Patient Information Leaflet

Warning! Keep this leaflet. The information on the immediate packaging is in a foreign language.
Fluoresceine SERB (Fluoresceine 10% Faure)
100 mg/ml (10%) solution for injection
Fluoresceinum natricum
Fluoresceine SERB and Fluoresceine 10% Faure are different trade names for the same medicinal product.
Please read this leaflet carefully before using this medicine, as it contains important information for you.

Keep this leaflet for future reference.
If you have any further questions, please consult your doctor.
If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of Contents

What Fluoresceine SERB is and what it is used for
Important information before using Fluoresceine SERB
How to use Fluoresceine SERB
Possible side effects
How to store Fluoresceine SERB
Contents of the pack and other information

1. What Fluoresceine SERB is and what it is used for

This medicine is intended for diagnostic use only.
Fluoresceine SERB contains fluorescein, a dye used in diagnostic procedures. Fluorescein is not used for treatment, as it has no pharmacological activity.
Fluorescein is used to perform fluorescein angiography. This examination involves taking photographs of the blood vessels in the back of the eye. The test is essential for confirming the diagnosis, guiding appropriate treatment decisions, and monitoring the condition of the retinal blood vessels over time.
Small amounts of sodium fluorescein are administered by intravenous injection into the arm or hand and are rapidly distributed throughout the body via the bloodstream, reaching the eyes within seconds. Using a specialized camera equipped with a specific filter that allows light to excite the dye, photographs of the fundus are taken at various time intervals (up to 30 minutes after injection).
The observed fluorescence pattern helps the physician identify abnormalities in ocular blood flow.
The dye is eliminated from the body via urine and feces within 48 hours.

2. Important information before using Fluoresceine SERB

When not to use Fluoresceine SERB

if the patient is allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6). In such case, inform the doctor about the allergy before administering fluorescein. If an allergic reaction is suspected, consult a physician.

Warnings and precautions
Before administration of Fluoresceine SERB, tell the doctor:

if the patient has previously been diagnosed with cardiovascular disease, diabetes, or lung disease,
if the patient has previously experienced allergies or asthma,
if the patient has previously had severe intolerance reactions during prior angiographic examinations or diagnostic tests using other contrast agents,
if the patient is taking beta-adrenolytic drugs (medications used to treat heart conditions), including beta-adrenolytic eye drops (medications used to treat eye diseases).

If any of the above points apply to the patient, inform the doctor before
administration of Fluoresceine SERB. Fluorescein may affect blood and urine test results.
Children and adolescents (under 18 years of age)
The use of Fluoresceine SERB in children and adolescents has not been studied. If use in this age group is necessary, the physician will adjust the dose accordingly.
Fluoresceine SERB and other medicines
Inform the doctor about all medicines currently used or recently used, as well as any medicines the patient intends to use, especially beta-adrenolytic drugs, including those in the form of eye drops.
Concomitant intravenous administration of sodium fluorescein with other solutions or mixing with other solutions or agents should be avoided, as interactions cannot be excluded.
Elderly patients
Fluoresceine SERB may also be used in patients aged 65 years and older.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, or suspects she may be pregnant, she should consult a doctor before using this medicine.
Pregnancy
There is insufficient data on the use of sodium fluorescein in pregnant women. Sodium fluorescein should be avoided during pregnancy unless absolutely necessary.
Breastfeeding
If the patient is breastfeeding, she should consult a doctor before using this medicine.
Fluorescein is excreted in breast milk. Breastfeeding should be interrupted for 7 days, and milk expressed and discarded during this period.
Driving and operating machinery
Until vision returns to normal, driving motor vehicles and operating machinery is not recommended.

3. How to use Fluoresceine SERB

This medicinal product is intended for intravenous injection use only for diagnostic purposes.
A single dose of Fluoresceine SERB (500 mg - 1 vial of 5 ml) will be administered as an intravenous
injection into the arm or hand.
Depending on the patient's response, the physician may use a higher or lower dose.
The physician will prepare and administer the injection.
Children and adolescents
When administering sodium fluorescein to children, dose adjustment is recommended, e.g. 5 mg/kg
body weight.
The patient must remain under close observation for at least 30 minutes after the procedure to monitor
for possible allergic reactions.
Fluoresceine SERB must not be administered intrathecally (into the spinal canal) or intra-arterially (into
an artery).

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
If you have any questions, please contact your doctor or nurse.
Some adverse reactions may be serious and may require immediate medical attention

Severe allergic reactions, including life-threatening anaphylactic shock, have been reported in patients administered Fluoresceine SERB. This condition requires immediate medical attention. You should immediately inform your doctor or nurse if any of the following symptoms occur after administration of Fluoresceine SERB: chest pain or tightness, wheezing, difficulty breathing, fever, rash and hives, swelling of the face, neck and throat, fainting.
Reactions at the site of administration, such as phlebitis: symptoms may include swelling, pain, redness at the injection site, which may lead to tissue damage. Inform your doctor if any of these symptoms occur.

The patient will be asked to remain under medical supervision for at least an additional 30 minutes after the procedure, if necessary.
Other adverse reactions include:
Frequency not known (cannot be estimated from available data):
cerebrovascular event, fainting, loss of consciousness, seizures, headache, dizziness,
paresthesia, cardiac arrest, acute myocardial infarction, bradycardia, tachycardia,
shock, thrombophlebitis, hypotension, hypertension, pallor, hot flushes,
respiratory arrest, pulmonary edema, asthma, laryngeal edema, dyspnea, cough, sensation of tightness
in the throat, throat irritation, sneezing, vomiting, vomiting reflex, nausea, abdominal pain,
skin inflammation, rash, cold sweats, erythema, itching, excessive sweating, skin discoloration, chromaturia
(change in urine color), chest pain, pain, malaise, feeling of warmth, chills.

Yellowish skin discoloration may occur after administration, but usually resolves within 6 to 12 hours.
Urine may become light yellow in color. The discoloration returns to normal within 24 to 36 hours.
Diagnostic tests
Fluorescein may alter the results of blood and urine laboratory tests for up to 3 to 4 days.
Fluorescein has been reported to interfere with serum digoxin and cortisol assay results.
If any of the above symptoms are severe, you should immediately inform your doctor or nurse.
If any adverse reactions occur, including those not listed in this leaflet, inform your doctor or nurse.
Reporting of adverse reactions
If any adverse reactions occur, including those not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse reactions can be reported directly to the Department of Monitoring of Adverse Drug Reactions at the Office for Registration of Medicinal Products,
Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 (22) 4921301
Fax: +48 (22) 4921309
Website: https://smz.ezdrowie.gov.pl
Reporting adverse reactions helps to provide more information on the safety of this medicine.

5. How to store Fluoresceine SERB

No special storage instructions are required.
The medicine will be stored by the physician.
Keep the medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
Do not use the medicine if the packaging is torn or shows signs of tampering.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Contents of the pack and other information

What Fluoresceine SERB contains

The active substance is fluorescein sodium. 1 ml of solution contains 100 mg of fluorescein sodium. One 5 ml ampoule contains 500 mg of fluorescein sodium.
Other components are sodium hydroxide (for pH adjustment) and water for injections.

What Fluoresceine SERB looks like and contents of the pack
Fluoresceine SERB is a dark orange solution available in 5 ml ampoules made of type I glass.
The pack contains 10 ampoules of 5 ml in a cardboard box.
For more detailed information, please contact the responsible entity or the parallel importer.
Responsible entity in Belgium, country of export:
Serb SA
Avenue Louise 480
1050 Brussels
Belgium
Manufacturer:
Laboratoires Serb
40 Avenue George V
75008 Paris
France
Parallel importer:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Repackaged in:
Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Belgium, country of export, licence number: BE162811
Parallel import licence number: 88/13

Information intended exclusively for healthcare professionals:

Prior to administration of Fluoresceine SERB, inspect the contents of the ampoule to ensure that there has been no discoloration of the product or precipitation of particles from the solution.
Do not mix or dilute Fluoresceine SERB in the syringe with other medicinal products or solutions.
Do not administer Fluoresceine SERB by intramuscular or intra-arterial route.
Do not administer other medicinal products with acidic pH (especially antihistamines) simultaneously through the same intravenous cannula, as this may lead to precipitation of fluorescein.
Extravasation of fluorescein solution should be avoided, as its high pH may cause severe damage to surrounding tissues (intense hand pain lasting several hours, moist skin necrosis, superficial phlebitis). Ensure correct placement of the needle within the vein. In case of extravasation, administration of the product must be stopped immediately.
Appropriate measures for the treatment of damaged tissues and analgesic therapy should be provided.
All information provided must be reviewed prior to administering Fluoresceine SERB to the patient.