플루오레세인나트륨

® 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)

® Injection 10% is contraindicated in patients with known hypersensitivity to fluorescein or any other ingredients in this product (4.1) 4.1 Hypersensitivity 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 ( 6.3 , 6.4 )]. 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.

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) 5.1 Respiratory Reactions Monitor closely when used 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 IV 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. 5.2 Severe Local Tissue Damage Avoid extravasation during injection as the high pH of fluorescein solution can result in severe local tissue damage. The following complications resulting from extravasation of fluorescein have been reported: severe pain in the arm for several hours, sloughing of the skin, superficial phlebitis, subcutaneous granuloma, and toxic neuritis along the median curve in the antecubital area. When significant extravasation occurs, the injection should be discontinued and conservative measures to treat damaged tissue and to relieve pain should be implemented. [ see Administration (2.3) and Adverse Reactions (6.6) ] . 5.3 Gastrointestinal Distress Nausea and/or vomiting and gastrointestinal distress occur …

8.1 Pregnancy Risk Summary There is insufficient data with the use of fluorescein in pregnant women to inform a drug-associated risk. Adequate animal reproduction studies have not been conducted with fluorescein. Fluorescein sodium should be given to a pregnant woman only if clearly needed. The background risk of major birth defects and miscarriage for the indicated population is unknown; however, in the U.S. general population, the estimated background risk of major birth defects is 2%-4% and of miscarriage is 15%-20% of clinically recognized pregnancies Data Animal Data Intravenous administration of a single dose of fluorescein to pregnant rats resulted in rapid distribution into the …