Fluoresceine Serb

Leaflet attached to the packaging: information for the user

Warning! The leaflet should be kept. Information on the immediate packaging 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 drug.

You should carefully read the contents of the leaflet before using the drug, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if necessary.
• In case of any doubts, you should consult a doctor.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

• 1. What is Fluoresceine SERB and what is it 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. Package contents and other information

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

The drug is intended exclusively for diagnostic purposes.
The Fluoresceine SERB drug contains fluorescein, which is a dye used in diagnostic tests. Fluorescein is not used for treatment, as it is not a pharmacologically active substance.
Fluorescein is used to perform fluorescein angiography. This test involves taking photographs of the blood vessels in the eye. The test is necessary to confirm the diagnosis by the doctor, provide proper treatment guidelines, and maintain constant control of the condition of the blood vessels in the eye.
Small amounts of sodium fluorescein administered by intravenous injection into the arm or hand are distributed throughout the body by the bloodstream, reaching the eyes within a few seconds. With the help of a device equipped with a special filter, through which the light illuminating the dye passes, photographs of the eye are taken at different time intervals (up to 30 minutes after injection).
The visible pattern of staining on the photographs helps the doctor determine problems related to blood circulation in the eye.
The dye is excreted from the body with 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 any of the other ingredients of this drug (listed in section 6). In such a case, the doctor should be informed of the allergy before using fluorescein. If an allergy is suspected, the doctor should be consulted.

Warnings and precautions

Before administering Fluoresceine SERB, the doctor should be informed:

• if the patient has previously been diagnosed with cardiovascular disease, diabetes, or lung disease,
• if the patient has previously been diagnosed with allergies or asthma,
• if the patient has experienced severe intolerance reactions during previous angiographic tests or tests using other diagnostic agents,
• if the patient is taking beta-adrenergic blockers (drugs used to treat heart diseases), including beta-adrenergic blockers in the form of eye drops (drugs used to treat eye diseases).

If any of the above points apply to the patient, the doctor should be informed before using Fluoresceine SERB. Fluorescein may affect the results of blood and urine tests.

Children and adolescents (under 18 years of age)

The use of Fluoresceine SERB in children and adolescents has not been studied. If the use of the drug is necessary in this age group, the doctor will adjust the dose accordingly.

Fluoresceine SERB and other drugs

The doctor should be informed about all drugs currently or recently used by the patient, as well as any planned use of drugs, especially beta-adrenergic blockers, including those in the form of eye drops.
Concomitant intravenous use of sodium fluorescein with other solutions or mixing with other solutions or agents should be avoided, as interactions cannot be ruled out.

Elderly patients

Fluoresceine SERB can also be used by patients aged 65 and over.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, or suspects that they may be pregnant, they should consult their doctor before using this drug.
Pregnancy
There is insufficient data on the use of sodium fluorescein in pregnant women.
Sodium fluorescein should be avoided in pregnant women unless absolutely necessary.
Breastfeeding
If the patient is breastfeeding, they should consult their doctor before using this drug.
Fluorescein is excreted in breast milk. Breastfeeding should be interrupted for 7 days, and the milk should be expressed and discarded during this period.

Driving and operating machinery

Until vision returns to normal, it is not recommended to drive vehicles or operate machinery.

3. How to use Fluoresceine SERB

This drug is intended for use as an intravenous injection for diagnostic purposes only.
A single dose of Fluoresceine SERB (500 mg - 1 ampoule of 5 ml) will be administered by intravenous injection into the arm or hand.
Depending on the patient's response, the doctor may use a larger or smaller dose.
The doctor will prepare and administer the injection.

Children and adolescents

In the case of using sodium fluorescein in children, a dose modification is recommended, e.g., 5 mg/kg body weight.
The patient must remain under close observation for possible allergic reactions for at least 30 minutes after the test.
Fluoresceine SERB should not be injected intracanalically (into the spinal canal) or intraarterially (into an artery).

4. Possible side effects

Like all drugs, this drug can cause side effects, although not everybody gets them.
In case of questions, you should contact your doctor or nurse.

Some side effects can be serious and may require immediate medical attention

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

The patient will be asked to remain under medical supervision for at least an additional 30 minutes after the test if necessary.

Other side effects include:

Frequency not known (cannot be estimated from the available data):
vascular cerebral event, fainting, loss of consciousness, seizures, headaches, dizziness, paresthesia, cardiac arrest, acute myocardial infarction, bradycardia, tachycardia, shock, thrombophlebitis, hypotension, arterial hypertension, pallor, hot flashes, respiratory arrest, pulmonary edema, asthma, laryngeal edema, dyspnea, cough, sensation of throat constriction, throat irritation, sneezing, vomiting, nausea, abdominal pain, skin inflammation, rash, cold sweats, flushing, itching, excessive sweating, skin discoloration, chromaturia (change in urine color), chest pain, pain, malaise, feeling of heat, chills.
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Yellowish skin discoloration may occur after administration, but it usually disappears within 6 to 12 hours.
Urine may turn bright yellow. The color returns to normal after 24 to 36 hours.

Diagnostic tests

Fluorescein may change the results of blood and urine analytical tests for a period of 3 to 4 days. It has been reported that fluorescein affects the results of digoxin and cortisol tests in blood serum.
If any of the above symptoms are severe, you should immediately inform your doctor or nurse.
If you experience any side effects, including any side effects not listed in this leaflet, you should inform your doctor or nurse.

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, you should inform your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products,
Aleje Jerozolimskie 181C,
02-222 Warsaw,
phone: +48 (22) 49 21 301,
fax: +48 (22) 49 21 309,
website: https://smz.ezdrowie.gov.pl.
By reporting side effects, you can help gather more information on the safety of the drug.

5. How to store Fluoresceine SERB

There are no special recommendations for storage.
The drug will be stored by the doctor.
The drug should be stored in a place that is invisible and inaccessible to children.
Do not use this drug after the expiration date stated on the packaging. The expiration date is the last day of the specified month.
Do not use the drug if the packaging is torn or signs of its damage are visible.
Drugs should not be thrown into the sewage system or household waste containers. You should ask your pharmacist how to dispose of unused drugs. This will help protect the environment.

6. Package contents and other information

What Fluoresceine SERB contains

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

What Fluoresceine SERB looks like and what the package contains

Fluoresceine SERB is a dark orange solution available in type I glass ampoules with a capacity of 5 ml.
The package contains 10 ampoules of 5 ml in a cardboard box.
To obtain more detailed information, you should contact the marketing authorization holder or the parallel importer.

Marketing authorization holder in Belgium, the 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 by:

Delfarma Sp. z o.o.
ul. Św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
Belgian marketing authorization number, country of export: BE162811

Parallel import authorization number: 88/13 Date of approval of the leaflet: 25.01.2023

[Information about the trademark]

Information intended exclusively for medical professionals:

Before using Fluoresceine SERB, the contents of the ampoule should be checked to ensure that the product has not discolored or precipitated.
Do not mix or dilutethe drug in a syringe with other drugs or solutions.
Do not administerFluoresceine SERB intracanalically or intraarterially.
Do not administerthe drug simultaneously in the same intravenous line with other drugs with an acidic pH (especially antihistamine drugs), as this may cause precipitation of fluorescein.
Extravasation of the fluorescein solution outside the blood vessel should be avoided, as its high pH may cause severe damage to the surrounding tissues (severe pain in the hand lasting for several hours, wet gangrene of the skin, superficial phlebitis). The correct position of the needle in the vein should be ensured. In case of extravasation, the injection of the product should be stopped immediately.
Appropriate measures should be taken to treat damaged tissues and provide pain relief.

All the information provided should be consulted before using Fluoresceine SERB in a patient.