Adenosine 30mg/10ml solution for infusion vials

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Adenosine

Available from:

Advanz Pharma

ATC code:

C01EB10

INN (International Name):

Adenosine

Dosage:

3mg/1ml

Pharmaceutical form:

Solution for infusion

Administration route:

Intravenous

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 02030200; GTIN: 5060064792025

Patient Information 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 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 Infusion is and
what it is used for
2. What you need to know before you are given
Adenosine Solution for Infusion
3. How you will be given Adenosine Solution for
Infusion
4. Possible side effects
5. How to store Adenosine Solution for Infusion
6. Contents of the pack and other information
1.WHAT ADENOSINE SOLUTION FOR INFUSION IS
AND WHAT IT IS USED FOR
Adenosine
30mg/10ml
Solution
for
Infusion
(called
Adenosine
Solution
for
Infusion
throughout the rest of this leaflet) belongs to a
group of medicines called coronary vasodilators.
Adenosine Solution for Infusion is given with other
medicines,
called
radionuclides,
during
a
diagnostic
test,
called
myocardial
perfusion
imaging, to open up your heart’s blood vessels
to allow your blood to flow more freely. Once in
your blood, the radionuclide allows the doctor
or nurse to see your heart and assess your heart condition.
This medicine is for diagnostic use only and is
used if you are incapable of exercise. You will
usually be in hospital when you receive this medicine.
2.WHAT YOU NEED TO KNOW BEFORE YOU ARE
GIVEN ADENOSINE SOLUTION FOR INFUSION
DO NOT HAVE ADENOSINE SOLUTION FOR INFUSION
• 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 a disorder that affects the heart’s
electrical activity (Long QT syndrome);
• if you have very low blood pressure (severe
hypotension);
• if you have unstable angina (severe chest
pain) that is not currently controlled by either
treatment or m

Summary of Product characteristics

OBJECT 1
ADENOSINE 30MG/10ML SOLUTION FOR INFUSION
Summary of Product Characteristics Updated 26-Sep-2014 | Concordia
International- formerly Focus
Pharmaceuticals Ltd
1. Name of the medicinal product
Adenosine 30mg/10ml Solution for Infusion
2. Qualitative and quantitative composition
Each 1ml of solution contains 3mg of adenosine.
Each vial contains 30mg of adenosine per 10ml of solution (3mg/ml).
It also contains 3.54mg (0.15mmol) of sodium per 1ml of solution.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Solution for infusion (infusion).
Clear, colourless solution.
4. Clinical particulars
4.1 Therapeutic indications
Intravenous (IV) Adenosine 30mg/10ml Solution for Infusion 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.
Adenosine 30mg/10ml Solution for Infusion is indicated in adults.
4.2 Posology and method of administration
Adenosine 30mg/10ml Solution for Infusion is intended for use in
hospitals. It should be administered
following the same procedure as for exercise testing, where facilities
for cardiac monitoring and cardio-
respiratory resuscitation are available for immediate use, if
necessary. During administration of
Adenosine 30mg/10ml Solution for Infusion, continuous
electrocardiogram (ECG) control is necessary,
as life-threatening arrhythmia might occur. Heart rate and blood
pressure should be monitored every
minute.
Adults:
1. Adenosine 30mg/10ml 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 30mg/10ml Solution for Infusion
and radionuclide administration are
recommended to avoid an adenosine bolus effect.
2. After three minutes of infusion of Adenosine 30mg/10ml Solution for
Infusion, the radionuclide is
injected to ensure sufficient time for peak coronary blood flow to
occur.