Adenosinum delfarma

Package leaflet: Information for the user

Warning! Keep this leaflet. The information on the immediate packaging is in a foreign language.
Adenosinum Delfarma
3 mg/ml, solution for injection
Adenosinum
Please read all of this leaflet carefully before using this medicine, as it contains
important information for the patient.

• Keep this leaflet so that you can read it again if necessary.
• If you have any questions, please consult your doctor or nurse.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm someone else, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or nurse. See section 4.

Table of contents of the leaflet:

1. What Adenosinum Delfarma is and what it is used for
2. Important information before using Adenosinum Delfarma
3. How to use Adenosinum Delfarma
4. Possible side effects
5. How to store Adenosinum Delfarma
6. Contents of the pack and other information

1. What Adenosinum Delfarma is and what it is used for

Adenosine is a purine nucleoside present in all cells of the body.
It belongs to the group of antiarrhythmic drugs. Adenosinum Delfarma works by slowing down
electrical impulses between the atria and ventricles (upper and lower chambers) of the heart. This
slows down rapid or irregular heartbeat known as arrhythmia.
Indications

• Rapid restoration of sinus rhythm in paroxysmal supraventricular tachycardia, including cases with an accessory conduction pathway (Wolff-Parkinson-White syndrome).
• Aid in the differential diagnosis of supraventricular tachycardia with either broad or narrow QRS complexes. Although adenosine is not effective in the treatment of atrial flutter, atrial fibrillation, or ventricular tachycardia, slowing conduction through the atrioventricular node facilitates assessment of atrial electrical activity.

Children and adolescents

• Rapid restoration of normal heart rhythm in paroxysmal supraventricular tachycardia in children and adolescents aged 0 to 18 years.

2. Important information before using Adenosinum Delfarma

When not to use Adenosinum Delfarma:

• if the patient is allergic to adenosine or any of the other ingredients of this medicine (listed in section 6). An allergic reaction may manifest as rash, itching, breathing difficulties, or swelling of the lips, face, throat, or tongue.
• if the patient has chronic obstructive pulmonary disease with bronchospasm symptoms – breathing difficulties (e.g. bronchial asthma).
• if the patient has very low blood pressure (severe hypotension).
• if the patient has a certain type of heart failure in which the heart is unable to pump sufficient blood.
• if the patient has heart rhythm disorders, except in patients with an implanted cardiac pacemaker (second- and third-degree atrioventricular block, sick sinus syndrome).
• if the patient has long QT syndrome. This is a rare heart disorder that may lead to rapid heartbeat and fainting.

Do not take this medicine if any of the above conditions apply.
If in doubt about the presence of any of these conditions, consult a doctor before
starting treatment with Adenosinum Delfarma.
Warnings and precautions
Before starting treatment with Adenosinum Delfarma, discuss with a doctor if:

• the patient has a certain type of irregular heartbeat (atrial fibrillation and atrial flutter), particularly with an "accessory conduction pathway";
• the patient has a heart condition in which electrical impulses in the heart responsible for depolarization and subsequent repolarization (discharge and recharge) last longer than usual (prolonged QT interval);
• the patient has low blood volume (hypovolemia) that has not been corrected by appropriate treatment;
• the patient has problems with part of the nervous system called the autonomic nervous system;
• the patient has carotid artery stenosis. This means insufficient blood flow to the brain (cerebrovascular insufficiency);
• the patient has ever had seizures or convulsions;
• the patient has chronic obstructive pulmonary disease;
• the patient has heart disease caused by narrowing of heart valves;
• the patient has inflammation of the membrane surrounding the heart (pericarditis) or fluid accumulation around the heart (pericardial effusion);
• the patient has a left-to-right cardiac shunt. This means blood flows directly from the left side of the heart to the right;
• the patient has narrowing of the left main coronary artery supplying blood to the heart;
• the patient has recently suffered a myocardial infarction, severe heart failure, or heart transplantation within the past year;
• the patient has minor heart problems (first-degree atrioventricular block or bundle branch block). Symptoms of these conditions may temporarily worsen during treatment with Adenosinum Delfarma;
• the patient is taking dipyridamole (see below).

If the patient has very slow heart rate (severe bradycardia), respiratory failure, life-threatening heart problems (asystole), severe chest pain (angina pectoris), or very low blood pressure (severe hypotension), treatment with Adenosinum Delfarma must be stopped immediately.
Children and adolescents
In children with Wolff-Parkinson-White (WPW) syndrome (a condition characterized by heart rhythm disturbances), Adenosinum Delfarma may cause severe heart rhythm disorders.
Adenosinum Delfarma and other medicines
Inform the doctor about all medicines currently used or recently used, including those obtained without a prescription, as well as herbal preparations. Adenosinum Delfarma and other medicines taken concomitantly may affect each other's actions.
In particular, inform the doctor or pharmacist if the patient is taking any of the following medicines:

• dipyridamole (a medicine used to thin the blood). Inform the doctor if dipyridamole is being taken. The doctor will decide either not to administer Adenosinum Delfarma or to discontinue dipyridamole 24 hours before starting Adenosinum Delfarma and to reduce the dose of Adenosinum Delfarma;
• aminophylline or theophylline (medicines used to improve breathing). The doctor will decide to discontinue these medicines 24 hours before starting Adenosinum Delfarma;
• caffeine (sometimes used in the treatment of headaches).

Adenosinum Delfarma with food and drink
Do not consume food or beverages containing caffeine (e.g. coffee, tea, chocolate, cola) for 12 hours before administration of Adenosinum Delfarma.
Pregnancy and breastfeeding
Do not take Adenosinum Delfarma if the patient is pregnant (or suspects she may be pregnant) or is breastfeeding, unless absolutely necessary. Therefore, inform the doctor about pregnancy or breastfeeding before starting treatment with Adenosinum Delfarma.
Driving and using machines
Not applicable.
Adenosinum Delfarma contains sodium
Adenosinum Delfarma contains 3.54 mg of sodium per 1 ml (in the form of 9 mg of sodium chloride per 1 ml). This should be taken into account in patients with impaired renal function and in patients controlling sodium intake in their diet.
The medicine contains less than 1 mmol (23 mg) of sodium per vial, meaning the medicine is considered "sodium-free".

3. How to use Adenosinum Delfarma

• Adenosinum Delfarma is intended for use in hospital settings with immediate access to cardiopulmonary resuscitation equipment.
• Adenosinum Delfarma is to be administered by a doctor or nurse as an intravenous injection or via an intravenous catheter. After administration via an intravenous catheter, the doctor or nurse will immediately flush the catheter with 0.9% sodium chloride solution.
• During administration of Adenosinum Delfarma, the doctor or nurse will monitor heart activity and arterial blood pressure.

If you have any further questions or doubts regarding the use of this medicine, consult your
doctor or nurse.
Dosage for rapid restoration of sinus rhythm in paroxysmal supraventricular tachycardia
Adults (including elderly patients):

• initial dose: 3 mg administered as a rapid intravenous injection (within 2 seconds), followed immediately by flushing the catheter with physiological saline;
• second dose: if supraventricular tachycardia has not terminated within 1 to 2 minutes after the first dose, administer 6 mg also as a rapid intravenous injection, followed immediately by flushing the catheter with physiological saline;
• third dose: if supraventricular tachycardia has not terminated within 1 to 2 minutes after the second dose, administer 12 mg also as a rapid intravenous injection;
• further doses or doses exceeding 12 mg are not recommended.

Elderly patients:
Recommended dosage as in adults.
Use in children and adolescents:
Adenosinum Delfarma is intended for use in hospitals where cardiopulmonary resuscitation
equipment is available. The decision on using the medicine and the dose administered is made by
the physician based on the child's body weight. The physician will also decide whether further
injections are necessary.
During administration of Adenosinum Delfarma, the patient will be continuously monitored,
including continuous recording of cardiac electrical activity (ECG).
Adenosinum Delfarma is administered intravenously by a doctor or nurse.
Recommended dosage for treatment of paroxysmal supraventricular tachycardia in children and
adolescents:

• first bolus: 0.1 mg/kg body weight (maximum dose 6 mg);
• increase by 0.1 mg/kg body weight as needed until termination of supraventricular tachycardia (maximum dose 12 mg).

Dosage used in differential diagnosis of supraventricular tachycardia
The above dosage regimen may be used by the physician until sufficient data are obtained to
determine the type of arrhythmia present in the patient.
Use in children and adolescents:
Currently available data do not support the use of adenosine in children and adolescents for
diagnostic purposes.
Patients with hepatic and/or renal impairment
The efficacy of Adenosinum Delfarma is not altered in cases of renal or hepatic insufficiency.
Overdose of Adenosinum Delfarma
It is unlikely that a patient would receive an excessive dose, as Adenosinum Delfarma is
administered by a doctor or nurse.
The doctor will carefully assess the appropriate dose for the patient.
If an overdose occurs, the following adverse effects may occur:

• very low blood pressure (severe hypotension);
• slowed heart rate (bradycardia);
• heart problems (asystole).

The doctor will monitor heart function during treatment.
Adenosine has a short duration of presence in the blood. Therefore, any adverse effects following
an overdose are likely to resolve quickly after discontinuation of Adenosinum Delfarma.
Intravenous administration of aminophylline or theophylline may be necessary.
If an overdose is suspected, seek immediate medical advice from a doctor.
If you have any further questions or uncertainties regarding the use of this medicine, consult your
doctor.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
The following adverse reactions may occur during treatment with Adenosinum Delfarma.
If any of the following adverse reactions worsen, inform your doctor or nurse, as it may be necessary to discontinue the medicine:
Adverse reactions usually resolve within a few seconds or minutes after the injection has ended, but you should inform your doctor or nurse if any of them occur.

Very common (affect more than 1 in 10 patients)

• Slowed heart rate (bradycardia);
• Sinus arrest;
• Heart problem called atrioventricular block;
• Extra atrial contractions;
• Ventricular excitability disorders, such as: extra ventricular contractions, ventricular tachycardia;
• Sensation of irregular heartbeat;
• Shortness of breath or difficulty breathing;
• Pain and (or) pressure, squeezing sensation in the chest;
• Facial flushing with a feeling of warmth.

Common (affect less than 1 in 10 patients)

• Dizziness or feeling faint;
• Headache;
• Nausea;
• Burning sensation;
• Anxiety.

Uncommon (affect less than 1 in 100 patients)

• Head pressure sensation;
• Blurred vision;
• Palpitations, sinus tachycardia;
• Metallic taste in the mouth;
• Faster and deeper breathing than usual (hyperventilation);
• Sensation of heaviness in the arms;
• General discomfort, malaise, and pain;
• Excessive sweating.

Very rare (affect less than 1 in 10,000 patients)

• Severe shortness of breath and breathing problems due to bronchospasm;
• Redness, pain, or itching at the injection site;
• Increased intracranial pressure;
• Severe bradycardia (slowed heart rate);
• Life-threatening irregular heartbeat (torsade de pointes – ventricular arrhythmia);
• Ventricular fibrillation, atrial fibrillation.

Frequency not known (cannot be estimated from available data)

• Loss of consciousness;
• Fainting;
• Seizures, particularly in patients with a predisposition to seizures;
• Hypotension;
• Absence of ventricular muscle contractions;
• Cardiac arrest (asystole), sometimes with fatal outcome, particularly in patients with concomitant ischemic heart disease or other heart diseases;
• Myocardial infarction;
• Coronary artery spasm, which may lead to myocardial infarction;
• Stroke or transient ischemic attack;
• Vomiting;
• Respiratory failure;
• Apnea and (or) respiratory arrest;
• Anaphylactic reaction (angioedema manifested by swelling of lips, face, tongue, or throat, and breathing or swallowing difficulties; urticaria; rash).

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or nurse.
Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, Website: https://smz.ezdrowie.gov.pl
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Adenosinum Delfarma

Keep the 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 stated month.
Do not freeze.
The medicine is intended for single use only and should be used immediately after opening.
Any unused portion of the solution remaining after opening must be discarded.
If the doctor or nurse observes any particles in the solution or discoloration before injection, Adenosinum Delfarma must not be used.
If the appearance of the medicine has changed, the vial should be discarded.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the pack and other information

What Adenosinum Delfarma contains:

• The active substance is adenosine. One ml of injection solution contains 3 mg of adenosine.
• The other ingredients are: sodium chloride, water for injections.

One 2 ml vial contains 6 mg of adenosine.
Available pack sizes:
6 vials of 2 ml
For more detailed information, please contact the marketing authorisation holder or the parallel importer.
Marketing authorisation holder in Greece, the country of export:
VIANEX S.A., 8 Varibobi str., 14671 N. Erythrea, Kifisia, Greece
Manufacturer:
VIANEX S.A – Plant A', 12th km Athens-Lamia National Road, 14451 Metamorfosis, Attica, Greece
Parallel importer:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Repackaged in:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Marketing authorisation number in Greece, the country of export: 131653/05-11-2019
Parallel import authorisation number: 58/24