Adcus 3mg/ml Solution for Infusion

Pajjiż: Irlanda

Lingwa: Ingliż

Sors: HPRA (Health Products Regulatory Authority)

Ingredjent attiv:

ADENOSINE

Disponibbli minn:

Focus Pharmaceuticals Ltd

Kodiċi ATC:

C01EB; C01EB10

INN (Isem Internazzjonali):

ADENOSINE

Dożaġġ:

3 milligram(s)/millilitre

Għamla farmaċewtika:

Solution for infusion

Tip ta 'preskrizzjoni:

Product subject to prescription which may not be renewed (A)

Żona terapewtika:

Other cardiac preparations; adenosine

L-istatus ta 'awtorizzazzjoni:

Not marketed

Data ta 'l-awtorizzazzjoni:

2013-01-11

Fuljett ta 'informazzjoni

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ADCUS
TM 3MG/ML SOLUTION FOR INFUSION Adenosine
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 Adcus is and what it is used for
2. What you need to know before you are given Adcus
3. How you will be given Adcus
4. Possible side effects
5. How to store Adcus
6. Contents of the pack and other information
1. WHAT ADCUS IS AND WHAT IT IS USED FOR
Adcus
TM
3mg/ml Solution for Infusion (called Adcus throughout the rest of this
leaflet)
belongs to a group of medicines called coronary vasodilators.
Adcus 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 ADCUS
DO NOT HAVE ADCUS
•
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 medication;
•
if you have a type of heart failure where your heart does not pump out
enough
blood;
•
if you have asthma or any other sever

Karatteristiċi tal-prodott

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Adcus 3mg/ml 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) Adcus 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.
Adcus is indicated in adults.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Adcus 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 Adcus, continuous electrocardiogram (ECG)
control is necessary, as life-
threatening arrhythmia might occur.
Heart rate and blood pressure should be monitored every minute.
Adults:
1. Adcus 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
Adcus and radionuclide administration are
recommended to avoid an adenosine bolus effect.
2. After three minutes of infusion of Adcus, 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 infusion of Adcus.
3. To avoid an adenosine bolus effect, blood pressure should be
measured in the arm opposite to the infusion of Adcus.
The table below is given as a guide for adjustment of the infusion
rate of undiluted Adcus, in line with bodyweight
(total dose 0.84 mg/kg).
Patient Weight (kg)
Infusion Rate (ml/min)
45 - 49
2