Luminity · 4.1 Therapeutic indications · 1

HOS-094244 · has-adverse-reaction-information · PDF-Seite 5

Summary of the safety profile The reported adverse reactions following the use of Luminity in pivotal and supportive trials (total of 2,526 patients) occur within minutes after administration and usually resolve without therapeutic intervention within 15 minutes. The most frequently reported adverse reactions are: headache (2.0%), flushing (1.0%) and back pain (0.9%). Tabulated list of adverse reactions Adverse reactions were reported with the following frequencies (Very common ≥ 1/10; Common ≥ 1/100 to < 1/10; Uncommon ≥ 1/1,000 to < 1/100; Rare ≥ 1/10,000 to < 1/1,000; Very rare < 1/10,000), not known (cannot be estimated from the available data). Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness. Blood and lymphatic Not known: Sickle cell anaemia vaso-occlusive crisis system disorders Immune system disorders Not known: Allergic type reactions, anaphylaxis, anaphylactic shock and anaphylactoid type reactions, hypotension, angioedema, lip swelling, bronchospasm, rhinitis, upper airway swelling, throat tightness, facial swelling, eye swelling Nervous system disorders Common: Headache Uncommon: Dizziness, dysgeusia Rare: Paraesthesia Not known: seizures, facial hypoaesthesia, loss of consciousness Eye disorders Not known: Abnormal vision Cardiac disorders Rare: Bradycardia, Tachycardia, Palpitations Not known: Cardiac arrest, Kounis Syndrome, ventricular arrhythmias (ventricular fibrillation, ventricular tachycardia, premature ventricular contactions), asystole, atrial fibrillation, cardiac ischaemia, supraventricular tachycardia, supraventricular arrhythmia 5 Vascular disorders Common: Flushing Uncommon: Hypotension Rare: Syncope, hypertension, peripheral coldness Respiratory, thoracic and Uncommon: Dyspnoea, Throat Irritation mediastinal disorders Rare: Respiratory Distress, Cough, Dry Throat Not known: Respiratory arre

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HOS-094240 · has-contraindication-information · PDF-Seite 3

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1

HOS-094239 · has-indication-information · PDF-Seite 2

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.

HOS-094242 · has-interaction-information · PDF-Seite 4

No interaction studies have been performed and no other forms of interaction have been identified. 4

HOS-094243 · has-pregnancy-information · PDF-Seite 5

Pregnancy For perflutren, no clinical data on exposed pregnancies are available. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development (see section 5.3). Caution should be exercised when prescribing to pregnant women. Breast-feeding It is not known whether Luminity is excreted in human breast milk. Therefore, caution should be exercised when Luminity is administered to breast-feeding women. Fertility Animal studies do not indicate direct or indirect harmful effects on fertility.

HOS-094241 · has-warning-information · PDF-Seite 3

This product must only be administered intravenously. Luminity should not be used with fundamental imaging technique for stress echocardiography since efficacy and safety have not been established. Patients with unstable cardiopulmonary status During contrast-enhanced echocardiography, serious cardiopulmonary reactions, including fatalities, have occurred during or within 30 minutes of Luminity administration in patients including those with severe cardiac and pulmonary diseases (see section 4.8). Extreme caution should be used when considering the administration of Luminity to patients with unstable cardiopulmonary status, for example: unstable angina, acute myocardial infarction, severe ventricular arrhythmias, severe heart failure (NYHA IV) or respiratory failure. Luminity should only be administered to such patients after careful risk/benefit assessment. Contrast-enhanced echocardiography should only be considered in such patients if the results are likely to produce a change in individual patient management. 3 Patients with unstable cardiopulmonary status should be monitored during and for at least 30 minutes following Luminity administration. For such patients monitoring should include vital sign measurements, electrocardiography, and, if clinically appropriate, cutaneous oxygen saturation. Resuscitation equipment and trained personnel must always be readily available. Patients with adult respiratory distress syndrome, endocarditis, prosthetic heart valves, systemic inflammation, sepsis, hyperactive coagulation and/or recurrent thromboembolism Luminity should be used only after careful consideration and such use should be monitored closely during administration in patients with adult respiratory distress syndrome, endocarditis, a heart with prosthetic valves, acute states of systemic inflammation or sepsis, known states of hyperactive coagulation and/or recurrent thromboembolism. Hypersensitivity reactions Serious immediate hypersensitivity reactions (eg: anaphylaxis, anaphylactic shock and anaphylactoid reactions, hypotension and angioedema) have been reported following the administration of Luminity, including in patients with prior allergic reaction(s) to polyethylene glycol (see Section 6.1). Patients should be closely monitored and administration should be under the direction of a physician experienced in the management of hypersensitivity reactions including severe allergic reactions,

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