RETINOFLUOR

What it is

RETINOFLUOR is a sterile solution containing fluorescein sodium for intravenous injection. Each 1.0 mL of solution contains 100 mg fluorescein sodium. RETINOFLUOR is a diagnostic dye. When fluorescein sodium is stimulated by blue light (465 nm to 490 nm) it shows yellow-green (520 nm to 530 nm) fluorescence.

Approved indications

— Fluorescein angiography of the fundus and of the iris vasculature.

Dosing overview

Adults: One single dose of 500 mg (1 ampoule of 5 mL). There is no indication that dosage needs to be modified for the elderly. If RETINOFLUOR is used in children, a dosage adjustment is recommended, e.g. 5 mg/kg. RETINOFLUOR is given by intravenous (IV) injection.

Key safety warnings

Hypersensitivity reactions, including rare cases of anaphylactic/anaphylactoid shock (some with fatal outcome), have been reported. If serious hypersensitivity reactions have occurred during previous angiography with other diagnostic agents or there is a history of severe allergic reactions, the need for fluorescein angiography must be very carefully considered and the diagnostic importance balanced against the risk of a severe, possibly fatal (rate 1 in 220,000 angiographies as collected in a survey), allergic reaction. The patient must be kept under close observation for at least 30 minutes after angiography. A protocol for management of anaphylaxis, and an emergency tray with appropriate resuscitation equipment such as adrenaline for intravenous or intramuscular use, intravenous fluids, oxygen, volume substitution and corticosteroids, should always be available in case of such reaction. Patients with a history of cardiovascular disease require careful evaluation before undergoing an elective procedure with sodium fluorescein. Rarely, severe cardiovascular complications such as chest pain, myocardial infarction and death have occurred following administration of fluorescein sodium. Combination with beta-blockers may in rare cases cause lethal anaphylactic reactions. In patients identified as being at risk of hypersensitivity reactions, but in whom a fluorescein angiography is considered to be essential, the procedure must be carried out in the presence of a specialist in resuscitation, particularly when the patient is under beta-blocker therapy, including beta-blocker eye-drops. Care must be taken to avoid extravasation during injection. The high pH of the fluorescein solution can result in severe local tissue damage. Complications from extravasation can cause severe pain, thrombophlebitis and an inflammatory reaction of the tissue leading to tissue necrosis.

Contraindications

Known hypersensitivity to the active substance or to any of the excipients. Intrathecal or intra-arterial use.

Regulatory history

RETINOFLUOR fluorescein sodium 10% injection 500mg/5mL vial was first listed on the ARTG on 2007-10-22. The most recent amendment was 8 March 2017.