Rapiscan

Maa: Euroopan unioni

Kieli: englanti

Lähde: EMA (European Medicines Agency)

Aktiivinen ainesosa:

regadenoson

Saatavilla:

GE Healthcare AS 

ATC-koodi:

C01EB21

INN (Kansainvälinen yleisnimi):

regadenoson

Terapeuttinen ryhmä:

Cardiac therapy

Terapeuttinen alue:

Myocardial Perfusion Imaging

Käyttöaiheet:

This medicinal product is for diagnostic use only.Rapiscan is a selective coronary vasodilator for use as a pharmacological stress agent for radionuclide myocardial perfusion imaging (MPI) in adult patients unable to undergo adequate exercise stress.

Tuoteyhteenveto:

Revision: 15

Valtuutuksen tilan:

Authorised

Valtuutus päivämäärä:

2010-09-06

Pakkausseloste

24
B.
PACKAGE LEAFLET
25
PACKAGE LEAFLET: INFORMATION FOR THE USER
RAPISCAN 400 MICROGRAM SOLUTION FOR INJECTION
Regadenoson
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 pharmacist.
If you get any side effects, talk to your doctor, or pharmacist. This
includes any possible side effects
not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1.
What Rapiscan is and what it is used for
2.
What you need to know before you are given Rapiscan
3.
How Rapiscan is given
4.
Possible side effects
5.
How to store Rapiscan
6.
Contents of the pack and other information
1.
WHAT RAPISCAN IS AND WHAT IT IS USED FOR
Rapiscan contains the active substance regadenoson
_. _
This belongs to a group of medicines called
‘coronary vasodilators’
_. _
It makes the heart arteries expand and heart rate increase. This makes
more
blood flow to the muscles of the heart.
This medicine is for diagnostic use only.
Rapiscan is used in a type of heart scan in adults called
‘myocardial perfusion imaging’.
The scan uses a diagnostic agent
_ _
to create images. These images show how well blood flows to the
muscles of the heart. Usually, exercise on a treadmill is used to put
the heart under stress before a
scan. During the exercise, a small amount of the diagnostic agent is
injected into the body, often into a
vein in the hand. Images are then taken of the heart. The doctor can
then see if the heart muscles are
getting enough blood flow when it is under stress.
If you are unable to exercise enough to reach sufficient stress to the
heart, Rapiscan will be injected to
provide a stress of similar amplitude to the heart to increase the
blood flow.
Rapiscan is also used during catheterisation and imaging arteries of
the heart (invasive coronary
angiography) to expand the arteries of the heart to measure the
difference in pressure, caused by a
narrowing wit

Valmisteyhteenveto

1
ANNEX 1
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Rapiscan 400 microgram solution for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 400 micrograms regadenoson in 5ml solution (80
micrograms/ml).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection
Clear, colourless solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
This medicinal product is for diagnostic use only.
Rapiscan is a selective coronary vasodilator for use in adults as a
pharmacological stress agent for:
•
myocardial perfusion imaging (MPI) in patients unable to undergo
adequate exercise stress.
•
the measurement of fractional flow reserve (FFR) of a single coronary
artery stenosis during
invasive coronary angiography, when repeated FFR measurements are not
anticipated (see
sections 4.2 and 5.1).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Treatment with Rapiscan is restricted to use in a medical facility
where cardiac monitoring and
resuscitation equipment are available.
Posology
The recommended dose is a single injection of 400 micrograms
regadenoson (5 ml) into a peripheral
vein, with no dose adjustment necessary for body weight.
Patients should avoid consumption of any products containing
methylxanthines (e.g. caffeine) as well
as any medicinal products containing theophylline for at least 12
hours before Rapiscan administration
(see section 4.5).
When possible, dipyridamole should be withheld for at least two days
prior to Rapiscan administration
(see section 4.5).
Aminophylline may be used to attenuate severe and/or persistent
adverse reactions to regadenoson but
should not be used solely for the purpose of terminating a seizure
induced by Rapiscan (see section
4.4).
Regadenoson causes a rapid increase in heart rate (see sections 4.4
and 5.1). Patients should remain
sitting or lying down and be monitored at frequent intervals after the
injection until the ECG
parameters, heart rate and blood pressure have returned to pre-dose
levels.
3