Consumer medicine information

RETINOFLUOR

Fluorescein sodium

BRAND INFORMATION

Brand name

Retinofluor

Active ingredient

Fluorescein sodium

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using RETINOFLUOR.

What is in this leaflet

This leaflet answers some common questions about Retinofluor. It does not contain all the available information. It does not take the place of talking to your doctor.

All medicines have risks and benefits. Your doctor has weighed the risks of you being given Retinofluor against the benefits they expect it will have for you.

If you have any concerns about being given this medicine, ask your doctor.

Keep this leaflet in a safe place. You may need to read it again.

What Retinofluor is used for

Retinofluor is used to highlight blood vessels in the back of the eye so that a special camera can be used to take pictures and analyze the blood circulation in the eye. This helps doctors diagnose any problems or diseases of the eye.

This medicine belongs to a group of medicines called synthetic dyes. Retinofluor is an orange to red coloured fluorescent dye.

This medicine works by making the blood vessels in the eye fluoresce for a short time so that these vessels can be more easily seen in a photograph.

Ask your doctor if you have any questions about why this medicine has been prescribed for you. Your doctor may have prescribed it for another reason.

Before you are given Retinofluor

When you must not be given it

You should not be given Retinofluor if you have an allergy to:

  • any medicine containing fluorescein sodium
  • any of the ingredients listed at the end of this leaflet
  • any other similar medicines such as synthetic dyes.

Some of the symptoms of an allergic reaction may include:

  • shortness of breath
  • wheezing or difficulty breathing
  • swelling of the face, lips, tongue or other parts of the body
  • rash, itching or hives on the skin.

You should not be given this medicine if you are pregnant. It may affect your developing baby if you are given it during pregnancy.

Do not breast-feed if you are being given this medicine. The active ingredient in Retinofluor passes into breast milk and there is a possibility that your baby may be affected.

This medicine should not be given to children. Safety and effectiveness in children has not been established.

You should not be given this medicine if the solution is discoloured, cloudy, turbid, or a precipitate or particles are present. The solution is normally an orange to red liquid.

The doctor or nurse will check to ensure the medicine is not past its expiry date and has not been tampered with.

If you are not sure whether you should be given this medicine, talk to your doctor.

Before you are given it

Tell your doctor if you have allergies to any other medicines, foods, preservatives or dyes.

Tell your doctor if you have or have had any of the following medical conditions:

  • heart disease or heart problems
  • diabetes mellitus
  • asthma
  • suffer from any allergies.

If you have not told your doctor about any of the above, tell him/her before you are given Retinofluor.

Taking other medicines

Tell your doctor or pharmacist if you are taking any other medicines, including any that you get without a prescription from your pharmacy, supermarket, health food shop, naturopath or herbalist. Some medicines and Retinofluor may interfere with each other.

Your doctor and pharmacist have more information on medicines to be careful with or avoid while being given this medicine.

How Retinofluor is given

Retinofluor must only be given by a doctor or nurse.

How it is given

Retinofluor is rapidly injected into a vein, usually at the bend of the elbow (the antecubital vein).

How much is given

Your doctor will decide what dose of Retinofluor you will receive. This depends on your medical condition and other factors, such as your weight.

Usually only a single dose of Retinofluor is required.

If you are given too much (overdose)

Retinofluor must only be given by a doctor or nurse so an overdose is not likely to occur.

If you experience any severe side effects tell your doctor or nurse immediately. The symptoms of a side effect are listed under Side effects below.

If you notice any symptoms of an overdose immediately contact your doctor or go to the Emergency Department at the nearest hospital.

Contact the Poisons Information Centre on 13 11 26 for further advice on overdose management.

While you are being given Retinofluor

Things you must do

If you are about to be started on any new medicine, remind your doctor and pharmacist that you have been given Retinofluor.

Tell any other doctors, dentists, and pharmacists who treat you that you have been given this medicine.

If you are about to have any blood tests, tell your doctor that you have been given this medicine. It may interfere with the results of some tests.

Things you must not do

Do not drive or operate machinery after being treated with Retinofluor. This medicine causes a temporary decrease in vision in most people. Do not drive, operate machinery or do anything else that could be dangerous.

Things to be careful of

If you feel light-headed, dizzy or faint when getting out of bed or standing up, get up slowly. Standing up slowly, especially when you get up from bed or chairs, will help your body get used to the change in position and blood pressure. If this problem continues or gets worse, talk to your doctor.

Side effects

Tell your doctor or nurse as soon as possible if you do not feel well while you are being given Retinofluor. This medicine may have unwanted side effects in a few people. All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical attention if you get some of the side effects.

Do not be alarmed by the following lists of side effects. You may not experience any of them.

Ask your doctor to answer any questions you may have.

Retinofluor will cause:

  • a temporary decrease in vision and images appear red as a result of the flash photography.
  • urine to turn orange in colour for a brief period.

Tell your doctor or nurse if you notice any of the following and they worry you:

  • nausea
  • headache
  • tingling or numbness in the hands or feet, tongue and lips
  • excessive sneezing
  • yellow discolouration of the skin and eyes.

The above list includes the more common side effects of your medicine.

Tell your doctor as soon as possible if you notice any of the following:

  • dizziness, light-headedness
  • skin rash, itching, hives
  • vomiting, stomach upset, pain or cramping
  • intense lower back pain.

The above list includes serious side effects that may require medical attention.

If any of the following happen, tell your doctor immediately or go to the Emergency Department at your nearest hospital:

  • chest pain
  • shortness of breath, difficulty breathing which may be very severe and usually worsens when lying down
  • swelling, redness and severe pain at the injection site
  • sudden severe signs of allergy including:
    - rash, itching or hives on the skin
    - swelling of face, lips or tongue
    - shortness of breath, wheezing or trouble breathing.

The above list includes very serious side effects. You may need urgent medical attention or hospitalisation. These side effects are very rare.

Tell your doctor or nurse if you notice anything that is making you feel unwell. Other side effects not listed above may also occur in some people.

After being given Retinofluor

Storage

Retinofluor will be stored in the surgery, pharmacy or ward of a hospital. The injection is kept in a cool, dry place protected from light and stored at less than 30°C.

Retinofluor will only be opened when it is time for you to have the injection.

Product description

What it looks like

Retinofluor is an orange to red solution in a clear glass vial sealed with a grey rubber stopper and aluminium seal and a plastic flip off top.

Ingredients

  • Retinofluor 10% contains 100mg/mL of fluorescein sodium in water for injections.
  • Retinofluor 25% contains 250mg/mL of fluorescein sodium in water for injections.
  • Sodium hydroxide and/or hydrochloric acid are added to both strengths when required for pH adjustment.

This medicine does not contain lactose, sucrose, gluten, tartrazine or any other azo dyes, alcohol or preservatives.

Manufacturer

Retinofluor is made in Australia by:
Phebra Pty Ltd
19 Orion Road
Lane Cove West, NSW 2066
Australia

  • Retinofluor 10% 10mL vial.
    AUST R 23130
    Phebra product code INJ028
  • Retinofluor 10% 5mL in a 7mL vial.
    AUST R 121873
    Phebra product code INJ140
  • Retinofluor 25% 5mL in a 7mL vial.
    AUST R 23138
    Phebra product code INJ030

This leaflet was amended in May 2013.

Phebra and the Phi symbol are trademarks of Phebra Pty Ltd, 19 Orion Road, Lane Cove West, NSW 2066, Australia.

Published by MIMS May 2014

BRAND INFORMATION

Brand name

Retinofluor

Active ingredient

Fluorescein sodium

Schedule

S4

 

1 Name of Medicine

Fluorescein sodium.

2 Qualitative and Quantitative Composition

Fluorescein sodium 10% injection contains 100 mg in 1 mL (available in 5 and 10 mL vials) and fluorescein sodium 25% injection contains 250 mg in 1 mL (5 mL vials) in water for injection.
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

General.

Fluorescein sodium contains no iodine. A yellowish discolouration of the skin and conjunctiva may occur. This usually subsides after several hours. 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 drug incompatibility reactions. Don't use if container or closure is damaged in any way.

Extravasation at the injection site.

There is a possibility of extravasation at the injection site. This may cause discomfort, severe pain, subcutaneous granuloma, phlebitis, necrosis of the skin and/or neuritis. Therefore, care must be taken to avoid extravasation. If extravasation occurs, cease injection and take corrective action to minimise tissue damage and control pain.

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. Yannuzzi (1986) reports an incidence of 1 in 5,300 for these complications. In such cases there is often a history of cardiovascular disease (Karhunen 1986). It is, therefore, advisable that patients with a history of cardiovascular disease be carefully evaluated before receiving fluorescein sodium injection.

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.

Diabetes mellitus.

In some cases in 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.

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.

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 the elderly.

No data available.

Paediatric use.

Safety and effectiveness in children has not been established.

Effects on laboratory tests.

No data available.

4.5 Interactions with Other Medicines and Other Forms of Interactions

No data available.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

There have been no long-term studies using fluorescein sodium in animals to evaluate impairment of fertility.
(Category B3)
Neither human nor animal reproduction studies have been done with fluorescein sodium. It is also not known whether fluorescein sodium can cause foetal harm when administered to a pregnant woman or can affect reproduction capacity. Fluorescein sodium should therefore not be given to a pregnant woman.
 Fluorescein sodium has been shown to be present in breast milk in lactating women. It is therefore not advisable to administer to a nursing woman.

4.7 Effects on Ability to Drive and Use Machines

The effects of this medicine on a person's ability to drive and use machines were not assessed as part of its registration.

4.8 Adverse Effects (Undesirable Effects)

A summary of treatment of 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.
Other adverse effects reported in the literature include: vasovagal reaction with or without collapse; dyspnoea; convulsions; intense lower back pain; local complications such as paraesthesia, pain, thrombophlebitis and inadvertent intra-arterial injection; paraesthesia of tongue and lips; abdominal cramping; excessive sneezing and more serious reactions (see Section 4.4 Special Warnings and Precautions for Use).
Severe reactions (0.1 to 0.2%) such as anaphylactic reaction or respiratory and cardiac arrest (requiring medical treatment, see Section 4.4 Special Warnings and Precautions for Use), severe shock and rare cases of death have been reported. Fluorescein sodium dye will turn a patient's urine orange for a brief period. Extravasation (see Section 4.4 Special Warnings and Precautions for Use) can lead to severe pain at the injection site. Paraesthesia has occurred after administration of intravenous fluorescein sodium.
594,687 angiographic procedures reported in the literature indicated that the incidence of serious reactions was 1 in 18,020 and 1 in 49,557 fatal reactions. Reactions included anaphylactic shock, cardiac arrest, myocardial infarction and shock with hypotension or respiratory distress.
A USA survey of 221,781 fluorescein angiograms reported frequency rates of 1 in 63 for a moderate reaction (urticaria, syncope, thrombophlebitis, pyrexia, tissue necrosis or nerve palsy) and 1 in 1,900 for severe reactions (respiratory or cardiac events or tonic clonic seizures); there was one death.

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 http://www.tga.gov.au/reporting-problems.

4.9 Overdose

For information on the management of overdose, contact the Poisons Information Centre on 131126 (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 injection, 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)1. The expiry date can be found on the packaging.
1 AUST R 23130; AUST R 121873; AUST R 23138.

6.4 Special Precautions for Storage

Store below 30°C. Protect from light.

6.5 Nature and Contents of Container

Retinofluor (Fluorescein Sodium Injection) is a sterile single use injection supplied in cartons of 10 rubber capped vials.
It is presented as:
Retinofluor, Fluorescein Sodium 10% - 5 mL in a 7 mL vial. Pack of 10 vials.
Phebra product code - INJ140.
Retinofluor, Fluorescein Sodium 10% - 10 mL in a 10 mL vial. Pack of 10 vials.
Phebra product code - INJ028.
Retinofluor, Fluorescein Sodium 25% - 5 mL in a 7 mL vial. Pack of 10 vials.
Phebra product code - INJ030.

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)

S4.

Summary Table of Changes