Optison

Χώρα: Ευρωπαϊκή Ένωση

Γλώσσα: Αγγλικά

Πηγή: EMA (European Medicines Agency)

Δραστική ουσία:

perflutren

Διαθέσιμο από:

GE Healthcare AS

Φαρμακολογική κατηγορία (ATC):

V08DA01

INN (Διεθνής Όνομα):

perflutren

Θεραπευτική ομάδα:

Contrast media

Θεραπευτική περιοχή:

Echocardiography

Θεραπευτικές ενδείξεις:

This medicinal product is for diagnostic use only.Optison is a transpulmonary echocardiographic contrast agent for use in patients with suspected or established cardiovascular disease to provide opacification of cardiac chambers, enhance left-ventricular-endocardial-border delineation with resulting improvement in wall-motion visualisation.Optison should only be used in patients where the study without contrast enhancement is inconclusive.

Περίληψη προϊόντος:

Revision: 19

Καθεστώς αδειοδότησης:

Authorised

Ημερομηνία της άδειας:

1998-05-17

Φύλλο οδηγιών χρήσης

16
B. PACKAGE LEAFLET
17 PACKAGE LEAFLET: INFORMATION FOR THE USER
OPTISON 0.19 MG/ML DISPERSION FOR INJECTION
Perflutren-containing microspheres
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.
-
If you get any side effects, talk to your doctor. This includes any
possible side effects not listed
in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What OPTISON is and what it is used for
2.
What you need to know before you use OPTISON
3.
How to use OPTISON
4.
Possible side effects
5.
How to store OPTISON
6.
Contents of the pack and other information
1.
WHAT OPTISON IS AND WHAT IT IS USED FOR
OPTISON is an ultrasound contrast agent that helps to obtain clearer
pictures (scan) of the heart during
an echocardiography (a procedure where an image of the heart is
obtained by using ultrasound).
OPTISON improves the visualization of the inner cardiac walls in
patients where the walls are
difficult to see.
OPTISON contains microspheres (tiny gas bubbles) that after injection
travel through the veins to the
heart and fill the left heart chambers, allowing the doctor to
visualise and asses the function of the heart.
This medicine is for diagnostic use only.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE OPTISON
DO NOT USE OPTISON
-
if you are allergic (hypersensitive) to perflutren or any of the other
ingredients of OPTISON (listed
in section 6).
-
i
f you have severe pulmonary hypertension (systolic pulmonary artery
pressure > 90 mm Hg).
WARNINGS AND PRECAUTIONS
Talk to your doctor before using OPTISON
-
if you have any known allergies
-
if you have a severe heart, lung, kidney or liver disease. The
experience of OPTISON in severely ill
patients is limited
-
if you have an artificial valve in your heart
-
if you have acute severe inflammation or sepsis
-
if you have a known blood clotting problem
Your heart activity and rhythm will be monitored wh

Αρχείο Π.Χ.Π.

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
OPTISON 0.19 mg/ml dispersion for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
OPTISON consists of perflutren-containing microspheres of heat treated
human albumin, suspended in
human albumin solution, 1%.
Concentration: Perflutren-containing microspheres, 5-8 x 10
8
/ml with a mean diameter range of
2.5 - 4.5 µm.
The approximate amount of perflutren gas in each ml of OPTISON is 0.19
mg.
Excipient with known effect
Each ml contains 0.15 mmol (3.45 mg) of sodium.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Dispersion for injection.
Clear solution with white microsphere layer on top.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
This medicinal product is for diagnostic use only.
OPTISON is a transpulmonary echocardiographic contrast agent for use
in patients with suspected or
established cardiovascular disease to provide opacification of cardiac
chambers, enhance left
ventricular endocardial border delineation with resulting improvement
in wall motion visualisation.
OPTISON should only be used in patients where the study without
contrast enhancement is
inconclusive.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
OPTISON should only be administered by physicians experienced in the
field of diagnostic ultrasound
imaging.
Before administering OPTISON, please see section 6.6 for instructions
for use/handling.
This medicinal product is intended for left ventricular opacification
after intravenous administration.
Ultrasound imaging must be performed during injection of OPTISON as
optimal contrast effect is
obtained immediately after administration.
Posology
The recommended dose is 0.5 ml - 3.0 ml per patient. A dose of 3.0 ml
is usually sufficient, but some
3
patients may need higher doses. The total dose should not exceed 8.7
ml per patient. The duration of
the useful imaging time is 2.5 - 4.5 minutes for a dose of 0.5 - 3.0
ml. OPTISON could be repeatedly
administered, however, the clinical experience