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ADENOSINE 3MG/ML SOLUTION FOR INJECTION

Active substance(s): ADENOSINE

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Package leaflet: Information for the patient

Adenosine 3mg/ml Solution for Injection

1. What Adenosine Solution for Injection is
and what it is used for

2. What you need to know before you
are given Adenosine Solution for Injection

Do not have Adenosine Solution for Injection
• if you are allergic to adenosine or any of the
other ingredients of this medicine (listed in
section 6);
• if you have an irregular heart rhythm and do
not currently have a pacemaker fitted;
• if you have asthma or any other severe
breathing problems;
• if you have a disorder that affects the heart’s
electrical activity (Long QT syndrome);
• if you have very low blood pressure (severe
hypotension);
• if you have a type of heart failure where your
heart does not pump out enough blood;
• if you are below 18 years of age. In children
with a heart rhythm problem called
‘Wolff-Parkinson-White (WPW) syndrome’,
Adenosine Solution for Injection may cause
some unexpected severely abnormal heart
rhythm.
Tell your doctor or nurse if any of the following
apply to you:
• if you have recently had a heart attack,
heart failure, or you have had a heart
transplant within the last year;
• if you have a low blood volume level that has
not been corrected by either treatment or
medication;
• if you have a type of heart disease caused
by the narrowing of your heart valves;
• if your heart is inflamed, enlarged, or you
have fluid around your heart;
• if you have seizures or convulsions (fits);
• if you have difficulty breathing;
• if you suffer from problems with your
autonomic nervous system;
• if you suffer from a narrowing of the main

3. How you will be given
Adenosine Solution for Injection

You will usually be in hospital when you are
given Adenosine Solution for Injection. You will
be given it by a doctor or nurse, as an injection,
into your vein. Your heart and blood pressure
will be closely monitored.
Adults and the elderly
• The usual dose is 3mg (1ml) given over 2
seconds.
• If the first dose does not bring your heartbeat
back to normal within 1-2 minutes, you will be
given a second dose of 6mg (2ml).
• If the second dose does not bring your
heartbeat back to normal within 1-2 minutes,
you will be given a third dose of 12mg (4ml).
• You should not be given any more doses
after the 12mg (4ml) dose.
Infants and Children
Adenosine Solution for Injection is a medicine
for use in hospitals with resuscitation equipment
available. Your doctor will decide if this

Technical Leaflet intended for healthcare professionals only
GENERAL INFORMATION
Adenosine 3mg/ml Solution for Injection is for single use
only. Any portion of the vial, not used at once, should be
discarded.
THERAPEUTIC INDICATIONS
Adenosine 3mg/ml Solution for Injection is indicated in
adults and children aged 0 to 18 years.
Adults
Rapid conversion to a normal sinus rhythm of
paroxysmal supraventricular tachycardias, including
those associated with accessory by-pass tracts
(Wolff-Parkinson-White Syndrome).
Diagnostic Indications
Aid to diagnosis of broad or narrow complex
supraventricular tachycardias. Although Adenosine
3mg/ml Solution for Injection will not convert atrial
flutter, atrial fibrillation or ventricular tachycardia to sinus
rhythm, the slowing of AV conduction helps diagnosis of
atrial activity.
Sensitisation of intra-cavitary electrophysiological investigations.
Paediatric population
Rapid conversion to a normal sinus rhythm of
paroxysmal supraventricular tachycardia in children
aged 0 to 18 years.

• convulsions (fits)
• vomiting (being sick)
• cardiac arrest (a sudden loss of heart
function)
• asystole (a severe and fatal heart problem)
Very rare effects which may occur at the site of
injection (affecting up to 1 in 10,000 people):
• redness
• itching
• pain
• abscesses
• swelling
• swollen and painful veins
You will be observed by medical staff at all
times, whilst being given Adenosine Solution for
Injection, to monitor the effects on your heart.

4. Possible side effects

This medicine will be stored, by your doctor,
nurse or pharmacist, out of the sight and reach
of children.
This medicine should not be used after the expiry
date stated on the carton and vial label. The
expiry date refers to the last day of that month.
This medicinal product does not require any
special storage conditions.
This product is for single use only. Once your
doctor or nurse has opened the vial, it should be
used immediately. Any remaining Adenosine
Solution for Injection must be thrown away by
the doctor or nurse.

Like all medicines, this medicine can cause side
effects, although not everybody gets them.
If you experience any of the following side
effects after you have been given your
medicine, tell your doctor or nurse
immediately. If you are not in hospital, you
MUST GO straight away.
• Severe allergic reaction which may include
a red and lumpy skin rash, difficulty
breathing, swelling of face, mouth, lips or
eyelids, unexplained high temperature
(fever) and feeling faint. If the swelling
affects your throat and makes breathing and
swallowing difficult, go to hospital straight
away.
• Severe chest pain.
• An extreme lowering in heart rate.
• An extreme lowering in blood pressure.
• Respiratory failure.
Very common side effects (may affect more
than 1 in 10 people):
• slow beating of your heart
• chest pain or pressure on the chest
• flushing (sudden reddening of the skin
accompanied by the feeling of heat)
• shortness of breath or the urge to take a
deep breath
• skipped heartbeats or extra heartbeats
• a delayed, slow and irregular heartbeat
Common side effects (may affect up to 1 in 10
people):
• headache
• nausea (feeling sick)
• dizziness or feeling light headed
• apprehension (feeling nervous)
• burning sensation of the skin
Uncommon side effects (may affect up to 1 in
100 people):
• feeling pressure in your head
• blurred vision
• metallic taste in your mouth
• feeling of general discomfort, weakness or
pain
• sweating
• hyperventilation (breathing more quickly or
more deeply than normal)
• palpitations (the awareness of an increased,
irregular heartbeat)
• increased heart rate or arrhythmia
Very rare side effects (may affect up to 1 in
10,000 people):
• intracranial hypertension (increased high
blood pressure around the brain)
• fast, slow or uneven heartbeat
• difficulty breathing
Other side effects which may occur:
• fainting or loss of consciousness

Third dose: If the second dose does not result in
elimination of the supraventricular tachycardia within 1
to 2 minutes, 12mg should be given also as a rapid
intravenous bolus.
Additional or higher doses are not recommended.
Paediatric population
During administration of Adenosine 3mg/ml Solution for
Injection, cardio-respiratory resuscitation equipment
must be available for immediate use if necessary.
Adenosine 3mg/ml Solution for Injection is intended for
use with continuous monitoring and ECG recording
during administration.
The dosing recommended for the treatment of
paroxysmal supraventricular tachycardia in the
paediatric population is:
- first bolus of 0.1mg/kg body weight (maximum dose of 6mg)
- increments of 0.1mg/kg body weight as needed to
achieve termination of supraventricular tachycardia
(maximum dose of 12mg).
Elderly
See dosage recommendations for adults.
Diagnostic dose
The above ascending dosage schedule should be
employed until sufficient diagnostic information has
been obtained.

ADENOSINE 3MG/ML SOLUTION FOR INJECTION

POSOLOGY AND METHOD OF ADMINISTRATION
Adenosine 3mg/ml Solution for Injection is intended for
hospital use only with monitoring and cardiorespiratory
resuscitation equipment available for immediate use, if
necessary.
Method of administration
It should be administered by rapid IV bolus injection
according to the ascending dosage schedule below. To
be certain the solution reaches the systemic circulation,
administer either directly into a vein or into an IV line. If
given into an IV line, it should be injected as proximally
as possible and followed by a rapid saline flush.
Adenosine 3mg/ml Solution for Injection should only be
used when facilities exist for cardiac monitoring. Patients
who develop high-level AV block at a particular dose
should not be given further dosage increments.
Therapeutic dose
Adult:
Initial dose: 3mg given as a rapid intravenous bolus
(over 2 seconds).
Second dose: If the first dose does not result in
elimination of the supraventricular tachycardia within 1
to 2 minutes, 6mg should be given also as a rapid
intravenous bolus.
12mm

350 mm

Adenosine 3mg/ml Solution for Injection (called
Adenosine Solution for Injection throughout the rest
of this leaflet) belongs to a group of medicines
called antiarrhythmics.
Antiarrhythmics are used to treat an irregular
heartbeat (arrhythmias). Adenosine Solution for
Injection is used during hospital tests to help
doctors or nurses determine what type of
irregular heartbeat you have. It works by slowing
down electrical impulses in your heart, in turn,
slowing down either a fast or irregular heartbeat.
In children, Adenosine Solution for Injection is
used to bring your child’s heartbeat back to
normal if your child has a type of heart rhythm problem
called ‘paroxysmal supraventricular tachycardia’ (PSVT).
You will usually be in hospital when you receive this
medicine.

arteries in your neck (carotid arteries) that
prevents sufficient blood getting to your brain;
• if you have a known heart defect;
• if you have an unusual heart rhythm (atrial
fibrillation or flutter).
Using other medicines
Make sure your doctor or nurse knows if you are
taking, or have recently taken, any of the
medicines listed here:
• Dipyridamole (used to thin the blood); taking
dipyridamole at the same time as Adenosine
Solution for Injection will increase the effect
of adenosine on the body. Your doctor or
nurse may decide not to give you Adenosine
Solution for Injection, may tell you to stop
taking dipyridamole 24 hours before you are
given Adenosine Solution for Injection, or
they may lower the dose.
• Aminophylline and theophylline (used to
help breathing difficulties), or medicines
containing Xanthines (caffeine), which are
found in certain medicines used to treat
headaches. Your doctor may tell you to stop
taking these medicines 24 hours before you
are given Adenosine Solution for Injection.
• Medicines that affect the rate at which your
heart conducts electrical impulses such as
calcium channel blockers e.g. diltiazem and
amlodipine,
beta-adrenergic
blocking
agents e.g. propranolol and metoprolol and
centrally acting agents e.g. clonidine and
guanfacine.
Please also tell your doctor or nurse if you are
taking, or have recently taken, any other
medicines, including medicines obtained
without a prescription.
Taking Adenosine Solution for Injection with
food and drink
• Where possible, do not drink or eat products
containing caffeine, such as tea, coffee,
chocolate, or cola, for at least 12 hours before
you are given Adenosine Solution for Injection.
Pregnancy and breast-feeding
• If you are pregnant or breast-feeding, think
you may be pregnant or are planning to
have a baby, ask your doctor or nurse for
advice before they give you this medicine.
• You should not be given this medicine if you
are breast-feeding.
Important information about some of the other
ingredients in Adenosine Solution for Injection
• Your medicine contains sodium (salt). This
medicinal
product
contains
3.54mg
(0.15mmol) of sodium (salt) per 1ml of solution.
To be taken into consideration by patients on
a controlled sodium (salt) diet.

350 mm

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 or nurse.
• If you get any side effects, talk to your
doctor, or nurse. This includes any side
effects not listed in this leaflet. See section 4.
What is in this leaflet:
1. What Adenosine Solution for Injection is and
what it is used for
2. What you need to know before you are
given Adenosine Solution for Injection
3. How you will be given Adenosine Solution for Injection
4. Possible side effects
5. How to store Adenosine Solution for Injection
6. Contents of the pack and other information

medicine is needed, how much should be
given, depending on your child’s weight, and if
several injections are neeed.
• Your child will be closely monitored, including
the recording of his/her heart’s electrical
activity using an ECG (electrocardiogram)
machine.
• It will be given as an injection into your child’s
vein by a doctor or nurse.
If you are given too much Adenosine Solution
for Injection
As this medicine will be given to you by a
doctor or nurse, it is unlikely that you will be
given too much. However, if you are given too
much medicine, the following side effects may
occur:
• an extreme lowering in blood pressure;
• a lowering in heart rate;
• a heart problem.
Adenosine stays in the blood for a very short
period of time. Therefore, any side effects
would soon subside once the injection has
been stopped. You may be given a medicine
called aminophylline or theophylline to help
with any side effects experienced.
If you have any further questions on the use of
this medicine, ask 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 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 Solution for
Injection

6. Contents of
information

the

pack

and

8pt Main Body text

other

What Adenosine Solution for Injection contains
- The active substance is adenosine. Each 2ml
vial contains 6mg adenosine (3mg per ml).
- The other ingredients are sodium chloride
and water for injections.
What Adenosine Solution for Injection looks like
and contents of the pack
Adenosine Solution for Injection (Adenosine
Injection) is a clear, colourless solution in a
clear, glass vial. Each vial contains 2ml of
medicine. This product is available in cartons
containing 6 x 2ml vials.
Marketing Authorisation Holder
Focus Pharmaceuticals Limited, Capital House,
1st Floor, 85 King William Street, London EC4N 7BL,
UK.
Tel:
00 44 (0)1283 495280
Fax:
00 44 (0)1283 495290
Email:
medinfo@focuspharma.co.uk
Manufacturer
Vianex S.A., Plant A, 12km National Road
Athinon-Lamias, Metamorfosi Attiki, 14451,
Greece.
For any information about this medicinal
product, please contact the Marketing
Authorisation Holder, details provided above.
This medicinal product is authorised in the
Member States of the EEA under the following
names:
United Kingdom: Adenosine 3mg/ml Solution for
Injection
Ireland: Adenosine 3mg/ml Solution for Injection
Greece: ADENORYTHM® 3mg/ml Ενέσιμο διάλυμα
This leaflet was last revised in 06/2015
Other sources of information

CLEARLY MARK ANY AMENDMENTS
AND RESUBMIT

tel:
01283 495280

For information in large print, audio CD or
Braille please telephone
00 44 (0)1283 495 280 or email
medinfo@focuspharma.co.uk.

pharmaceuticals ltd

Method of administration:
Adults and the elderly: Rapid intravenous injection only.
Paediatrics: Adenosine 3mg/ml Solution for Injection
should be administered by rapid intravenous (IV) bolus
injection into a vein or into an IV line. If given into an IV
line, it should be injected through as proximally as
possible and followed by a rapid saline flush. If
administered through a peripheral vein, a large bore
cannula should be used.
STORAGE AND DISPOSAL OF ADENOSINE 3MG/ML
SOLUTION FOR INJECTION
This medicinal product does not require any special
storage conditions.
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.
Dispose of any remaining solution after a single use. Any
unused product or waste material should be disposed of
in accordance with local requirements.
Shelf life:
Unopened: 3 years.
Once opened, the product should be used
immediately.

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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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