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ADENOCOR INJECTION 3MG/ML

Active substance(s): ADENOSINE

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Adenocor 3mg/ml solution
for injection
Adenosine

The following information is extracted from the SPC.
Technical information for the administration of
Adenocor 3mg/ml solution for injection
1. Trade Name of Medicinal Product
Adenocor 3mg/ml Solution for injection
2. Qualitative and Quantitative Composition
Each vial contains 6mg of adenosine per 2ml
(3mg/ml).
For the full list of excipients, see section 6.1
3. Pharmaceutical Form
Solution for injection
Clear, colourless solution
4.2 Posology and Method of Administration
Adenocor is intended for hospital use only with
monitoring and cardiorespiratory resuscitation
equipment available for immediate use.
Method of administration
It should be administered by rapid IV bolus injection
according to the ascending dosage schedule below.

PACKAGE LEAFLET: INFORMATION FOR THE USER

Adenocor 3mg/ml solution
for injection
Adenosine

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 after reading
this leaflet, ask your doctor
• If any of the side effects gets serious, or if you
notice any side effects not listed in this leaflet,
please tell your doctor, nurse or pharmacist
In this leaflet:
1. What Adenocor is and what it is used for
2. Before you are given Adenocor
3. How Adenocor is given
4. Possible side effects
5. How to store Adenocor
6. Further information
1. What Adenocor is and what it is
used for

i

Adenocor contains a medicine called adenosine.
This belongs to a group of medicines called
'antiarrhythmics'.
Adenocor works by slowing down electrical
impulses between the upper and lower chambers
of the heart. This slows the fast or uneven
heartbeats called 'arrhythmias'.
Adenocor is used:
• During a test. This is to help doctors find out what
type of arrhythmia (uneven heart beat) you have
• To bring your heart beat back to normal if you
have a type of arrhythmia called ‘paroxysmal
supraventricular tachycardia (SVT)’ or
‘Wolff-Parkinson-White Syndrome’
In children, Adenocor bolus is used:
• To bring your child’s heart beat back to normal
if your child have a type of heart rhythm
trouble called ‘paroxysmal supraventricular
tachycardia’ (PSVT)
2. Before you are given Adenocor
Do not have this medicine and tell your
doctor if:
 You are allergic (hypersensitive) to adenosine or
any of the other ingredients of Adenocor (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 asthma or any other severe breathing
problem
 You have very low blood pressure (severe
hypotension)
 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, nurse
or pharmacist before you are given Adenocor.
Take special care with Adenocor
Check with your doctor, nurse or pharmacist
before you have Adenocor if:
 You have a certain type of unusual heart rhythm
(atrial fibrillation or atrial flutter) and in particular
if you have an ‘accessory conduction pathway’
 You have been told that you have a heart problem
whereby the electrical impulses in parts of your
heart take longer than normal to discharge and
then recharge (prolonged QT interval)
 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’

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.
Adenocor 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.
Posology
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.
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 cardio-respiratory
resuscitation equipment must be available for
immediate use if necessary.
11502847-05

 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 year
 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
Adenocor
If you get a very slow heartbeat (severe bradycardia),
respiratory failure, a heart problem that can be fatal
(asystole), severe chest pains (angina) or very low
blood pressure (severe hypotension), then treatment
with Adenocor should be stopped.
If you are below 18 years of age
In children with a heart rhythm trouble called
‘Wolff-Parkinson-White (WPW) syndrome’,
Adenocor bolus may cause some unexpected
severely abnormal heart rhythm.
If you are not sure if any of the above apply to
you, talk to your doctor or nurse before being
given Adenocor.
Taking or using other medicines
Please tell your doctor, nurse or pharmacist 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 Adenocor can affect the
way some other medicines work. Also some
medicines can affect the way Adenocor works.
In particular, check with your doctor, nurse or
pharmacist 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 decide you
should not have Adenocor or may tell you to
stop taking dipyridamole 24 hours before you
are given Adenocor or may need to give you a
lower dose of Adenocor
• Aminophylline or theophylline (medicines used to
help breathing) Your doctor may tell you to stop
taking it 24 hours before you are given Adenocor
• Caffeine (sometimes found in headache medicines)
Taking Adenocor with food and drink
Food and drinks containing caffeine such as tea,
coffee, chocolate and cola should be avoided for
at least 12 hours before you are given Adenocor.
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 Adenocor if you are pregnant or think
you may be pregnant, unless clearly necessary
• You are breast-feeding. You should not be given
Adenocor if you are breast-feeding
Ask you doctor or nurse for advice before taking
any medicine if you are pregnant or breast-feeding.
Important information about some of the
ingredients of Adenocor
Sodium: Adenocor injection contains 3.54 mg
sodium per dose (7.08 mg/2 ml vial).
This should be taken into consideration by
patients on a controlled sodium diet.
3. How Adenocor is given
How Adenocor is given
• Adenocor is a medicine for use in hospitals
• It will be given to you by a doctor or nurse
as an injection into your vein
• Your heart and blood pressure will be
closely monitored

11502847-05

Adenosine 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 0.1 mg/kg body weight (maximum dose
of 6mg)
- increments of 0.1 mg/kg body weight as needed to
achieve termination of supraventricular tachycardia
(maximum dose of 12mg).
Method of administration
Adenosine 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.
Elderly
See dosage recommendations for adults.
Diagnostic dose
The above ascending dosage schedule should be
employed until sufficient diagnostic information has
been obtained.
Method of administration: Rapid intravenous injection
only.

6. Pharmaceutical Particulars
6.1 List of Excipients
Sodium Chloride
Water for Injections
6.2 Incompatibilities
Compatibility with other medicines is not known.
6.3 Shelf-Life
3 years.
Any portion of the vial not used at once should be
discarded.
6.4 Special Precautions for Storage
Do not refrigerate.
6.5 Nature and Contents of Container
Clear, type I glass vials with chlorobutyl rubber
closures secured with aluminium caps. Packs of 6
vials in plastic trays in cardboard cartons.
6.6 Special precautions for disposal
Any unused medicinal product or waste material
should be disposed of in accordance with local
requirements.
7. Marketing Authorisation Holder
Aventis Pharma Limited trading as Sanofi, One
Onslow Street, Guildford, Surrey, GU1 4YS, UK
8. Marketing Authorisation Number
PL 04425/0159
9. Date of First Authorisation/Renewal of Authorisation
01 September 2010
10. Date of (Partial) Revision of Text
11502847-05
04 September 2013

How much Adenocor is given
If you are not sure why you are being given
Adenocor or have any questions about how much
Adenocor is being given to you, speak to your
doctor, nurse or pharmacist.
Adults (including the elderly)
• The first dose is 3mg given over 2 seconds. This
is given by rapid injection into your vein
• If the first dose does not bring your heart beat to
normal then you will be given a second dose. The
second dose is 6 mg given as a rapid injection
• If the second dose does not bring your heart beat
to normal then you will be given a third dose:
The third dose is 12mg given as a rapid injection
• You should not have any more doses after the
12mg dose
Infants and Children
Adenocor bolus is a medicine for use in hospitals
with resuscitation equipment available
Your doctor will decide if this medicine is needed,
how much should be given depending on your
child’s weight, and if several injections are needed.
• Your child will be closely monitored, including
recording of his/her heart’s electrical activity
using an ECG (electrocardiogram) machine
• It will be given as an injection into your child
vein by a doctor or nurse
If you have more Adenocor 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 Adenocor 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
Adenocor would quickly stop when the injection 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,
nurse or pharmacist

Very rare (affects less than 1 person in 10 000)
• Severe breathlessness or problems in breathing
• Redness, pain or swelling at the site of injection
• Feeling uncomfortable during the injection
• Worsening of high blood pressure that affects
the brain (intracranial hypertension)
• Very slow, fast or uneven heartbeats
• Severe bradycardia (very slow heartbeat)
Other side effects
• Fainting
• Fits (convulsions)
• Being sick (vomiting)
• Stopping breathing (respiratory arrest)
If any of the above side effects get worse, tell your
doctor or nurse and they may stop the injection.
The side effects normally settle within seconds or
minutes after the injection is finished but you should
tell your doctor or nurse if any of them happen.
Reporting of side effects
If you get any side effects, talk to your doctor,
pharmacist or nurse. This includes any possible
side effects not listed in this leaflet.
United Kingdom
You can also report side effects directly via the
Yellow Card Scheme at: www.mhra.gov.uk/yellowcard
Malta
ADR Reporting, The Medicines Authority,
Post-Licensing Directorate, 203 Level 3, Rue
D'Argens, GŻR-1368 Gżira
Website: www.medicinesauthority.gov.mt
e-mail: postlicensing.medicinesauthority@gov.mt
By reporting side effects you can help provide
more information on the safety of this medicine.

4. Possible side effects
Like all medicines, Adenocor can cause side
effects, although not everybody gets them. While
you are being given Adenocor you may have some
of the following side effects:
If any of the following side effects get worse,
tell your doctor or nurse and they may stop
the injection:
The side effects normally settle within seconds or
minutes after the injection is finished but you
should tell your doctor or nurse if any of them
happen.
Very common (affects more than 1 person in 10)
• Reddening of skin with a feeling of heat (flushing)
• Slow heartbeat (bradycardia)
• Skipped heart beats or extra heartbeats
• A heart problem called an AV block
• Severe heart problems which can be fatal
(asystole) or uneven heartbeat
• Shortness of breath or the urge to breathe
deeply (dyspnoea)
• Chest pain or pressure on the chest
Common (affects less than 1 person in 10)
• Feeling dizzy or light-headed
• Feeling sick (nausea)
• Headache
• Unusual skin sensations such as burning
• Feeling nervous
Uncommon (affects less than 1 person in 100)
• Blurred vision
• Being aware of your heartbeat or feeling it ‘racing’
• Metallic taste in your mouth
• Breathing more quickly or more deeply than
normal (hyperventilation)
• Feeling pressure in your head, or weighed down
in your arms
• Feeling of general discomfort, weakness or pain
• Sweating

HEALTH CARE SERVICES MADRID, S.A.U.

5. How to store Adenocor
This medicine will be kept by your doctor, nurse
or pharmacist in a safe place where children
cannot see or reach it.
Adenocor 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.
Adenocor should not be refrigerated.
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.
Adenocor 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. The pharmacist will dispose of
medicines no longer required. These measures will
help to protect the environment.
6. Further information
What Adenocor contains
• The active substance is adenosine. Each 2ml vial
of Adenocor contains 6mg of adenosine (3 mg
per ml).
• The other ingredients are sodium chloride and
water for injections.
What Adenocor looks like and contents of the
pack
Adenocor is a clear, colourless solution for injection.
Each pack contains 6 vials.
Marketing Authorisation Holder and
Manufacturer
Marketing Authorisation Holder:
Sanofi, One Onslow Street, Guildford,
Surrey, GU1 4YS, UK
Tel: 01483 505515
Fax: 01483 535432
email: uk-medicalinformation@sanofi.com
Manufacturer:
FAMAR HEALTH CARE SERVICES MADRID, S.A.U.
Avda. Leganés, 62
Alcorcón 28923 (Madrid) Spain
This leaflet does not contain all the information
about your medicine. If you have any questions or
are not sure about anything, ask your doctor or
nurse.
This leaflet was last revised in 09/2013
© Sanofi, 1991-2013
11502847-05

Artworks Department. Madrid. Spain

COLOURS

Product Description: Adenocor 6mg/2ml 6 viales
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04.09.2013
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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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