Label: information for the user

Verdye25 mg powder for injectable solution

Indocyanine green

Read this label carefully before starting to use this medication, as it contains important information for you.

• Keep this label, as you may need to read it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• This medication has been prescribed only for you, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this label. See section 4.

Verdye is a dark green powder that is mixed with water to prepare injectable preparations. The active principle of the solution is called indocyanine green, a dye. This dye is injected into one of your veins, where it mixes with the blood. Your doctor will be able to see:

•how far the dye travels from where it was injected

•how much is present in various parts of your body.

When Verdye is injected into the skin or subcutaneous fat of patients with breast cancer, it accumulates in the lymph nodes and visualizes the lymphatic pathways.

This medication is only for diagnostic use, to determine what medical problems you may have, for example:

a) how blood circulation works in a part of your body, for example:

− the heart

− the brain

− the liver

− a layer of the inner part of the eye called the choroid.

b) how much blood is present in certain parts of your body.

c) how your liver functions.

Verdye is also used to make visible the sentinel lymph nodes and lymphatic pathways or to identify them during surgery in adult patients with breast cancer. For this, the medication is injected into the skin, subcutaneous fat under the skin, or in the tumor area, instead of into the veins.

The lymph nodes closest to the tumor are called sentinel lymph nodes. It is most likely that these lymph nodes and associated lymphatic vessels are the first place where cancer cells spread. When Verdye has reached the sentinel lymph nodes, it can be checked if there are cancer cells present. Verdye accumulates in the sentinel lymph nodes and can be detected by a special camera.

No use Verdye:

• if you are allergic to indocyanine green or any of the other components of this medicine (listed in section 6).

• if you have hyperthyroidism or benign thyroid tumors.

• if you have ever experienced any side effects after receiving these injections.

Warnings and precautions

Consult your doctor, pharmacist or nurse before starting to use Verdye.

Be especially careful with Verdye if:

• you have kidney insufficiency.

Consult your doctor to see if this medicine is suitable for you.

• if you need to undergo a test called “iodine radioactive capture”, which evaluates the functioning of the thyroid gland.

This test should be postponed for at least one week after receiving Verdye, because the injection could affect the result of the thyroid test.

The skin may become more sensitive to sunlight and UV radiation in patients who receive Verdye injected into the skin or subcutaneous tissue. Therefore, affected patients should avoid direct exposure to the sun or artificial UV radiation (e.g. tanning bed) for at least 1 week after the application of Verdye, until any green discoloration in the injection site has disappeared.

The identification of sentinel lymph nodes and visualization of lymphatic pathways may be affected if they are located in deeper tissue layers or are covered by fatty tissue. Similarly, in patients with pronounced obesity (BMI >40), the mapping of sentinel lymph nodes and visualization of lymphatic pathways may be affected.Indocyanine green may be used in combination with radioisotopes whenindicated for the detection of sentinel lymph nodes.

Patient preparation

It may be useful to administer medication to sensitive patients to prevent nausea and vomiting and to perform the injection slowly.

Patients with kidney insufficiency and patients with liver insufficiency

Since severe kidney insufficiency has resulted in adverse reactions with the administration of indocyanine green, special attention should be paid to the indication for the use ofVerdyein these patients.

Reduced hepatic perfusion and/or liver function will lead to a reduced plasma disappearance rate of indocyanine green.

Patients with heart failure

Heart failure may influence the rate of extraction of indocyanine green due to reduced hepatic/splanchnic perfusion.

Children and adolescents

It is contraindicated to useVerdyein premature and newborn infants in whom an exchange transfusion is indicated for hyperbilirubinemia.

Use of Verdye with other medicines

Inform your doctor or pharmacist if you are using or have recently used or may need to use any other medicine.

Inform your doctor if:

• you are taking any medicine that affects liver function, because the process of eliminating indocyanine green from the body after injection may be affected.

• you are taking, or think you may be taking, any of the medicines listed below, because some of these medicines may alter the absorption of indocyanine green, the active ingredient of Verdye, and may make the diagnosis imprecise:

− anticonvulsants (medicines for treating epilepsy)

− cyclopropane (anesthetic)

− enalapril maleate (medicine for treating hypertension)

− haloperidol (medicine for treating mental illnesses and anxieties)

− meperidine (strong analgesic)

− metamizol (analgesic)

− methadone (medicine for treating opioid addiction)

− morphine and other opioids (strong analgesics and/or antidiarrheal medicines)

− nifedipine (medicine for treating hypertension)

− nitrofurantoin (antibiotic)

− phenobarbital (medicine for treating epilepsy and anesthetic)

− phenylbutazone (analgesic)

− progestin (contraceptive)

− propranolol (medicine for treating hypertension and heart conditions)

− rifampicin (antibiotic)

− any injection containing sodium bisulfite (preservative).

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant or intend to become pregnant, consult your doctor or pharmacist before using this medicine.

Driving and operating machinery

No studies have been conducted on the effects on the ability to drive and operate machinery.

Consult your doctor before driving or operating machinery immediately after an injection.

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor again.

This injection is administered only under the supervision of a doctor.

• To dissolve indocyanine green, only injectable preparation water is used.

• The injection solution must be inspected before administering it. If it is turbid, it will not be used.

• The doctor or nurse injects the medication directly into a vein using a needle, catheter, or cardiac catheter.

• The vein chosen for the injection depends on the type of study being performed.

• If this medication is injected into a vein in the arm, the doctor or nurse may apply a temporary tourniquet. This facilitates the insertion of the needle into the vein.

• The dose you receive will depend on the type of test being performed and your body weight.

• Your doctor may add a product called heparin to the blood samples they obtain. (It serves to prevent the blood samples from clotting).

• If this medication is injected into the skin, under the skin fat, or in the tumor area, a needle specifically made for this purpose will be used.

Adults

Single dose by measurement

Cardiac, circulatory, and microcirculatory diagnosis:

0.1 to 0.3 mg/kg of body weight in the form of a bolus injection

Liver function diagnosis:

0.25 to 0.5 mg/kg of body weight in the form of a bolus injection

Ophthalmic angiography:

0.1 to 0.3 mg/kg of body weight in the form of a bolus injection

Imaging of sentinel lymph nodes and visualization of lymphatic pathways, regardless of body weight:

1 to 10 mg per injection. The injection volume should not exceed 2 mL, and the concentration of indocyanine green should not exceed 5 mg/mL. Larger volumes may be administered per injection if dilutions of less than 5 mg/mL are used. A lower dose (1 to 5 mg per injection) may be advantageous if the administration is in the skin or under the skin fat. A higher dose (5 to 10 mg) may be advantageous in deeper tissue areas.

Total daily dose:

The total daily dose of Verdye should be less than 5 mg/kg of body weight.

For the detection of sentinel lymph nodes and visualization of lymphatic pathways, the total daily dose should not exceed 10 mg.

Older adults

Single dose by measurement

Cardiac, circulatory, and microcirculatory diagnosis:

0.1 to 0.3 mg/kg of body weight in the form of a bolus injection

Liver function diagnosis:

0.25 to 0.5 mg/kg of body weight in the form of a bolus injection

Ophthalmic angiography:

0.1 to 0.3 mg/kg of body weight in the form of a bolus injection

Imaging of sentinel lymph nodes and visualization of lymphatic pathways, regardless of body weight:

1 to 10 mg per injection. The injection volume should not exceed 2 mL, and the concentration of indocyanine green should not exceed 5 mg/mL. Larger volumes may be administered per injection if dilutions of less than 5 mg/mL are used. A lower dose (1 to 5 mg per injection) may be advantageous if the administration is in the skin or under the skin fat. A higher dose (5 to 10 mg) may be advantageous in deeper tissue areas.

Total daily dose:

The total daily dose of Verdye should be less than 5 mg/kg of body weight.

For the detection of sentinel lymph nodes and visualization of lymphatic pathways, the total daily dose should not exceed 10 mg.

Patients with renal insufficiency

In patients with terminal renal insufficiency, the incidence of anaphylactic reactions appears to increase.

Patients with liver insufficiency

For patients with liver function deterioration, there is a low plasma elimination rate.

Patients with heart failure

The extraction rate of ICG may be influenced in patients with heart failure due to reduced hepatic/splanchnic perfusion.

Use in children and adolescents

Single dose by measurement

Cardiac, circulatory, and microcirculatory diagnosis:

0.1 to 0.3 mg/kg of body weight in the form of a bolus injection

Liver function diagnosis:

Not recommended due to lack of data

Ophthalmic angiography:

0.1 to 0.3 mg/kg of body weight in the form of a bolus injection

Imaging of sentinel lymph nodes and visualization of lymphatic pathways:

Not recommended due to lack of data.

Total daily dose:

Children 0 to 2 years:old:

The total daily dose of Verdye should be less than 1.25 mg/kg of body weight.

Children 2 to 11 years old:

The total daily dose of Verdye should be less than 2.5 mg/kg of body weight.

Children 11 to 18 years old:

The total daily dose of Verdye should be less than 5 mg/kg of body weight.

If you use more Verdye than you should:

Inform your doctor if you think you have been given too much medication.

If you have any other questions about the use of this medication, ask your doctor or pharmacist.

Like all medications, this medication may produce adverse effects, although not all people will experience them.

Severe Allergic Reactions:Very rare (affect fewer than one in 10,000 patients).

The symptoms are:

• throat constriction

• pruritus

• skin discoloration

• urticaria

• coronary artery spasm

• facial edema

• respiratory difficulties

• chest oppression or pain

• rapid heartbeats

• decreased blood pressure and shortness of breath

• heart failure (cardiac arrest)

• restlessness

• nausea

• sensation of heat

• hot flashes.

The likelihood of an allergic reaction is higher in patients with extremely severe renal insufficiency. Additionally, reversible green discoloration of the skin at the injection site has been reported after application of indocyanine green to the skin or subcutaneous tissue.

If you experience symptoms ofsevere allergic reaction, you may need to receiveemergency treatment, such as:

• adrenaline, hydrocortisone, and antihistamine injections

• artificial blood or electrolyte solutions (via IV)

• oxygen to facilitate breathing.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through the Spanish Medication Adverse Event Reporting System:www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information about the safety of this medication

Keep this medication out of the sight and reach of children.

Do not store at a temperature above 86°F (30°C).

Glass vials must be stored in their outer packaging to protect the medication from light.

Once the injectable solution has been prepared, it must be protected from light and used immediately. Only use solutions that are free of visible particles.

Do not useVerdyeafter the expiration date that appears on the packaging and on the vial label. The expiration date is the last day of the month indicated.

Medications should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the containers and medications you no longer need. By doing so, you will help protect the environment.

Composition of Verdye

The active principle is indocyanine green.

Each amber glass vial contains:

25 mg of indocyanine green powder (to be reconstituted with 5 ml of water for injectable preparations).

Appearance of the product and contents of the packaging

Verdye injectable solution powder is available in the following presentation: 5 vials containing 25 mg of the active principle, indocyanine green.

The container is hermetically sealed with a grey rubber stopper and fixed with an aluminium cap covered by a blue polypropylene cap.

Marketing Authorization Holder:

Diagnostic Green Limited,

Athlone Business and Technology Park,

Garrycastle, Athlone, Westmeath

N37 F786, Ireland

www.diagnosticgreen.com

T: +353 90 646 5499

Last review date of this leaflet: December 2023.

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This information is intended solely for medical professionals or healthcare professionals:

The complete technical datasheet for Verdye 25 mg injectable solution powder is included as a separate document in the product packaging, in order to provide healthcare professionals with additional scientific and practical information on the administration and use of this medication.

Please consult the technical datasheet .