Verdye 5 mg/ml Powder for solution for injection

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

1. What Verdye is and what it is used for
2. What you need to know before you use Verdye
3. How to use Verdye
4. Possible side effects
5. How to store Verdye
6. Contents of the pack and other information

Verdye is a dark-green powder, which is mixed with water for injections. The active substance in the solution is called indocyanine green, a coloured dye. This solution is injected into one of your veins, where it mixes with your blood. The doctor will then be able to see:

• how far the dye moves from where it was injected
• how much of it there is in various parts of your body.

It is used for diagnosis only, to find out which medical problems you may have, for example:

a) how well the blood is flowing through a part of your body, for example:

• your heart
• your brain
• your liver
• a layer of the inner part of your eye called the choroid

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

c) how well your liver is working.

• if you are allergic to indocyanine green, sodium iodide or iodine
• if you suffer from an over-active thyroid or from benign tumours of the thyroid
• if you have ever had any side effects after receiving these injections.

Premature babies and new-born infants

If suffering from hyperbilirubinaemia (an illness in which there is an unusually large amount of bilirubin in their blood), premature babies and new-born infants should not receive Verdye.

Talk to your doctor or pharmacist before using Verdye,

• if you suffer from kidney failure. Consult your doctor to see whether this medicine is suitable for you.
• if you need to have a test called “radio-active iodine uptake”, a test which assesses how well your thyroid gland functions. This test should be delayed for at least a week after you have received Verdye, because the injection could affect the outcome of the thyroid test.

Tell your doctor or pharmacist if you are taking/using or have recently taken/used or might take/use any other medicines.

This applies especially

• if you are taking any drugs that affect the way your liver works, because the process of eliminating indocyanine green from your body after the injection may be affected.
• if you are taking/using, or think you may be taking/using, any of the drugs listed below, because some of these drugs could alter the way in which indocyanine green, the active substance in Verdye, is absorbed into the body, and could make the diagnosis inaccurate:
  • anticonvulsants (anti-epileptic drug)
  • morphine (severe pain-relieving drug)
  • any injections containing sodium bisulphite (preservative)
  • nitrofurantoin (antibiotic)
  • bisulphite compounds (preservative)
  • opium alkaloids (anti-diarrhoea drugs)
  • cyclopropane (anaesthetic drug)
  • pethidine (severe pain-relieving drug)
  • diamorphine (narcotic drug)
  • phenobarbital (anti-epileptic and anaesthetic drug)
  • haloperidol (antipsychotic drug)
  • phenylbutazone (pain relieving drug)
  • metamizole (pain relieving drug)
  • probenecid (drug for gout therapy)
  • methadone (drug for substitution treatment of opioid addicts)
  • rifamycin (antibiotic)

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before you receive this medicine. Your doctor will decide if it is appropriate to give you this medicine.

No studies on the effects on the ability to drive and use machines have been performed. Please check with your doctor before you consider driving or using machinery immediately after an injection.

Adults (18 - 64 years), the elderly (65 years or more), adolescents and children (11 - 18 years):

• For investigating blood flow through the heart, brain, general blood circulation and micro-circulation, (for example, blood flows through parts of the eye, the choroid), the recommended dose is 0.1 - 0.3 mg/kg body weight.
• For assessing liver function, the recommended dose is 0.25 - 0.5 mg/kg body weight.

Adults and the elderly:

The total daily dose should be kept below 5 mg/kg body weight.

Adolescents and children:

• (11 - 18 years): The total daily dose should be kept below 5 mg/kg body weight.
• (2 - 11 years): The total daily dose should be kept below 2.5 mg/kg body weight.
• (0 month - 2 years): The total daily dose should be kept below 1.25 mg/kg body weight.

Use in children and adolescents

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

Use in patients with kidney or liver impairment

Verdye should be dosed cautiously in the presence of severe kidney or liver impairment.

After the injection, your doctor may measure how much dye there is in relation to the amount of blood. Measurements are usually taken at an artery, a finger or an earlobe. You can ask your doctor to explain the techniques associated with your procedure.

Please tell your doctor if you think you have been given too much of the medicine.

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system Yellow Card Scheme, Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

By reporting side effects, you can help provide more information on the safety of this medicine.

The active substance is indocyanine green.

Each vial contains:

either

25 mg indocyanine green as powder (to be reconstituted with 5 ml water for injections)

or

50 mg indocyanine green as powder (to be reconstituted with 10 ml water for injections)

Verdye is a dark-green powder for solution for injection in an amber glass vial, which is sealed with a grey rubber stopper and fixed with an aluminium cap covered by a blue polypropylene cap.

It is available in two pack sizes:

• 5 vials, each containing 25 mg of indocyanine green
• 5 vials, each containing 50 mg of indocyanine green

Not all pack sizes may be marketed.