FLUORESCEIN SODIUM

Use in adults (18 years old and over), including the elderly One 5 ml ampoule of fluorescein sodium 100 mg/ml to be injected intravenously into the antecubital vein after taking precautions to avoid extravasation. Use in paediatric patients Fluorescein Sodium 100 mg/ml Solution for Injection has not been studied in children and dose-adaptation data are not available.

Therefore Fluorescein Sodium 100 mg/ml Solution for Injection should not be used in patients below 18 years as efficacy and safety in this group has not been established. Use in patients with renal insufficiency (glomerular filtration rate below 20 ml/min) There is limited data regarding the use of Fluorescein Sodium 100 mg/ml Solution for Injection in renally impaired patients (glomerular filtration rate below 20ml/min) and indicates, in general, no dose adjustment is required.

5ml (half an ampoule) as an intravenous injection. Method of administration and fluorescence angiography Fluorescein Sodium 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. 4). Luminescence usually appears in the retina and choroidal vessels in 15 to 20 seconds.

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

Tabulated list of adverse reactions The following undesirable effects have been observed to be treatment related and are classified according the convention: 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).

Within each frequency grouping, undesirable effects are presented by decreasing order of seriousness. System Organ Classification MedDRA Preferred Term (PT) Frequency Blood and lymphatic system disorders Thrombocytopenia Very rare Anaphylactic shock, anaphylactic reaction, hypersensitivity Uncommon Immune system disorders Anaphylactoid reaction Rare Loss of consciousness Uncommon Coma, syncope, seizure, headache, dizziness, paraesthesia, dysgeusia, tremor Rare Hypoaesthesia Very rare Nervous system disorders Cerebrovascular event, aphasia Not known Cardiac arrest, acute myocardial infarction, cardiovascular collapse, bradycardia, tachycardia Rare Cardiac disorders Angina pectoris, Very rare Hypotension Uncommon Shock, pallor, hot flush RareVascular disorders Thrombophlebitis, hypertension Not known Laryngeal oedema, asthma, dyspnoea, cough, throat irritation, sneezing, bronchospasm Rare Respiratory arrest, pulmonary oedema Very rare Respiratory, thoracic and mediastinal disorders Respiratory distress, throat tightness Not known Abdominal discomfort Common Vomiting, nausea Uncommon Abdominal pain Rare Salivary hypersecretion Very rare Gastrointestinal disorders Retching Not known Rash, erythema, urticaria, pruritus, angioedema Uncommon Dermatitis, hyperhydrosis, skin discolouration2 Rare Skin and subcutaneous tissue disorders Cold sweat Very rare Renal and urinary disorders Chromaturia3 Rare Extravasation, malaise Uncommon Chest pain, oedema, asthenia, feeling hot, chills Rare General disorders and administration site conditions Infusion site thrombosis4, pain Not known 1 Hypersensitivity reactions including rare cases of anaphylactic/anaphylactoid shock which may have fatal outcome 2 A yellowish discoloration of the skin may appear following administration, but usually disappears within 6 to 12 hours.

3 Urine, which may also exhibit a bright yellow colouration, returns to its normal colour after 24 to 36 hours. 4 Special warnings and precautions for use 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. uk/yellowcard.

Special warning Hypersensitivity reactions:

Fluorescein sodium can trigger severe allergic reactions: A detailed medical history of each patient must be carried out before examination including any history of allergy, cardiopulmonary disease diabetes mellitus or concomitant treatments (in particular beta-blocking drugs, including those in ophthalmic dosage forms).

If the examination appears to be necessary for a patient taking beta-blocking drugs, then the examination should be performed under the supervision of a physician experienced in intensive care and resuscitation. Beta-blocking drugs can 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 check if the patient is treated with beta blocking drugs. If serious allergic reactions occur during the first angiography, any further requirement for a fluorescein angiography must be carefully considered: the value of the diagnosis must be weighed with the risk of severe hypersensitivity which development is sometimes fatal.

These allergic reactions are most of the time unpredictable but they occur more frequently in patients who have poorly tolerated a previous injection of fluorescein sodium (other than by nausea and vomiting) or in patients who have displayed a history of allergy such as food- induced or iatrogenic urticaria, asthma, eczema, allergic rhinitis or in patients with history of bronchial asthma.

These allergic reactions may not be detected by carrying out a specific intradermal skin allergy fluorescein test, whose results are unreliable and sometimes possibly dangerous. A specialised allergy consultation may provide a more precise diagnosis.

Premedication can be administered. However, it does not prevent the occurrence of severe adverse reactions. Premedication can include oral antihistamines, followed by corticosteroids before fluorescein is injected. Given the low percentage of adverse reactions, premedication may not be needed in all patients.

The risk of hypersensitivity reactions to fluorescein sodium means that it is necessary throughout the examination: - to ensure close patient monitoring by the ophthalmologist carrying out the examination throughout the duration of the examination and for at least 30 minutes following completion of the examination.

- to maintain the venous infusion line for at least 5 minutes, in order to treat any severe adverse drug reaction without delay; - to have available the facilities required for emergency resuscitation, which are based on inserting a second intravenous line, permitting vascular filling (polyionic solution or colloidal plasma substitute) and the intravenous injection of adrenaline at an appropriate dose.

8). Extravasation Due to the alkaline pH of the solution, care must be taken not to inject the fluorescein solution outside the vein as this can result in severe local tissue damage (severe pain in the arm for several hours, sloughing of the skin, superficial phlebitis).

It is important to make sure that the needle is inserted properly into the vein before beginning to inject the fluorescein; if the product passes into the surrounding tissues (extravasation), the injection must be stopped immediately.

g. probenecid) and interference with other diagnostic procedures. Analytical interference is possible with blood and urine tests, due to the fluorescence, for up to 3 days after the procedure has been conducted. 3% of the WHO recommended maximum daily intake of 2 g sodium for an adult.

The amount of sodium should be taken into consideration by patients who are on a controlled sodium diet.

1. Fluorescein Sodium 100 mg/ml Solution for Injection should not be injected by the intrathecal or intra-arterial routes.