Consumer Medicine Information (CMI) summary
The
full CMI on the next page has more details. If you are worried about using this medicine,
speak to your doctor or pharmacist.
This medicine is new or being used differently. Please report side effects. See the
full CMI for further details.
1. Why am I using Verdye Injection?
Verdye Injection contains the active ingredient indocyanine green. Verdye Injection
is used for the diagnosis of eye, heart and liver conditions.
2. What should I know before I am given Verdye Injection?
Do not use if you have ever had an allergic reaction to indocyanine green.
Talk to your doctor if you have any other medical conditions, take any other medicines,
or are pregnant or plan to become pregnant or are breastfeeding.
3. What if I am taking other medicines?
Some medicines may interfere with Verdye Injection and affect how it works.
4. How do I use Verdye Injection?
Your doctor will decide the correct dosage of Verdye Injection for you. This will
depend on your age, weight and the investigation being performed.
The doctor or nurse injects this medicine directly into a vein using a needle, catheter
or cardiac (heart) catheter, depending on the kind of investigation you are having.
5. What should I know while being given Verdye Injection?
Things you should do
|
Remind any doctor, dentist or pharmacist you visit that you have been given Verdye
Injection.
Check with your doctor if you are pregnant or intend to become pregnant.
Talk to your doctor if you are breastfeeding or intend to breastfeed.
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Things you should not do
|
Do not use Verdye Injection if you are allergic to indocyanine green, sodium iodide
or iodine.
Do not use Verdye Injection if you suffer from an over-active thyroid or from benign
tumours of the thyroid.
Do not use Verdye Injection if you have ever had any side effects after receiving
these injections.
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Driving or using machines
|
Check with your doctor before you consider driving or operating machinery immediately
after an injection.
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Looking after your medicine
|
Store below 25°C. Keep the glass vials in the outer carton in order to protect from
light.
The vials will usually be stored in the clinic for you.
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6. Are there any side effects?
Symptoms of severe allergic reactions include: tightness in the throat, itchy skin,
blotchy skin, nettle-rash, coronary artery spasm, facial swelling, breathing difficulties,
tightness and/or pain in the chest, faster heart-beat, a fall in blood pressure and
shortness of breath, heart failure (cardiac arrest), restlessness, feeling sick, feeling
of warmth or flushes.
This medicine is subject to additional monitoring. This will allow quick identification
of new safety information.
You can help by reporting any side effects you may get. You can report side effects
to your doctor, or directly at www.tga.gov.au/reporting-problems .
Active ingredient(s):
indocyanine green
Full Consumer Medicine Information (CMI)
This leaflet provides important information about using Verdye Injection. You should also speak to your doctor or pharmacist if you would like further information
or if you have any concerns or questions about using Verdye Injection.
Where to find information in this leaflet:
1. Why am I being given Verdye Injection?
Verdye Injection contains the active ingredient indocyanine green. Indocyanine green is a dark-green powder dye which is mixed with water for injections.
This dye is then 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:
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.
how much blood there is in certain parts of your body.
how well your liver is working.
2. What should I know before I am given Verdye Injection?
Warnings
Do not use Verdye Injection if:
you are allergic to indocyanine green, sodium iodide or iodine.
you suffer from an over-active thyroid or from benign tumours of the thyroid.
you have ever had any side effects after receiving these injections.
Take special care with Verdye Injection if:
you suffer from kidney failure. Consult your doctor to see whether this medicine is
suitable for you.
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 Injection, because the injection could affect
the outcome of the thyroid test.
During treatment, you may be at risk of developing certain side effects. It is important
you understand these risks and how to monitor for them. See additional information
under Section
6. Are there any side effects?
Pregnancy and breastfeeding
Check with your doctor if you are pregnant or intend to become pregnant. Your doctor
will decide if it is appropriate to give you this medicine.
Talk to your doctor if you are breastfeeding or intend to breastfeed. Ask your doctor
or pharmacist for advice before taking any medicine.
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 Injection.
3. What if I am taking other medicines?
Tell your doctor or pharmacist if you are taking any other medicines, including any
medicines, vitamins or supplements that you buy without a prescription from your pharmacy,
supermarket or health food shop.
Tell your doctor 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.
you are taking, or think you may be taking, any of the drugs listed below, because
some of these drugs could alter the way in which indocyanine green, the active substance
in Verdye Injection, is absorbed into the body, and could make the diagnosis inaccurate:
anticonvulsants (anti-epileptic drug)
cyclopropane (anaesthetic drug)
bisulphite compounds (preservative)
haloperidol (antipsychotic drug)
diamorphine (narcotic drug)
morphine (severe pain-relieving drug)
nitrofurantoin (antibiotic)
opium alkaloids (anti-diarrhoea drugs)
phenobarbital (anti-epileptic and anaesthetic drug)
pethidine (severe pain-relieving drug)
metamizole (pain relieving drug)
methadone (drug for substitution treatment of opioid addicts)
phenylbutazone (pain relieving drug)
probenecid (drug for gout therapy)
rifamycin (antibiotic)
any injections containing sodium bisulphite (preservative).
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect Verdye Injection.
4. How do I use Verdye Injection?
How Verdye Injection is given
The injection is given only under the supervision of a doctor.
Only water for injections is used to dissolve the indocyanine green powder.
The solution for injection has to be inspected before it is given to you. If it is
cloudy, it will not be used.
The doctor or nurse injects the medicine directly into a vein using a needle, catheter
or cardiac (heart) catheter.
The vein chosen for the injection will depend on the kind of investigation you are
having.
If this medicine is injected into a vein in your arm, the doctor or nurse may first
have to apply a temporary tourniquet. This is to make it easier to put the needle
into the vein.
The dose you receive will depend both on the sort of test which is being done and
on your body weight.
Your doctor may need to add something called heparin to the blood samples which she/he
takes from you. (This is to prevent the samples from clotting).
Single doses
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.
Maximum daily dose
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.
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.
If you have any further questions on the use of this medicinal product, ask your doctor
or pharmacist.
If you use too much Verdye Injection
Please tell your doctor if you think you have been given too much of this medicine.
You should immediately:
phone the Poisons Information Centre
(by calling
13 11 26), or
contact your doctor, or
go to the Emergency Department at your nearest hospital.
You should do this even if there are no signs of discomfort or poisoning.
5. What should I know while being given Verdye Injection?
Driving or using machines
Be careful before you drive or use any machines or tools until you know how Verdye
Injection affects you.
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.
Looking after your medicine
Store below 25°C.
Keep the glass vials in the outer carton in order to protect from light.
Once the solution for injection is prepared, it must be protected from light and used
immediately.
Only use clear solutions free from visible particles.
Do not use Verdye after the expiry date which is stated on the carton and on the label
of the vial. The expiry date refers to the last day of that month.
Store it in a cool dry place away from moisture, heat or sunlight; for example, do
not store it:
in the bathroom or near a sink, or
in the car or on window sills.
Keep it where young children cannot reach it.
Verdye Injection vials will usually be stored in the clinic for you.
Getting rid of any unwanted medicine
If you no longer need to use this medicine or it is out of date, take it to any pharmacy
for safe disposal.
Do not use this medicine after the expiry date.
6. Are there any side effects?
All medicines can have side effects. However, some side effects may need medical attention.
See the information below and, if you need to, ask your doctor or pharmacist if you
have any further questions about side effects.
Serious side effects are very rare and affect fewer than one in every 10,000 patients.
Serious side effects
Serious side effects
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What to do
|
Severe allergic reaction:
tightness in the throat
itchy skin
blotchy skin
nettle-rash
coronary artery spasm
facial swelling (facial oedema)
breathing difficulties
tightness and/or pain in the chest
faster heartbeat
a fall in blood pressure and shortness of breath
heart failure (cardiac arrest)
death
restlessness
feeling sick (nausea)
feeling of warmth
flushes
Together with the symptoms of the allergic reaction an increase of special white blood
cells associated with allergic reactions can occur (hypereosinophilia).
The possibility of an allergic reaction is greater in patients with extremely serious
kidney failure.
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Call your doctor straight away, or go straight to the Emergency Department at your
nearest hospital if you notice any of these serious side effects.
|
In the case of a severe allergic reaction, it may be necessary for you to receive
emergency treatment such as:
injections of adrenaline (epinephrine), hydrocortisone or antihistamine,
artificial blood or electrolyte solutions (by drip feed),
oxygen, to help your breathing.
Tell your doctor or pharmacist if you notice anything else that may be making you
feel unwell.
Other side effects not listed here may occur in some people.
Reporting side effects
After you have received medical advice for any side effects you experience, you can
report side effects to the Therapeutic Goods Administration online at
www.tga.gov.au/reporting-problems . By reporting side effects, you can help provide more information on the safety of
this medicine.
Always make sure you speak to your doctor or pharmacist before you decide to stop
taking any of your medicines.
7. Product details
This medicine is only available with a doctor's prescription.
What Verdye Injection contains
Active ingredient
(main ingredient)
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Indocyanine green
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Other ingredients
(inactive ingredients)
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None
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Do not take this medicine if you are allergic to any of these ingredients.
What Verdye Injection looks like
Verdye powder for solution for injection is available in a 5 pack:
5 amber glass vials containing 25 mg of the active ingredient indocyanine green (AUST
R 391356). The 25 mg vial is to be reconstituted with 5 mL water for injections.
The container is sealed with a grey rubber stopper and fixed with an aluminium cap
covered by a blue polypropylene cap.
Who distributes Verdye Injection
Clinect Pty Ltd
120-132 Atlantic Drive
Keysborough, VIC 3173
Australia
Telephone: 1800 899 005
This leaflet was prepared in November 2024.