PATIENT INFORMATION LEAFLET

Adenosina Kabi 3 mg/ml injectable solution in pre-filled syringe

Adenosina

Read this 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, ask your doctor or nurse.
• If you experience any side effects, ask your doctor or nurse, even if they are not listed in this leaflet. See section 4.

Adenosina Kabi contains a medication called adenosine that belongs to a group of medications called antiarrhythmics.

Adenosina Kabi reduces electrical impulses between the upper and lower chambers of the heart. This slows down rapid or irregular heartbeats called "arrhythmias".

Adenosina Kabi is used in adults:

• To perform a diagnosis. This medication helps the doctor to determine the type of arrhythmia (irregular heart rhythm) that you have.
• To get your heart to return to a normal heartbeat if you have a type of arrhythmia called "paroxysmal supraventricular tachycardia" or "Wolff-Parkinson-White syndrome"

Do not use Adenosina Kabi if

• you are allergic to adenosine or any of the other components of this medication (listed in section 6). Signs of an allergic reaction include: skin rash, difficulty swallowing or breathing, swelling of the lips, face, throat, or tongue
• you have problems with your heart rhythm and do not have a pacemaker (second- or third-degree atrioventricular block, intrinsic sinus node dysfunction)
• you have severe low blood pressure (hypotension)
• you have asthma or other severe respiratory problems
• you have a type of heart failure in which your heart does not pump enough blood
• you have been told that you have “long QT interval syndrome” which is a heart problem that appears in rare cases and can cause rapid heartbeat and fainting
• you have unstable angina (a disease in which your heart does not receive enough blood and oxygen) that is not stabilized correctly with medical treatment
• you are taking dipiridamol (a medication used to thin the blood)

Do not use this medication if any of the above contraindications affect you. If you are unsure, consult your doctor, nurse, or pharmacist before Adenosina Kabi is administered to you.Adenosina Kabi.

Warnings and precautions

Consult your doctor or nurse before using Adenosina Kabi if you have:

• low blood volume (hypovolemia) and it is not corrected adequately with medication
• left main coronary artery stenosis (narrowing of the artery that supplies blood to the heart)
• you have been told that you have a heart problem in which the electrical impulses in parts of your heart take longer than normal to discharge and recharge afterwards (prolongation of the QT interval)
• carotid artery stenosis (narrowing of the main arteries in the neck). This means that not enough blood is reaching your brain (cerebrovascular insufficiency)
• a heart disease caused by narrowing of your heart valves (valvular stenosis)
• a left-to-right shunt in your heart. This means that blood is passing directly from the left side to the right side of your heart
• problems with a part of your nervous system called the “autonomic nervous system”
• inflammation of the membrane surrounding your heart (pericarditis) or accumulation of fluid around your heart (pericardial effusion)
• you have had severe heart failure
• you have recently had a heart attack or have had a heart transplant in the last year
• any minor heart problem (first-degree atrioventricular block or branch block). These conditions may worsen temporarily when you are given adenosine
• a rare heart rhythm, for example, your heartbeat is very fast or irregular (atrial fibrillation or flutter) and in particular if you have a condition in which your heart has abnormal electrical activity (“accessory conduction pathway”)
• difficulty breathing (bronchospasm)
• you have ever had seizures

Treatment with adenosine should be discontinued if you observe a very slow heart rate (severe bradycardia), respiratory insufficiency, a potentially fatal heart problem (asystole), severe chest pain (angina), or very low blood pressure (severe hypotension).

If you are unsure whether any of the above effects affect you, consult your doctor or nurse before Adenosina Kabi is administered to you.

Use of Adenosina Kabi with other medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication, including those purchased without a prescription.

This is because adenosine may affect how some medications work. Some of these medications may also change the effect of adenosine.

In particular, inform your doctor, nurse, or pharmacist if you are taking any of the following medications:

• Dipiridamol(a medication used to thin the blood). Inform your doctor that you are taking dipiridamol. Your doctor will decide whether you should or should not take Adenosina Kabi or may tell you to stop taking dipiridamol 24 hours before Adenosina Kabi is administered or may need to give you a lower dose of Adenosina Kabi.
• AminophyllineorTheophylline(medications used to help you breathe). Your doctor may tell you to stop taking them 24 hours before Adenosina Kabi is administered.
• Caffeine(sometimes found in headache medications)

Use of Adenosina Kabi with food and drinks

It is recommended to avoid foods or drinks that contain caffeine, such as tea, coffee, chocolate, and cola for at least 12 hours before Adenosina Kabi is administered.

Pregnancy, breastfeeding, and fertility

Consult your doctor or pharmacist before using this medication if:

• you are pregnant, may become pregnant, or think you may be pregnant. Adenosina Kabi should not be administered to you unless it is clearly necessary.
• you are breastfeeding. Adenosina Kabi should not be administered to you if you are breastfeeding.

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

Adenosina Kabi contains sodium

This medication contains less than 1 mmolof sodium (23 mg) per ml; it is essentially “sodium-free”.

How Adenosina Kabi Should Be Administered

Adenosina Kabi is a medication for use in hospitals.

It will be administered to you by a doctor or nurse through an intravenous injection.

Your heart and blood pressure will be closely monitored.

What Amount of Adenosina Kabi Is Administered

If you are unsure why you are being administered Adenosina Kabi or have questions about the amount being administered, ask your doctor, nurse, or pharmacist.

Adults

• The first dose is 3 mg administered in 2 seconds. It is administered through a rapid intravenous injection.
• If the first dose does not make your heartbeat return to normal, you will be administered a second dose. The second dose is 6 mg administered through a rapid intravenous injection.
• If the second dose does not make your heartbeat return to normal, you will be administered a third dose. The third dose is 12 mg administered through a rapid intravenous injection.
• You should not be administered more doses after the 12 mg dose.

Children

These preloaded syringes are not suitable for the administration of small volumes required for children.

Older Adults

See the adult dose recommendation.

If You Have Received More Adenosina Kabi Than You Should Have

As this medication is administered by a doctor or nurse, it is unlikely that you will receive more than the intended amount. Your doctor will carefully calculate how much Adenosina Kabi you should receive.

If you receive more medication than you should, the following effects may occur:

• Severe low blood pressure (hypotension).
• Slow heart rate (bradycardia).
• Cardiac arrest (asystole).

Your doctor will continuously monitor your heart during the process.

As the time that adenosine remains in the blood is very short, any adverse effect due to an overdose of Adenosina Kabi will cease rapidly when the injection is stopped. Sometimes, you may need an injection of a medication called aminophylline or theophylline to prevent any possible adverse effect.

If you have any other questions about the use of this medication, ask your doctor or nurse.

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

While you are being given Adenosina Kabi, you may experience the following side effects.

If any of the following side effects worsen, inform your doctor or nurse immediately and they will decide whether you should continue with the injection or not.

Side effects usually resolve in a few seconds or minutes after the injection has finished, but you should inform your doctor or nurse if you experience any of them.

Very common (may affect more than 1 in 10 people)

• Redness of the skin with a sensation of heat (flushing)
• Low heart rate (bradycardia)
• Extra or intermittent heartbeats
• A heart condition called atrioventricular block where the heart begins to beat slowly
• Severe cardiac problems that may cause death (asystole) or irregular heart rhythm
• Shortness of breath or need to breathe deeply (dyspnea)
• Chest pain or pressure in the chest

Common (may affect up to 1 in 10 people)

• Sensation of dizziness.
• Nausea
• Headache
• Unusual sensations in the skin, such as burning
• Sensation of nerves.

Rare (may affect up to 1 in 100 people)

• Blurred vision
• Perceiving heartbeats or feeling like it's going very fast (palpitations)
• Metals taste in the mouth
• Respiring more quickly or more deeply than normal (hyperventilation)
• Sensation of pressure in the head or heaviness in the arms
• General discomfort, feeling of weakness or pain.
• Sweating

Very rare (may affect up to 1 in 10,000 people)

• Severe shortness of breath or difficulty breathing.

• Redness, pain or swelling at the injection site
• Feeling uncomfortable during the injection
• Worsening of high blood pressure affecting the brain (intracranial hypertension)
• Irregular, rapid or very slow heartbeats
• Severe bradycardia (very slow heart rate)

Frequency not known (cannot be estimated from available data)

• Loss of consciousness, fainting
• Seizures
• Vomiting
• Low blood pressure
• Your heart is not functioning properly to circulate blood around your body (cardiac arrest). This can be fatal.
• Your lungs are not functioning
• Shortness of breath (respiratory arrest)
• Allergic reaction (including swelling of the face and throat, and skin reactions such as blisters or skin rash)
• Spasm of the coronary artery that may cause a heart attack
• Heart attack (myocardial infarction/elevation of the ST segment) especially in patients with narrowing of the coronary arteries
• Infarct / small infarct as a consequence of the hemodynamic effects of adenosine, including hypotension

Reporting of side effects

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

Your doctor, nurse or pharmacist will keep this medication in a safe place where children cannot see it or reach it.

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

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

Do not refrigerate.

This medication is for single use and should be used immediately after opening. Any unused remainder of the pre-filled syringe should be discarded.

Adenosina Kabi should not be used if, before administering the medication, your doctor or nurse observe particles in the solution or any change in the color of the solution.

The pre-filled syringe should be discarded if the appearance of the medication has changed.

Medications should not be thrown down the drain or in the trash. Your doctor or nurse will dispose of the packaging and unused medications. This will help protect the environment.

Composition of Adenosina Kabi

• The active ingredient is adenosine.Each pre-filled syringe of single-dose 1 ml contains 3 mg of adenosine. Each pre-filled syringe of single-dose 2 ml contains 6 mg of adenosine. Each pre-filled syringe of single-dose 4 ml contains 12 mg of adenosine..
• The other components are sodium chloride and water for injection.

Appearance of the product and contents of the pack

Adenosina Kabi is a transparent and colorless injectable solution.

Adenosina Kabi is supplied in packs containing 1, 6 or 10 pre-filled syringes.

Only some pack sizes may be marketed.

Marketing authorization holder and manufacturer responsible

Marketing authorization holder:

Fresenius Kabi España, S.A.U.

C/ Marina, 16-18, 08005 Barcelona

Spain

Manufacturer responsible:

Fresenius Kabi Austria GmbH

Hafnerstrasse 36, 8055 Graz

8055 Graz

Austria

This medicinal product is authorized in the Member States of the European Economic Area and the United Kingdom (Northern Ireland) with the following names:

Name ofName of medicinal product

Member State

BelgiumAdenosine Fresenius Kabi 3 mg/ml, solution for injection in a pre-filled syringe

DenmarkAdenosin Fresenius Kabi

ItalyAdenosina Kabi

IrelandAdenosine 3 mg/ml solution for injection in pre-filled syringe

NetherlandsAdenosine Fresenius Kabi 3 mg/ml, solution for injection in a pre-filled syringe

PolandAdenosine Kabi

PortugalAdenosina Kabi

SpainAdenosina Kabi 3mg/ml solution for injection in pre-filled syringe

United KingdomAdenosine 3 mg/ml solution for injection in pre-filled syringe

(Northern Ireland)

Last update of the summary of product characteristics: February 2024

The detailed and updated information on this medicinal product is available on 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

Adenosina Kabi 3 mg/ml solution for injection in pre-filled syringe

For more details on this medicinal product, consult the technical dossier

Qualitative and quantitative composition

1 ml of solution contains 3 mg of adenosine.

Each pre-filled syringe of single-dose 1 ml contains 3 mg of adenosine.

Each pre-filled syringe of single-dose 2 ml contains 6 mg of adenosine.

Each pre-filled syringe of single-dose 4 ml contains 12 mg of adenosine

To consult the complete list of excipients, see section 6.1.

Pharmaceutical form

Solution for injection in pre-filled syringe

Therapeutic indications

Conversion to normal sinus rhythm of paroxysmal supraventricular tachycardias, including those associated with abnormal conduction pathways (Wolff-Parkinson-White syndrome).

Diagnostic indications

Aid to diagnosis of supraventricular tachycardias with wide or narrow complexes. Although Adenosina Kabi does not reverse atrial flutter, atrial fibrillation or ventricular tachycardia to sinus rhythm, slowing of AV conduction facilitates diagnosis of atrial activity.

Sensitization in endocardial electrophysiological investigations.

Dosage and administration

Adenosina Kabi is only for usein hospitals with monitoring and cardiorespiratory resuscitation equipment available for immediate use if necessary.

Adenosina Kabi should only be used in facilities with cardiac monitoring. Patients who, after a certain dose, present with high-grade AV block should not receive additional doses.

Dosage

Adults:

Initial dose:3 mg administered as a bolus intravenous injection (2-second injection)

Second dose:if the first dose does not stop supraventricular tachycardia in 1 or 2 minutes, 6 mg should be administered as a bolus intravenous injection.

Third dose:if the second dose does not stop supraventricular tachycardia in 1 or 2 minutes, 12 mg should be administered as a bolus intravenous injection.

No additional or higher doses are recommended.

Pediatric population

These pre-filled syringes are not suitable for pediatric use.

Geriatric population

See recommended dosage for adults.

Diagnostic dose

The ascending dosage indicated above may be administered until sufficient diagnostic information is obtained.

Administration

Adenosina should be administered by intravenous bolus injection (IV) directly into a vein or through an intravenous catheter. If administered through an intravenous catheter, the injection should be made as close to the catheter as possible, followed by a rapid flush with physiological saline. If administered through a peripheral vein, a larger diameter cannula should be used.

Pharmacological properties

Excipients

Sodium chloride.

Water for injection.

Incompatibilities

In the absence of compatibility studies, this medicinal product should not be mixed with other medicinal products.

Shelf-life

36 months

The medicinal product should be used immediately after opening.

Special precautions for storage

Do not refrigerate.

Nature and contents of the container

Pre-filled syringe of plastic 1 ml containing 1 ml (3 mg/1 ml) with halobutilo protective cap.

Packs containing:

1 pre-filled syringe

6 pre-filled syringes

10 pre-filled syringes

Pre-filled syringe of plastic 5 ml containing 2 ml (6 mg/2 ml) with halobutilo protective cap.

Packs containing:

1 pre-filled syringe

6 pre-filled syringes

10 pre-filled syringes

Pre-filled syringe of plastic 5 ml containing 4 ml (12 mg/4 ml) with halobutilo protective cap.

Packs containing:

1 pre-filled syringe

6 pre-filled syringes

10 pre-filled syringes

Only some pack sizes may be marketed.

Special precautions for disposal

Do not use if particles or change in color of the solution are observed.

The disposal of unused medicinal product and all materials that have been in contact with it, should be carried out in accordance with local regulations.

Instructions for use of the pre-filled syringe:

When using the pre-filled syringe of plastic 5 ml containing 4 ml (12 mg of adenosine / 4 ml) to administer only a dose of 6 mg, first 2 ml of the syringe should be discarded before administering the remaining 2 ml to the patient.

Use an aseptic technique

1. Remove the protective cap

1. Hold the plunger and push the syringe barrel forward to overcome any resistance it may present

1. Slide the barrel down to remove any air that may be inside the syringe