Source: European Medicines Agency (EU) Revision Year: 2019 Publisher: GE Healthcare AS, Nycoveien 1, NO-0485, Oslo, Norway
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Pulmonary hypertension with a systolic pulmonary artery pressure >90 mm Hg.
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. Other routes of administration not specified in section 4.2 above (e.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.
OPTISON contrast echocardiography should be accompanied by ECG monitoring.
In animal studies, the application of echo-contrast agents revealed biological side effects (e.g. endothelial cell injury, capillary rupture) by interaction with the ultrasound beam. Although these biological side effects have not been reported in humans, the use of a low mechanical index and end- diastolic triggering is recommended.
Efficacy and safety in patients below 18 years has not been studied.
No interaction studies have been performed.
Use during anaesthesia with halothane and oxygen has not been studied.
The safety of OPTISON for use during human pregnancy has not been established. In pregnant rabbits exposed to daily doses of 2.5 ml/kg (approximately 15 x the maximum recommended clinical dose) during organogenesis, maternal toxicity and embryo-foetal toxicity including a slight to extreme dilation of ventricles in the brain of developing rabbit embryos was observed. The clinical relevance of this finding is unknown. Therefore, OPTISON should not be used in pregnancy unless benefit outweighs risk and it is considered necessary by the physician.
It is not known whether OPTISON is excreted in human milk. Therefore, caution should be exercised when OPTISON is administered to breast-feeding women.
No studies on the effects on the ability to drive and use machines have been performed.
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.
Uncommon: Eosinophilia
Common: Dysgeusia (altered taste), headache
Rare: Tinnitus, dizziness, paraesthesia
Not known*: Visual disturbances
Rare: Ventricular tachycardia
Uncommon: Dyspnoea
Common: Flushing
Common: Nausea
Common: Warm sensation
Uncommon: Chest pain
Not known*: Allergic type symptoms (e.g. anaphylactoid reaction or -shock, face oedema, urticaria)
* Reactions for which no frequency rate can be provided due to lack of clinical trial data have been classified as “Not known”.
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.
OPTISON must not be mixed with other medicinal products. A separate syringe should be used.
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