ADENOSCAN adenosine 30mg/10mL injection vial

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

adenosine, Quantity: 30 mg

Available from:

Sanofi-Aventis Australia Pty Ltd

Pharmaceutical form:

Injection, solution

Composition:

Excipient Ingredients: sodium chloride; water for injections

Administration route:

Intravenous

Units in package:

6 x 10mL vial

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Intravenous ADENOSCAN is a coronary vasodilator for use in conjunction with radionuclide myocardial perfusion imaging, in patients unable to exercise adequately.

Product summary:

Visual Identification: A clear, colourless solution.; Container Type: Vial; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius

Authorization status:

Licence status A

Authorization date:

1996-07-19

Patient Information leaflet

ADENOSCAN
®
_Adenosine_
CONSUMER MEDICINE INFORMATION (CMI)
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Adenoscan.
It does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you being given this
medicine against the benefits they
expect it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
BEING GIVEN THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
WHAT ADENOSCAN IS
USED FOR
Adenoscan is used as an aid to
doctors, to understand how your
heart is working. Adenoscan is used
during radionuclide imaging of your
heart.
Adenoscan is given to you before the
radionuclide (the agent which allows
them to see your heart).
Adenoscan works by opening up
your heart's blood vessels to allow
blood to flow more freely and can
then be seen more clearly by doctors.
Adenoscan is only given in hospitals.
It is given to you as an injection.
Your doctor, however, may prescribe
Adenoscan for another purpose.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY IT HAS BEEN
PRESCRIBED FOR YOU.
This medicine is only available with
a doctor's prescription.
This medicine is not addictive.
BEFORE YOU ARE GIVEN IT
_WHEN YOU MUST NOT BE GIVEN_
_IT_
DO NOT RECEIVE ADENOSCAN IF YOU
HAVE:
•
asthma or any other lung disease
•
recently had a heart transplant
•
some other problems with your
heart or heart rhythm
•
severe low blood pressure
DO NOT RECEIVE ADENOSCAN IF YOU
ARE ALLERGIC TO IT OR ANY OF THE
INGREDIENTS LISTED AT THE END OF THIS
LEAFLET.
Some symptoms of an allergic
reaction include skin rash, itching,
shortness of breath or swelling of the
face, lips or tongue, which may cause
difficulty in swallowing or breathing.
_BEFORE YOU ARE GIVEN IT_
TELL YOUR DOCTOR IF YOU HAVE
ALLERGIES TO:
-
ANY OF THE INGREDIENTS LISTED AT
THE END OF THIS LEAFLET
-
ANY OTHER MEDICINES INCLUDING
•
theophylline or aminophylline
•
dipyridamole
•
carbamazepine
-
ANY OTHER SUBSTANCES, SUCH AS

Summary of Product characteristics

adenoscan-ccdsv8-piv5-16jul20
Page 1 of 13
AUSTRALIAN PRODUCT INFORMATION – ADENOSCAN
®
(ADENOSINE)
1
NAME OF THE MEDICINE
Adenosine
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 30 mg of adenosine in 10 mL of a 0.9% w/v solution
of sodium chloride in
sterile water for injections.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Adenoscan is a clear colourless sterile solution for intravenous
infusion.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Intravenous Adenoscan is a coronary vasodilator for use in conjunction
with radionuclide
myocardial perfusion imaging, in patients unable to exercise
adequately.
4.2
DOSE AND METHOD OF ADMINISTRATION
Adenoscan is intended for use in hospitals, where facilities for
cardiac monitoring and
resuscitation are available.
DIAGNOSTIC DOSE
Adults
1.
Adenoscan should be administered undiluted as a continuous peripheral
intravenous
infusion at a dose of 140 µg/kg/min over fixed time interval of six
minutes (total dose
0.84 mg/kg) 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.
3.
Heart rate and blood pressure should be recorded at 1 minute
intervals, and ECG should
be monitored continuously during Adenoscan infusion. To avoid an
adenosine bolus
effect, blood pressure should be measured in the arm opposite to the
Adenoscan
infusion.
adenoscan-ccdsv8-piv5-16jul20
Page 2 of 13
The table below is given as a guide for adjustment of the infusion
rate of undiluted
Adenoscan, in line with body weight (total dose 0.84 mg/kg).
Patient Weight
Infusion Rate
_(kg) _
_(mL/min) _
45-49
2.1
50-54
2.3
55-59
2.6
60-64
2.8
65-69
3.0
70-74
3.3
75-79
3.5
80-84
3.8
85-89
4.0
90-94
4.2
95-99
4.4
100-104
4.7
Children
In the absence of data, the use of Adenoscan in children cannot be
recommended.
Elderly
See dosage recommendations for adults.
4.3
CONTRAINDICATIONS
Adenos