Special Warning : אזהרת שימוש

4.4.     Special warnings and precautions for use
A detailed medical history of each patient must be carried out before examination including any history of allergy, history of cardiopulmonary disease, diabetes mellitus or concomitant treatments (in particular beta-blocking drugs, including eye drops solutions). Beta-blocking agents can reduce the vascular compensation reactions and reduce the effectiveness of adrenaline in the case of cardiovascular collapse.

Special warnings
Hypersensitivity
Fluorescein sodium may induce severe hypersensitivity reactions.
The benefit of Fluorescein angiography must be carefully weighed against the risk of severe hypersensitivity reactions (sometimes with a fatal outcome).


These hypersensitivity reactions are always unforeseeable, 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 drug-induced urticaria, asthma, eczema, allergic rhinitis; these hypersensitivity 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 is proposed. However, it does not prevent the occurrence of severe accidents:
• premedication mainly includes H1 antihistamines administered orally, followed by corticosteroids before fluorescein injection,
• it is not currently considered necessary to administer the premedication to all patients given the low percentage of accidents.
The risk of hypersensitivity reactions to fluorescein sodium means that throughout the examination: 
•   fluorescein angiography must be performed only in facilities with staff trained in emergency resuscitation with the appropriate materials and equipment,
•   close patient monitoring must be ensured by the ophthalmologist carrying out the examination throughout the duration of the examination and for at least 30 minutes following completion of the examination,
•   the venous infusion line must be maintained for at least 5 minutes in order to treat any potential accident without delay,
•   the materials required for emergency resuscitation must be available. This involves inserting a second intravenous line to enable vascular filling (polyionic solution or colloidal plasma substitute) and the intravenous injection of adrenaline in an appropriate dose.

Cardiovascular complications
Severe cardiovascular complications such as chest pain, myocardial infarction and shock have occurred following administration of fluorescein sodium (see section 4.8).
Pre-existing conditions and concomitant treatments
The benefit to risk of the angiography procedure should also be considered in patients with pre-existing conditions such as cardiovascular disease, diabetes mellitus and multiple concomitant drug therapies.
Extravasation:
Due to the alkaline pH of the solution, care must be taken not to inject the fluorescein solution outside the vein. 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.
Laboratory tests
The fluorescence may interfere with the analysis of blood and urinary parameters for a period of 3 to 4 days. Interference of fluorescein with serum concentration determination of digoxin and cortisol has been reported. Caution is advised when performing therapeutic drug monitoring for drugs with a narrow therapeutic window.
Excipient with known effect
This medicinal product contains 65.5 mg of sodium per ampoule, equivalent to 3.3% of the maximum daily amount recommended by the WHO which is 2 g of sodium per adult.

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