Patient leaflet - Fluorescein Sodium 100 mg/ml solution for injection
1. What Fluorescein Sodium Injection is and what it is used for
Fluorescein Sodium Injection contains the active ingredient fluorescein sodium which works as a diagnostic stain. It is used in adults (18 years and older) in a hospital-based procedure on the eye called fluorescein angiography of the ocular fundus (part of the eye).
Fluorescein angiography is a test that allows the blood vessels in the back of the eye to be photographed as a fluorescent dye is injected into the bloodstream. This will assist your doctor in the diagnosis of diseases which affect these blood vessels, especially in elderly people and diabetics.
This medicinal product is for diagnostic use only.
2. What you need to know before you are given Fluorescein Sodium Injection
Do not use Fluorescein Sodium Injection:
- if you are allergic (hypersensitive) to fluorescein sodium or any of the other ingredients of this medicine (listed in section 6).
- as an injection into the arteries (arterial route) or into the spinal column
(intrathecal route).
If the above applies to you or you are in any doubt you should ask your doctor or pharmacist for advice before being given this medicine.
Warning and Precautions:
Your doctor or other healthcare professional will give you this medicine through an injection into one of your veins.
Fluorescein Sodium Injection is for intravenous injection only and MUST NOT be injected into the arteries (arterial route) or into the spinal column (intrathecal route).
Reactions to this injection may happen during treatment with Fluorescein Sodium
Injection. Before injection, you may be given medicines that help to lower the chance of infusion-related reactions (see “Medicines given during treatment with Fluorescein Sodium Injection” in section 3). Tell your doctor or nurse straight away if you get any signs of an infusion-related reaction. These signs are listed at the beginning of section 4.
You must tell your doctor if:
- You have previously undergone a hospital procedure on the eye called fluorescein angiography of the ocular fundus (a part of the eye)
- You have a history of allergy or asthma
- You have a history of heart or pulmonary disease or diabetes
- You are taking drugs known as Beta-blockers including those applied in eye drops
- You have kidney disease
Fluorescein sodium can induce serious allergic reactions that are more frequent in patients who have either experienced an adverse reaction to a previous administration of the medicine or in patients with a known history of allergy including food or drug-induced urticaria (red, itchy skin also known as hives), asthma, eczema and hayfever. Your doctor will monitor you closely during and after the procedure and will ensure that appropriate emergency treatment facilities are available in case a serious reaction occurs.
Children and adolescents
The use of Fluorescein Sodium Injection in children and adolescents has not been studied. Therefore, this medicine should not be used in children and adolescents under 18 years old.
Taking other medicines
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines including medicines obtained without a prescription. Fluorescein sodium can sometimes interact with other medicines that you could be taking causing unwanted side effects. It is especially important to tell your doctor if you are taking any of the following:
- Medicines known as beta-blockers. These medicines can be used for a range of different therapeutic conditions and can be taken either by mouth or sometimes applied in eye drops. Common examples of beta-blockers include atenolol, bisoprolol, metoprolol and propranolol, betaxolol, levobunolol, and timolol.
- Medicines used for the treatment of gout (known as organic anion transporters) such as probenecid.
If you are due to have other diagnostic tests including blood and urine
Fluorescein Sodium Injection may interfere with the results of some blood and urine tests within 3 days of having the procedure. If you are having any blood or urine tests taken, you should tell the doctor or nurse that you have been given Fluorescein Sodium Injection.
Pregnancy, breastfeeding and fertility
If you are pregnant or think you may be pregnant prior to using Fluorescein Sodium Injection, tell your doctor who will decide whether to give you this medicine or not.
The use of Fluorescein Sodium Injection should be avoided in pregnant women unless absolutely necessary.
As Fluorescein sodium is excreted in breast milk, stop all breast feeding for 7 days after administration of Fluorescein sodium. During this period, breast milk should be expressed and discarded.
Driving or operating machinery
The angiography procedure causes dilation of the pupil. It is not recommended to drive vehicles or operate machinery until the eyesight returns to normal.
Fluorescein Sodium Injection contains sodium
This medicinal product contains 65.5 mg sodium (the main constituent of cooking/table salt) per dose. This is equivalent to 3.3% of the maximum recommended daily dietary amount for an adult. This should be taken into consideration if you are on a controlled sodium diet.
3. How to use Fluorescein Sodium Injection
Adults (including the elderly)
A doctor will administer Fluorescein Sodium Injection into the antecubital vein
(the antecubital vein is situated in the arm) usually through a cannula.
This medicine MUST NOT be injected via any other injection route, including into the arteries (arterial route) or into the spinal column (intrathecal route). The exact dose, to be determined by the doctor, is up to a maximum dose of Fluorescein sodium 500 mg (equivalent to one 5 ml ampoule) administered by intravenous injection.
Children and adolescents
Fluorescein Sodium Injection should not be used in people under the age of 18.
Use in patients with kidney problems
If you have a renal (kidney) impairment, the dose should not be adjusted.
If you are on kidney dialysis, your dose may be reduced to half of the normal recommended dose.
If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.
Medicines given during treatment with Fluorescein Sodium Injection
Before injection, your doctor or nurse may give you medicines that help to lower the risk of infusion related reactions. These include anti-histamines and corticosteroids
(a medicine that suppresses inflammation).
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. If you have undergone a similar examination, please tell your doctor if you have experienced an intolerance reaction regardless of how severe it may or may not have been.
Some side effects may be serious and may require medical attention
Severe allergic reactions, including life-threatening anaphylactic (uncommon, may affect up to 1 in 100 people)/ anaphylactoid shock (rare, may affect up to 1 in 1,000 people) have been reported in patients given Fluorescein Sodium Injection. These reactions require urgent medical attention.
If you experience any of the following reactions during the examination immediately tell the doctor:
- swelling of the hands, face, lips or tongue
- wheezing or difficulty in breathing
- chest pain or feeling of tightness
- a sudden, unexpected rash, hives or burning, red or peeling skin
- severe dizziness or fainting
- fast, deep breathing, cold clammy skin and feelings of anxiety
If the product leaks into the tissue surrounding the site of the injection (extravasation), a painful inflammatory reaction (swelling, pain and redness of the site of injection) could occur even leading to the death of tissue.
The patient will be asked to remain under medical care for at least an additional
30 minutes after the test if necessary.
Other side effects:
COMMON May affect up to 1 in 10 people | Abdominal discomfort |
UNCOMMON May affect up to 1 in 100 people | Allergic reactions such as oedema of the face, urticaria (red itchy skin also known as hives), loss of consciousness, lowering of blood pressure, vomiting, nausea, rash, redness and itching of the skin, malaise |
RARE May affect up to 1 in 1,000 people | Coma, blackout (also known as syncope), seizure (fits), headache, feeling dizzy, tingling (also known as paresthesia), taste change, shaking of part of your body, cardiac arrest, myocardial infarction, collapse of the cardiovascular system, slow heart rate, fast heart rate, shock, pallor, feeling flushed, laryngeal oedema, chest pain, breathing difficulties including shortness of breath or bronchospasm, cough, throat irritation, sneezing, abdominal pain, dermatitis, excessive sweating, discolouration (yellowing) of the skin and eyes, discolouration (yellowing) of the urine, oedema, asthenia, feeling hot, chills, pain at the site of injection (If the product leaks into the tissue surrounding the site of the injection (extravasation), a painful inflammatory reaction could occur even leading to the death of tissue.) |
VERY RARE May affect up to 1 in 10,000 people | Low platelet count, feeling numb (partial or total loss of sensation in a part of your body), respiratory arrest, pulmonary oedema, salivary hypersecretion, cold sweat, angina pectoris |
| NOT KNOWN | Cerebrovascular event such as a brain haemorrhage, aphasia, venous clot (also known as thrombophlebitis), high blood pressure, retching |
S. BLANCHET accord technique le 27/11/25
FP00000032_20251_NO
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme (Website: www.mhra.gov.uk/yellowcard). By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store your medicine
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and ampoule label after EXP. The expiry date refers to the last day of that month.
For single use only. Once opened the ampoule must be used immediately.
Any unused product or waste material should be disposed of in accordance with local requirements.
6. Contents of the pack and other information
What Fluorescein Sodium Injection contains
The active substance is fluorescein sodium (equivalent to 88.3 mg/ml of anhydrous fluorescein).
The other ingredients are sodium hydroxide and water for injections.
What Fluorescein Sodium Injection looks like and the contents of the pack
Fluorescein Sodium Injection is a clear red solution supplied in 5ml colourless glass ampoules. Each pack contains 10 ampoules of solution.
Marketing Authorisation Holder:
SERB SA
Avenue Louise, 480
1050 Brussels,
Belgium
The manufacturer of this product is:
SERB S.A.S
32 rue de Monceau
75008 Paris – France
Date of last revision: November 2025
The following information is intended for healthcare professionals only:
Posology:
Use in adults, including the elderly:
One 5 ml ampoule of fluorescein sodium 100 mg/ml to be injected intravenously into the antecubital vein after taking precautions to avoid extravasation.
Use in paediatric patients:
Fluorescein Sodium Injection should not be used in patients below 18 years as efficacy and safety in this group has not been established.
Use in patients with renal insufficiency (glomerular filtration rate below 20 ml/min):
There is limited data regarding the use of Fluorescein Sodium Injection in renally impaired patients (glomerular filtration rate below 20 ml/min) and indicates, in general, no dose adjustment is required. Patients with renal impairment will exhibit a slower excretion rate (see section 5.2 of the SmPC).
In dialysis patients:
Reduce the dose to 2.5 ml (half an ampoule) as an intravenous injection.
Method of administration and fluorescence angiography:
- Fluorescein Sodium Injection should be used exclusively by qualified physicians with technical expertise in performing and interpreting fluorescence angiography.
- This product should only be administered intravenously.
- Flush intravenous cannulas with sterile sodium chloride solution (0.9%) before and after medicinal products are injected to avoid physical incompatibility reactions. The injection should be administered into the antecubital vein, after taking precautions to avoid extravasation using a 23 gauge butterfly needle for injection. Luminescence usually appears in the retina and choroidal vessels in 15 to 20 seconds.
Precaution and advice for administration:
Fluorescein Sodium Injection MUST NOT be injected outside of the vein due to the alkaline pH of the solution.
It is important that the needle is inserted properly into the vein before starting the injection of Fluorescein Sodium Injection.
If the product leaks into the tissue surrounding the site of injection, further injection of fluorescein must be stopped immediately.
Incompatibilities:
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
To avoid physical incompatibilities, Fluorescein Sodium Injection should not be administered simultaneously with other solutions for injection, especially those with an acid pH (especially antihistamines) by the same intravenous route.
Special precautions for disposal and other handling:
For single use only. Any unused product or waste material should be disposed of in accordance with local requirements. Do not use Fluorescein for Injection if the ampoule is cracked or damaged or if there is any visible particulate matter or discolouration. After drawing up the solution into a syringe, the solution should be inspected visually again for particulate matter prior to administration. The solution should only be used if the solution is clear and free from particles.
Fluorescein Sodium Injection contains 65.5 mg sodium (the main constituent of cooking/table salt) per ampoule. This is equivalent to 3.3% of the maximum recommended daily dietary amount for an adult.
Instructions to open the ampoule:
Ampoules are equipped with the OPC (One Point Cut) opening system and must be opened following the below instructions:
- Hold bottom part of ampoule between thumb and index finger of one hand.
- Gently tab top part of ampoule with a finger of the other hand to get all liquid into bottom part.
- Put the other hand on top of ampoule positioning thumb above coloured point.
- Press with light, even pressure. The ampoule should break with a clean snap.
- Using too much force can cause the ampoule to shatter. If the ampoule shatters or if the opened ampoule contains visible glass particles after opening, discard it and use a new ampoule.
Special warning
Fluorescein Sodium injection can trigger severe allergic reactions (section 4.4 of the SmPC).
| If serious allergic reactions occur during the first angiography, any further requirement for a fluorescein angiography must be carefully considered: the value of the diagnosis must be weighed with the risk of severe hypersensitivity which development is sometimes fatal. |