Fluoresceine Serb

Package Leaflet: Information for the User

Fluoresceine SERB, 100 mg/ml (10%), Solution for Injection

(Fluorescein)

Read the package leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this package leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• If you experience any side effects, talk to your doctor. See section 4.

Contents of the Package 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. Contents of the pack and other information

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

This product is for diagnostic use only.
Fluoresceine SERB contains fluorescein, which is a dye used in diagnostic tests for adults (18 years and older). Fluorescein is not used for treatment, as it is not a pharmacologically active substance.
Fluorescein is used for 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, to provide proper treatment guidelines, and to maintain constant control of the condition of the blood vessels in the eye.
Small amounts of sodium fluorescein administered by intravenous injection are distributed throughout the body by the circulatory system, reaching the eyes within 15 to 20 seconds.
Using a device equipped with a special filter, through which the lighting passes, photographs of the eye are taken at different time intervals (up to 30 minutes after injection). The visible staining pattern on the photographs helps the doctor to determine problems related to blood circulation in the eye.
The dye is excreted from the body with urine and feces within 24-36 hours.

2. Important information before using Fluoresceine SERB

When not to use Fluoresceine SERB

• This medicine must not be injected into an artery (intra-arterial administration) or into the spinal canal (intrathecal administration).

Warnings and precautions

The doctor or other healthcare professional will administer this medicine by injection into one of the veins. Sodium fluorescein is intended only for intravenous injection and MUST NOT be administered into an artery (intra-arterial administration) or into the spinal canal (intrathecal administration).
A reaction to the injection may occur during the administration of Fluoresceine SERB. Before administration, the patient may be given medicines that help reduce the likelihood of an injection reaction (see: Medicines administered during the use of Fluoresceine SERB in section 3).
The doctor or nurse should be informed immediately if any symptoms of an injection reaction occur. These symptoms are listed at the beginning of section 4.

Before using Fluoresceine SERB, tell your doctor:

If any of the above points apply to you, you should inform your doctor before using Fluoresceine SERB.

Children and adolescents

Fluoresceine SERB should not be used in children and adolescents under 18 years of age, as its efficacy and safety have not been established in this age group. See section 2.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.
Pregnancy
There are limited data on the use of sodium fluorescein in pregnant women. Sodium fluorescein should not be used during pregnancy unless clearly necessary.
Breastfeeding
If you are breastfeeding, ask your doctor for advice before using this medicine.
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 using machines

As a result of angiography, the pupil will be dilated. You should not drive or operate machinery until your vision has returned to normal.

Fluoresceine SERB contains sodium

The medicine contains 65.5 mg of sodium (the main component of common salt) in each ampoule. This corresponds to 3.3% of the maximum recommended daily intake of sodium in the diet for adults.

3. How to use Fluoresceine SERB

This product is for diagnostic use only.

Adults

A single dose of Fluoresceine SERB (500 mg - 1 ampoule of 5 ml) will be administered by intravenous injection into the arm or hand.
The doctor will prepare and administer the injection.
Fluoresceine SERB must not be administered intrathecally (into the spinal canal) or intra-arterially (into an artery). Fluoresceine SERB should be administered into a vein (preferably into the cephalic vein in the hand) while taking precautions to avoid leakage of Fluoresceine SERB outside the vein into the surrounding tissues (extravasation).
The patient must remain under close observation for the occurrence of any allergic reactions for at least 30 minutes after the examination.

Children and adolescents

This medicine should not be used in children and adolescents under 18 years of age, as its efficacy and safety have not been established in this age group. See section 2.

Medicines administered during the use of Fluoresceine SERB

Before injection, the doctor or nurse may administer medicines to the patient that help reduce the risk of an injection reaction, such as antihistamines and corticosteroids (medicines that suppress inflammation).

4. Possible side effects

Like all medicines, Fluoresceine SERB can cause side effects, although not everybody gets them.
If you have any further questions, ask your doctor or pharmacist.

Some side effects may be serious and require immediate medical attention

• Severe allergic reactions, including anaphylactic shock (not very common, may affect up to 1 in 100 people) and anaphylactoid shock (rare, may affect up to 1 in 1,000 people) that can be life-threatening have been reported in patients who have used Fluoresceine SERB. This condition requires immediate medical attention. You should inform your doctor or nurse immediately if you experience any of the following symptoms after using Fluoresceine SERB: chest pain or tightness (rare, may affect up to 1 in 1,000 people) or chest tightness (frequency not known - cannot be estimated from the available data), wheezing (rare, may affect up to 1 in 1,000 people), difficulty breathing (rare, may affect up to 1 in 1,000 people), rash and urticaria (rare, may affect up to 1 in 1,000 people), swelling of the face, lips, tongue, fainting (rare, may affect up to 1 in 1,000 people).
• Reactions at the injection site, such as phlebitis: symptoms may include thrombosis at the injection site (frequency not known - cannot be estimated from the available data), swelling (rare, may affect up to 1 in 1,000 people), pain (frequency not known - cannot be estimated from the available data), redness at the injection site, which can cause tissue damage. If the medicine leaks into the tissues surrounding the injection site (extravasation) (not very common, may affect up to 1 in 100 people), a painful inflammatory reaction may occur, and tissue necrosis may occur. You should inform your doctor if you experience any of the above symptoms.
  You will be asked to remain under medical supervision for at least an additional 30 minutes after the examination, if necessary.

Other side effects include:

Not very common: may affect up to 1 in 100 people
allergic reactions, loss of consciousness, hypotension, vomiting, nausea, rash, erythema, urticaria, itching, malaise.
Rare, may affect up to 1 in 1,000 people
coma, seizures, headache, dizziness, paresthesia, taste disorders, tremors, cardiac arrest, acute myocardial infarction, cardiovascular collapse, bradycardia, tachycardia, shock, pallor, hot flashes, laryngeal edema, asthma, dyspnea, cough, throat irritation, sneezing, respiratory disorders, including bronchospasm, abdominal pain, skin inflammation, excessive sweating, skin discoloration (yellowish discoloration), urine discoloration (bright yellow discoloration), edema, weakness, feeling of heat, chills.
Very rare, may affect up to 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.
Frequency not known: cannot be estimated from the available data
vascular events, aphasia, thrombophlebitis, hypertension, respiratory disorders, feeling of constriction in the throat, gagging.

Reporting side effects

If you experience any side effects, talk to your doctor or pharmacist. Side effects can also be reported to the Department of Drug Safety Monitoring of 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. Side effects can also be reported to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Fluoresceine SERB

There are no special precautions for storage.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and ampoule after EXP.
The expiry date refers to the last day of that month.
Do not use the medicine if the packaging is damaged or shows signs of tampering.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack 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.
• The other ingredients are sodium hydroxide (to adjust pH) and water for injections.

What Fluoresceine SERB looks like and contents of the pack

Fluoresceine SERB is a dark orange solution available in sterile, tamper-evident, colorless glass ampoules of 5 ml.
The pack contains 10 ampoules of 5 ml in a cardboard box.

Marketing authorization holder

SERB SA
Avenue Louise, 480
1050 Brussels
Belgium

Manufacturer

SERB
40 avenue George V
75008 Paris
France
To obtain more detailed information, please contact the representative of the marketing authorization holder: Tel. +48 (0)22 307 03 61

Date of last revision of the package leaflet:

Information intended for healthcare professionals only:

Before using Fluoresceine SERB, carefully examine the contents of the ampoule to ensure that the product has not discolored or precipitated.
Do not mix or dilutethe product in a syringe with other medicines or solutions.
Flush the intravenous cannula before and after administration of the medicine to avoid the risk of reactions due to physical incompatibility.
Sodium fluorescein is for single use only. Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Do not administerFluoresceine SERB intrathecally or intra-arterially. Fluoresceine SERB should be administered into a vein, preferably into the cephalic vein in the hand, while taking precautions to avoid extravasation.
Do not administerFluoresceine SERB simultaneously with other medicines with an acidic pH (especially antihistamines) in the same intravenous cannula, as this may cause precipitation of fluorescein.
Avoid extravasation of the fluorescein solution, as its high pH may cause severe damage to the surrounding tissues (severe pain in the hand lasting for several hours, moist gangrene of the skin, superficial phlebitis). Ensure proper placement of the needle in the vein. In case of extravasation, discontinue administration of the product immediately. Ensure adequate measures for the treatment of damaged tissues and pain relief.
Fluoresceine SERB contains 65.5 mg of sodium (the main component of common salt) in each ampoule. This corresponds to 3.3% of the maximum recommended daily intake of sodium in the diet for adults.

Read the information in section 3 of this package leaflet and the Summary of Product Characteristics before using Fluoresceine SERB in a patient.