Luminity

4). 9%) or glucose 50 mg/ml (5%) solution for injection to maintain optimal contrast enhancement. 6 ml. 9%) or glucose 50 mg/ml (5%) solution for injection. 9%) or glucose 50 mg/ml (5%) solution for injection may be administered 5 minutes after the first injection to prolong contrast enhancement.

9%) or glucose 50 mg/ml (5%) solution for injection. The rate of infusion should be initiated at 4 ml/minute, but titrated as necessary to achieve optimal image enhancement, not to exceed 10 ml/minute. Paediatric population The safety and efficacy of Luminity in children and adolescents below 18 years have not been established.

No data are available. Patients with hepatic impairment Luminity has not been specifically studied in patients with hepatic impairment. Use in this patient group should be on the basis of a benefit risk assessment by the physician. Patients with renal impairment Luminity has not been specifically studied in patients with renal impairment.

Use in this patient group should be on the basis of a benefit risk assessment by the physician. Elderly patients Luminity has not been specifically studied in elderly patients. Use in this patient group should be on the basis of a benefit risk assessment by the physician.

Method of administration Intravenous use. 6.

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.

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 system disorders Not known:

Sickle cell anaemia vaso-occlusive crisis 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 6 Vascular disorders Common: Flushing Uncommon: Hypotension Rare: Syncope, hypertension, peripheral coldness Respiratory, thoracic and mediastinal disorders Uncommon: Dyspnoea, Throat Irritation Rare: Respiratory Distress, Cough, Dry Throat Not known: Respiratory arrest, decreased oxygenation, hypoxia Gastrointestinal disorders Uncommon: Abdominal Pain, diarrhoea, nausea, vomiting, Rare: Dyspepsia Not known: Tongue disorder Skin and subcutaneous tissue disorders Uncommon: Pruritus, increased sweating Rare: Rash, urticaria, erythema, erythematous rash Musculoskeletal and connective tissue disorders Uncommon: Back pain Rare: Arthralgia, flank pain, neck pain, muscle cramp Not known: Muscle spasm, musculoskeletal pain, musculoskeletal discomfort, myalgia, hypertonia General disorders and administration site conditions Uncommon: Chest Pain, fatigue, feeling hot, injection site pain Rare: Pyrexia, rigors Investigations Rare: Abnormal electrocardiogram Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.

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. 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.

4 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.

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, which might require resuscitation.

Emergency equipment and personnel trained in its use must be readily available. Pulmonary disease Caution should be exercised in patients with clinically significant pulmonary disease, including diffuse interstitial pulmonary fibrosis and severe chronic obstructive pulmonary disease, as no studies have been performed in these patients.

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