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Active substance(s): ADENOSINE / ADENOSINE

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The following information is intended for medical
or healthcare professionals only

ADENOSCAN® 30 mg/10 ml

Adenoscan 30 mg/10 ml, solution for infusion
Each 10 ml vial of Adenoscan contains 30 mg of
adenosine (3 mg/ml)
Excipient: each vial contains 90 mg of sodium chloride
(9 mg/ml). For a full list of excipients, see section 6.1.
Solution for infusion.
Adenoscan is a sterile clear, colourless solution.
4.1 Therapeutic indications
Intravenous (IV) Adenoscan is a coronary vasodilator for
use in conjunction with radionuclide myocardial
perfusion imaging in patients who cannot exercise
adequately or for whom exercise is inappropriate
4.2 Posology and method of administration
Adenoscan is intended for use in hospitals with monitoring
and cardio-respiratory resuscitation equipment available
for immediate use if necessary. It should be administered
following the same procedure as for exercise testing where
facilities for cardiac monitoring and cardio-respiratory
resuscitation are available. During administration of
Adenoscan continuous electrocardiogram (ECG) control is
necessary as life-threatening arrhythmia might occur. Heart
rate and blood pressure should be monitored every minute.
1. Adenoscan should be administered undiluted as a
continuous peripheral intravenous infusion at a dose
of 140 µg/kg/min for six minutes using an infusion
pump. Separate venous sites for Adenoscan and
radionuclide administration are recommended to
avoid an adenosine bolus effect.
2. After three minutes of Adenoscan infusion, the
radionuclide is injected to ensure sufficient time for
peak coronary blood flow to occur. The optimal
vasodilator protocol is achieved with six minutes of
Adenoscan infusion.
3. To avoid an adenosine bolus effect, blood pressure
should be measured in the arm opposite to the
Adenoscan infusion.
The table below is given as a guide for adjustment of the
infusion rate of undiluted Adenoscan, in line with
bodyweight (total dose 0.84 mg/kg).
Patient Weight (kg)
45 - 49
50 - 54
55 - 59
60 - 64
65 - 69
70 - 74
75 - 79
80 - 84
85 - 89
90 - 94
95 - 99
100 - 104

Infusion Rate (ml/min)

Paediatric population:
The safety and efficacy of adenosine in children aged
0 to 18 years have not been established.
Currently available data are described in section 5.1 but
no recommendation on a posology can be made.
See dosage recommendations for adults.
4.3 Contraindications
Adenoscan is contra-indicated in patients suffering from:
• Hypersensitivity to the active substance or to any of
the excipients
• Second or third degree AtrioVentricular (AV) block,
sick sinus syndrome except in patients with a
functioning artificial pacemaker
• Long QT syndrome
• Severe hypotension
• Unstable angina not successfully stabilised with
medical therapy
• Decompensated states of heart failure
• Chronic obstructive lung disease with evidence of
bronchospasm (e.g. asthma bronchiale)
• Concomitant use of dipyridamole (see section 4.5).

4.4. Special warnings and precautions for use
Adenosine is intended for use in a hospital setting with
monitoring and cardio-respiratory resuscitation
equipment available for immediate use if necessary.
During administration, continuous ECG monitoring is necessary
as life-threatening arrhythmia might occur (see section 4.2).
Because it has the potential to cause significant hypotension,
Adenoscan should be used with caution in patients with left
main coronary stenosis, uncorrected hypovolemia, stenotic
valvular heart disease, left to right shunt, pericarditis or
pericardial effusion, autonomic dysfunction or stenotic
carotid artery disease with cerebrovascular insufficiency.
Adenoscan infusion should be discontinued in any patient
who develops persistent or symptomatic hypotension.
Adenoscan should be used with caution in patients with
recent myocardial infarction or severe heart failure.
Adenoscan should be used with caution in patients with minor
conduction defects (first degree AV block, bundle branch
block) that could be transiently aggravated during infusion.
Adenosine may trigger convulsions in patients who are
susceptible to convulsions.
Adenoscan should be used with caution in patients with
atrial fibrillation or flutter and especially in those with an
accessory by-pass tract since particularly the latter may
develop increased conduction down the anomalous pathway.
Rare cases of severe bradycardia have been reported.
Some occurred in early post-transplant patients; in the other
cases occult sino-atrial disease was present. The occurrence of
severe bradycardia should be taken as a warning of underlying
disease and should lead to treatment discontinuation. Severe
bradycardia would favour the occurrence of torsades de
pointes, especially in patients with prolonged QT intervals.
But to date, no case of torsades de pointes has been reported
when adenosine is continuously infused.
The occurrence of respiratory failure (potentially fatal),
asystole/cardiac arrest (potentially fatal), angina, severe
bradycardia or severe hypotension should also lead to
treatment discontinuation.
In patients with recent heart transplantation (less than 1
year) an increased sensitivity of the heart to adenosine
has been observed.
Adenosine may precipitate or aggravate bronchospasm
(see sections 4.3 and 4.8).
Adenoscan contains 9 mg sodium chloride per ml.
(corresponding to 3.54 mg sodium per ml)
To be taken into consideration by patients on a
controlled sodium diet.
4.5 Interaction with other medicinal products and
other forms of interaction
Dipyridamole inhibits adenosine cellular uptake and
metabolism, and potentiates the action of Adenoscan. In
one study dipyridamole was shown to produce a 4 fold
increase in adenosine actions. It is therefore suggested
that Adenoscan should not be administered to patients
receiving dipyridamole; if use of Adenoscan is essential,
dipyridamole should be stopped 24 hours before hand,
or the dose of Adenoscan should be greatly reduced.
Aminophylline, theophylline and other xanthines are
competitive adenosine antagonists and should be
avoided for 24 hours prior to use of Adenoscan.
Food and drinks containing xanthines (tea, coffee,
chocolate and cola) should be avoided for at least 12
hours prior to use of Adenoscan.
Adenosine may interact with drugs tending to impair
cardiac conduction.
4.6 Fertility, pregnancy and lactation
There are no or limited amount of data from the use of
adenosine in pregnant women. Animal studies are
insufficient with respect to reproductive toxicity.
Adenosine is not recommended during pregnancy unless
the physician considers the benefits to outweigh the
potential risks.
It is unknown whether adenosine metabolites are
excreted in human milk. Adenoscan should not be used
during breast-feeding.
4.7 Effects on ability to drive and use machines
Not relevant.
4.8 Undesirable effects
Effects related to the known pharmacology of adenosine
are frequent, but usually self-limiting and of short
duration. Discontinuation of infusion may be necessary
if the effect is intolerable.
Methylxanthines, such as IV aminophylline or
theophylline have been used to terminate persistent side
effects (50-125 mg by slow intravenous injection).
Adverse events are ranked under the heading of the
Very common (>1/10), Common (≥1/100, <1/10),
Uncommon (≥1/1000, <1/100), Rare (≥1/10000, <1/1000),
Very rare (<1/10000), Not known (cannot be estimated
from available data).


Adenoscan® 30 mg/10 ml solution
for infusion

If this leaflet is hard to see or read
Phone 01483 505515 for help
Read all of this leaflet carefully before you are given
this medicine.
• Keep this leaflet. You may need to read it again
• If you have any further questions, ask your doctor or
• If any of the side effects gets serious, or if you notice
any side effects not listed in this leaflet, please tell
your doctor or nurse.
In 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

 You have narrowing of the main arteries in the neck
(carotid artery). This means that not enough blood is
getting to the brain (cerebrovascular insufficiency)
 You have or have ever had fits or convulsions
 You have difficulty in breathing (bronchospasm)
 You have heart disease due to narrowing of your
heart valves (stenotic valvular heart disease)
 You have inflammation of the membrane
surrounding your heart (pericarditis) or a build-up of
fluid around your heart (pericardial effusion)
 You have a left-right shunt in your heart. This will
mean blood goes directly from the left side of your
heart to the right side
 You have narrowing of the left main artery supplying
blood to your heart (left main coronary stenosis)
 You have had a recent heart attack, severe heart
failure or you have had a heart transplant in the last
 You have an unusual heart rhythm. For example, your
heartbeat is very fast or uneven (atrial fibrillation or
atrial flutter) and in particular if you have an
‘accessory conduction pathway’
 You have any minor problem with your heart (first
degree AtrioVentricular block or bundle branch
block). These conditions may be temporarily
aggravated when you are given Adenoscan
If you are not sure if any of the above apply to you, talk
to your doctor or nurse before being given Adenoscan.

1. What Adenoscan is and what it is used for
Adenoscan contains a medicine called adenosine. This
belongs to a group of medicines called ‘coronary
This medicine is for diagnostic use only.
Adenoscan is used before a test called “myocardial
perfusion imaging” to look at your heart. During this test
you are given a medicine called a
Adenoscan works by opening up your heart’s blood
vessels and allowing blood to flow more freely. This
allows the “radiopharmaceutical” medicine to get into
your heart. The doctor can see your heart and assess
your heart condition. This procedure is used if you are
not capable of exercise or if an exercise stress test is not
2. Before you are given Adenoscan
Do not have this medicine and tell your
doctor if:
 You are allergic (hypersensitive) to adenosine or any
of the other ingredients of Adenoscan (listed in
section 6 below).
Signs of an allergic reaction include: a rash,
swallowing or breathing problems, swelling of your
lips, face, throat or tongue
 You have very low blood pressure (severe
 You have unstable angina which is not controlled by
treatment with medicine
 You have asthma or any other severe breathing
 You are taking a medicine called dipyridamole used
to thin the blood.
 You have a type of heart failure where your heart is
not pumping out enough blood
 You have problems with your heart rhythm and do
not have a pace maker (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
heart-beat and fainting
Do not have this medicine if any of the above apply to
you. If you are not sure, talk to your doctor or nurse
before you are given Adenoscan.
Take special care with Adenoscan
Check with your doctor or nurse before you
have Adenoscan if:
 You have low blood volume (hypovolaemia) that is
not adequately corrected by treatment with
 You have problems with a part of your nervous
system called the ‘autonomic nervous system’

Taking or using other medicines
Please tell your doctor or nurse if you are taking or have
recently taken any other medicines. This includes
medicines you buy without a prescription, including
herbal medicines. This is because Adenoscan can affect
the way some other medicines work. Also some
medicines can affect the way Adenoscan works.
In particular, check with your doctor or nurse if you are
taking any of the following:
• Dipyridamole (medicine used to thin the blood). Make
sure your doctor knows you are taking dipyridamole.
Your doctor may tell 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 to help breathing). Your doctor may
tell you to stop taking it 24 hours before you are given
Taking Adenoscan with food and drink
Food and drinks containing xanthines such as tea,
coffee, chocolate and cola should be avoided for at least
12 hours before you are given Adenoscan.
Pregnancy and breast-feeding
Talk to your doctor or nurse before having this medicine
• You are pregnant, might become pregnant, or think
that you may be pregnant. You should not be given
Adenoscan unless clearly necessary
• You are breast-feeding. You should not be given
Ask you doctor or nurse for advise before taking any
medicine if you are pregnant or breast-feeding.
If you are below 18 years of age
Adenoscan use in children and adolescents has not been
sufficiently studied.
Important information about some of the
ingredients of Adenoscan
Sodium: Adenoscan contains 35.4 mg sodium per
infusion vial (10 ml). You may receive up to 0.99 mg of
sodium per kilogram of body weight.This should be
taken into consideration by patients on a controlled
sodium diet.
3. How Adenoscan is given
How Adenoscan is given
• Adenoscan is a medicine for use in hospitals
• It will be given to you by a doctor or nurse as an
injection. The injection will be into one of your veins
and be given over a period of time (this is called an
intravenous infusion)
• Your heart and blood pressure will be closely

Cardiac Disorders:
- common: hypotension, sometimes severe (see section
4.4), ST segment depression, sustained or non-sustained
ventricular tachycardia, AV block (see section 4.4).
If sustained second or third degree AV block develops
the infusion should be discontinued. If first degree AV
block occurs, the patient should be observed carefully
as a quarter of patients will progress to a higher
degree of block.
- uncommon: bradycardia sometimes severe (see
section 4.4)
- not known: asystole /Cardiac arrest (sometimes fatal,
especially in patients with underlying ischemic heart
disease/cardiac disorders, see section 4.4): sinus
tachycardia, atrial fibrillation, ventricular fibrillation
Nervous system disorders:
- very common: headache
- common: dizziness, light-headedness, paraesthesia,
- rare: tremor, drowsiness
- not known: loss of consciousness / syncope, convulsions,
especially in predisposed patients (see section 4.4)
Eye disorders:
- rare: blurred vision
Ear and labyrinth disorders:
- rare: tinnitus
Respiratory, thoracic and mediastinal disorders:
- very common: dyspnea (or the urge to breathe deeply)
- rare: bronchospasm (see section 4.4), nasal congestion
- very rare: respiratory failure (see section 4.4)
- not known: apnea/respiratory arrest
Cases with fatal outcome of respiratory failure, of
bronchospasm, and of apnea / respiratory arrest have
been reported
Gastro-intestinal disorders:
- very common: abdominal discomfort
- common: dry mouth
- uncommon: metallic taste
- not known: nausea, vomiting
Renal and Urinary disorders:
- rare: urinary urgency
Vascular disorders:
- very common: flushing
General disorders and administration site conditions:
- very common: chest pain or pressure, feeling of
thoracic constriction/oppression
- common: throat, neck and jaw discomfort
- uncommon: sweating, discomfort in the leg, arm or
back, feeling of general discomfort, weakness/pain
- very rare: injection site reactions
Reproductive system and breast disorders:
- rare: nipple discomfort
Psychiatric disorders:
- uncommon: nervousness
4.9 Overdose
Overdosage would cause severe hypotension,
bradycardia or asystole. The half life of adenosine in
blood is very short, and side effects of Adenoscan (when
they occur) would quickly resolve when the infusion is
discontinued. Administration of IV aminophylline or
theophylline may be needed.
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: Other Cardiac Preparations
ATC Code: C01EB10
Endogenous nucleoside with peripheral
vasodilator/antiarrhythmic effect
Adenosine is a potent vasodilator in most vascular beds,
except in renal afferent arterioles and hepatic veins where
it produces vasoconstriction. Adenosine exerts its
pharmacological effects through activation of purine
receptors (cell-surface A1 and A2 adenosine receptors).
Although the exact mechanism by which adenosine
receptor activation relaxes vascular smooth muscle is not
known, there is evidence to support both inhibition of
the slow inward calcium current reducing calcium uptake,
and activation of adenylate cyclase through A2 receptors
in smooth muscle cells. Adenosine may reduce vascular
tone by modulating sympathetic neurotransmission. The
intracellular uptake of adenosine is mediated by a
specific transmembrane nucleoside transport system.
Once inside the cell, adenosine is rapidly phosphorylated
by adenosine kinase to adenosine monophosphate, or
deaminated by adenosine deaminase to inosine. These
intracellular metabolites of adenosine are not vasoactive.
Intracoronary Doppler flow catheter studies have
demonstrated that intravenous Adenoscan at 140 µg/kg/min
produces maximum coronary hyperaemia (relative to
intracoronary papaverine) in approximately 90 % of cases
within 2-3 minutes of the onset of the infusion. Coronary
blood flow velocity returns to basal levels within 1-2
minutes of discontinuing the Adenoscan infusion.

The increase in blood flow caused by Adenoscan in normal
coronary arteries is significantly more than that in stenotic
arteries. Adenoscan redirects coronary blood flow from the
endocardium to the epicardium and may reduce collateral
coronary blood flow thereby inducing regional ischaemia.
Continuous infusion of adenosine in man has been shown
to produce a mild dose-dependent fall in mean arterial
pressure and a dose-related positive chronotropic effect,
most likely caused by sympathetic stimulation. The onset
of this reflex increase in heart rate occurs later than the
negative chronotropic/dromotropic effect. This differential
effect is mostly observed after bolus injection thus explaining
the potential use of adenosine as a treatment for
supraventricular arrhythmias when administered as a bolus
or as a coronary vasodilator when administered as an infusion.
Although Adenoscan affects cardiac conduction, it has been
safely and effectively administered in the presence of other
cardioactive or vasoactive drugs such as beta adrenergic
blocking agents, calcium channel antagonists, nitrates, ACE
inhibitors, diuretics, digitalis or anti-arrhythmics.
Paediatric population
Literature review identified three studies where intravenous
adenosine infusion was used in conjunction with radionuclide
myocardial perfusion imaging at a dose of 0.14 mg/kg body
weight/min for 2-4 minutes in paediatric patients aged 1
month to 18 years. The largest study included 47 patients
aged 1 month to 18 years of age and reported 87% sensitivity
(CI 52-97%) and 95% specificity (CI 79-99%) for cardiovascular
magnetic resonance imaging under pharmacological stress
with intravenous adenosine in a dose of 0.14 mg/kg/min
for 3 minutes. No adverse events were reported in the study.
However, the currently available data is considered very
limited to support the use of adenosine for diagnostic
purposes in the paediatric population.
5.2 Pharmacokinetic properties
It is impossible to study adenosine in classical
pharmacokinetic studies. It is present in various forms in
all the cells of the body where it plays an important role
in energy production and utilisation systems. An efficient
salvage and recycling system exists in the body, primarily
in erythrocytes and blood vessel endothelial cells. The
half-life in vitro is estimated to be less than 10 seconds.
The in vivo half-life may be even shorter.
Since neither the kidney nor the liver are involved in the
degradation of exogenous adenosine, the efficacy of
Adenoscan should be unaffected by hepatic or renal
5.3 Preclinical safety data
Because adenosine is naturally present in all living cells,
studies in animals to evaluate the carcinogenic potential
of Adenoscan (adenosine) have not been performed.
No controlled reproductive studies were conducted in
animals with adenosine.
6.1 List of excipients
Sodium Chloride
Water for Injection
6.2 Incompatibilities
In the absence of compatibility studies, this medicinal
product must not be mixed with other medicinal products.
6.3 Shelf life
The shelf life of the unopened product is 3 years.
The product should be used immediately after opening
6.4 Special precautions for storage
Do not refrigerate. See Section 6.3
6.5 Nature and contents of container
Type I glass vials with chlorobutyl rubber stoppers, packs
with 6 vials
6.6 Special precautions for disposal and handling
See section 4.2.
The product is for single use only.
The product should be inspected visually for particulate
matter and colouration prior to administration. Where the
visual appearance of the product may have changed, the vial
should be discarded. Any unused product or waste material
should be disposed of in accordance with local requirements.
One Onslow Street
PL 04425/0682
26 September 2005
September 2013

How much Adenoscan is given
If you are not sure why you are being given Adenoscan
or have any questions about how much Adenoscan is
being given to you, speak to your doctor or nurse.
Adults (including the elderly)
• The dose is calculated according to your weight
• The usual dose is 140 micrograms per kilogram of
body weight, per minute. This is given over a period
of six minutes through an infusion pump (a slow
injection into a vein)
• The dose of Adenoscan is not changed if you have
liver or kidney problems
If you have more Adenoscan than you should
As this medicine is given to you by a doctor or nurse it is
unlikely that you will be given too much. Your doctor
will carefully work out how much Adenoscan you should
be given.
If you have more of this medicine than you should, the
following effects may happen:
• Very low blood pressure (severe hypotension)
• Slow heartbeat (bradycardia)
• A heart problem (asystole)
Your doctor will be monitoring your heart throughout
the procedure.
As the length of time adenosine stays in the blood is very
short, any side effects of too much Adenoscan would
quickly stop when the infusion is stopped. Sometimes you
may need an injection of a medicine called aminophylline
or theophylline to help with any side effects.
If you have any further questions on the use of
this medicine, ask your doctor or nurse.
4. Possible side effects
Like all medicines, Adenoscan can cause side effects,
although not everybody gets them. While you are being
given Adenoscan you may have some of the following
side effects:
If any of the following side effects get worse, tell
your doctor or nurse immediately and they will
decide if you should continue the infusion or not:
The side effects normally settle within seconds or
minutes after the infusion is finished but you should tell
your doctor or nurse if any of them happen.
Very common (affects more than 1 user in 10)
• Reddening of skin with a feeling of heat (flushing)
• Shortness of breath or the urge to breathe deeply
• Headache
• Chest pain or pressure on the chest
• Abdominal discomfort
Common (affects less than 1 user in 10)
• Feeling dizzy or light-headed
• Unusual skin sensations such as numbness, tingling,
prickling, burning or creeping on the skin
• Low blood pressure
• A heart problem called an AtrioVentricular block
• Fast or irregular heartbeat (disorders of cardiac
• Dry mouth
• Discomfort in throat, jaw or neck
Uncommon (affects less than 1 user in 100)
• Metallic taste in your mouth
• Sweating
• Discomfort in leg, arm or back
• Feeling of weakness or pain, or of general discomfort
• Feeling nervous
• Slow heartbeat (bradycardia)
Rare (affects less than 1 user in 1000)
• Difficulty in breathing (bronchospasm)
• Blocked nose
• Feeling drowsy
• Blurred vision
• Ringing in the ear (tinnitus)
• Feeling a sudden need to urinate
• Nipple discomfort
• Tremors
Very rare (affects less than 1 user in 10 000)
• Severe breathlessness or problems in breathing
• Redness, pain or swelling at the site of injection

Other side effects (frequency cannot be estimated
from the available data)
• Severe heart problems which can be fatal (asystole)
or uneven heartbeat
• Fits (convulsions)
• Fainting
• Stopping breathing (respiratory arrest)
• Feeling sick (nausea) or being sick (vomiting)
If any of the above side effects get worse, tell your doctor
or nurse immediately and they will decide if you should
continue the infusion or not. The side effects normally
settle within seconds or minutes after the infusion is
finished but you should tell your doctor or nurse if any
of them happen.
If you notice any side effects not listed in this leaflet,
please tell your doctor or nurse.
5. How to store Adenoscan
This medicine will be kept by your doctor or nurse or
pharmacist in a safe place where children cannot see or
reach it.
Adenoscan should not be used after the expiry date
which is stated on the carton and on the label. The
expiry date refers to the last day of that month.
Do not refrigerate.
The product is for single use only and should be used
straight away after opening. Any portion of the vial not
used at once should be disposed of.
Adenoscan should not be used if your doctor or nurse
notice any particles in the solution or any discolouration
before they give you the medicine. If the appearance of
the medicine has changed, the vial must be thrown away.
Medicines should not be disposed of via wastewater or
household waste. These measures will help to protect
the environment.
6. Further information
What Adenoscan contains
• The active substance is adenosine. Each 10 ml vial of
Adenoscan contains 30 mg of adenosine (3 mg per ml).
• The other ingredients are sodium chloride and sterile
water for injections.
What Adenoscan looks like and contents of the pack
Adenoscan is a clear, sterile, colourless solution for
Each pack contains 6 single use vials of 30 mg/10 ml.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
One Onslow Street
Tel: 01483.505515
Fax: 01483.535432
Avda. Leganés, 62, Alcorcón 28923 (Madrid) Spain
This medicinal product is authorised in the Member
States of the EEA under the following names:
Adenoscan Infusionslösung
Adenoscan 30 mg/10 mL, solution
pour perfusion
Adenoscan 30 mg /10 ml solución
para perfusión
The Netherlands
Adenoscan oplossing voor
intraveneuze infusie 30 mg/10 ml
Adenoscan 30 mg/10 mL, solution
for infusion.
This leaflet was last approved in September 2013
© Sanofi, 1995-2013

Artworks Department. Madrid. Spain
Product Description: Adenoscan 30mg / 10ml 6 vial.
SAP-/ID number:
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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.