INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION

Logo FLUORESCITE® 25%

SCHEDULING STATUS:
S1

PROPRIETARY NAME
(and dosage form):

FLUORESCITE® 25%
intravenous injection

COMPOSITION:
Each mL contains 250 mg
fluorescein.

PHARMACOLOGICAL CLASSIFICATION:
A 28 Contrast media

PHARMACOLOGICAL ACTION:
Fluorescein has a green fluorescence that is maximal at the ultraviolet wavelength of 3600 A0. It appears readily in the extracellular fluid and gains access only to viable cells.

INDICATIONS:
Fluorescite 25% is used for the examination of the ophthalmic vasculature.

CONTRA-INDICATIONS:
Hypersensitivity to fluorescein.

WARNINGS:
Bronchospasm and anaphylaxis have been reported.

DOSAGE AND DIRECTIONS OF USE:
Inject contents of ampoule into the antecubital vein. In 9 to 14 seconds luminescence appears in the retinal and choroidal vessels which can be observed by standard viewing equipment. If potential allergy is suspected, an intradermal skin test may be performed prior to intravenous administration i.e., 0,05 mL injected intradermally to be evaluated 30 to 60 minutes following injection. The patient must be observed for at least 60 minutes after administration of the final dose.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Nausea, vomiting, urticaria, syncope and other hypersensitivity reactions may occur.

WARNING:
Acute allergic and anaphylactoid reactions may occur in rare instances.

SUGGESTIONS FOR THE MANAGEMENT OF LIFE-THREATENING ACUTE HYPERSENSITIVITY REACTIONS OR ACUTE ANAPHYLAXIS AFTER ADMINISTRATION OF CONTRAST MEDIA.
Give adrenaline solution: 1:1000 concentration in a dose of 1 mg intravenously slowly. If the patient does not respond immediately give 0,1-0,4 mL of 1:1000 concentration diluted in 10 mL physiological saline intravenously SLOWLY. Maintain an open airway. An emergency tracheostomy may be necessary. Positive pressure oxygen administration may be required. An antihistamine (e.g., diphenhydramine hydrochloride –20 mg) given intravenously after adrenaline subcutaneously is indicated in the presence of urticaria or angio-oedema.
For prolonged or severe reactions give hydrocortisone sodium succinate 250 mg or methylprednisolone sodium succinate 100 mg, intravenously over 30 seconds after adrenaline and the antihistamine.
Aminophylline injection 250-500 mg should be given slowly intravenously in the presence of bronchospasm.
Intravenous fluids may be required to correct hypovolemia.

PREGNANCY: Avoid angiography especially during the first trimester of pregnancy.

PATIENT WARNING: The skin will obtain a temporary yellow discolouration which fades after 2 hours. Urine will attain a bright yellow colour which fades in 24 to 36 hours.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
See side-effects and special precautions. Treatment is symptomatic.

IDENTIFICATION:
Transparent, clear, orange-red solution with a green fluorescence.

PRESENTATION:
Ampoule containing 2 mL.

STORAGE INSTRUCTIONS:
Store below 25°C. KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBER:
R/28/116

NAME AND BUSINESS ADDRESS OF THE APPLICANT:
Alcon Laboratories (S.A.) (Pty) Ltd.
Surrey Avenue
RANDBURG 2194

DATE OF PUBLICATION OF THIS PACKAGE INSERT
13 October 1983

0990VL
347211
34721-B

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