Fluoresceine serb

Package leaflet: Information for the user

Warning! Keep this leaflet! Information on the immediate packaging is in a foreign language.
Fluoresceine SERB (Fluoresceína Oculos)
100 mg/ml, solution for injection
Fluoresceinum natricum
Fluoresceine SERB and Fluoresceína Oculos are different brand names for the same medicine.
Please read this leaflet carefully before using the medicine, as it contains
important information for the patient.

• Keep this leaflet to be able to read it again if necessary.
• If you have any doubts, 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

1. What Fluoresceine SERB is and what it is used for
2. Important information before using Fluoresceine SERB
3. How to use Fluoresceine SERB
4. Possible side effects
5. How to store Fluoresceine SERB
6. Contents of the pack and other information

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

This product is intended for diagnostic use only.
Fluoresceine SERB contains fluorescein, a dye used in diagnostic procedures in adults (18 years of age and older). Fluorescein is not used for treatment, as it is not a pharmacologically active substance.
Fluorescein is used to perform fluorescein angiography. This procedure involves taking photographs of the blood vessels in the back of the eye. This examination is essential for confirming the diagnosis, guiding appropriate treatment, and maintaining continuous monitoring of the blood vessels in the retina.
Small amounts of sodium fluorescein, administered by intravenous injection, are distributed throughout the body via the bloodstream, reaching the eyes within 15 to 20 seconds.
Using a camera equipped with a special filter that allows light to illuminate the dye, photographs of the back of the eye are taken at various time intervals (up to 30 minutes after injection). The pattern of fluorescence visible on the images helps the doctor identify problems related to blood circulation in the eye.
The dye is eliminated from the body through urine and feces within 24–36 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 administration of fluorescein. In case of suspected allergy, consult a physician.
• This medicine must not be injected into an artery (intra-arterial administration) or into the spinal canal (intrathecal administration).

Warnings and precautions
Fluoresceine SERB will be administered by injection into one of the veins by the attending physician or another healthcare professional. Sodium fluorescein is intended for intravenous use ONLY and MUST NOT be injected into an artery (intra-arterial administration) or into the spinal canal (intrathecal administration).
A reaction to the injection may occur during administration of Fluoresceine SERB. Prior to administration, the patient may be given medications to help reduce the likelihood of injection-related reactions (see: Medications administered during use of Fluoresceine SERB in section 3).
Inform the doctor or nurse immediately if any symptoms of an injection-related reaction occur. These symptoms are listed at the beginning of section 4.
Before administering Fluoresceine SERB, tell the doctor:

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

If any of the above points apply to the patient, inform the doctor before administering Fluoresceine SERB.
Children and adolescents
The use of Fluoresceine SERB in children and adolescents has not been studied. Therefore, this medicine should not be used in children and adolescents under 18 years of age.
Elderly patients
Fluoresceine SERB may be used in patients aged 65 years and older.
Fluoresceine SERB and other medicines
Inform the doctor about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take, especially beta-blockers, including those in the form of eye drops.
Avoid simultaneous intravenous administration of sodium fluorescein with other solutions or mixing with other solutions or agents, as interactions cannot be ruled out.
If the patient requires other blood or urine diagnostic tests
Fluorescein may affect the results of certain blood and urine tests for 3 to 4 days after administration. Fluorescein has been reported to interfere with serum digoxin and cortisol measurements.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, or suspects she may be pregnant, she should consult a doctor or other qualified healthcare professional before using this medicine.
Pregnancy
There are no data or only limited data on the use of sodium fluorescein in pregnant women. Sodium fluorescein should be avoided during pregnancy unless its administration is 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 discontinued for 7 days after administration, and milk expressed during this period should be discarded.
Driving and operating machinery
Pupil dilation is a consequence of angiography. Until vision returns to normal, driving and operating machinery are not recommended.
Fluoresceine SERB contains sodium
This medicine contains 65.5 mg of sodium (the main component of table salt) per ampoule. This corresponds to 3.3% of the maximum recommended daily sodium intake in the adult diet.

3. How to use Fluoresceine SERB

This product is intended for intravenous injection use only for diagnostic purposes.
Adults
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.
The physician will prepare and administer the injection.
Fluoresceine SERB must not be administered intrathecally (into the spinal canal) or intra-arterially (into the artery). Fluoresceine SERB should be given intravenously (preferably into the antecubital vein in the arm), taking precautions to avoid leakage of Fluoresceine SERB outside the vein into surrounding tissues (extravasation).
The patient must remain under close observation for at least 30 minutes after the procedure to monitor for possible allergic reactions.
Children and adolescents
This medicinal product should not be used in children and adolescents under 18 years of age, as efficacy and safety have not been established in this age group. See section 2.
Medicinal products administered during use of Fluoresceine SERB
Prior to injection, the physician or nurse may administer to the patient medicinal products that may help reduce the risk of reactions related to Fluoresceine SERB administration, such as antihistamines and corticosteroids (medicinal products that suppress the development of inflammation).

4. Possible adverse reactions

Like all medicines, this product may 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 require immediate medical attention

• Severe allergic reactions, including anaphylactic shock (uncommon, may affect less than 1 in 100 people), anaphylactoid shock (rare, may affect less than 1 in 1,000 people) have been reported in patients administered Fluoresceine SERB. Such conditions require immediate medical attention. Inform your doctor or nurse immediately if any of the following symptoms occur after administration of Fluoresceine SERB: chest pain or tightness in the chest (rare, may affect less than 1 in 1,000 people) or tightness in the chest (frequency unknown – cannot be estimated from available data), gasping (rare, may affect less than 1 in 1,000 people), difficulty breathing (rare, may affect less than 1 in 1,000 people), rash and urticaria (rare, may affect less than 1 in 1,000 people), swelling of the face, lips, tongue, fainting (rare, may affect less than 1 in 1,000 people).

• Reactions at the site of administration, e.g. phlebitis: symptoms may include thrombosis at the injection site (frequency unknown – cannot be estimated from available data), swelling (rare, may affect less than 1 in 1,000 people), pain (frequency unknown – cannot be estimated from available data), redness at the injection site which may lead to tissue damage. If the drug leaks into surrounding tissues (extravasation) (uncommon, may affect less than 1 in 100 people), a painful inflammatory reaction may occur, and even tissue necrosis may develop. Inform your doctor if any of the above 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:
Uncommon: may affect less than 1 in 100 people
allergic reactions, loss of consciousness, hypotension, vomiting, nausea, rash, erythema, urticaria, pruritus, malaise.

Rare: may affect less than 1 in 1,000 people
coma, convulsions, headache, dizziness, paresthesia, taste disturbances, tremor of various body parts, cardiac arrest, acute myocardial infarction, cardiovascular collapse, bradycardia, tachycardia, shock, pallor, hot flushes, laryngeal edema, asthma, dyspnea, cough, throat irritation, sneezing, respiratory disorders including airway constriction, abdominal pain, dermatitis, excessive sweating, skin discoloration (yellowish tint), change in urine color (bright yellow), edema, weakness, sensation of warmth, chills.

Very rare: may affect less than 1 in 10,000 people
low platelet count, partial or complete loss of sensation in parts of the body, respiratory arrest, pulmonary edema, excessive salivation, cold sweats.

Not known: frequency cannot be estimated from available data
cerebrovascular event, aphasia, thrombophlebitis, arterial hypertension, respiratory disorders, sensation of throat tightness, vomiting reflex.

If any of the above symptoms are severe, you must immediately inform your doctor or nurse.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Reactions of Medicinal Products at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, Tel: +48 22 49 21 301, Fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Fluoresceine SERB

Do not store above 25°C.
Keep the ampoules in the outer packaging.
Keep the medicine out of the 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 any signs of tampering.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the packaging and other information

What Fluoresceine SERB contains

• The active substance is sodium fluorescein. 1 ml of solution contains 100 mg of sodium fluorescein. One 5 ml ampoule contains 500 mg of sodium fluorescein.
• 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 sterile, hermetically sealed glass ampoules with a capacity of 5 ml.
The pack contains 10 ampoules of 5 ml in a cardboard box.
For further information, contact the marketing authorisation holder or the parallel importer.
Marketing authorisation holder in Spain, country of export:
SERB SA
Avenue Louise, 480
1050 Brussels
Belgium
Manufacturer:
SERB
40, Avenue George V
75008 Paris
France
Parallel importer:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw
Repackaged in:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Marketing authorisation number in Spain, country of export: 858480.2
Parallel import authorisation number: 217/20

Information intended exclusively for medical professionals:

Before administering Fluoresceine SERB, carefully inspect the contents of the ampoule,
ensuring that no discoloration of the product or precipitation of particles from the
solution has occurred.
Do not mix or dilute the product in the syringe with other medicinal products or solutions.
Flush the intravenous cannula before and after administration of the drug to avoid the risk of
reactions due to physical incompatibility.
Sodium fluorescein is intended for single use only. Any unused portions of the medicinal product or waste material should be disposed of in accordance with local regulations.
Do not administer Fluoresceine SERB intramuscularly or intra-arterially. Fluoresceine SERB should be administered preferably into the antecubital vein, taking appropriate precautions to avoid extravasation.
Do not administer other medicinal products with acidic pH (especially antihistamines) simultaneously through the same intravenous cannula, as this may cause precipitation of fluorescein.
Avoid leakage of fluorescein solution outside the blood vessel, as its high pH may cause severe damage to surrounding tissues (intense hand pain lasting for several hours, moist skin necrosis, superficial phlebitis). Ensure correct placement of the needle within the vein. In case of extravasation, immediately discontinue injection of the product. Appropriate measures for treatment of damaged tissues and analgesics should be provided.
Fluoresceine SERB contains 65.5 mg of sodium (main component of table salt) per ampoule. This corresponds to 3.3% of the maximum recommended daily dietary sodium intake for adults.
Please read the information contained in section 3 of this leaflet and the Product Characteristics
before administering Fluoresceine SERB to the patient.