BioGlo

BioGlo

Fluorescein

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

V/v, jet.

Adults - 5 ml of the drug (1 amp.).

Elderly patients no correction of the dosage regimen of the drug is required.

Children and teenagers. Clinical studies on the use of Novartis Fluorescein solution in children and adolescents under 18 years of age have not been conducted. In this category of patients, the drug is recommended to be prescribed at the rate of, for example, 5 mg/kg.

hypersensitivity to sodium fluorescein or any other component of the drug,

intrathecal or intra-arterial administration.

With caution: caution should be exercised when using the drug in patients with allergies or a history of bronchial asthma.

If it is necessary to conduct PHAG in patients with intolerance to other angiographic dyes or a history of severe allergic reactions, the expected benefit from the study and the potential risk of developing severe allergies should be very carefully correlated with a possible fatal outcome (according to the literature, 1 fatal case per 220000 angiographic studies).

Clinical studies on the use of Novartis Fluorescein solution in children and adolescents under 18 years of age have not been conducted.

The most common adverse reactions when using the drug are nausea and vomiting.

Allergic reactions: the development of hypersensitivity, manifested by skin reactions (urticaria) and in rare cases-anaphylactic / anaphylactoid shock with a possible fatal outcome.

From the central nervous system and peripheral nervous system: loss of consciousness, convulsions, cerebral circulation disorder, headache, dizziness.

From the cardiovascular system: hypotension, chest pain, cardiac arrest, acute myocardial infarction, and severe shock.

From the respiratory system: dyspnea, laryngeal edema, bronchospasm.

From the digestive system: nausea, vomiting, constipation, diarrhea.

Dermatological reactions: hyperemia, itching, dermatitis, temporary yellowish staining of the skin, persisting up to 12 hours after administration of fluorescein.

From the genitourinary system: bright yellow staining of urine is possible within 24-36 hours after administration of sodium fluorescein.

From the body as a whole: chills, hot flashes.

Reactions at the injection site: thrombophlebitis at the injection site, extravasation of the drug solution, causing severe pain with the possible subsequent development of tissue necrosis, if the drug gets under the skin, it is possible to develop subcutaneous granuloma and toxic neuritis of the ulnar nerve.

There are no data on drug overdose.

Sodium fluorescein solution is a diagnostic dye. When fluorescein is stimulated with blue light (absorption from 465 to 490 nm), yellow-green fluorescence with a wavelength from 520 to 530 nm is observed. The method of fluorescent angiography (PHAG) of the fundus allows you to diagnose a violation of blood circulation in the retina.

Distribution. After intravenous administration, sodium fluorescein is rapidly distributed in the body and reaches the retinal vessels in a few seconds.

Binding to plasma proteins. In the blood plasma, 50-84% of the drug binds to proteins (especially albumin) and about 15-17% - to red blood cells.

After administration of sodium fluorescein, the patient's skin temporarily becomes yellowish, 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 to plasma proteins to a lesser extent than fluorescein.

Output. Final T_1/2 sodium fluorescein and its glucuronic metabolite from plasma are approximately 23.5 and 264 min, respectively.

In 48 hours, almost complete (90%) elimination of sodium fluorescein and its metabolites with bile and urine occurs. The drug is detected in the urine for 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 the urine is observed.

In patients with diabetes mellitus, the pharmacokinetic parameters of sodium fluorescein do not change.

• Ophthalmic products

When using sodium fluorescein in patients receiving beta-blockers, anaphylactic / anaphylactoid reactions may be more pronounced.

PHAGE can affect the results of clinical blood and urine tests.

Incompatibility. The drug should not be mixed with other drugs. In solutions of drugs with an acidic pH (especially antihistamines), fluorescein is precipitated. Drugs with an acidic pH should not be administered simultaneously with the drug through a common system for intravenous administration.