Adenosinum Delfarma

Leaflet attached to the packaging: information for the user

Warning! The leaflet should be kept. Information on the immediate packaging in a foreign language.

Adenosinum Delfarma

3 mg/ml, solution for injection
Adenosinum

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if necessary.
• In case of any doubts, you should consult a doctor or nurse.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or nurse. See section 4.

Table of contents of the leaflet:

• 1. What is Adenosinum Delfarma and what is it 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 packaging and other information

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

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

Indications for use

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

Children and adolescents

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

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 a rash, itching, or difficulty breathing, swelling of the lips, face, throat, or tongue.
• if the patient has chronic obstructive pulmonary disease with symptoms of bronchospasm - difficulty breathing (e.g., 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 not able to pump enough blood.
• if the patient has arrhythmias, except for patients with a pacemaker (second- and third-degree atrioventricular block, sick sinus syndrome).
• if the patient has a long QT interval syndrome. This is a rare heart disorder that can lead to rapid heartbeat and fainting.

You should not take this medicine if you have any of the above conditions.
In case of doubts about their occurrence, you should consult a doctor before starting to use Adenosinum Delfarma.

Warnings and precautions

Before starting to use Adenosinum Delfarma, you should discuss it with your doctor if:

• the patient has a certain type of irregular heart rhythm (atrial flutter and fibrillation), in particular "additional conduction pathway";
• the patient has heart disease characterized by prolonged electrical impulses in the heart (prolonged QT interval);
• the patient has low blood volume (hypovolemia) that is not compensated by appropriate treatment;
• the patient has problems with the part of the nervous system called the autonomic nervous system;
• the patient has carotid artery stenosis. This means that too little blood reaches the brain (cerebrovascular insufficiency);
• the patient has had or currently has seizures or convulsions;
• the patient has chronic obstructive pulmonary disease;
• the patient has heart disease caused by narrowing of the heart valves;
• the patient has pericarditis (inflammation of the membrane surrounding the heart) or fluid accumulation around the heart (pericardial effusion);
• the patient has a left-to-right heart shunt. This means that 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 had a recent heart attack, severe heart failure, or heart transplant in the last year;
• the patient has minor heart problems (first-degree atrioventricular block or bundle branch block). The symptoms of these diseases may temporarily worsen during the use of 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), the treatment with Adenosinum Delfarma should be stopped immediately.

Children and adolescents

In children with Wolff-Parkinson-White syndrome (WPW; a condition characterized by arrhythmia), Adenosinum Delfarma may cause severe arrhythmias.

Adenosinum Delfarma and other medicines

You should tell your doctor about all the medicines you are taking now or have taken recently, including those that are available without a prescription, including herbal preparations. Adenosinum Delfarma and other medicines used at the same time may affect each other's action.
In particular, you should inform your doctor or pharmacist if you are taking any of the following medicines:

• dipyridamole (a medicine used to thin the blood). You should inform your doctor if you are taking dipyridamole. The doctor will decide whether to stop taking Adenosinum Delfarma or discontinue dipyridamole for 24 hours before starting Adenosinum Delfarma and reduce the dose of Adenosinum Delfarma;
• aminophylline or theophylline (medicines used to improve breathing). The doctor will decide to discontinue these medicines for 24 hours before starting Adenosinum Delfarma;
• caffeine (sometimes used to treat headaches).

Adenosinum Delfarma with food and drink

You should not consume foods and drinks containing caffeine, such as coffee, tea, chocolate, and cola, for 12 hours before administering Adenosinum Delfarma.

Pregnancy and breastfeeding

You should not take Adenosinum Delfarma if you are pregnant or breastfeeding, unless it is absolutely necessary. Therefore, before starting to use Adenosinum Delfarma, you should tell your doctor about pregnancy or breastfeeding.

Driving and using machines

This is not applicable.

Adenosinum Delfarma contains sodium

Adenosinum Delfarma contains 3.54 mg of sodium in 1 ml (in the form of 9 mg of sodium chloride in 1 ml).
This should be taken into account in patients with reduced kidney function and in patients controlling their sodium intake.
The medicine contains less than 1 mmol (23 mg) of sodium per vial, which means the medicine is considered "sodium-free".

3. How to use Adenosinum Delfarma

• Adenosinum Delfarma is intended for use in hospital settings with the possibility of immediate use of cardiopulmonary resuscitation equipment.
• Adenosinum Delfarma is intended for administration by a doctor or nurse via intravenous or venous catheter injection. After administration via a venous catheter, the doctor or nurse will immediately flush the catheter with 0.9% sodium chloride solution.
• During the administration of Adenosinum Delfarma, the doctor or nurse will monitor the patient's heart function and blood pressure.

In case of any further doubts or questions related to the use of this medicine, you should consult a doctor or nurse.

Dosing for rapid restoration of sinus rhythm in paroxysmal supraventricular tachycardia

Adults (including elderly patients):

• initial dose: 3 mg in rapid intravenous injection (within 2 seconds), and after administration, the catheter should be immediately flushed with physiological saline;
• second dose: if after the first dose the supraventricular tachycardia does not stop within 1 to 2 minutes, 6 mg should be administered in rapid intravenous injection, and after administration, the catheter should be immediately flushed with physiological saline;
• third dose: if after the second dose the supraventricular tachycardia does not stop within 1 to 2 minutes, 12 mg should be administered in rapid intravenous injection;
• it is not recommended to use subsequent doses or doses higher than 12 mg.

Elderly patients:

The recommended dosing is the same as for adults.

Use in children and adolescents:

Adenosinum Delfarma is intended for use in hospitals where cardiopulmonary resuscitation equipment is available. The decision to use the medicine and the dose administered is made by the doctor based on the child's body weight. The doctor will also decide if further injections of the medicine are needed.
During the administration of Adenosinum Delfarma, the patient will be constantly monitored, including electrocardiogram (ECG) recording.
Adenosinum Delfarma is administered intravenously by a doctor or nurse.
The recommended dosing for the treatment of paroxysmal supraventricular tachycardia in children and adolescents:

• first bolus 0.1 mg/kg body weight (maximum dose 6 mg);
• increasing by 0.1 mg/kg body weight as needed until the supraventricular tachycardia stops (maximum dose 12 mg).

Dosing used in the differential diagnosis of supraventricular tachycardia

The above dosing scheme will be used by the doctor until sufficient data is obtained to determine the type of arrhythmia the patient has.

Use in children and adolescents:

Currently available data do not confirm the justification for the use of adenosine in children and adolescents for diagnostic purposes.

Patients with liver and/or kidney function disorders

The efficacy of Adenosinum Delfarma is not affected in case of renal or liver failure.

Use of a higher dose of Adenosinum Delfarma than recommended

It is unlikely that the patient will take too much of the medicine, as Adenosinum Delfarma is administered by a doctor or nurse.
The doctor will carefully assess what dose of the medicine should be administered to the patient.
In case of taking a higher dose of the medicine than recommended, the following side effects may occur:

• very low blood pressure (severe hypotension);
• slow heart rate (bradycardia);
• heart problem (asystole).

The doctor will monitor the patient's heart function during the use of the medicine.
Adenosine remains in the blood for a short period. Therefore, possible side effects that occur after administration of too much medicine will probably disappear quickly after discontinuation of Adenosinum Delfarma. It may be necessary to administer aminophylline or theophylline intravenously.
In case of suspected use of a higher dose of the medicine than recommended, you should immediately consult a doctor.
In case of any further doubts related to the use of this medicine, you should consult a doctor.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects may occur during the use of Adenosinum Delfarma.

If any of the following side effects worsen, you should inform your doctor or nurse, as it may be necessary to discontinue the use of the medicine:

Side effects usually disappear within a few seconds or minutes after the end of the injection, but you should inform your doctor or nurse if any of them occur.
Very common (affecting more than 1 in 10 patients)

• slow heart rate (bradycardia);
• sinus arrest;
• heart problem called atrioventricular block;
• additional atrial contractions;
• ventricular excitability disorders, such as: additional ventricular contractions, ventricular tachycardia;
• feeling of irregular heartbeat;
• shortness of breath or dyspnea;
• chest pain and/or feeling of pressure or squeezing in the chest;
• flushing of the face with a feeling of heat.

Common (affecting less than 1 in 10 patients)

• dizziness or feeling of emptiness in the head;
• headaches;
• nausea;
• feeling of burning;
• anxiety.

Uncommon (affecting less than 1 in 100 patients)

• feeling of pressure in the head;
• blurred vision;
• palpitations, sinus tachycardia;
• metallic taste in the mouth;
• faster and deeper breathing than usual (hyperventilation);
• feeling of heaviness in the arms;
• feeling of general discomfort, weakness, and pain;
• excessive sweating.

Rare (affecting less than 1 in 10,000 patients)

• severe shortness of breath and breathing difficulties due to bronchospasm;
• redness, pain, or itching at the injection site;
• increased intracranial pressure;
• severe bradycardia (slow heart rate);
• life-threatening irregular heartbeat (torsade de pointes - ventricular arrhythmia);
• ventricular fibrillation, atrial fibrillation.

Frequency not known (cannot be estimated from the available data)

• loss of consciousness;
• fainting;
• seizures, especially in people with a tendency to seizures;
• hypotension;
• lack of ventricular contractions;
• cardiac arrest (asystole), sometimes with a fatal outcome, especially in patients with concomitant coronary artery disease or other heart diseases;
• myocardial infarction;
• coronary artery spasm, which can lead to myocardial infarction;
• stroke or transient cerebral ischemic attack;
• vomiting;
• respiratory failure;
• apnea and/or respiratory arrest;
• anaphylactic reaction (angioedema characterized by swelling of the lips, face, tongue, or throat, and difficulty breathing and swallowing; urticaria; rash).

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, you should tell your doctor or nurse.
Side effects can be reported directly to the Department of Monitoring of Adverse Reactions of Medicinal Products 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
By reporting side effects, you can help gather more information on the safety of the medicine.

5. How to store Adenosinum Delfarma

The medicine should be stored out of 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 specified month.
Do not freeze.
The medicine is intended for single use only and should be used immediately after opening.
Any unused contents of the vial should be discarded after opening.
If the doctor or nurse observes any particles in the solution or discoloration before administration, Adenosinum Delfarma should not be used.
If the appearance of the medicine has changed, the vial should be discarded.
Medicines should not be disposed of in the sewage system or household waste containers. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging and other information

What Adenosinum Delfarma contains:

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

One vial with a capacity of 2 ml contains 6 mg of adenosine.

Available packaging:

6 vials of 2 ml each
In order to obtain more detailed information, you should contact the marketing authorization holder or parallel importer.

Marketing authorization 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 by:

Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Marketing authorization number in Greece, the country of export: 131653/05-11-2019

Parallel import authorization number: 58/24

Date of leaflet approval: 12.02.2024