Active substanceFluorescein sodiumFluorescein sodium
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  • Dosage form: & nbspsolution for intravenous administration
    Composition:
    active substances:
    fluorescein 100 mg (in the form of fluorescein sodium 113.2 mg); Excipients:
    sodium hydroxide and / or hydrochloric acid to adjust the pH, water for injection.

    Description:
    Transparent solution of red-orange color.

    Pharmacotherapeutic group:diagnostic tool
    ATX: & nbsp

    S.01.J.A.01   Fluorescein

    Pharmacodynamics:
    The yellowish-green fluorescence of the drug delineates the vascular region under study and adjacent structures. It is a diagnostic tool for determining the lesions of the cornea, the study of retinal blood flow.

    Indications:
    Diagnostic angiography, angioscopy of the vascular network of the fundus and iris.

    Contraindications:
    Hypersensitivity to one of the components of the drug.
    Pregnancy (especially the first trimester).

    Carefully:
    With polyvalent allergies (in the anamnesis), bronchial asthma.
    Fluorescein is excreted into the milk of a nursing woman. Care should be taken when prescribing the drug to nursing mothers.

    Dosing and Administration:
    Parenteral medications prior to administration should be visually inspected for foreign contaminants, signs of discoloration.
    If a suspected allergy is suspected before the introduction of the drug, a skin test should be carried out: 0.05 ml of the drug is administered intradermally followed by an evaluation of the reaction for 30-60 minutes.
    Quickly enter the contents of the ampoule or pre-filled syringe into the ulnar vein, taking all precautions against getting the drug out of the vein. A syringe filled with fluorescein is connected to a transparent tube and to a 25-gauge venous needle. Insert the needle and pull the patient's blood into the syringe so that a small air bubble separates the patient's blood from the syringe cylinder from the fluorescein. With the light on, slowly inject blood back into the vein and carefully watch the skin above the tip of the needle. If the tip of the needle is outside the vein, the patient's blood forms a swelling of the skin above him, and then the injection should be stopped before fluorescein is injected. If you are convinced that the tip of the needle is exactly in the vein, then you can turn off the light in the room and introduce fluorescein.In the vessels of the retina and in the choroidal vessels, a luminescence glow appears within 9-14 seconds, which can be seen with the help of conventional instruments for examination.
    One ampoule of Fluorescite is a full dose for adults.
    For children, the dose should be calculated from the ratio of 7.7 mg per 1 kg of body weight.

    Side effects:
    Allergic reactions: rash, itching, bronchospasm, anaphylactic shock. Nausea, vomiting, gastrointestinal disorders, headache, hypotension. There have been reports of cardiac arrest, ischemia in the basilar artery basin, shock, seizures, thrombophlebitis at the injection site, and single deaths.
    The following complications were noted, caused by the drug getting outside the vein: skin necrosis, surface venous phlebitis, subcutaneous granuloma and toxic ulnar nerve neuritis. Exposure of the drug outside the vein can cause severe pain in the arm for several hours. If the solution gets into the paravenous space, the drug should be stopped immediately and emergency measures taken to prevent, treat tissue damage and relieve pain.

    Overdose:
    There are no data on the drug overdose.

    Interaction:
    Data on interactions with other drugs are not available.

    Special instructions:
    The drug is intended only for intravenous administration, not for intrathecal injections. Care should be taken to ensure that during injection, the drug does not enter the vein, because a high pH of the fluorescein solution can cause serious damage to the surrounding tissue.
    A set of special preparations for stopping allergic reactions should always be at the time of injection (0.1% epinephrine for intravenous or intramuscular injections, antihistamine, glucocorticosteroid, aminophylline). Always should be on hand oxygen in case of an adverse reaction to the administration of fluorescein.

    Form release / dosage:
    Solution for intravenous administration is 100 mg / ml (10%).

    Packaging:
    For 5 ml in bottles of colorless glass, type I, F. USA, sealed with rubber stoppers under an aluminum run-off, with a plastic lid on top.
    12 bottles with instructions for use are placed in a cardboard box.

    Storage conditions:
    At a temperature of 2-25 ° C.
    Keep out of the reach of children.

    Shelf life:24 months
    Terms of leave from pharmacies:On prescription
    Registration number:LSR-001107/08
    Date of registration:27.02.2008
    The owner of the registration certificate:Alcon Laboratories Inc.Alcon Laboratories Inc. USA
    Manufacturer: & nbsp
    Representation: & nbspALCON PHARMACEUTICALS LTD. ALCON PHARMACEUTICALS LTD. USA
    Information update date: & nbsp26.09.2015
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