One vial (5 ml) contains 500 mg fluorescein as the sodium salt. The product contains sodium in an amount of up to 1.45% (about 3.15 mmol) per dose.
Action:
Diagnostic dye used to visualize the blood vessels of the fundus in retinal and choroidal angiography. After intravenous administration (within the ulnar margin), fluorescein appears in the central eye artery within 7-14 sec. It is metabolised quickly to monoglucuronate. Fluorescein and its metabolites are eliminated by renal excretion.
Contraindications:
Hypersensitivity to fluorescein and other components of the preparation. The preparation should not be injected intrathecally or intraarterially.
Precautions:
In elderly patients with comorbidities, such as heart and vascular disease, diabetes and multiple medicinal products, the benefit-risk balance of angiography should be considered. Each patient should have a detailed history of cardiovascular diseases, allergies or concomitant medications such as β-blockers (including eye drops) before performing angiography. If it is necessary to examine a patient treated with beta-blockers (including eye drops), they should be performed under the supervision of a physician experienced in resuscitation. Β-blockers can reduce vascular compensatory reactions to anaphylactic shock and reduce the effectiveness of adrenaline in cases of cardiovascular collapse. In the case of serious intolerance reactions during the first angiography, the benefit of additional fluorescein angiography should be assessed against the risk of severe hypersensitivity reactions (in some cases with fatal outcome). Intolerance reactions are more common in patients who have previously experienced side effects (other than nausea and vomiting) after injection of fluorescein or in patients with a history of allergy (food or drug rash, asthma, eczema, allergic rhinitis). Intradermal skin tests are not reliable in predicting these intolerance reactions, and the use of tests can be dangerous. To make a diagnosis, consult an allergist doctor. Premedication (oral antihistamines blocking H-receptors) can be performed1followed by glucocorticoids), but the risk of serious side effects remains. Adverse reactions, however, occur sporadically, therefore the use of this premedication is not recommended in all patients. Due to the risk of hypersensitivity reactions, one should: closely monitor the patient during the examination and for at least 30 min after it; keep the puncture in the vein for at least 5 min (possibility of immediate treatment of serious side effects); have adequate means for resuscitation (the second injection into the vein). Fluorescein should not be allowed to enter the blood vessel, as it may cause severe damage to surrounding tissues (severe hand pain persisting for several hours, skin wet necrosis, surface vein inflammation) - In case of extravasation, stop the injection. If a radiological examination is performed within 36 hours of the fluorescein injection, the resulting strong imaging of the secretory organs may lead to misinterpretations. It should not be used in patients under 18 years of age, as its safety and efficacy have not been established in this group of patients. The sodium content (about 3.15 mmol per dose) should be taken into account in patients who are controlling the sodium content of the diet.
Pregnancy and lactation:
Avoid use during pregnancy. After systemic administration, sodium fluorescein is excreted in human milk - do not breastfeed for 7 days after fluorescein angiography.
Side effects:
Very often: nausea. Common: fainting, discomfort in the abdomen, vomiting, pruritus, extravasation.Uncommon: hypersensitivity reaction, dysphasia, paraesthesia, dizziness, headache, thrombophlebitis, cough, tightness in the throat, abdominal pain, urticaria, pain, feeling hot. Rarely: anaphylactic reaction, cardiac arrest, hypotension, shock, bronchospasm. Very rare: anaphylactic shock, convulsions, angina, bradycardia, tachycardia, hypertension, vasoconstriction, vasodilatation, paleness, hot flushes, respiratory arrest, pulmonary edema, asthma, laryngeal edema, dyspnea, sneezing, nasal congestion. Not known: cerebrovascular accident, vertebrobasilar insufficiency, loss of consciousness, tremor, hypoaesthesia, dysgeusia, myocardial infarction, throat irritation, retching, rash, cold sweats, eczema, erythema, hyperhidrosis, yellowish discoloration of the skin (usually subside within 6-12 h), chest pain, swelling, malaise, weakness. A pale yellow urine may appear (usually resolves within 24-36 hours).
Dosage:
Intravenously. The preparation should only be used by qualified physicians skilled in the performance and interpretation of fluorescein angiography. Adults (including elderly patients): 5 ml of the preparation is administered rapidly (usually 1 ml / s) to the vein within the ulnar margin, taking care that the solution does not penetrate the vein. Luminescence usually appears in the retinal and choroidal vessels after 7-14 sec. When using high-sensitivity imaging devices (eg laser scanning ophthalmoscope) the dose should be reduced to 2 ml. In patients with renal insufficiency (glomerular filtration <20 ml / min), it is possible to prolong the time of excretion, however, no dosage adjustment is necessary. Dialyzed patients should reduce the dose to 2.5 ml. To avoid physical incompatibilities, intravenous cannulae should be rinsed with sterile sodium chloride (0.9%) before and after injecting other medications.