Adenosine Kabi 3 mg/ml solution for injection in pre-filled syringe
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
PACKAGE LEAFLET: INFORMATION FOR THE USER
Adenosine Kabi 3 mg/ml solution for injection in pre-filled syringe
Adenosine
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, ask your doctor or nurse.
- If you experience any adverse effects, consult your doctor or nurse, even if they are not listed in this leaflet. See section 4.
Leaflet contents
- What Adenosine Kabi is and what it is used for
- What you need to know before using Adenosine Kabi
- How to use Adenosine Kabi
- Possible adverse effects
- How to store Adenosine Kabi
- Contents of the pack and other information
1. What Adenosine Kabi is and what it is used for
Adenosine Kabi contains a medicine called adenosine, which belongs to a group of medicines known as antiarrhythmics.
Adenosine Kabi reduces electrical impulses between the upper and lower chambers of the heart. This slows down rapid or irregular heartbeats known as "arrhythmias".
Adenosine Kabi is used in adults:
- For diagnostic purposes. This medicine helps your doctor determine the type of arrhythmia (irregular heartbeat) you have.
- To restore a normal heartbeat if you have a type of arrhythmia called "paroxysmal supraventricular tachycardia" or "Wolff-Parkinson-White syndrome"
2. What you need to know before using Adenosina Kabi
Do not use Adenosina Kabi if
- you are allergic to adenosine or to any of the other ingredients of this medicine (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 heart rhythm problems and do not have a pacemaker implanted (second- or third-degree atrioventricular block, intrinsic sinus node dysfunction).
- you have very low blood pressure (severe hypotension).
- you have asthma or other serious breathing problems.
- you have a type of heart failure in which your heart does not pump enough blood.
- you have been diagnosed with "long QT syndrome," a rare heart condition that may cause rapid heartbeat and fainting.
- you have unstable angina (a condition in which your heart does not receive enough blood and oxygen) that is not adequately controlled with medical treatment.
- you are taking dipyridamole (a medicine used to thin the blood).
Do not use this medicine if any of the above contraindications apply to you. If you are unsure, consult your doctor, nurse, or pharmacist before receiving Adenosina Kabi.
Warnings and precautions
Talk to your doctor or nurse before using Adenosina Kabi if you have:
- low blood volume (hypovolemia) that is not adequately corrected with medication.
- narrowing of the main left artery supplying blood to the heart (left main coronary stenosis).
- been told you have a heart condition causing electrical impulses in parts of your heart to take longer than normal to discharge and recharge (prolongation of QT interval).
- narrowing of the main arteries in the neck (carotid artery stenosis). This means insufficient blood reaches the brain (cerebrovascular insufficiency).
- heart disease caused by narrowing of your heart valves (valvular stenosis).
- a left-to-right shunt in your heart. This means blood flows 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 fluid accumulation around your heart (pericardial effusion).
- a history of severe heart failure.
- recently had a heart attack or received a heart transplant within the past year.
- any minor heart problems (first-degree atrioventricular block or bundle branch block). These conditions may temporarily worsen when adenosine is administered.
- an irregular heart rhythm, for example, very fast or irregular heartbeat (atrial fibrillation or atrial flutter), especially if you have a condition involving abnormal electrical activity in your heart ("accessory conduction pathway").
- difficulty breathing (bronchospasm).
- a history of seizures.
Treatment with adenosine must be discontinued if you experience very slow heart rate (severe bradycardia), respiratory failure, a potentially fatal heart condition (asystole), severe chest pain (angina), or very low blood pressure (severe hypotension).
If you are unsure whether any of the above conditions apply to you, consult your doctor or nurse before receiving Adenosina Kabi.
Using Adenosina Kabi with other medicines
Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines, including those obtained without a prescription.
This is because adenosine may affect how some medicines work. Also, some of these medicines may alter the effect of adenosine.
In particular, inform your doctor, nurse, or pharmacist if you are taking any of the following medicines:
- Dipyridamole (a medicine used to thin the blood). Inform your doctor that you are taking dipyridamole. Your doctor will decide whether or not to administer Adenosina Kabi or may instruct you to stop taking dipyridamole 24 hours before receiving Adenosina Kabi, or you may require a lower dose of Adenosina Kabi.
- Aminophylline or theophylline (medicines used to help you breathe). Your doctor may instruct you to stop taking these 24 hours before receiving Adenosina Kabi.
- Caffeine (sometimes found in headache medicines).
Using Adenosina Kabi with food and drinks
Avoid food or drinks containing caffeine, such as tea, coffee, chocolate, and cola, for at least 12 hours before receiving Adenosina Kabi.
Pregnancy, breastfeeding, and fertility
Consult your doctor or pharmacist before using this medicine if:
- you are pregnant, could become pregnant, or think you might be pregnant. Adenosina Kabi should not be administered unless clearly necessary.
- you are breastfeeding. Adenosina Kabi should not be administered during breastfeeding.
If you are pregnant or breastfeeding, think you might be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.
Adenosina Kabi contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per ml; therefore, it is essentially "sodium-free".
3. How to use Adenosina Kabi
How Adenosina Kabi should be administered
Adenosina Kabi is a medicine for hospital use.
It will be administered to you by a doctor or nurse as an intravenous injection.
Your heart and blood pressure will be closely monitored.
What dose of Adenosina Kabi will be administered
If you are unsure why you are being given Adenosina Kabi or have questions about the dose being administered, ask your doctor, nurse, or pharmacist.
Adults
- The initial dose is 3 mg given over 2 seconds. It is administered as a rapid intravenous injection.
- If the first dose does not restore your heartbeat to normal, a second dose will be given. The second dose is 6 mg administered as a rapid injection.
- If the second dose does not restore your heartbeat to normal, a third dose will be given. The third dose is 12 mg administered as a rapid injection.
- You should not be given any further doses after the 12 mg dose.
Children
These pre-filled syringes are not suitable for administration of the small volumes required for children.
Elderly patients
See the dosage recommendations for adults.
If you have received more Adenosina Kabi than you should have
Since this medicine is administered by a doctor or nurse, it is unlikely that you will receive more than the correct amount. Your doctor will carefully calculate the amount of Adenosina Kabi to be administered.
If you receive more medicine than you should, the following effects may occur:
- Very low blood pressure (severe hypotension).
- Slow heart rate (bradycardia).
- A heart problem (asystole).
Your doctor will continuously monitor your heart during treatment.
Because adenosine remains in the bloodstream for a very short time, any adverse effects due to an overdose of Adenosina Kabi will cease rapidly once the injection is stopped. Sometimes you may need an injection of a medicine called aminophylline or theophylline to counteract any possible adverse effects.
If you have any further questions about the use of this medicine, ask your doctor or nurse.
4. Possible adverse effects
Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
While you are receiving Adenosine Kabi, you may experience the following adverse effects.
If any of the following effects worsen, inform your doctor or nurse immediately. They will decide whether you should continue with the injection or not.
Adverse effects usually resolve within 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)
- Skin flushing with a sensation of warmth (hot flushes)
- Slow heart rate (bradycardia)
- Extra or intermittent heartbeats
- A heart problem called atrioventricular block, in which the heart begins to beat slowly
- Serious heart problems that may lead to death (asystole) or irregular heartbeat
- Difficulty breathing or need to breathe deeply (dyspnea)
- Chest pain or pressure in the chest
Common (may affect up to 1 in 10 people)
- Dizziness
- Nausea
- Headache
- Unusual skin sensations, such as burning
- Feeling nervous
Uncommon (may affect up to 1 in 100 people)
- Blurred vision
- Awareness of heartbeats or feeling that the heart is racing (palpitations)
- Metallic taste in the mouth
- Breathing faster or more deeply than normal (hyperventilation)
- Feeling of pressure in the head or heaviness in the arms
- General discomfort, feeling of weakness or pain
- Sweating
Rare (may affect up to 1 in 10,000 people)
- Severe shortness of breath or breathing problems
- Redness, pain, or swelling at the injection site
- Feeling uncomfortable during the injection
- Worsening of arterial hypertension affecting the brain (intracranial hypertension)
- Fast, irregular, 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 does not function properly to circulate blood around your body (cardiac arrest). This may be fatal.
- Failure of the lungs
- Breathing difficulty (respiratory arrest)
- Allergic reaction (including swelling of the face and throat, and skin reactions such as blisters or rash)
- Spasm of the heart artery that may cause a heart attack
- Heart attack (myocardial infarction/ST-segment elevation), especially in patients with narrowing of the heart arteries
- Infarction / minor infarction as a consequence of the haemodynamic effects of adenosine, including hypotension
Reporting of adverse effects
If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if these are possible adverse effects not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Adenosine Kabi
Your doctor, nurse, or pharmacist will keep this medicine in a safe place where children cannot see or reach it.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month indicated.
Do not refrigerate.
This medicine is for single use only and must be used immediately after opening. Any unused portion of the pre-filled syringe must be discarded.
Adenosine Kabi must not be used if, before administration, your doctor or nurse observes particles in the solution or any change in its colour.
Discard the pre-filled syringe if the appearance of the medicine has changed.
Medicines must not be disposed of via wastewater or household waste. Your doctor or nurse will dispose of any unused medicines and their packaging appropriately. This helps protect the environment.
6. Contents of the container and other information
Composition of Adenosine Kabi
- The active substance is adenosine. Each single-dose pre-filled syringe of 1 ml contains 3 mg of adenosine. Each single-dose pre-filled syringe of 2 ml contains 6 mg of adenosine. Each single-dose pre-filled syringe of 4 ml contains 12 mg of adenosine.
- The other components are sodium chloride and water for injections.
Appearance of the product and contents of the container
Adenosine Kabi is a clear, colourless injectable solution.
Adenosine Kabi is supplied in packs containing 1, 6 or 10 pre-filled syringes.
Only certain pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Fresenius Kabi España, S.A.U.
C/ Marina, 16-18, 08005 Barcelona
Spain
Manufacturer:
Fresenius Kabi Austria GmbH
Hafnerstrasse 36, 8055 Graz
8055 Graz
Austria
This medicinal product is authorised in the European Economic Area (EEA) Member States and the United Kingdom (Northern Ireland) under the following names:
Medicinal Product Name
Member State
Belgium Adenosine Fresenius Kabi 3 mg/ml, solution for injection in a pre-filled syringe
Denmark Adenosin Fresenius Kabi
Italy Adenosina Kabi
Ireland Adenosine 3 mg/ml solution for injection in pre-filled syringe
Netherlands Adenosine Fresenius Kabi 3 mg/ml, oplossing voor injectie in een voorgevulde spuit
Poland Adenosine Kabi
Portugal Adenosina Kabi
Spain Adenosina Kabi 3mg/ml solución inyectable en jeringa precargada
United Kingdom Adenosine 3 mg/ml solution for injection in pre-filled syringe
(Northern Ireland)
Date of the latest revision of this leaflet: February 2024
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/.
This information is intended for healthcare professionals only
Adenosine Kabi 3 mg/ml solution for injection in pre-filled syringe
For further details on this medicinal product, refer to the Summary of Product Characteristics
Qualitative and quantitative composition
1 ml of solution contains 3 mg of adenosine.
Each single-dose 1 ml pre-filled syringe contains 3 mg of adenosine.
Each single-dose 2 ml pre-filled syringe contains 6 mg of adenosine.
Each single-dose 4 ml pre-filled syringe contains 12 mg of adenosine.
For the complete list of excipients, see section 6.1.
Pharmaceutical form
Injectable solution in pre-filled syringe
Therapeutic indications
Rapid conversion to normal sinus rhythm of paroxysmal supraventricular tachycardias, including those associated with anomalous conduction pathways (Wolff–Parkinson–White syndrome).
Diagnostic indications
Aid in the diagnosis of supraventricular tachycardias with wide or narrow complexes. Although Adenosine Kabi does not revert atrial flutter, atrial fibrillation or ventricular tachycardia to sinus rhythm, the slowing of AV conduction facilitates the diagnosis of atrial activity.
Sensitization in endocavitary electrophysiological investigations.
Posology and method of administration
Adenosine Kabi is for hospital use only, with monitoring and cardiopulmonary resuscitation equipment immediately available if needed.
Adenosine Kabi must be used only in facilities equipped with cardiac monitoring. Additional doses must not be administered to patients who develop high-grade atrioventricular block after a given dose.
Posology
Adults:
Initial dose: 3 mg administered as a rapid intravenous bolus (2-second injection).
Second dose: if the first dose does not terminate supraventricular tachycardia within 1 to 2 minutes, 6 mg should be administered as a rapid intravenous bolus.
Third dose: if the second dose does not terminate supraventricular tachycardia within 1 to 2 minutes, 12 mg should be administered as a rapid intravenous bolus.
Higher or additional doses are not recommended.
Paediatric population
These pre-filled syringes are not suitable for paediatric use.
Elderly patients
See recommended posology for adults.
Diagnostic dosing
The ascending dosing regimen described above may be administered up to the point where sufficient diagnostic information is obtained.
Method of administration
Adenosine must be administered by rapid intravenous (IV) bolus injection directly into a vein or via an intravenous catheter. If administered through an intravenous catheter, the injection should be given as proximally as possible, followed immediately by a rapid saline flush. When administered via a peripheral vein, a large-bore cannula should be used.
Pharmaceutical data
List of excipients
Sodium chloride.
Water for injections.
Incompatibilities
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
Shelf life
36 months
The medicinal product must be used immediately after opening.
Special precautions for storage
Do not refrigerate.
Nature and contents of the container
1 ml plastic pre-filled syringe containing 1 ml (3 mg/1 ml) with halobutyl rubber protective cap.
Packs containing:
1 pre-filled syringe
6 pre-filled syringes
10 pre-filled syringes
5 ml plastic pre-filled syringe containing 2 ml (6 mg/2 ml) with halobutyl rubber protective cap.
Packs containing:
1 pre-filled syringe
6 pre-filled syringes
10 pre-filled syringes
5 ml plastic pre-filled syringe containing 4 ml (12 mg/4 ml) with halobutyl rubber protective cap.
Packs containing:
1 pre-filled syringe
6 pre-filled syringes
10 pre-filled syringes
Only certain pack sizes may be marketed.
Special precautions for disposal
Do not use if particles are observed or if there is a change in the solution’s colour.
Disposal of unused medicinal product and all materials that have come into contact with it must be carried out in accordance with local regulations.
Instructions for use of the pre-filled syringe:
When using the 5 ml plastic pre-filled syringe containing 4 ml (12 mg of adenosine / 4 ml) to administer a 6 mg dose only, first discard 2 ml from the syringe before administering the remaining 2 ml to the patient.
Use aseptic technique
- Remove the protective cap
- Hold the plunger and push the syringe barrel forward to overcome any resistance that may be present
- Slide the barrel downwards to expel all air from the syringe
