Fluorescite

FLUORESCITE ® Injection 10% is indicated in diagnostic fluorescein angiography or angioscopy of the retina and iris vasculature. FLUORESCITE ® Injection 10% is indicated in diagnostic fluorescein angiography or angioscopy of the retina and iris vasculature. (1)

FLUORESCITE ® Injection 10% is contraindicated in patients with known hypersensitivity to fluorescein sodium or any other ingredients in this product. Rare cases of death due to anaphylaxis have been reported. [see Warnings and Precautions (5.1) and Adverse Reactions (6) ]. Fluorescein sodium can induce serious intolerance reactions. 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) or in patients with history of allergy such as food or drug induced urticaria, asthma, eczema, allergic rhinitis.

Detailed questioning of each patient is recommended before the angiography to evaluate any prior history of allergy. FLUORESCITE ® Injection 10% is contraindicated in patients with known hypersensitivity to fluorescein sodium or any other ingredients in this product (4.1)

Respiratory reactions may require intervention. (5.1) Severe local tissue damage can occur with extravasation during injection. (5.2) Nausea and/or vomiting may occur within minutes following injection. (5.3)

5.1Respiratory Reactions

Caution is to be exercised in patients with a history of allergy or bronchial asthma. An emergency tray should be available in the event of possible reaction to FLUORESCITE ® Injection 10%. If a potential allergy is suspected, an intradermal skin test may be performed prior to intravenous administration, i.e., 0.05 mL injected intradermally to be evaluated 30 to 60 minutes following injection. Given the sensitivity and specificity of skin testing, a negative skin test is not proof that a patient is not allergic to fluorescein.