Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Fluorescein sodium may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
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.
Fluorescein Sodium Injection Do not use Fluorescein Sodium Injection:
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:
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 betablockers 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.
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).
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:
Other side effects: COMMON May affect up to 1 in 10 people UNCOMMON May affect up to 1 in 100 people
Abdominal discomfort 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
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.
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.
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 5 ml colourless glass ampoules. Each pack contains 10 ampoules of solution. Marketing Authorisation Holder:
The manufacturer of this product is:
SERB SA
SERB S.A.S
Avenue Louise, 480
Laboratoires Pharmaceutiques
1050 Brussels
32 rue de Monceau
Belgium
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:
MUST
NOT
be
injected
outside
of
the
vein
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.
Fluorescein sodium 100 mg/ml, solution for injection comes as injection containing 100mg/ml. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
The active substance in Fluorescein sodium 100 mg/ml, solution for injection is fluorescein sodium.
Medicines with the same active substance, strength and form include: ANATERA 100mg/ml solution for injection. They are interchangeable only if your prescriber or pharmacist says so.
This leaflet reproduces the patient information leaflet approved for Fluorescein sodium 100 mg/ml, solution for injection, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
Fluorescein angiography of the ocular fundus.
This medicinal product is for diagnostic use only.
Use in adults (18 years old and over), 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 100 mg/ml Solution for Injection has not been studied in children and dose-adaptation data are not available. Therefore Fluorescein Sodium 100 mg/ml Solution for 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 100 mg/ml Solution for Injection in renally impaired patients (glomerular filtration rate below 20ml/min) and indicates, in general, no dose adjustment is required. Patients with renal impairment will exhibit a slower excretion rate (see section 5.2)
In dialysis patients: Reduce the dose to 2.5ml (half an ampoule) as an intravenous injection.
Method of administration and fluorescence angiography
Fluorescein Sodium 100 mg/ml Solution for 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 (see section 4.4). Luminescence usually appears in the retina and choroidal vessels in 15 to 20 seconds.
For further instructions on the correct administration/use of this product, see sections 6.2 and 6.6.
Hypersensitivity to fluorescein or to any of the excipients listed in section 6.1.
Fluorescein Sodium 100 mg/ml Solution for Injection should not be injected by the intrathecal or intra-arterial routes.
Special warning
Hypersensitivity reactions: Fluorescein sodium can trigger severe allergic reactions:
A detailed medical history of each patient must be carried out before examination including any history of allergy, cardiopulmonary disease diabetes mellitus or concomitant treatments (in particular beta-blocking drugs, including those in ophthalmic dosage forms). If the examination appears to be necessary for a patient taking beta-blocking drugs, then the examination should be performed under the supervision of a physician experienced in intensive care and resuscitation. Beta-blocking drugs can reduce the vascular compensation reactions to anaphylactic shock and reduce the effectiveness of adrenaline in the case of cardiovascular collapse. Before any fluorescein sodium injection, the physician should check if the patient is treated with beta blocking drugs.
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.
These allergic reactions are most of the time unpredictable but they occur more frequently in patients who have poorly tolerated a previous injection of fluorescein sodium (other than by nausea and vomiting) or in patients who have displayed a history of allergy such as food- induced or iatrogenic urticaria, asthma, eczema, allergic rhinitis or in patients with history of bronchial asthma. These allergic reactions may not be detected by carrying out a specific intradermal skin allergy fluorescein test, whose results are unreliable and sometimes possibly dangerous. A specialised allergy consultation may provide a more precise diagnosis.
Premedication can be administered. However, it does not prevent the occurrence of severe adverse reactions. Premedication can include oral antihistamines, followed by corticosteroids before fluorescein is injected. Given the low percentage of adverse reactions, premedication may not be needed in all patients.
The risk of hypersensitivity reactions to fluorescein sodium means that it is necessary throughout the examination:
- to ensure close patient monitoring by the ophthalmologist carrying out the examination throughout the duration of the examination and for at least 30 minutes following completion of the examination. - to maintain the venous infusion line for at least 5 minutes, in order to treat any severe adverse drug reaction without delay;
- to have available the facilities required for emergency resuscitation, which are based on inserting a second intravenous line, permitting vascular filling (polyionic solution or colloidal plasma substitute) and the intravenous injection of adrenaline at an appropriate dose.
Cardiovascular complications
Severe cardiovascular complications such as chest pain, myocardial infarction and shock have occurred following administration of fluorescein sodium (see Section 4.8).
Extravasation
Due to the alkaline pH of the solution, care must be taken not to inject the fluorescein solution outside the vein as this can result in severe local tissue damage (severe pain in the arm for several hours, sloughing of the skin, superficial phlebitis). It is important to make sure that the needle is inserted properly into the vein before beginning to inject the fluorescein; if the product passes into the surrounding tissues (extravasation), the injection must be stopped immediately.
Laboratory tests
There are few case reports on potential interactions with organic anion transporters (e.g. probenecid) and interference with other diagnostic procedures.
Analytical interference is possible with blood and urine tests, due to the fluorescence, for up to 3 days after the procedure has been conducted.
Special warning
Each 5 ml ampoule of Fluorescein Sodium 100mg/ml Solution for Injection contains 65.5 mg sodium per ampoule, equivalent to 3.3% of the WHO recommended maximum daily intake of 2 g sodium for an adult. The amount of sodium should be taken into consideration by patients who are on a controlled sodium diet.
Fluorescein sodium is a relatively inert dye and specific drug interaction studies have not been reported. There are few case reports on potential interactions with organic anion transporters (e.g. probenecid).
Concomitant intravenous injections of other solutions, especially those with an acid pH (in particular antihistamines) may induce precipitation of fluorescein because of its alkaline pH. Therefore, concomitant use of, or the mixing of Fluorescein Sodium 100mg/ml Solution for Injection with other solutions should be avoided as the possibility of interactions cannot be excluded (see section 6.2 Incompatibilities).
Pregnancy
There are no or limited amount of data from the use of Fluorescein Sodium 100 mg/ml Solution for Injection during pregnancy. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3).
Animal studies demonstrate that fluorescein crosses the placental barrier (see section 5.3). The use of Fluorescein Sodium 100 mg/ml Solution for Injection should be avoided during pregnancy unless the benefit of the procedure is likely to exceed the risk.
Lactation
Fluorescein sodium is excreted in human milk for up to 7 days. Following fluorescein angiography, breast-feeding should therefore be discontinued for 7 days and the milk should be pumped off and discarded during this period.
Fertility
No human data on the effect of fluorescein on fertility are available. Animal studies have not been performed to evaluate the effect of fluorescein on fertility.
Due to the mydriasis induced by the angiography examination, visual acuity may be reduced and thus affects the patient's ability to drive or use machinery. Therefore, the patient must be made aware and advised not to drive or operate machinery until visual acuity returns to normal.
Summary of the safety profile
The most frequently reported, treatment related, undesirable effects were nausea, vomiting, syncope and pruritus. Less frequent, but more severe and serious, adverse reactions have been reported shortly after fluorescein injection such as: angioedema, respiratory disorders (bronchospasm, laryngeal oedema, respiratory failure), anaphylactic shock, hypotension, loss of consciousness, convulsion, respiratory arrest, and cardiac arrest.
Tabulated list of adverse reactions
The following undesirable effects have been observed to be treatment related and are classified according the convention: very common (≥ 1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (≥1/10,000). Within each frequency grouping, undesirable effects are presented by decreasing order of seriousness.
System Organ Classification
MedDRA Preferred Term (PT)
Frequency
Blood and lymphatic system disorders
Thrombocytopenia
Very rare
Immune system disorders
Anaphylactic shock, anaphylactic reaction, hypersensitivity
Uncommon
Anaphylactoid reaction
Rare
Nervous system disorders
Loss of consciousness
Uncommon
Coma, syncope, seizure, headache, dizziness, paraesthesia, dysgeusia, tremor
Rare
Hypoaesthesia
Very rare
Cerebrovascular event, aphasia
Not known
Cardiac disorders
Cardiac arrest, acute myocardial infarction, cardiovascular collapse, bradycardia, tachycardia
Rare
Angina pectoris,
Very rare
Vascular disorders
Hypotension
Uncommon
Shock, pallor, hot flush
Rare
Thrombophlebitis, hypertension
Not known
Respiratory, thoracic and mediastinal disorders
Laryngeal oedema, asthma, dyspnoea, cough, throat irritation, sneezing, bronchospasm
Rare
Respiratory arrest, pulmonary oedema
Very rare
Respiratory distress, throat tightness
Not known
Gastrointestinal disorders
Abdominal discomfort
Common
Vomiting, nausea
Uncommon
Abdominal pain
Rare
Salivary hypersecretion
Very rare
Retching
Not known
Skin and subcutaneous tissue disorders
Rash, erythema, urticaria, pruritus, angioedema
Uncommon
Dermatitis, hyperhydrosis, skin discolouration2
Rare
Cold sweat
Very rare
Renal and urinary disorders
Chromaturia3
Rare
General disorders and administration site conditions
Extravasation, malaise
Uncommon
Chest pain, oedema, asthenia, feeling hot, chills
Rare
Infusion site thrombosis4, pain
Not known
1 Hypersensitivity reactions including rare cases of anaphylactic/anaphylactoid shock which may have fatal outcome
2 A yellowish discoloration of the skin may appear following administration, but usually disappears within 6 to 12 hours.
3 Urine, which may also exhibit a bright yellow colouration, returns to its normal colour after 24 to 36 hours.
4 Extravasation of the solution which causes intense pain and may be followed by tissue necrosis (see Section 4.4 Special warnings and precautions for use
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation 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 via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.
No case of overdose has been reported.
Ask anything about Fluorescein sodium 100 mg/ml, solution for injection. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.
We use essential cookies to make the site work. We would also like to set optional cookies to understand how the site is used, so we can improve it. We will not set optional cookies unless you accept. See our cookie policy and privacy policy.