ADENOSINA 6 mg /2 Ml Инъекционный Раствор

Содержание инструкции

1. Adenosina Hikma, 6 mg/2 ml, injectable solution
   1. What is Adenosina Hikma and what it is used for
   2. What you need to know before using Adenosina Hikma
   3. How to use Adenosina Hikma
   4. Possible side effects
   5. How to store Adenosina Hikma
   6. Package Contents and Other Information
2. Adenosina Hikma is used with continuous monitoring and recording of the

Adenosina Hikma, 6 mg/2 ml, injectable solution

Adenosina

Equivalent medicine

Read this leaflet carefully before using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or nurse.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or nurse. See section 4.

Contents of this leaflet:

• 1. What Adenosina Hikma is and what it is used for
• 2. What you need to know before you use Adenosina Hikma
• 3. How to use Adenosina Hikma
• 4. Possible side effects
• 5. How to store Adenosina Hikma
• 6. Contents of the pack and other information

1. What is Adenosina Hikma and what it is used for

Adenosina Hikma contains a medicine called adenosine. This belongs to a
group of medicines called “antiarrhythmics”.
Adenosina Hikma works by slowing down the electrical impulses between the upper and
lower chambers of the heart. This slows down fast and irregular heartbeats called
“arrhythmias”.

Adenosina Hikma is used:

• During a test. This helps doctors to find out what type of arrhythmia (irregular heartbeat) you have.
• To regulate the heartbeat if you have a type of arrhythmia called “paroxysmal supraventricular tachycardia (SVT)” or “Wolff-Parkinson-White syndrome”.

Children
In children, Adenosina Hikma is used to regulate your child's heartbeat if your
child has a type of arrhythmia called “paroxysmal supraventricular tachycardia
(PSVT)”.
Adenosina Hikma has been shown not to be effective in patients with atrial
or ventricular tachycardia or tachycardias attributable to atrial fibrillation or atrial flutter.

2. What you need to know before using Adenosina Hikma

Do not take Adenosina Hikma if:

• you are allergic to adenosine or to any of the other ingredients of this medicine (listed in section 6). Symptoms of an allergic reaction include: skin rash, difficulty swallowing or breathing, swelling of the lips, face, throat or tongue.
• You suffer from asthma or any other serious breathing problem.
• You have very low blood pressure (severe hypotension).
• You suffer from a type of heart failure in which the heart is not pumping enough blood.
• You have heart rhythm problems and do not have a pacemaker (second or third degree atrioventricular block, sick sinus syndrome).
• You have been told you have “long QT syndrome”. This is a rare heart problem that can lead to a fast heartbeat and fainting.

Do not take this medicine if any of the above conditions apply to you. If you are not
sure, ask your doctor or nurse before you are given
Adenosina Hikma.

Warnings and precautions
Talk to your doctor or nurse before using Adenosina Hikma if:

• You suffer from a certain type of unusual heart rhythm (atrial fibrillation or atrial flutter), especially if you have an “accessory conduction pathway”.
• You have a condition called long QT syndrome (prolonged QT interval).
• You have a low blood volume (hypovolemia) that has not been adequately stabilized by medical therapy.
• You suffer from disorders of a part of the nervous system called the “autonomic nervous system”.
• You have a narrowing of the main arteries in the neck (carotid artery). This means that the blood supply to the brain is insufficient (cerebrovascular insufficiency).
• You have or have had seizures or convulsions.
• You have breathing difficulties (bronchospasm).
• You have a narrowing of the heart valves (stenosis of the heart valves).
• You have inflammation of the membrane surrounding the heart (pericarditis) or a build-up of fluid around the heart (pericardial effusion).
• You have a left-to-right shunt in the heart. This means that blood flows directly from the left side of the heart to the right.
• You have a narrowing of the main left artery that carries blood to the heart (stenosis of the left main coronary artery).
• You have recently had a heart attack, severe heart failure, or undergone a heart transplant in the last year.
• You have minor heart problems (first-degree atrioventricular block or bundle branch block). These conditions may be temporarily worsened when Adenosina Hikma is administered.
• If you suffer from a very slow heartbeat (severe bradycardia), respiratory failure, a heart problem that can be fatal (asystole), severe chest pain (angina) or very low blood pressure (severe hypotension), then the
  treatment with Adenosina Hikma must be stopped.

You have a history of unstable angina pectoris (chest pain due to altered circulation in the coronary arteries) not properly stabilized by medical therapy.

Patients who develop high-grade AV (atrioventricular) block should not
be given further dose increments.
Your doctor will stop treatment with adenosine if you experience any
serious adverse effect.
If you are unsure whether any of the above conditions apply to you, ask your doctor or
nurse before receiving Adenosina Hikma.

Children and adolescents
In children with a heart rhythm disorder called “Wolff-Parkinson-
White (WPW) syndrome”, Adenosina Hikma can cause a severely abnormal and unexpected heart rhythm.
If you are unsure whether this applies to your child, ask your doctor or nurse
before they receive Adenosina Hikma.

Patients with kidney and/or liver disease
Since exogenous adenosine (administered) is not metabolized by either
the kidneys or the liver, the efficacy and tolerability of Adenosina Hikma should not
be affected by hepatic or renal insufficiency.

Other medicines and Adenosina Hikma
Tell your doctor or nurse if you are taking, have recently taken or might take
any other medicines, including those available without a prescription and herbal
remedies.
This is because Adenosina Hikma can affect how other medicines
work.
Also, some medicines can affect the way Adenosina Hikma works.
In particular, check with your doctor or nurse if you are taking any of the following medicines:

• Dipyridamole (a medicine used to thin the blood). Make sure your doctor knows that you are taking dipyridamole. Your doctor may decide not to administer Adenosina Hikma or may tell you to stop taking dipyridamole 24 hours before taking Adenosina Hikma or you may need lower doses of Adenosina Hikma.
• Aminophylline or theophylline (medicines used to help you breathe). Your doctor may tell you to stop taking them 24 hours before being given Adenosina Hikma.
• Caffeine (sometimes found in headache medicines).
• Adenosina Hikma can interact with other drugs that inhibit conduction (e.g. beta-blockers, digoxin, verapamil) or that accelerate conduction (e.g. beta-sympathomimetics).

Adenosina Hikma with food, beverages and alcohol
Foods and beverages containing caffeine, such as tea, coffee, chocolate and cola-based drinks
should be avoided for at least 12 hours before the administration of Adenosina
Hikma.

Pregnancy and breastfeeding
If you are pregnant or breastfeeding, if you suspect or are planning
a pregnancy, ask your doctor or nurse for advice before taking
this medicine.

Pregnancy
You should not be given Adenosina Hikma if you are pregnant or suspect you
are, unless it is clearly necessary.

Breastfeeding
You should not be given Adenosina Hikma if you are breastfeeding.

Driving and using machines
Not known.

Adenosina Hikma contains Sodium
This medicine contains less than 1 mmol of sodium (23 mg) per dose, which is
essentially “sodium-free”.

3. How to use Adenosina Hikma

• Adenosina Hikma is a medicine for hospital use in hospitals equipped with available resuscitation equipment.
• It will be administered to you by the doctor or nurse as an injection into a vein.
• Your heart and blood pressure will be carefully monitored.

If you are not sure why you are being given Adenosina Hikma or have questions about how much Adenosina Hikma you are being given, ask your doctor or nurse.
The recommended dose (in adults and elderly patients) is:

• The first dose is 3 mg administered in 2 seconds. This is given to you as a rapid injection into a vein.
• If the first dose does not restore your heartbeat to normal, you will be given a second dose. The second dose is 6 mg administered as a rapid injection.
• If the second dose does not restore your heartbeat to normal, you will be given a third dose. The third dose is 12 mg administered as a rapid injection.
• After the 12 mg dose, you should not receive any further doses.

Dose for diagnostics:
The above increasing dose schedule should be used until sufficient diagnostic information is obtained.

Use in children and adolescents
Adenosina Hikma is a medicine for hospital use in hospitals equipped with available resuscitation equipment. The doctor will decide if this medicine is necessary, how much of it should be given based on the child's weight, and if several injections are needed.

• Your child will be carefully monitored, including recording their heart's electrical activity using an ECG machine (electrocardiogram).
• Administration to the child will be carried out by a doctor or nurse via an injection into a vein.

If you receive more Adenosina Hikma than you should
Because this medicine will be administered by a doctor or nurse, it is unlikely that you will be given too much. The doctor will carefully assess how much medicine you should be given.
If you take more medicine than you should, the following effects may occur:

• Very low blood pressure (severe hypotension).
• Slow heartbeat (bradycardia).
• Cessation of heartbeat (asystole, cardiac arrest).

The doctor will monitor your heart throughout the procedure.
Because the duration of time that adenosine remains in the blood is very short, any undesirable effects of Adenosina Hikma should resolve quickly with discontinuation of the injection.
Sometimes it may be necessary to inject a medicine called aminophylline or theophylline to help with some undesirable effects.
If you have any further questions about the use of this medicine, ask your doctor or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
While you are given Adenosina Hikma you may experience the following side effects. The
side effects usually resolve within a few seconds or minutes after the
completion of the injection but you should inform your doctor or nurse if any
side effect occurs.
If any of the following side effects worsen, tell your doctor or
nurse and they may stop the injection.

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

• Flushing with a burning sensation (hot flushes)
• Slow heartbeat (bradycardia)
• Missed heartbeats or extra heartbeats
• A heart problem called atrioventricular block
• Temporary and self-limiting heart problems (asystole)
• Shortness of breath or the need to breathe deeply (dyspnea)
• Chest pain or pressure

Common (may affect up to 1 in 10 people)

• Feeling dizzy or lightheaded
• Feeling sick (nausea)
• Headache
• Unusual skin sensations such as burning
• Feeling nervous

Not common (may affect up to 1 in 100 people)

• Blurred vision
• Being aware of your heartbeat and feeling it fast
• Metallic taste in the mouth
• Breathing more quickly and deeply than normal (hyperventilation)
• Increased pressure in the skull
• General feeling of being unwell, weak or in pain
• Sweating

Very 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 discomfort during the injection
• Worsening of high blood pressure affecting the brain (intracranial hypertension)
• Very slow, fast or irregular heartbeats
• Very slow heartbeat (severe bradycardia)

Not known (frequency cannot be estimated from the available data)

• Serious heart problems that can be fatal (asystole) or irregular heartbeats
• Fainting
• Seizures (convulsions)
• Feeling sick (vomiting)
• Stoppage of breathing (respiratory arrest)
• Hypotension sometimes severe
• Stroke/transient ischemic attack; secondary to the hemodynamic effects of adenosine, including hypotension
• Anaphylactic reaction (including angioedema and skin reactions such as hives and rash)
• Myocardial infarction/ST segment elevation, especially in patients with severe and pre-existing coronary artery disease

If any of the above side effects worsen, tell your
doctor or nurse who may stop the injection.
Side effects usually resolve within a few seconds or minutes after the
completion of the injection but you should inform your doctor or nurse if any
side effect occurs.

Reporting of side effects
If you get any side effects, talk to your doctor or nurse. You can also report side effects directly
through the national reporting system at
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side
effects you can help provide more information on the safety of this
medicine

5. How to store Adenosina Hikma

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 packaging and
on the vial after SCAD. The expiry date refers to the last day of that month.
Do not store above 30°C. Do not refrigerate.
The product is for single use only and must be used immediately after
opening. Any remaining unused content of the vial must be
discarded.
Do not use this medicine if you notice the presence of particles or colour changes
before administration.
Do not dispose of any medicine in wastewater. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.

6. Package Contents and Other Information

What Adenosina Hikma Contains

• The active ingredient is adenosine.
• The other ingredients are sodium chloride (see section 2) and water for injections.

Each 2 ml vial of Adenosina Hikma contains 6 mg of adenosine.
Each ml of injectable solution contains 3 mg of adenosine.

Description of the Appearance of Adenosina Hikma and Package Contents
Adenosina Hikma is a sterile, clear and colourless injectable solution, free from
particles.
Each pack contains 10 vials.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Hikma Farmacêutica (Portugal), S.A.
Estrada do Rio da Mó, 8 A-B – Fervença
2705-906 Terrugem SNT
Portugal

Manufacturer
Hikma Italia S.p.A.
Viale Certosa, 10
27100 Pavia
Italy

This medicinal product is authorised in the Member States of the European
Economic Area under the following denominations
Italy Adenosina Hikma
Austria Adenosin Hikma 6 mg/2 ml Injektionslösung
Belgium Adenosine Hikma 6 mg/2 ml Injektionslösung /
Solution injectable / Oplossing voor injectie
France Adenosine Hikma 6 mg/2 ml, solution injectable
Germany Adenosin Hikma 6 mg/2 ml Injektionslösung
Netherlands Adenosine Hikma, 6 mg/2 ml, Oplossing voor
injectie
Portugal Adenosina Hikma
United Kingdom/Ireland Adenosine, 6 mg/2 ml, Solution for injection
Spain Adenosina Hikma, 6 mg/2 ml, Solución inyectable
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The following information is intended for healthcare professionals only:

• Dosage and Administration

Adenosina Hikma is intended for use in hospitals with monitoring and cardiorespiratory resuscitation equipment immediately available.
Dosage

Adults
Initial dose: 3 mg administered as a rapid intravenous bolus (within 2 seconds).
Second dose: if the first dose does not suppress supraventricular tachycardia within 1 or 2 minutes, a further
dose of 6 mg should be administered as a rapid intravenous bolus.
Third dose: if the second dose does not suppress supraventricular tachycardia within 1 or 2 minutes, 12 mg should be administered as a rapid
intravenous bolus.
Additional or higher doses are not recommended.

Paediatric population
Resuscitation equipment should be readily available during the administration of adenosine if necessary.

Adenosina Hikma is used with continuous monitoring and recording of the

ECG during administration.
The recommended dosage regimen for the treatment of paroxysmal supraventricular
tachycardia in the pediatric population is:

• first bolus of 0.1 mg/kg body weight (maximum dose 6 mg)
• increase of 0.1 mg/kg body weight until necessary to eliminate paroxysmal supraventricular tachycardia (maximum dose 12 mg).

Elderly
See the recommended doses for adults.
Method of administration
Adenosina Hikma must be administered by rapid intravenous bolus injection in
accordance with the dosage regimen above. To ensure that the solution
reaches systemic circulation, administer directly into a vein or into an intravenous
line. If administered into an intravenous line, the medicine must be
injected as proximally as possible and must be followed by a rapid flush with
saline solution. If administered through a peripheral vein, a
large-caliber cannula should be used.
Adenosina Hikma should only be used when facilities for cardiac monitoring are available.
Patients who develop high-grade AV block should not be
subjected to further dose increments.
Diagnostic dose
The dosage regimen with increasing doses described above should be used until
sufficient diagnostic information is obtained.

• Incompatibilities

In the absence of compatibility studies, this medicine should not be mixed with
other medicines.

• Special precautions for disposal and handling

No particular precautions.
Any unused fraction of the medicine or waste material must be
disposed of in accordance with current local regulations.