ADENOSCAN 30 mg Infusion Solution

Зміст інструкції

1. ADENOSCAN 30 mg/10 ml solution for infusion
   1. WHAT IS ADENOSCAN AND WHAT IT IS USED FOR
   2. BEFORE YOU ARE GIVEN Adenoscan
   3. HOW ADENOSCAN IS GIVEN
   4. POSSIBLE SIDE EFFECTS
   5. HOW TO STORE ADENOSCAN
   6. OTHER INFORMATION

ADENOSCAN 30 mg/10 ml solution for infusion

adenosine

Read this leaflet carefully before you are given this medicine.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or nurse.
• If any of the side effects gets worse, or if you notice any side effect not listed in this leaflet, tell your doctor or nurse.

Contents of this leaflet:

• 1. What Adenoscan is and what it is used for
• 2. Before you are given Adenoscan
• 3. How Adenoscan is given
• 4. Possible side effects
• 5. How to store Adenoscan
• 6. Further information

1. WHAT IS ADENOSCAN AND WHAT IT IS USED FOR

Adenoscan contains a medicine called adenosine. This drug belongs to a
group of medicines called “coronary vasodilators”.
This medicine is for diagnostic use only.
Adenoscan is used before performing an examination called “myocardial perfusion imaging” to observe the heart. During this examination, you will be administered a
medicine called a “radiopharmaceutical”.
Adenoscan works by opening the blood vessels of the heart and allowing blood to flow more
freely. This allows the “radiopharmaceutical” to enter the heart. The doctor can observe the
heart and assess its condition. This procedure is used if you are unable to perform physical exercise or if a stress test is not possible.

2. BEFORE YOU ARE GIVEN Adenoscan

Do not take Adenoscan and tell your doctor if:
× you are allergic (hypersensitive) to adenosine or any of the excipients of Adenoscan
(listed in section 6).
The signs of an allergic reaction include: rash, difficulty swallowing or
breathing, swelling of the lips, face, throat or tongue
× you have very low blood pressure (severe hypotension)
× you suffer from unstable angina not controlled by medical therapy
× you suffer from asthma or any other serious respiratory problem
× you are taking a medicine called dipyridamole used to make the blood more
fluid
× you suffer from a type of heart failure in which the heart does not pump blood out
sufficiently
× you suffer from heart rhythm disturbances and you have not had a pacemaker implanted (second or third degree AV block, sick sinus syndrome)
× you have been told you suffer from “long QT syndrome”. This is a rare heart problem that can lead to an increase in heart rate and fainting
Do not take this medicine if the above applies to you in any way. If you have
any doubts, ask your doctor or nurse before you are given Adenoscan.

Pay particular attention with Adenoscan
Before treatment with Adenoscan, check with your doctor or nurse if:
 you have a low circulating blood volume (hypovolemia) that has not been stabilized
adequately by medical therapy
 you suffer from disorders of a part of the central 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 currently have or have had in the past seizures or convulsions
 you have breathing difficulties (bronchospasm)
 you suffer from a heart condition due to narrowing of the heart valves (valvular heart stenosis)
 you have inflammation of the membrane surrounding the heart (pericarditis) or fluid accumulation
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 an abnormal heart rhythm. For example, the heartbeat is very fast or irregular
(atrial fibrillation or atrial flutter) and in particular you have “abnormal conduction
through accessory pathways”
 you have minor heart problems (first-degree AV block or bundle branch block). These
conditions may be temporarily aggravated by taking Adenoscan.

Use of Adenoscan with other medicines
Tell your doctor or nurse if you are taking or have recently taken any
other medicines, including over-the-counter medicines, including herbal remedies. This
is because Adenoscan can change the way other medicines work. Also, some
medicines can change the way Adenoscan works.
In particular, consult your doctor or nurse if you are taking any of the
following medicines:

• dipyridamole (medicine used to thin the blood). Make sure the doctor knows you are taking dipyridamole. The doctor may ask you to stop taking dipyridamole 24 hours before you are given Adenoscan or you may be given a much lower dose of Adenoscan
• aminophylline, theophylline or other xanthines (medicines used for breathing problems). The doctor may ask you to stop taking them 24 hours before Adenoscan is administered

Use of Adenoscan with food and drink
Foods and drinks containing xanthines such as tea, coffee, chocolate and cola-based beverages
should be avoided for at least 12 hours before the administration of Adenoscan.

Pregnancy and breastfeeding
Ask your doctor or nurse before receiving this medicine if:

• you are pregnant, may become pregnant or think you may be pregnant. The use of Adenoscan is not recommended unless it is absolutely necessary.
• you are breastfeeding. The use of Adenoscan is not recommended. Ask your doctor or nurse for advice before taking any medicine if you are pregnant or breastfeeding.

If you are under 18 years of age
The use of Adenoscan in children and adolescents has not been sufficiently studied.

Important information about some excipients of Adenoscan
Sodium:Adenoscan contains 35.4 mg of sodium per vial for injection (10 ml). You
may receive up to 0.99 mg of sodium per kg of body weight. This must be kept
in mind in patients following a low-sodium controlled diet.

3. HOW ADENOSCAN IS GIVEN

How Adenoscan is given

• Adenoscan is reserved for hospital use
• It must be administered by the doctor or nurse via injection. The injection will be given into a vein and will last for a certain period of time (this procedure is called intravenous infusion)
• your heart and blood pressure will be carefully monitored

How much Adenoscan is given
If you have doubts about why you are being given Adenoscan or if you would like more
information about the amount of Adenoscan that is being administered to you, please ask your doctor or
nurse.

Adults (including the elderly)

• the dose is calculated based on body weight
• the usual dose is 140 micrograms per kilogram of body weight, per minute. This amount is infused for a period of six minutes using an infusion pump (slow injection into a vein)
• the dose of Adenoscan is not modified in case of liver or kidney disorders

If you receive more Adenoscan than you should
It is unlikely that you will be injected with an excessive amount of this medicine as it is
administered by the doctor or nurse. The doctor will carefully check the amount of Adenoscan to be administered to you.
If you are administered a higher quantity of this medicine than
necessary, the following effects may occur:

• very low blood pressure (severe hypotension)
• slowing of the heartbeat (bradycardia)
• a heart problem (asystole) The doctor will monitor your heart throughout the entire procedure. Because the time during which adenosine remains in the blood is very short, any adverse effect related to the amount of Adenoscan received should stop quickly as soon as the infusion is stopped. Sometimes, to help you in case of adverse effects, it may be necessary to administer an injection of a medicine called aminophylline or theophylline. If you have any doubts about the use of this medicine, please ask your doctor or nurse.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Adenoscan can cause side effects, although not everybody gets them. Some of the following side effects may occur while
you are receiving Adenoscan.

If any of these side effects get worse, tell your doctor or
nurse immediately, who will decide whether you should continue the infusion or not.
Usually, side effects disappear within a few seconds or minutes of stopping
the infusion, but you must tell your doctor or nurse if any of these occur.

Very common (affects more than 1 in 10 people)

• redness of the skin accompanied by a feeling of warmth (hot flushes)
• shortness of breath or a need to breathe deeply (dyspnea)
• headache
• chest pain or a feeling of tightness in the chest
• abdominal discomfort

Common (affects less than 1 in 10 people)

• dizziness or feeling lightheaded
• abnormal skin sensation such as numbness, tingling, prickling, burning or chills on the skin (paresthesia)
• low blood pressure
• heart problem called Atrio Ventricular block
• fast or irregular heartbeat (heart rhythm disturbances)
• dry mouth
• discomfort in the throat, jaw or neck

Uncommon (affects less than 1 in 100 people)

• metallic taste in the mouth
• sweating
• discomfort in the legs, arms or back
• feeling weak, painful or unwell generally
• nervousness
• slow heartbeat (bradycardia)

Rare (affects less than 1 in 1,000 people)

• difficulty breathing (bronchospasm)
• nasal congestion
• drowsiness
• blurred vision
• ringing in the ears (tinnitus)
• feeling a sudden need to urinate
• uncomfortable sensation in the nipple
• tremors

Very rare (affects less than 1 in 10,000 people)

• severe breathing failure or breathing problems
• redness, pain or swelling at the injection site

Other side effects (frequency cannot be estimated from available
data)

• serious heart problems that can be fatal (asystole) or irregular heartbeat
• seizures (convulsions)
• fainting
• stopping of breathing (respiratory arrest)
• feeling sick (nausea) or being sick (vomiting)

If any of these side effects get worse, tell your doctor or nurse who
will decide whether to continue the infusion or not. Usually, side effects disappear in
a few seconds or minutes of stopping the infusion, but you must tell your doctor or
nurse if any of these occur.
If you notice any other side effects not listed in this leaflet, tell your doctor or
nurse immediately.

5. HOW TO STORE ADENOSCAN

This medicine will be stored by the doctor, nurse or pharmacist in a safe place
out of the reach and sight of children.
Do not use Adenoscan after the expiry date which is reported on the outer cardboard box
and on the label. The expiry date refers to the last day of the month.
Do not store in a refrigerator.
The medicine is for single use only and must be used immediately after
opening.
Any unused portion of the vial must be discarded.
Adenoscan must not be used if the doctor or nurse notice particles in the
solution or any discoloration of the medicine before administration. If
the product appears visually changed, the vial must be discarded.
Medicines should not be disposed of via drains or household waste. This
will help protect the environment.

6. OTHER INFORMATION

What Adenoscan contains

• The active ingredient is adenosine. Each 10 ml vial of Adenoscan contains 30 mg of adenosine (3 mg per ml).
• The excipients are sodium chloride and sterile water for injectable preparations.

Description of the appearance of Adenoscan and contents of the pack
Adenoscan is a clear, sterile and colourless solution for infusion.
Each pack contains 6 single-dose vials of 30mg/10ml.

Marketing Authorisation Holder
sanofi-aventis S.p.A.
Viale L. Bodio, 37/B
20158 Milano

Manufacturer
Glaxo Wellcome Production
1, rue de l’Abbaye
76960 Notre-Dame de Bondeville
France
Or
Famar Health Care Services Madrid, S.A.U.
Avenida de Leganes, 62
28925 Alcorcon (Madrid)
Spain

This medicinal product is authorised in the Member States of the European Economic Area
with the following denominations:
Austria Adenoscan Infusionslösung
France Adenoscan 30mg/10mL, solution for perfusion
Germany Adenoscan
Italy ADENOSCAN
Portugal Adenoscan
Spain Adenoscan 30mg/10ml solution for perfusion
Netherlands Adenoscan solution for intravenous infusion 30mg/10ml
United Kingdom Adenoscan 30mg/10mL, solution for infusion