Fluorescein Novartis (Fluorescein Novartis)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
Read on
Active substanceFluorescein sodiumFluorescein sodium
Similar drugsTo uncover
  • Fluorescein sodium
    solution in / in 
    SSC NIOPIK, FSUE     Russia
  • Fluorescein Novartis
    solution in / in 
    Novartis Pharma AG     Switzerland
  • Fluorescence ®
    solution in / in 
    Alcon Laboratories Inc.     USA
    • Dosage form: & nbspsolution for intravenous administration
    Composition:

    1 ampoule contains:

    active substance: sodium fluorescein 0,5 g (corresponding to 0.442 g fluoresceinic acid);

    Excipients: (sodium hydroxide - up to pH 8.5 - 9.5, water for injections - 4,680 g) - 5 ml.

    Description:Transparent dark orange solution
    Pharmacotherapeutic group:diagnostic tool
    ATX: & nbsp

    S.01.J.A.01   Fluorescein

    Pharmacodynamics:
    A solution of sodium fluorescein is a diagnostic dye. When fluorescein is stimulated with blue light (absorption from 465 nm to 490 nm), yellow-green fluorescence with a wavelength of 520 nm to 530 nm is observed. The method of fluorescent angiography of the fundus allows to diagnose circulatory disorders of the retina.

    Pharmacokinetics:
    Distribution
    After intravenous administration sodium fluorescein quickly distributed in the body and reaches the retina in a few seconds.
    Binding to blood plasma proteins
    In blood plasma, 50 - 84% of the drug binds to proteins (especially albumin) and about 15 to 17% - to red blood cells.
    After the administration of fluorescein sodium, the patient's skin temporarily acquires a yellowish hue, disappearing after 6-12 hours.
    Metabolism
    In the body, the drug is rapidly metabolized to fluorescein glucuronide, which also has fluorescent properties. After 4-5 hours after administration, the drug is detected in the blood plasma, mainly in the form of glucuronide. The glucuronic metabolite binds less to plasma proteins than fluorescein.
    Excretion
    The final half-life of fluorescein sodium and its glucuronic metabolite from plasma is approximately 23.5 and 264 min, respectively.
    In 48 hours almost complete (by 90%) elimination of sodium fluorescein and its metabolites with bile and urine occurs. The drug is determined in the urine within 24-36 hours with a gradual decrease in its concentration. Within 24-36 hours after the administration of sodium fluorescein, a bright yellow staining of urine is observed.
    In patients with diabetes, the pharmacokinetic parameters of sodium fluorescein do not change.

    Indications:
    Fluorescence angiography of the fundus and vascular bed of the iris.
    The drug is intended only for diagnostic purposes.

    Contraindications:
    Hypersensitivity to sodium fluorescein or any other component of the drug;
    Intrathecal or intraarterial administration.
    Clinical studies on the use of Fluorescein Novartis solution in children and adolescents under the age of 18 have not been conducted.

    Carefully:
    Care should be taken when using the drug in patients with an allergy or bronchial asthma in the anamnesis.
    When need holding
    fluorescent angiography (PHAG ') in patients with history of allergic reactions to the administration of angiographic dyes or other severe allergic reactions in the anamnesis, the expected benefit from research and potential risk development of severe allergic reaction.

    Also, use caution when use of the drug in patients with cardiovascular diseases system in history, diabetes, and also in patients receiving simultaneous therapy with several medicines (especially, beta-blockers).


    Pregnancy and lactation:
    BREASTFEEDING PERIOD
    Studies have not revealed teratogenic effects in animals.
    The potential risk to the fetus during PHAG in pregnant women is unknown.
    The drug should not be used during pregnancy, except when the expected benefit from the study for the mother exceeds the potential risk to the fetus.
    Fluorescein sodium is excreted in breast milk and is determined in it up to 7 days. It is necessary to abandon breastfeeding within 14 days after the FAG; for complete removal of the drug from breast milk may take about two weeks after intravenous administration
    Dosing and Administration:

    Adults

    5 ml of the drug (1 ampoule) are administered intravenously.

    Patients aged> 65 years

    In elderly patients not correction of the dosing regimen is required

    preparation.

    Patients aged <18 years

    Clinical trials of use Fluorescein® Novartis in children

    and adolescents under the age of 18 were not held. This category of patients it is recommended to prescribe from for example, -5 mg / kg.


    Patients with impaired renal function

    Limited experience in the use of the drug in patients with renal insufficiency showed no need to adjust the dose of the drug for this category of patients.

    Patients with impaired hepatic function

    Clinical studies on the use of Fluorescein® Novartis in patients with hepatic was not conducted. There are no data on the need for dose adjustment in this category of patients.

    Side effects:
    Since reports of adverse events (AEs) in the nostmarketing period arrive in a voluntary
    order from a population of undetermined size, reliably estimate the frequency of their occurrence not is submitted
    possible. AEs are grouped according to the classification of bodies and systems of organs of the MESP, are listed in order of decreasing their significance. Most frequent undesirable
    reactions with the drug are nausea and vomiting.
    Immune system disorders: anaphylactic shock,
    anaphylactic reaction,
    Hypersensitivity, including rare cases
    anaphylactic / anaphlactoid shock, some with a legal outcome. Disturbances from the nervous system: acute violation of cerebral circulation, loss of consciousness, fainting, convulsions, headache, dizziness, paresthesia, dysphagia, dysgeusia.
    Violations from the heart: cardiac arrest, acute myocardial infarction, bradycardia, tachycardia.

    Vascular disorders: shock, thrombophlebitis, a marked decrease in blood pressure, rise blood pressure,"tides".

    Disturbances from respiratory

    system, chest organs and mediastinum: stop breathing, pulmonary edema, bronchospasm, A bronchial asthma, a larynx edema, a dyspnea, cough, a feeling of "restraint" in the throat, irritation in the throat, sneezing.

    Disorders from the gastro-intestinal tract: vomiting, the urge to vomit,nausea, pain at belly, constipation, diarrhea.

    Disturbances from the skin and subcutaneous fabrics: dermatitis, rash, "cold" notes, erythema, hives, itching, hyperhidrosis.

    temporary yellowish staining dermal covers, which can appear after the administration of the drug and disappear within 6-12 hours.

    Infringements from kidneys and urinary tract: chromatic (bright-yellow staining of urine, which disappears in 24-36 hours).

    General disorders and disorders in place introduction: thrombosis at the injection site (thrombophlebitis at the site of administration, extravasation of the drug solution with severe pain and possible development of necrosis surrounding tissues), pain in labor, swelling, pain, deterioration of general well-being, asthenia, a feeling of heat, chills.

    If the product gets under the skin development of a subcutaneous granuloma and toxic neuritis of the ulnar nerve.


    Overdose:no data
    Interaction:
    Simultaneous use of fluorescein with bsta-adrenoblockers (including solutions of eye drops) can in rare cases provoke the development of severe anaphylactic reactions. Beta-adrnosblokatori mshug suppress the development of compensatory vascular reactions at emergence of
    anaphylactic shock and reduce the effectiveness of adrenaline preparations in conditions cardiovascular
    insufficiency.
    The simultaneous use of other drugs of the day of intravenous administration should to avoid simultaneous
    intravenous administration of other drugs or mixing fluorescein sodium solution with other solutions, since it is impossible to exclude the possibility of developing drug interactions.
    Inhibitors of organic transport
    anions and laboratory studies
    Messages were received about the possible
    development of drug interactions
    with simultaneous application
    fluoroscein with some drugs
    inhibitors of organic transport
    anions, as well as the possible impact of
    fluorescein on the results of some
    laboratory research. Fluorescin
    can influence the results
    laboratory tests of blood and urine
    within 3-4 days.
    It was noted that the systemic concentration of fluorscein influences the results of determination of digoxin and cortisol in the serum using immunofluorescent analyzers.
    Care should be taken when conducting therapeutic
    monitoring the concentration of drugs with a narrow therapeutic index (for example, digoxin, gt;
    Medicinal substances that inhibit or have a competitive effect on the active transport of organic anions (including ibenecid). can affect the distribution of fluorescein. Incompatibility
    The drug should not be mixed with other drugs.
    In solutions of medicinal products with acidic
    pH (especially antihistamines, for example, promethazine) or when interacting with citric acid, fluorescent precipitation occurs.Medicines with acid pH should not be administered simultaneously with the drug through a common system for intravenous administration.

    Special instructions:
    Before the FAG ', a thorough medical history should be carefully collected, including allergic; it is necessary to clarify the use of drugs (special beta-
    adrenoblockers, including eye drops) and the presence of a history of cardiovascular disease.
    Hypervascular reaction Fluorescein sodium can cause development serious reactions
    intolerance. The development of such reactions is always unpredictable, but they tend to develop more often in patients who had a history of adverse reactions with fluorescene (except for symptoms such as nausea and vomiting), in patients with a history of food allergy (in the form of bronchial asthma , eczema, allergic rhinitis,
    urticaria), as well as in patients with a history of bronchial asthma. Results of intradermal tests have limited prognostic value, the development of allergic reactions is possible and with a negative result of intradermal tests.
    In connection with the risk of developing hypersensitivity reactions during the conduct of FAH, the following precautions should be observed:
    close supervision of the ophthalmologist conducting the study, both during the procedure and within 30 minutes after its completion;
    preservation of intravenous access for a minimum of 5 minutes after the administration of the drug for the purpose of urgent medical measures in case of serious adverse reactions;
    In the study room, appropriate equipment and medicines must be prepared in advance for emergency resuscitation, including, first of all providing additional intravenous access to restore the volume of blood plasma with the use of water-salt and colloidal plasma-substitution solutions, as well as intravenous administration of eninephrine in appropriate doses.
    Diseases of the cardiovascular system There have been cases of development of severe complications from the cardiovascular system, such as chest pain, myocardial infarction and shock after the administration of sodium fluoroscein.
    Patients with a history of cardiovascular disease, diabetes mellitus, as well as patients receiving concomitant therapy with several drugs (especially beta-blockers), before using the drug, the ratio of the expected benefits
    application of the drug to a possible risk. In patients with a high risk of developing hypersensitivity reactions that require PHAG, the study should be conducted in the presence of an analysand atoll. Extravasion
    Avoid extravasation of the drug solution due to high pH, ​​as this can lead to severe damage fabrics
    (severe pain in the limb for several hours, peeling of the skin, phlebitis of superficial

    veins).

    Before the introduction of the drug should be

    make sure the needle is correctly positioned

    in Vienna. In the case of extravasation of the solution

    The drug should be immediately discontinued and the necessary medical measures taken.

    Laboratory research

    Perhaps the influence of Fluorescein Novartis on the results of some studies

    blood and urine for 3-4 days.Influence of fluorescent on the results of the determination of digoxin and cortisol in serum was noted.

    Caution should be exercised in the therapeutic monitoring of the concentration of drugs with a narrow therapeutic index (for example, digoxin, quinidine).

    Before the introduction of the drug, you should carefully inspect the ampoule. A solution of fluorescent sodium can not be used when the color changes or the appearance of undissolved visible particles. The drug should not be mixed with drugs or diluted with other solutions in the same syringe. You should avoid simultaneous intravenous administration of other drugs or mixing fluorescein solution

    sodium with other

    solutions, since it can not be ruled out

    the possibility of developing physico-

    chemical interaction.

    To prevent reactions of physical

    incompatibility should be washed with a canula

    for intravenous administration before and after

    introduction of other drugs.

    Patients on

    ginonatrievoy diet should be taken into account,

    that the recommended dose of the drug contains 72.45 mg of sodium.

    Effect on the ability to drive transp. cf. and fur:It is necessary to avoid management vehicles, and other potentially hazardous activities requiring increased concentration of attention and speed of psychomotor reactions until the restoration of normal visual activity.
    Form release / dosage:A solution for intravenous administration of 100 mg / ml,
    Packaging:
    5 ml in a vial of colorless glass; On the ampoule, the copying rings and the break point are applied. 10 ampoules with instructions for use in a cardboard pack.

    Storage conditions:
    At a temperature of no higher than 25 ° C.
    Keep out of the reach of children.

    Shelf life:
    2 years
    The drug should not be used after the expiration date.

    Terms of leave from pharmacies:On prescription
    Registration number:LSR-000829/08
    Date of registration:18.02.2008
    The owner of the registration certificate:Novartis Pharma AGNovartis Pharma AG Switzerland
    Manufacturer: & nbsp
    Information update date: & nbsp27.09.2015
    Illustrated instructions
      Instructions
      Up