Fluorescite 100 mg/ml roztvur do vstzhikivani

Leaflet attached to the packaging: information for the user

Fluorescite, 100 mg/ml, solution for injection

Fluorescein

Please read the contents of the leaflet carefully before using the medicine, as it contains important information for the patient.

• Please 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. See section 4.

Table of contents of the leaflet

• 1. What is Fluorescite 100 mg/ml solution for injection and what is it used for
• 2. Important information before using Fluorescite 100 mg/ml solution for injection
• 3. How to use Fluorescite 100 mg/ml solution for injection
• 4. Possible side effects
• 5. How to store Fluorescite 100 mg/ml solution for injection
• 6. Package contents and other information
• 7. Information for healthcare professionals

1. What is Fluorescite 100 mg/ml solution for injection and what is it used for

Fluorescite 100 mg/ml solution for injection is a dye solution that, during an examination, allows visualization of blood vessels on the back of the eye (this procedure is called fluorescein angiography). The medicine is intended solely for diagnostic purposes. It is not used to treat any disease.

2. Important information before using Fluorescite 100 mg/ml solution for injection

for injection

When not to use Fluorescite 100 mg/ml solution for injection

• if the patient is allergic (hypersensitive) to fluorescein or any of the other ingredients of this medicine (listed in section 6). If the patient suspects that they may be hypersensitive or allergic to fluorescein or any other ingredient of Fluorescite 100 mg/ml solution for injection, they should inform their doctor.

Warnings and precautions

Before administering Fluorescite 100 mg/ml solution for injection, the patient should tell their doctor:

• if the patient has previously been diagnosed with cardiovascular disease or diabetes
• if the patient has kidney function disorders.Fluorescein angiography may weaken or damage kidney function, which can pose a risk to people with severe kidney disease. The patient should consult their doctor to check if the examination is safe for them. If necessary, the doctor may use a lower dose of Fluorescite 100 mg/ml solution for injection.
• if the patient is taking beta-adrenergic blockers.Beta-adrenergic blockers are used to treat hypertension and many heart diseases, as well as in eye drops to treat glaucoma. An allergic reaction to Fluorescite 100 mg/ml solution for injection may cause a sudden drop in blood pressure. This is more likely to occur in patients who are taking beta-adrenergic blockers (such as atenolol, sotalol, propranolol, metoprolol, bisoprolol).
• if the patient has previously experienced an abnormal reaction to fluorescein.In such cases, to avoid this, another medicine can be used.
• if the patient is on a low-sodium diet.Fluorescite 100 mg/ml solution for injection contains up to 3.15 mmol (72.45 mg) of sodium per dose.

Before using Fluorescite 100 mg/ml solution for injection, the patient should inform their doctor if any of the above circumstances apply.

Fluorescite 100 mg/ml solution for injection and other medicines

The patient should tell their doctor about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take. Do not mix this medicine with other medicines.

Pregnancy, breastfeeding, and fertility

Pregnancy and fertility
The patient should inform their doctor if they are pregnant or plan to become pregnant. Fluorescite 100 mg/ml solution for injection can only be used if prescribed by a doctor.
Due to limited experience, the use of Fluorescite 100 mg/ml solution for injection in pregnant women requires special caution.
Breastfeeding
The patient should inform their doctor if they are breastfeeding. Fluorescein, the active substance of Fluorescite 100 mg/ml solution for injection, passes into human milk, from which it is slowly eliminated. Therefore, for 7 days after using Fluorescite 100 mg/ml solution for injection, the patient should not breastfeed. During this period, milk should be expressed and discarded.

Driving and using machines

During an ophthalmic examination, eye drops that dilate the pupils may be administered. This may temporarily impair vision and make it difficult to drive or operate machinery. The patient should not drive or operate machinery until their vision returns to normal.

Fluorescite 100 mg/ml solution for injection contains sodium

The medicine contains 72.45 mg of sodium (the main component of common salt) in each 5 ml dose. This corresponds to 3.7% of the maximum recommended daily intake of sodium in the diet for adults.

3. How to use Fluorescite 100 mg/ml solution for injection

Fluorescite 100 mg/ml solution for injection is administered by a doctor. Depending on the patient's condition, the doctor may change the dose of the medicine. The medicine has not been tested in children, so there is no data on dose adjustment for them. Fluorescite 100 mg/ml solution for injection should not be used in patients under 18 years of age, as its efficacy and safety in this group have not been established.

Administration by injection:

Usually, one vial of Fluorescite 100 mg/ml solution for injection is injected into a vein in the arm. Fluorescite 100 mg/ml solution for injection should not be injected intracanalically (into the spinal canal) or intraarterially (into an artery).
If the patient has any further doubts about the use of this medicine, they should consult their doctor.

4. Possible side effects

Like all medicines, Fluorescite 100 mg/ml solution for injection can cause side effects, although not everybody gets them.
The following side effects have been observed:

Very common side effects

May occur in more than 1 in 10 patients
Nausea

Common side effects

May occur in up to 1 in 10 patients
Vomiting, stomach problems, fainting, itching, bleeding or fluid leakage into tissues

Uncommon side effects

May occur in up to 1 in 100 patients
Headache, dizziness, tingling or numbness, cough, feeling of constriction in the throat, abdominal pain, hives, speech disorders, pain, feeling of heat, hypersensitivity, phlebitis

Rare side effects

May occur in up to 1 in 1000 patients
Severe allergic reactions, cardiac arrest, hypotension, shock, difficulty breathing or wheezing (bronchospasm)

Very rare side effects

May occur in up to 1 in 10,000 patients
Anaphylactic shock, seizures, angina pectoris, bradycardia, tachycardia, hypertension, vasoconstriction, muscle cramps, circulatory disorders, sudden flushing, pallor, hot flashes, respiratory arrest, pulmonary edema, asthma, respiratory failure, laryngeal edema, dyspnea, nasal congestion, sneezing

Frequency not known

(Cannot be estimated from the available data)
Stroke, chest pain, loss of consciousness, tremor, abnormal or impaired skin sensation, rash, cold sweats, skin inflammation, sweating, edema, generalized weakness, myocardial infarction, throat irritation, skin discoloration, taste disorders, and chills, diarrhea.
After receiving Fluorescite 100 mg/ml solution for injection, the patient may experience taste disorders. The skin may turn yellow, which usually resolves within 6-12 hours. The urine may also have a bright yellow color, which normalizes within 24-36 hours.
After injection, vein inflammation or blood clots may occur in the vein. If the solution leaks from the vein into the surrounding tissues, it may cause skin damage and inflammation of the veins, nerves, and tissues near the injection site. This can be a cause of severe pain.
If the patient experiences pain or other problems at the injection site, they should inform their doctor.
It may be necessary to administer a pain reliever or other medical assistance.
As mentioned earlier, fluorescein can cause unexpected severe side effects.
This is especially likely if the patient has previously had an abnormal reaction to fluorescein, has allergies (food or drug), eczema, asthma, or hay fever.
If any of the described side effects occur or if any side effects not listed in the leaflet occur, the patient should inform their doctor.

Laboratory tests of blood and urine

For 3-4 days after administration, fluorescein may affect the results of some blood and urine tests. If any blood or urine tests or further radiological examinations are planned during this time, the patient should inform their doctor about the fluorescein injection.

Reporting side effects

If any side effects occur, including any side effects not listed in the leaflet, the patient should tell their doctor or pharmacist. 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
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.
Reporting side effects will help gather more information on the safety of the medicine.

5. How to store Fluorescite 100 mg/ml solution for injection

The medicine should be stored out of sight and reach of children.
Do not use this medicine after the expiry date stated on the label and carton after "EXP". The expiry date refers to the last day of the month.
After opening, the contents of the vial must be used immediately.
Doctors or nurses know the proper way to store Fluorescite 100 mg/ml solution for injection.
Do not store above 25°C. Do not freeze. Store in the original packaging to protect from light.
Do not use Fluorescite 100 mg/ml solution for injection if the vial is cracked or damaged in any way.
Do not use this medicine if you notice any solid particles or a change in color. The solution can only be administered if it is clear and free of solid particles.
Any unused medicine or waste material should be disposed of in accordance with local regulations.

6. Package contents and other information

What Fluorescite 100 mg/ml solution for injection contains

• -The active substance is fluorescein. 1 ml of solution contains 100 mg of fluorescein in the form of 113.2 mg of sodium fluorescein. One vial of 5 ml contains 500 mg of fluorescein in the form of 566 mg of sodium fluorescein.
• -The other ingredients are sodium hydroxide and/or hydrochloric acid (to adjust the pH of the solution) and water for injection.

What Fluorescite 100 mg/ml solution for injection looks like and what the package contains

Fluorescite 100 mg/ml solution for injection is a clear, red-orange solution.
Fluorescite 100 mg/ml solution for injection is available in packages containing 12 vials of 5 ml of solution for injection.

Marketing authorization holder

Alcon Polska Sp. z o.o.
ul. Marynarska 15
02-674 Warsaw
tel.: (+48) 22 820 34 50

Manufacturer and importer responsible for batch release

S.A. Alcon-Couvreur N.V.
Rijksweg 14
B-2870 Puurs
Belgium
Alcon Laboratories Belgium
Lichterveld 3
2870 Puurs-Sint-Amands
Belgium

The product is also authorized for marketing in the European Economic Area and the United Kingdom (Northern Ireland):

Member state
Product name
Denmark
Anatera 100 mg/ml solution for injection
Finland
Fluorescite 100 mg/ml solution for injection
Netherlands
Fluorescite 100mg/ml oplossing voor injectie
Iceland
Anatera 100 mg/ml solution for injection
Lithuania
Fluorescite 100 mg/ml solution for injection
Germany
Fluorescein Alcon 10%
Norway
Anatera 100 mg/ml solution for injection
Poland
Fluorescite 100 mg/ml roztwór do wstrzykiwań
Sweden
Fluorescite 100 mg/ml solution for injection
United Kingdom (Northern Ireland)
Anatera 100mg/ml solution for injection
Date of last revision of the leaflet:06/2025

7. Information intended for healthcare professionals

The full Summary of Product Characteristics is attached to the packaging of this medicine as a separate document.