Retinofluor™ Injection

MIMS Revision Date: 01 October 2025

1 Name of Medicine

Fluorescein sodium.

2 Qualitative and Quantitative Composition

Retinofluor injection 10% contains fluorescein sodium 500 mg in 5 mL or 1 g in 10 mL water for injections as a sterile solution in single dose vials.
Retinofluor injection 25% contains fluorescein sodium 1.25 g in 5 mL water for injections as a sterile solution in single dose vials.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Retinofluor is an orange/red sterile solution for intravenous administration.

4 Clinical Particulars

4.1 Therapeutic Indications

Diagnostic. Intravenous injection of fluorescein sodium dye followed by multiframe photography (angiography) or ophthalmoscopic evaluation (angioscopy). It is used in evaluation of a wide range of retinal and choroidal diseases. It is less commonly used to evaluate abnormalities of the optic nerve and iris. It may be used in diagnosis and management of macular and vascular (including diabetic) diseases.

4.2 Dose and Method of Administration

Product is for single use in one patient only. Discard any residue.
After taking precautions to avoid extravasation (e.g. checking with the lights on) 10% or 25% fluorescein sodium injection is rapidly injected in the antecubital vein and then the room lights turned off.
A recommended dose is 500 mg but this dose may be varied depending on the patient and the camera used in the diagnostic procedure and the individual experience of the operator. It is recommended that the dose be kept as low as possible.
About ten minutes after the injection, very little of the fluorescein sodium dye remains in the eye. The retina and choroidal vessels are stained within 15 seconds and the optic disc will normally fluoresce for several hours after injection.

4.3 Contraindications

Sensitivity to fluorescein sodium or any components in the injection. Concomitant use of contact lenses.

4.4 Special Warnings and Precautions for Use

Not for intrathecal use - for ophthalmic diagnostic use only.
General. Fluorescein sodium contains no iodine. A yellowish discolouration of the skin, urine and conjunctiva may occur. This usually subsides after several hours. Fluorescein sodium can stain skin, clothing, and soft contact lenses on contact. Intraocular fluorescein can produce transient blurring of vision.
This product is only to be used intravenously in ophthalmic diagnostic procedures. Do not mix or dilute with any other solutions or medicines. If a catheter is used, flush pre and post use to avoid any potential incompatibility reactions. Don't use if container or closure is damaged in any way.
The benefit to risk of the angiography procedure should be considered in patients with pre-existing conditions such as cardiovascular disease, diabetes mellitus, and multiple concomitant drug therapies (in particular, beta blockers).
Extravasation at the injection site. Extravasation should be avoided during injection as the high pH of fluorescein solution can result in severe local tissue damage. The following complications resulting from extravasation of fluorescein have been noted to occur: sloughing of the skin, superficial phlebitis, subcutaneous granuloma, and toxic neuritis along the median curve in the antecubital area. Complications resulting from extravasation can cause severe pain in the arm for up to several hours. The correct intravenous position of the needle tip must be ascertained. When extravasation occurs, the injection should immediately be discontinued and conservative measures to treat damaged tissue and relieve pain should be implemented.
Cardiovascular disease. Patients with a history of cardiovascular disease require careful evaluation before undergoing an elective procedure with fluorescein sodium. Rarely, severe cardiovascular complications such as chest pain, myocardial infarction and death have occurred following administration of fluorescein sodium.
Detailed questioning of each patient must be carried out before the angiography to evaluate any prior history of cardiopulmonary disease or allergy or concomitant medications.
Hypersensitivity reactions. Fluorescein sodium can induce serious hypersensitivity and intolerance reactions. These reactions of intolerance are always unpredictable but they are more frequent in patients who have previously experienced an adverse reaction after fluorescein injection (symptoms other than nausea and vomiting) or in patients with history of allergy such as food or drug induced urticaria, asthma, eczema, allergic rhinitis, or in patients with history of bronchial asthma.
Intradermal skin tests have limited predictive value for serious intolerance reactions to fluorescein. Fluorescein intolerance reactions can occur following a negative intradermal skin test.
In the event of serious hypersensitivity and intolerance reactions during a first angiography, the benefit of an additional fluorescein angiography should be balanced with the risk of severe hypersensitivity reactions (with fatal outcome in some cases).
The risk of hypersensitivity reactions with fluorescein sodium requires:
Close monitoring of the patient by the ophthalmologist performing the examination, throughout the examination and for at least 30 minutes thereafter;
Maintaining the infusion line for at least 5 minutes, to treat a possible severe adverse reaction without delay;
To have at one's disposal appropriate material for emergency resuscitation which is based at first on the installation of a second intravenous line, allowing the restoration of the plasma volume (aqueous solution polyionic or colloidal substitute of plasma) and the intravenous injection of adrenaline at the recommended dosage;
In patients identified as being at risk of hypersensitivity reactions, but in whom a fluorescein angiography is considered to be essential, it is recommended to carry out the procedure with the equipment and personnel trained in emergency resuscitation in the treatment room.
Anaphylaxis. Fluorescein sodium injection, may, rarely, cause life threatening or fatal anaphylaxis. A protocol for management of anaphylaxis and appropriate resuscitation equipment such as adrenaline for intravenous or intramuscular use, intravenous fluids and oxygen must always be available in case of such a reaction.
Bronchial asthmatic patients and patients with any history of allergy. Bronchial asthmatic patients and patients with any history of allergy must be treated with special caution. This may involve treatment with antihistamines and steroids, respectively. Acute pulmonary oedema has been reported in 2 patients following administration of fluorescein sodium.
Diabetes mellitus. In some patients with non-insulin dependent diabetes mellitus there has been an increase in whole blood viscosity, erythrocyte elongation index, blood pH, carboxyhaemoglobin and methaemoglobin levels and a sudden reduction of red cell acetylcholinesterase activity. These findings suggest that fluorescein interferes with the red cell membrane and with microcirculatory blood flow. The clinical relevance of these findings is uncertain.
Patient aftercare. Patients should be escorted by a responsible adult from the testing site.
Special instructions. Patients should expect temporary decrease in vision and red after image secondary to flash photography.
The skin and urine may be coloured yellow but this is transient. Fluorescein sodium can stain skin, clothing and soft contact lenses on contact. Intraocular fluorescein can produce transient blurring of vision.
Use in renal impairment. Limited experience in renally impaired subjects suggests that no dose adjustment is necessary in renal impaired patients.
Fluorescein Angiography (FA) may cause Contrast-Induced Nephropathy (CIN) based on increased serum creatinine. CIN is a possible risk factor for end-stage renal disease progression.
Use in hepatic impairment. Fluorescein undergoes hepatic metabolism to fluorescein glucuronide.
Use in the elderly. No overall differences in safety or effectiveness have been observed between elderly and other adult patients.
Paediatric use. Safety and effectiveness in children have not been established.
Effects on laboratory tests. The fluorescence may interfere with the analysis of blood and urinary parameters for a period of 3 to 4 days.

4.5 Interactions with Other Medicines and Other Forms of Interactions

Fluorescein is a relatively inert dye and specific drug interaction studies are not reported. There are few case reports of potential interactions with organic anion transporters and interference with certain laboratory tests. Caution is advised when performing therapeutic drug monitoring for medicines with a narrow therapeutic window, e.g. digoxin, quinidine. Compounds that inhibit or compete with the active transport of organic anions (e.g. probenecid) may affect the systemic profile of fluorescein.
The concomitant use of Retinofluor injection with beta-blocking agents (including eye-drop solutions) may rarely provoke severe anaphylactic reactions. Beta-blocking agents could reduce the vascular compensation reactions to anaphylactic shock and also reduce the effectiveness of adrenaline in the presence of cardiovascular collapse.
Concomitant intravenous injection of other solutions or the mixing of Retinofluor injection with other solutions or medicines should be avoided as the possibility of interactions cannot be excluded.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility. No studies investigating the effect of fluorescein on fertility have been conducted.
Use in pregnancy. (Category B2)
Embryo-fetal toxicity studies in animals showed that doses of sodium fluorescein associated with exposure levels approximately 9-times higher (rats) or the same (rabbits) as the human dose (on relative mg/m² body surface area basis) caused no fetal harm when administered IV during organogenesis.
Avoid angiography on patients who are pregnant, especially those in the first trimester. There have been no adequate and well-controlled human studies on the safety of Retinofluor injection during pregnancy. Retinofluor injection should be used in pregnancy only if clearly needed.
Use in lactation. Fluorescein has been demonstrated to be excreted in human milk for up to 7 days. Following fluorescein angiography, breastfeeding should therefore be discontinued for at least 7 days, and the milk should be pumped off and discarded during this period. Because of the potential for serious reactions in breastfed infants from fluorescein, a decision should be made whether to discontinue breastfeeding or to discontinue the medicine, taking into account the importance of the medicine to the mother.

4.7 Effects on Ability to Drive and Use Machines

The patient must be made aware that after application and until visual acuity returns to normal, driving a vehicle or operating dangerous machinery is not recommended.

4.8 Adverse Effects (Undesirable Effects)

Clinical trial experience. A summary of treatment emergent adverse effects and their estimate of frequencies (common, rare, very rare) in accordance with preferred term and system organ classes (SOC) of any severity are listed below*. All of these events and their frequencies are extracted from the uncontrolled studies of fluorescein safety.
Cardiovascular. Common: hypotension.
Uncommon: syncope.
Rare: arterial ischaemia basilar, cardiac arrest, shock (severe).
Dermatologic. Uncommon: injection site thrombophlebitis. Skin eruptions, urticaria and pruritus occur in about 1% of patients.
Gastrointestinal. Common: drug induced gastrointestinal disturbance, nausea, vomiting.
Immunologic. Common: generalised pruritus, hives, generalised hypersensitivity reaction.
Rare: anaphylaxis.
Neurologic. Common: headache.
Rare: seizure.
Respiratory. Uncommon: bronchospasm, dyspnoea and breathlessness.
*The CIOMS (Council for International Organisation of Medical Sciences) III standard categories are used for classification of frequencies:
very common: 10% or more;
common: (frequent) 1 to < 10%;
uncommon: (infrequent) 0.1 to < 1%;
rare: 0.01 to < 0.1%;
very rare: 0.01% or less.
Post-marketing experience. The most frequently reported treatment related undesirable effects were nausea, vomiting, syncope and pruritus. Less frequent but more severe adverse reactions have been reported shortly after fluorescein injection, such as respiratory disorders (bronchospasm, laryngeal oedema), anaphylactic shock, hypotension, loss of consciousness, convulsion, respiratory and cardiac arrest.
Additionally, a yellowish discoloration of the skin could appear but usually disappears within 6 to 12 hours. Urine, which may also exhibit a bright yellow colouration, returns to its normal colour after 24 to 36 hours.
A summary of treatment emergent adverse events based on literature and post-marketing experience, and their estimate of frequencies (very common, common, uncommon, rare, very rare, and not known) in accordance with preferred term and SOC, of any severity, are listed.
Immune system disorders. Uncommon: hypersensitivity.
Rare: anaphylactic reaction.
Very rare: anaphylactic shock, anaphylactoid reaction, anaphylactoid shock, hypersensitivity.
Nervous system disorders. Common: dysgeusia, syncope.
Uncommon: headache, paraesthesia, dizziness.
Very rare: convulsion.
Not known: vertebrobasilar insufficiency, loss of consciousness, tremor, hypoaesthesia, cerebrovascular accident.
Cardiac disorders. Rare: cardiac arrest.
Very rare: angina pectoris, bradycardia, tachycardia.
Not known: myocardial infarction.
Vascular disorders. Uncommon: thrombophlebitis.
Rare: hypotension, shock.
Very rare: hot flush, hypertension, intermittent claudication, pallor, peripheral vascular disorder, vasodilation, vasospasm.
Respiratory, thoracic and mediastinal disorders. Uncommon: cough, throat tightness.
Rare: bronchospasm.
Very rare: asthma, cough, dyspnoea, hypoventilation, laryngeal oedema, nasal oedema, pulmonary oedema, respiratory arrest, sneezing.
Not known: throat irritation.
Gastrointestinal disorders. Very common: nausea.
Common: abdominal discomfort, vomiting.
Uncommon: abdominal pain.
Not known: retching, diarrhoea.
Skin and subcutaneous tissue disorders. Common: pruritus, urticarial.
Not known: rash, cold sweat, eczema, erythema, hyperhidrosis, skin discolouration.
General disorders and administration site conditions. Common: extravasation.
Uncommon: pain, feeling hot.
Very rare: death.
Not known: oedema, malaise, asthenia, chills.
Reporting suspected adverse effects. Reporting suspected adverse reactions after registration of the medicinal product is important. It allows continued monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions at www.tga.gov.au/reporting-problems.

4.9 Overdose

For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action. Fluorescein sodium has a green-yellow fluorescence which may be used to highlight the vascular perfusion and its abnormalities.
Clinical trials. No data available.

5.2 Pharmacokinetic Properties

Absorption. No data available.
Distribution. No data available.
Metabolism. No data available.
Excretion. No data available.

5.3 Preclinical Safety Data

Genotoxicity. There have been no long-term studies using fluorescein sodium in animals to evaluate mutagenicity.
Carcinogenicity. There have been no long-term studies using fluorescein sodium in animals to evaluate carcinogenic potential.

6 Pharmaceutical Particulars

6.1 List of Excipients

Retinofluor contains water for injections, with the pH adjusted using sodium hydroxide and/or hydrochloric acid. Contains no antimicrobial agent.

6.2 Incompatibilities

Incompatibilities were either not assessed or not identified as part of the registration of this medicine.

6.3 Shelf Life

In Australia, information on the shelf life can be found on the public summary of the Australian Register of Therapeutic Goods (ARTG). The expiry date can be found on the packaging.

6.4 Special Precautions for Storage

Store below 30°C. Protect from light.

6.5 Nature and Contents of Container

Retinofluor Fluorescein Sodium 10% sterile single use injection 500 mg/5 mL in type 1 clear glass vials. Each carton contains 10 single dose vials (AUST R 121873).
Retinofluor Fluorescein Sodium 10% sterile single use injection 1 g/10 mL in type 1 clear glass vials. Each carton contains 10 single dose vials (AUST R 23130).^
Retinofluor Fluorescein Sodium 25% sterile single use injection 1.25 g/5 mL in type 1 clear glass vials. Each carton contains 10 single dose vials (AUST R 23138).^
^ Not currently marketed

6.6 Special Precautions for Disposal

In Australia, any unused medicine or waste material should be disposed of by taking to your local pharmacy.

6.7 Physicochemical Properties

Non-proprietary name: Fluorescein Sodium 10% and Fluorescein Sodium 25% for injection.
Chemical name: Disodium 2-(6-oxido-3-oxo- 3H-xanthen-9-yl) benzoate.
The molecular weight of the compound is 376.3. The molecular formula is C₂₀H₁₀Na₂O₅.
Chemical structure.

CAS number. 518-47-8.

7 Medicine Schedule (Poisons Standard)

Schedule S4 - Prescription Only Medicine.

Date of First Approval

14 October 1991

Date of Revision

28 July 2025

Summary Table of Changes