Fluorescein angiography of the fundus and iris vascularization. The preparation is intended for use only for diagnostic purposes.
Composition:
1 amp. (5 ml) contains 500 mg of fluorescein sodium.
Action:
Diagnostic preparation - dye. Stimulation of fluorescein sodium with blue light (465-490 nm) causes its yellow-green fluorescence (520-530 nm). This allows the identification of pathological changes in the retinal blood vessels. Fluorescein appears in the retinal vessels a few seconds after intravenous administration. Approx. 50-84% of fluorescein is bound to plasma proteins and 15-17% - to erythrocytes. After intravenous administration, fluorescein is rapidly converted to fluorescein glucuronide, which has fluorescent properties. T0,5 in the plasma of fluorescein and its glucuronide is about 23.5 min and 264 min respectively. Fluorine plasma glucuronide almost completely expires after about 4-5 hours. Fluorescein and its metabolites are excreted in bile and urine; within 48 hours 90% of the dose is excreted from the body.
Contraindications:
Hypersensitivity to the active substance or any of the ingredients. Do not administer intrathecally or intraarterially.
Precautions:
Before administration, a thorough interview should be conducted, taking into account the occurrence of allergies, cardio-pulmonary diseases, the use of drugs (especially beta blockers, including ocular drops). Caution should be used in patients with a history of bronchial allergy or asthma. If you have had severe intolerance or a history of severe allergic reactions during previous angiographic studies with other diagnostic measures, consideration should be given to the need to perform the test, taking into account the benefits of the risk of very serious allergic reactions. The use of the preparation in patients treated with β-adrenergic blocking drugs may in rare cases cause fatal anaphylactic reactions. In patients with an increased risk of hypersensitivity reactions, the procedure should be performed in the presence of a specialist in resuscitation. This is especially true for patients treated with β-blockers (including eye drops), as they may require more intensive resuscitation due to reduced epinephrine efficacy and problems with vascular bed filling. The patient must remain under observation for at least 30 minutes after the angiographic examination. When administering fluorescein one should have access to emergency resuscitation measures, including medications used in the event of hypersensitivity reactions. Care should be taken when injecting the product to avoid extravasation. High pH of the preparation may cause severe local tissue damage.
Pregnancy and lactation:
The potential risk to the fetus is unknown. Avoid use during pregnancy unless absolutely necessary. Fluorescein is excreted in breast milk - after the test breastfeeding should be discontinued for 2 days.
Side effects:
The most common are nausea and vomiting. In addition, fainting, convulsions, cerebrovascular events, headache and dizziness, hypotension, chest pain, cardiac arrest, acute myocardial infarction and severe cardiac shock, dyspnoea, larynx edema and bronchospasm, redness, pruritus, inflammation may occur. dermatitis, transient yellowish color of the skin (disappears up to 12 h after administration), light yellow urine (24-36 h after administration), chills, hot flushes, thrombophlebitis at the site of administration, extravasation of the solution that causes severe pain and may be the reason tissue necrosis, hypersensitivity reactions including skin reactions such as urticaria and rarely anaphylactic / anaphylactoid shock, which may result in death.
Dosage:
Intravenously. Adults: 1 amp. (500 mg). There are no studies on use in children; when used in children, a dosage adjustment is necessary, e.g. 5 mg / kg.
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