated anaesthetics, due to the risk of inducing ventricular fibrillation.

Adrenaline should not be used with local anaesthesia of peripheral structures, including fingers.

It should not be mixed with other drugs, unless compatibility is known.

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

Accidental intravascular injection may cause cerebral haemorrhage due to a sudden increase in blood pressure.

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

Incompatibilities

Dilution

For intravenous administration, Adrenaline Bradex 1 mg/ml Solution for injection must be diluted to a 0.1 mg/ml solution (a 1:10 dilution of the ampoule contents) with sodium chloride 0.9%.

Posology and method of administration

Adrenaline Bradex 1 mg/ml Solution for injection is for intramuscular or intraosseous administration. For intravenous administration only after dilution.

Acute anaphylaxis

The intramuscular (i.m.) routeis the route of choice for most people who are given adrenaline for the treatment of acute anaphylaxis, according to the doses indicated in Table 1.

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

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

In children, when the weight is not known, the following table can be consulted, which shows the recommended doses according to age:

Table 1.Dose 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 real doubt about the sufficiency of circulation and absorption from the i.m. injection site, Adrenaline Bradex 1 mg/ml Solution for injection may be administered by intravenous (i.v.) injection

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

Cardiopulmonary resuscitation

Adults

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

Paediatric population

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

Disposal

Disposal of the unused medicine and all materials that have been in contact with it should be done according to local regulations.

Overdose

Signs

Overdose with Adrenaline Bradex 1 mg/ml Solution for injection causes anxiety, confusion, pallor, tachycardia, bradycardia, cardiac arrhythmias and cardiac arrest.

Treatment

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