Luminity

Maa: Euroopan unioni

Kieli: englanti

Lähde: EMA (European Medicines Agency)

Aktiivinen ainesosa:

perflutren

Saatavilla:

Lantheus EU Limited

ATC-koodi:

V08DA04

INN (Kansainvälinen yleisnimi):

perflutren

Terapeuttinen ryhmä:

Contrast media

Terapeuttinen alue:

Echocardiography

Käyttöaiheet:

This medicinal product is for diagnostic use only.Luminity is an ultrasound contrast-enhancing agent for use in patients in whom non-contrast echocardiography was suboptimal (suboptimal is considered to indicate that at least two of six segments in the 4- or 2-chamber view of the ventricular border were not evaluable) and who have suspected or established coronary artery disease, to provide opacification of cardiac chambers and improvement of left ventricular endocardial border delineation at both rest and stress.

Tuoteyhteenveto:

Revision: 17

Valtuutuksen tilan:

Authorised

Valtuutus päivämäärä:

2006-09-20

Pakkausseloste

18
B. PACKAGE LEAFLET
19
PACKAGE LEAFLET: INFORMATION FOR THE USER
LUMINITY 150 MICROLITRES/ML GAS AND SOLVENT FOR DISPERSION FOR
INJECTION/INFUSION
perflutren
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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, pharmacist or
nurse.
-
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Luminity is and what it is used for
2.
What you need to know before you use Luminity
3.
How to use Luminity
4.
Possible side effects
5.
How to store Luminity
6.
Further information
1.
WHAT LUMINITY IS AND WHAT IT IS USED FOR
Luminity is an ultrasound contrast agent that contains microspheres
(tiny bubbles) of perflutren gas as
the active substance.
Luminity is for diagnostic use only. It is a contrast agent (a
medicine that helps to make internal body
structures visible during imaging tests).
Luminity is used in adults to obtain a clearer scan of the chambers of
the heart, especially of the left
ventricle, during echocardiography (a diagnostic test where an image
of the heart is obtained using
ultrasound). Luminity is used in patients with suspected or confirmed
coronary artery disease
(obstruction of the blood vessels supplying the heart muscle), when
the image obtained with non-
contrast echocardiography is not optimal.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE LUMINITY
_ _
DO NOT USE LUMINITY
-
if you are allergic to perflutren or any of the other ingredients of
Luminity.
(listed in section 6).
If you have had an allergic reaction in the past with Luminity or any
other ultrasound contrast agent
tell your doctor.
WARNINGS AND PRECAUTIONS
Talk to your doctor before using Luminity
- if you have been told you have a heart shunt
- if you have severe heart or lung diseases or if you need mechanical
help to breathe
- if you have an

Valmisteyhteenveto

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Luminity 150 microlitres/ml gas and solvent for dispersion for
injection/infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains a maximum of 6.4 x 10
9
perflutren-containing lipid microspheres, with a mean
diameter range of 1.1-2.5 micrometres (μm). The approximate amount of
perflutren gas in each ml is
150 microlitres (μl).
Excipient(s) with known effect
Each ml contains 2.679 mg sodium
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Gas and solvent for dispersion for injection/infusion
Colourless, uniformly clear to translucent liquid.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
This medicinal product is for diagnostic use only.
Luminity is an ultrasound contrast-enhancing agent for use in adult
patients in whom non-contrast
echocardiography was suboptimal (suboptimal is considered to indicate
that at least two of six
segments in the 4- or 2-chamber view of the ventricular border were
not evaluable) and who have
suspected or established coronary artery disease, to provide
opacification of cardiac chambers and
improvement of left ventricular endocardial border delineation at both
rest and stress.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Luminity should only be administered by trained physicians with
technical expertise in performing
and interpreting contrast echocardiograms, and appropriate
resuscitation equipment should be
available in case of cardiopulmonary or hypersensitivity reactions
(see section 4.4).
Posology
_ _
_Bolus intravenous injection using non-linear contrast imaging
technique at rest and stress: _
_ _
The recommended dose is multiple injections of 0.1 to 0.4 ml of
dispersion, followed by a 3 to 5 ml
bolus of sodium chloride 9 mg/ml (0.9%) or glucose 50 mg/ml (5%)
solution for injection to maintain
optimal contrast enhancement. The total dose of perflutren should not
exceed 1.6 ml.
_Bolus intravenous injection using fundamental imaging technique at
rest: _
_ _
The rec