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ADENOSINE 30 MG/10 ML SOLUTION FOR INFUSION

Active substance(s): ADENOSINE

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Package leaflet: Information for the user
Adenosine 30mg / 10ml solution for infusion
The name of your medicine is Adenosine 30 mg/10 ml solution for
infusion, which will be referred to as Adenosine throughout this
leaflet.
Read all of this leaflet carefully before you are given this
medicine because it contains important information for you.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor.
• If you get any side effects, talk to your doctor, nurse or
pharmacist. This includes any possible side effects not listed in
this leaflet. See section 4.
What is in this leaflet
1. What Adenosine is and what it is used for
2. Before you are given Adenosine
3. How Adenosine is given
4. Possible side effects
5. How to store Adenosine
6. Contents of the pack and other information
1. What Adenosine is and what it is used for
Adenosine contains a medicine called adenosine. This belongs to
a group of medicines called ‘coronary vasodilatators’.
This medicine is for diagnostic use only.
Adenosine is used before a test called “myocardial perfusion
imaging” to look at your heart. During this test you are given a
medicine called a “radiopharmaceutical”.
Adenosine 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 possible.
2. Before you are given Adenosine
Do not have this medicine and tell your doctor if:
• You are allergic (hypersensitive) to adenosine or any of the
other ingredients of Adenosine (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 hypotension).
• You have unstable angina which is not controlled by treatment
with medicine.
• You have asthma or any other severe breathing problem.
• 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 Adenosine.

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 Adenosine.
If you are not sure if any of the above apply to you, talk to your
doctor or nurse before being given Adenosine.
Other medicines and Adenosine
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 Adenosine can affect the way some other medicines
work. Also some medicines can affect the way Adenosine 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
Adenosine or you may be given a much lower dose of
Adenosine.
• 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 Adenosine.
Adenosine 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 Adenosine.
Pregnancy and breast-feeding
Talk to your doctor or nurse before having this medicine if:
• You are pregnant, might become pregnant, or think that you
may be pregnant. You should not be given Adenosine unless
clearly necessary
• You are breast-feeding. You should not be given Adenosine.
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
The use of Adenosine solution for infusion in children and
adolescents has not been sufficiently studied.
Driving and using machines
Not relevant. There are no known effects on driving and using
machines.
Adenosine contains sodium
Adenosine contains 35.42 mg sodium per infusion vial (10 ml).
This should be taken into consideration by patients on a controlled
sodium diet.
3. How Adenosine is given
How Adenosine is given
• Adenosine 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 monitored.

Warnings and precautions
Talk to your doctor or nurse before you have Adenosine if:
• You have low blood volume (hypovolaemia) that is not
adequately corrected by treatment with medicines.
• You have problems with a part of your nervous system called
the ‘autonomic nervous system’.
• You have narrowing of the main arteries in the neck (carotid
artery). This means that not enough blood is getting to the
brain (cerebrovascular insu ciency).
• 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 e usion).
• 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 year.
• 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’.

How much Adenosine is given
If you are not sure why you are being given Adenosine or have any
questions about how much Adenosine is being given to you,
speak to your doctor or nurse.

The following information is intended for healthcare professionals
only:

The table below is given as a guide for adjustment of the
infusion rate of undiluted Adenosine 30 mg/10 ml solution for
infusion, in line with bodyweight (total dose 0.84 mg/kg).

Posology and Method of Administration
Adenosine 30 mg/10 ml solution for infusion 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 cardiorespiratory resuscitation are available. During administration of
Adenosine 30 mg/10 ml solution for infusion continuous ECG
control is necessary as life- threatening arrhythmia might occur.
Heart rate and blood pressure should be monitored every minute.
Posology
Adults:
1. Adenosine 30 mg/10 ml solution for infusion 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 Adenosine
30 mg/10 ml solution for infusion and radionuclide
administration are recommended to avoid an adenosine bolus
effect.
2. After three minutes of Adenosine 30 mg/10 ml solution for
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 Adenosine 30 mg/10
ml solution for infusion.
3. To avoid an adenosine bolus effect, blood pressure should be
measured in the arm opposite to the Adenosine 30 mg/10 ml
solution for infusion.

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 Adenosine is not changed if you have liver or
kidney problems.
If you have more Adenosine 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 Adenosine 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 Adenosine would quickly stop when
the infusion is stopped. Sometimes you may need an injection of a

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)
2.1
2.3
2.6
2.8
3.0
3.3
3.5
3.8
4.0
4.2
4.4
4.7

Paediatric population:
The safety and efficacy of adenosine in children aged 0-18 years
old have not been established. Currently available data are
described in section 5.1 but no recommendation on a posology
can be made.
Elderly:
See dosage recommendations for adults.
Incompatibilities
Compatibility with other medicines is not known.
In the absence of compatibility studies, this medicinal product
must not be mixed with other medicinal products.

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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.

be disposed of.

4. Possible side effects
Like all medicines, Adenosine can cause side e ects, although

Do not throw away any medicines via wastewater or household
waste. Ask your pharmacist how to throw away medicines you no
longer use. These measures will help protect the environment.

not everybody gets them. While you are being given Adenosine
you may have some of the following side e ects:
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 (dyspnoea).
• 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 (paraesthesia).
• Low blood pressure.
• A heart problem called an AtrioVentricular block.
• Fast or irregular heartbeat (disorders of cardiac rhythm).
• 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).

Do not use this medicine if the solution contains particles or is
discolored.

6. Contents of the pack and other information
What Adenosine contains
• The active substance is adenosine.
Each ml of solution for infusion contains 3 mg adenosine.
Each 10 ml vial of contains 30 mg of adenosine.
• The other ingredients are sodium chloride and sterile water for
injections.
What Adenosine looks like and contents of the pack
Adenosine is a clear and colourless to almost colourless solution,
free from visible particle.
Each pack contains 5, 6, 10 and 25 vials.
Not all packs may be marketed.
Marketing Authorisation Holder
Claris Lifesciences UK Limited
Crewe Hall, Crewe, Cheshire CW 16UL,
United Kingdom.
Manufacturer
Peckforton Pharmaceuticals limited
Crewe Hall, Crewe, Cheshire CW 16UL,
United Kingdom.
This leaflet was last revised in month 10/2014

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.

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.

1400004269

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 you notice any side effects not listed in this leaflet, please tell
your doctor or nurse.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side effects not listed in this leaflet. You can
also report any side effects directly via the Yellow Card Scheme at
: www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide more information on
the safety of this medicine.
5. How to store Adenosine
Keep this medicine out of the sight and reach of children
Adenosine 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 store above 25 °C. 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

Shelf-Life
Unopened: 24 Months
Any portion of the vial not used at once should be discarded.
Special Precautions for Storage
Keep this medicine out of the sight and reach of children.
Do not store above 25 °C. Do not refrigerate.
Nature and Contents of Container
Sulfur treated clear tubular Glass vial, Ph. Eur. Type-I with Teflon
coated rubber closure and 10 ml fill volume.
Packs of 5, 6, 10 and 25 vials.
Not all pack sizes may be marketed.
Special precautions for disposal
Any unused medicinal product or waste material should be
disposed of in accordance with local requirement.

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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.

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