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LUMINITY
®
a77 PRESCRIBING INFORMATION
See Summary of Product Characteristics before prescribing. PRESENTATION: Solution
for dispersion for injection or infusion(150 microlitres/ml perflutren). Each ml contains
a maximum of 6.4 x 10
9
perflutren-containing lipid microspheres, with a mean
Table 3: Accuracy of Dobutamine Stress Echocardiography for
diameter range of 1.1-2.5 micrometres (µm).
Detection of Coronary Artery Disease
INDICATIONS: For diagnostic use in patients in whom non-contrast echocardiography
was suboptimal and who have suspected or established coronary artery disease, to
provide opacification of cardiac chambers and improvement of left ventricular
Study Year n Sensitivity % Specificity % Accuracy %
endocardial border delineation at both rest and stress. Cohen et al.
33
1991 70 86 86 85
DOSAGE: Before use, the product must be activated using a mechanical shaking device
Sawada et al.
34
1991 96 85 88 78
the VIALMIX
®
. For intravenous use only.
Marcovitz et al.
35
1992 141 96 66 89
Bolus intravenous injection using non-linear contrast imaging technique at rest and stress McNeill et al.
36
1992 80 70 88 78
- multiple injections of 0.1 to 0.4 ml (total dose not > 1.6 ml); then 3 to 5 ml bolus of
sodium chloride 9 mg/ml (0.9%) or glucose 50 mg/ml (5%) solution for injection.
Takeuchi et al.
37
1993 120 85 93 72
Previtali et al.
38
1993 80 79 83 80
Bolus intravenous injection using fundamental imaging technique at rest - 10 microlitre/kg
by slow bolus intravenous injection; then 10 ml bolus of sodium chloride 9 mg/ml (0.9%)
Elhendy et al.
39
1996 132 78 86 80
or glucose 50 mg/ml (5%) solution for injection. Intravenous infusion using non-linear Ling et al.
40
1996 183 95 51 64
contrast imaging technique (rest and stress) or fundamental imaging technique at rest -
intravenous infusion of 1.3 ml added to 50 ml sodium chloride 9 mg/ml (0.9%) or glucose
Wu et al.
41
1996 104 81 94 86
50 mg/ml (5%) solution for injection; rate of infusion not > 10 ml/minute.
Bigi et al.
42
1997 121 80 93 82
Other methods of administration not recommended. Safety and efficacy have not been
Hennessy et al.
43
1997 219 82 65 78
established for fundamental imaging technique for stress echocardiography and in Smart et al.
44
1997 206 82 80 82
children < 18 years. For further information, see SPC.
Elhendy et al.
45
1997 306 74 85 76
CONTRAINDICATIONS: Hypersensitivity to perflutren or to any of the excipients.
Hennessy et al.
46
1997 199 90 50 85
WARNINGS AND PRECAUTIONS: Serious immediate hypersensitivity reactions have
n = number of patients.
been reported, monitor patients closely following administration, emergency
equipment & staff must be readily available. Caution when used in patients with right-
to-left, bi-directional or transient right-to-left cardiac shunts, on mechanical
Table 4: Accuracy of Dobutamine versus Dipyridamole Stress
ventilation or with clinically significant pulmonary disease, as safety has not been Echocardiography for Detection of Coronary Artery Disease
established. Use only after careful consideration and monitor closely during
administration in patients with certain severe states of cardiac and pulmonary disease.
For further information, see SPC.
Sensitivity % Specificity % Accuracy %
DRUG INTERACTIONS: None known.
Dipy Dobu Dipy Dobu Dipy Dobu
SIDE EFFECTS: Common: Headache and flushing. Others: Allergic-type reactions. For
Salustri et al.
47
64 57 89 78 74 65
further information, see SPC.
Previtali et al.
38
60 79 96 83 70 80
LEGAL CATEGORY: POM.
Beleslin et al.
30
74 82 94 76 76 82
AUTHORISATION NUMBERS/BASIC NHS PRICE: LUMINITY
®
150 microlitres/ml solution
Dagianti et al.
48
52 72 97 97 78 87
for dispersion for injection or infusion; EU/1/06/361/001; £244.00 for 4 x 1.5 ml vials. Pingitore et al.
49
82 84 84 89 84 84
MARKETING AUTHORISATION HOLDER: Bristol-Myers Squibb Pharma Belgium Sprl,
Minardi et al.
50
73 75 67 67 72 74
Chaussée de la Hulpe, 185/Terhulpsesteenweg 185, B-1170 Bruxelles/Brussel, Belgium. Santoro et al.
51
55 60 96 96 73 77
FURTHER INFORMATION FROM: Bristol-Myers Squibb Medical Imaging, Uxbridge Loimaala et al.
52
93 95 75 63 63 87
Business Park, Sanderson Road, Uxbridge, Middlesex UB8 1DH. Freephone 0800 731
1736 Medical Information.
Dipy = dipyridamole; Dobu = dobutamine.
DATE OF P.I. PREPARATION: January 2008.
limitations such as a relatively subjective interpretation and the dependence
on image quality. Recognition of ischaemia may be challenging in the
Information about adverse event
reporting can also be found at
setting of extensive resting wall motion abnormalities. Technical
www.yellowcard.gov.uk
developments in echocardiography such as contrast echocardiography,
In the UK, adverse events should be reported to
myocardial Doppler imaging and 3D echocardiography may play an
Bristol-Myers Squibb Pharmaceuticals Ltd
important complementary role. These new, promising techniques may
Medical Information
on 0800 731 1736.
provide additional sensitivity and quantitation. Contrast echocardiography
improves myocardial border detection and is useful for the assessment of
myocardial perfusion. Opacification of LV cavity by injection of commercially
LUMINITY
®
and VIALMIX
®
are registered trademarks of Bristol-Myers Squibb Medical Imaging, Inc. available contrast agents improves visualisation of the endocardium, leading
© 2008 Bristol-Myers Squibb Medical Imaging, Inc. All rights reserved.
to a more complete assessment of wall motion. This offers the potential to
increase the sensitivity and specificity of the stress test. Recent studies have
References: confirmed the feasibility, accuracy and prognostic value of contrast stress
1. LUMINITY
®
SPC. January 2007.
2. Bristol-Myers Squibb. Data on file. MAA Submission: Common Technical Document
echocardiography. Tsutsui et al. demonstrated the incremental value of
Summaries. Section 2.7.3 p68. 2004.
perfusion information obtained by realtime contrast echocardiography
3. Weiss RJ et al. Bristol-Myers Squibb. Data on file. 2005.
during dobutamine stress to wall motion assessment, as well as the
Code: LUM/0408/0221 prognostic value of perfusion detects in predicting cardiac events.
20
Date of preparation: April 2008
However, the clinical implications of contrast stress echocardiography are
limited due to the lack of a standardised technique.
Strain and strain rate imaging are novel parameters derived from tissue
Doppler imaging and offer a more quantitative approach to regional LV
function. Recent studies have documented the value of strain rate analysis
during dobutamine infusion for the assessment of myocardial viability.
21,22
Strain rate analysis provides an incremental value to wall motion assessment
and increases sensitivity for the detection of viable segments. The limitations
of strain and strain rate imaging in stress echocardiography are the lack of
EUROPEAN CARDIOLOGY
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