Verdie

Package Leaflet: Information for the User

VERDYE, 5 mg/ml, Powder for Solution for Injection

Indocyanine green

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.
In case of any doubts, consult a doctor, pharmacist, or nurse.
This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm them, even if their symptoms are the same.
If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. See section 4.

Table of Contents of the Package Leaflet

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

1. What is VERDYE and what is it used for

What is VERDYE

VERDYE is a dark green powder that is mixed with water for injection. The active substance in the solution is called indocyanine green and is a colored dye. This solution is then injected into one of the patient's veins, where it mixes with the blood. The doctor will then be able to see:

• how far the dye has spread from the injection site;
• how much of it is in different parts of the patient's body.

What is VERDYE used for

It is used exclusively for diagnostic purposesto find out what health problems the patient may have, for example:

• how well the blood flows through a particular part of the patient's body, such as:
• the heart,
• the brain,
• the liver,
• the inner layer of the eye called the choroid.
• how much blood is in certain parts of the patient's body.
• how well the patient's liver is working.

2. Important information before using VERDYE

When not to use VERDYE

if the patient is allergic to indocyanine green, sodium iodide, or iodine.
if the patient has hyperthyroidism or thyroid nodules.
if the patient has ever had side effects after receiving these injections.

Special patient groups

Premature infants and newborns

If they have hyperbilirubinemia (a disease in which there is an exceptionally high amount of bilirubin in the blood), premature infants and newborns should notreceive VERDYE.

Warnings and precautions

Before using VERDYE, the patient should discuss it with their doctor or pharmacist:

if the patient has kidney failure. The patient should contact their doctor to check if this medicine is suitable for them.
if the patient is to undergo a test called "radioactive iodine uptake", which assesses how well the thyroid gland is working. This test should be postponed for at least one week after receiving VERDYE, as the injection may affect the test results.

VERDYE and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take. This is especially important in the following situations:

if the patient is taking any medicines that affect liver function, as the elimination of indocyanine green from the body after injection may be disrupted.
if the patient is taking or suspects they may be taking any of the following medicines, as some of these medicines may change the way indocyanine green, the active substance of VERDYE, is absorbed into the body, which may make the diagnosis inaccurate:

• antiepileptic drugs (medicines for epilepsy)
• morphine (a strong pain reliever)
• cyclopropane (an anesthetic)
• nitrofurantoin (an antibiotic)
• hydrogen sulfide compounds (a preservative)
• opium alkaloids (anti-diarrheal medicines)
• haloperidol (an antipsychotic medicine)
• phenobarbital (an antiepileptic and anesthetic medicine)
• diamorphine (an opioid medicine)
• phenylbutazone (a pain reliever)
• pethidine (a strong pain reliever)
• probenecid (a medicine used to treat gout)
• metamizole (a pain reliever)
• rifamycin (an antibiotic)
• methadone (a medicine used for substitution therapy)
• any injections containing sodium hydrosulfite (a preservative)

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor before using this medicine. The doctor will decide whether to give the patient this medicine.

Driving and using machines

No studies have been conducted on the effects on the ability to drive and use machines.
Before driving or using machines after receiving the injection, the patient should consult their doctor.

3. How to use VERDYE

The injection is performed only under the supervision of a doctor.
Only water for injection is used to dissolve the green powder - indocyanine green.
The solution for injection must be checked before administration to the patient. If it is cloudy, it will notbe used.
The doctor or nurse injects the medicine directly into a vein using a needle, catheter, or cardiac catheter.
The vein chosen for injection depends on the type of test being performed.
If the medicine is injected into a vein in the arm, the doctor or nurse may first apply a temporary tourniquet. This is to facilitate the insertion of the needle into the vein.
The dose the patient receives will depend on both the type of test being performed and the patient's body weight.
The doctor may need to add a substance called heparinto the blood samples taken from the patient. This is to prevent the samples from clotting.
Recommended dosage(mg/kg = milligrams of medicine per kilogram of patient's body weight)

Single doses Adults (18-64 years), elderly (65 years or older), adolescents, and children

(11-18 years):
For blood flow testing through the heart, brain, general circulation, and microcirculation (e.g., blood flow through certain parts of the eye, choroid), the recommended dose is 0.1-0.3mg/kg body weight.
For liver function testing, the recommended dose is 0.25-0.5mg/kg body weight.

Maximum daily dose

Adults and elderly:

The totaldaily dose should be below 5mg/kg body weight.

Adolescents and children:

• (11-18 years): the total daily dose should be less than 5mg/kg body weight
• (2-11 years): the total daily dose should be less than 2.5mg/kg body weight.
• (0 months-2 years): the total daily dose should be less than 1.25mg/kg body weight.

Use in children and adolescents

Single doses used in children and adolescents are the same as in adults, but the total daily dose should be kept below 2.5 mg/kg body weight in children aged 2-11 years and below 1.25 mg/kg body weight in children aged 0-2 years.

Use in patients with renal or hepatic impairment

VERDYE should be dosed with caution in patients with severe renal or hepatic impairment.
After injection, the doctor may measure the amount of dye in relation to the amount of blood. Measurements are usually taken in an artery, finger, or earlobe. The patient can ask their doctor to explain the techniques involved in the procedure.

Overdose of VERDYE

The patient should inform their doctor if they think they have been given too much VERDYE.
In case of any further doubts about using this medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, VERDYE can cause side effects, although not everybody gets them.
Severe allergic reaction:very rare (may occur in less than 1 in 10,000 people):

• throat constriction,
• skin itching,
• skin spots,
• hives,
• coronary artery spasm,
• facial swelling (facial edema),
• breathing difficulties,
• chest tightness and/or pain,
• rapid heartbeat,
• blood pressure drop and shortness of breath,
• heart failure (cardiac arrest),
• restlessness,
• nausea (nausea),
• feeling of heat,
• hot flashes.

Along with the symptoms of an allergic reaction, there may be an increase in the number of special white blood cells associated with allergic reactions (hypereosinophilia).
The likelihood of an allergic reaction is higher in patients with severe kidney failure.
If a severe allergic reactionoccurs, the patient may need emergency treatment, such as:

• injection of adrenaline (epinephrine), hydrocortisone, or antihistamines,
• artificial blood or electrolyte solutions (in a drip),
• oxygen to help the patient breathe.

Reporting side effects

If side effects occur, including any not listed in this leaflet, the patient should tell their doctor, pharmacist, or nurse. Side effects can be reported directly to the national reporting system: Department of Drug Safety Monitoring, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, PL-02 222 Warsaw, Tel.: + 48 22 49 21 301, Fax: + 48 22 49 21 309, Website: https://smz.ezdrowie.gov.pl.
By reporting side effects, more information can be gathered on the safety of the medicine.
Side effects can also be reported to the marketing authorization holder.

5. How to store VERDYE

The medicine should be stored out of sight and reach of children.
Do not store above 30°C.
Store the glass vials in the outer packaging to protect from light.
After preparing the solution for injection, protect it from light and use immediately.
Use only clear solutions without visible particles.
Do not use this medicine after the expiry date stated on the carton and vial label. The expiry date refers to the last day of the month stated.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What VERDYE contains

The active substance of VERDYE is indocyanine green.
Each vial contains: 25 mg of indocyanine green in the form of a powder (for reconstitution in 5 ml of water for injection)

What VERDYE looks like and contents of the pack

VERDYE is a dark green powder for solution for injection in a type I orange glass vial, closed with a gray rubber stopper and protected with an aluminum seal and a blue PP cap.
Pack sizes:

• 5 vials, each containing 25 mg of indocyanine green.

Marketing authorization holder

Diagnostic Green Limited
Athlone Business and Technology Park
Garrycastle
Athlone
Co. Westmeath
N37 F786
Ireland
Email: [email protected]
Tel.: +353 90 646 5499

Manufacturer

Renew Pharmaceuticals Ltd.
Athlone Business and Technology Park
Garrycastle, Athlone, Co. Westmeath
N37 F786
Ireland

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Austria, Belgium, Croatia, Greece, Netherlands, Poland, Czech Republic, Italy: VERDYE
Denmark, Finland, Ireland, Portugal, Romania, Slovenia, Sweden, Hungary: Verdye

Date of last revision of the package leaflet: 24.02.2023

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Information intended for healthcare professionals only:

Instructions for use

The medicinal product should be reconstituted immediately before use.
This medicinal product is reconstituted by adding 5 ml of water for injection to a vial containing 25 mg of the active substance or 10 ml of water for injection to a vial containing 50 mg of the active substance, which in both cases gives a dark green solution for injection with a concentration of 5 mg/ml (0.5% w/v).
The reconstituted solution should be inspected. If any irregularities are found, such as cloudiness of the solution, the reconstituted solution should be discarded.
Only clear solutions without visible particles should be used.
This medicinal product is intended for single use only.