Optison

OPTISON should only be administered by physicians experienced in the field of diagnostic ultrasound imaging. 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. 0 ml per patient. 0 ml is usually sufficient, but some 3 patients may need higher doses. 7 ml per patient.

0 ml. OPTISON could be repeatedly administered, however, the clinical experience is limited. Paediatric population The safety and efficacy of OPTISON in children and adolescents below 18 years has not been established. 1 but no recommendation on a posology can be made.

Adverse reactions to OPTISON are rare and usually of a non-serious nature. In general, the administration of human albumin has been associated with transient altered taste, nausea, flushing, rash, headache, vomiting, chills and fever.

Anaphylactic reactions have been associated with the administration of human albumin products. The reported adverse events following the use of OPTISON in Phase III human clinical studies have been mild to moderate with subsequent full recovery.

In clinical trials with OPTISON, undesirable effects were reported as adverse events with the following frequencies given in the table below: 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, undesirable effects are presented in order of decreasing seriousness. g. anaphylactoid reaction or -shock, face oedema, urticaria) Not known* * Reactions for which no frequency rate can be provided due to lack of clinical trial data have been classified as “Not known” Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.

It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.

Hypersensitivity has been reported. Care should therefore be exercised. A course of action should be planned in advance with necessary drugs and equipment available for immediate treatment, in case a serious reaction should occur. The experience of OPTISON in severely ill patients is limited.

There is limited clinical experience with OPTISON in patients with certain severe states of cardiac, pulmonary, renal and hepatic disease. Such clinical states include adult respiratory distress syndrome, the use of artificial respiration with positive end-expiratory pressure, severe heart failure (NYHA IV), endocarditis, acute myocardial infarction with on-going angina or unstable angina, hearts with prosthetic valves, acute states of systemic inflammation or sepsis, known states of hyperactive coagulation system and/or recurrent thromboembolism, renal or hepatic end-stage disease.

OPTISON should be used in these categories of patients only after careful consideration and monitored closely during and after administration. g. intracoronary injection) are not recommended. Standard measures to prevent infections resulting from the use of medicinal products prepared from human blood or plasma include selection of donors, screening of individual donations and plasma pools for specific markers of infection and the inclusion of effective manufacturing steps for the inactivation/removal of viruses.

Despite this, when medicinal products prepared from human blood or plasma are administered, the possibility of transmitting infective agents cannot be totally excluded. This also applies to unknown or emerging viruses and other pathogens.

There are no reports of virus transmissions with albumin manufactured to European Pharmacopoeia specifications by established processes. It is strongly recommended that every time that OPTISON is administered to a patient, the name and batch number of the product are recorded in order to maintain a link between the patient and the batch of the product.

1. Pulmonary hypertension with a systolic pulmonary artery pressure > 90 mm Hg.