FLUORESCEIN

Posology Adults, including elderly:

Inject 5 ml of Fluorescein 100 mg/ml Solution for injection rapidly into the antecubital vein after taking precautions to avoid extravasation. , scanning laser ophthalmoscope are used, the dose of this product should be reduced to 2 ml of Fluorescein 100 mg/ml solution for injection.

Paediatric population:

Fluorescein 100 mg/ml Solution for injection has not been studied in children and dose-adaptation data are not available. Therefore, Fluorescein 100 mg/ml Solution for injection should not be used in patients below 18 years as efficacy and safety in this group have not been established.

2). 5 ml (half a vial). Method of administration and fluorescence angiography Fluorescein 100 mg/ml solution for injection should be used exclusively by qualified physicians with technical expertise in performing and interpreting fluorescence angiography.

This product should only be administered intravenously. 9%) before and after medicinal products are injected to avoid physical incompatibility reactions. The injection should be administered rapidly (1 ml per second is normally recommended) into the antecubital vein, after taking precautions to avoid extravasation using a 23- gauge butterfly needle for injection.

Luminescence usually appears in the retina and choroidal vessels in 7 to 14 seconds. 6.

Summary of safety profile The most frequently reported treatment related undesirable effects were nausea, vomiting, syncope and pruritus. Less frequent but more severe adverse reactions have been reported shortly after fluorescein injection such as: angioedema, respiratory disorders (bronchospasm, laryngeal oedema, and respiratory failure), anaphylactic shock, hypotension, loss of consciousness, convulsion, respiratory arrest, and cardiac arrest.

Tabulated list of adverse reactions The following adverse reactions were assessed to be treatment-related and are classified according to the following convention: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000), or not known (cannot be estimated from the available data).

Within each frequency-grouping, adverse reactions are presented in order of decreasing seriousness. 0) Immune system disorders Uncommon: hypersensitivity Rare: anaphylactic reaction Very Rare: anaphylactic shock Nervous system disorders Common: syncope Uncommon: dysphasia, paraesthesia, dizziness, headache Very Rare: convulsion Not Known: cerebrovascular accident, vertebrobasilar insufficiency, loss of consciousness, tremor, hypoesthesia, dysgeusia Cardiac disorders Rare: cardiac arrest Very Rare: angina pectoris, bradycardia, tachycardia Not Known: myocardial infarction Vascular disorders Uncommon: thrombophlebitis Rare: hypotension, shock Very Rare: hypertension, vasospasm, vasodilatation, pallor, hot flush Respiratory, thoracic and mediastinal disorders Uncommon: cough, throat tightness Rare: bronchospasm Very Rare: respiratory arrest, pulmonary oedema, asthma, laryngeal oedema, dyspnoea, sneezing, nasal oedema Not Known: throat irritation Gastrointestinal disorders Very Common: nausea Common: abdominal discomfort, vomiting Uncommon: abdominal pain Not Known: retching Skin and subcutaneous tissue disorders Common: pruritus Uncommon: urticaria Not Known: rash, cold sweat, eczema, erythema, hyperhidrosis, skin discolouration General disorders and administration site conditions Common: extravasation Uncommon: pain, feeling hot Not Known: chest pain, oedema, malaise, asthenia, chills Description of selected adverse reactions A yellowish discolouration of the skin could appear but usually disappears within 6 to 12 hours.

Fluorescein sodium can induce serious intolerance reactions. In the event of serious intolerance reactions during a first angiography, the benefit of an additional fluorescein angiography should be balanced with the risk of severe hypersensitivity reactions (with fatal outcome in some cases).

These reactions of intolerance are always unpredictable but they are more frequent in patients who have previously experienced an adverse reaction after fluorescein injection (symptoms other than nausea and vomiting), in patients with history of allergy such as food or drug induced urticaria, asthma, eczema, allergic rhinitis or in patients with history of bronchial asthma.

Intradermal skin tests are not reliable in predicting these intolerance reactions and so their use can be dangerous. A specialized allergy consultation should be undertaken to make this diagnosis. 5). Any pre-existing systemic condition(s) impacting renal function could pose additional risk to the subject.

The physician must exercise medical judgement based on increased serum creatinine, patient’s age, medical history, and current health status to determine potential risk vs benefit prior to use of Fluorescein. Literature suggests Fluorescein Angiography (FA) may cause contrast-induced Nephropathy (CIN) based on increased serum creatinine.

CIN is a possible risk factor for end-stage renal disease progression. 5). If the examination appears to be really necessary for a patient identified as being at risk of hypersensitivity reactions and for a patient treated with beta- blocking agents (including eye-drops solutions), this examination should be performed under the supervision of a physician experienced in intensive care (resuscitation).

Beta-blocking agents could reduce the vascular compensation reactions to anaphylactic shock and reduce the effectiveness of adrenaline in the case of cardiovascular collapse. Before any fluorescein sodium injection, the physician should seek information about concomitant treatment with a beta-blocking agent.

1. Fluorescein 100 mg/ml Solution for injection should not be injected intrathecally or intra-arterially.