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ICG-PULSION

Active substance(s): INDOCYANINE GREEN

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PACKAGE LEAFLET: INFORMATION FOR THE USER

ICG-PULSION 5 mg/ml Injection
25 mg / 50 mg, powder for solution for injection
Indocyanine green

Read all of this leaflet carefully before you start using this medicine
medicine because it contains important information for you.





Keep this leaflet. You may need to read it again.
If you have any 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.

What is in this leaflet:
1.
2.
3.
4.
5.
6.
1.

What ICG-PULSION is and what it is used for
What you need to know before you use ICG-PULSION
How to use ICG-PULSION
Possible side effects
How to store ICG-PULSION
Content of the pack and other information
WHAT ICG-PULSION IS AND WHAT IT IS USED FOR

What ICG-PULSION is
ICG-PULSION 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 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.

What it is used for
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, through, 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.

2.
WHAT YOU NEED TO KNOW BEFORE YOU USE ICGPULSION
Do not use ICG-PULSION 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.
Special patient groups
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 ICG-PULSION.
Warnings and precautions
Take special care with ICG-PULSION 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 the
ICG-PULSION, because the injection could affect the outcome of the
thyroid test.
Other medicines and ICG-PULSION
Please note that the following information could also apply to products
which you used some time ago or which you may be using in the future, so
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 ICG-PULSION, is absorbed
into the body, and could make the diagnosis inaccurate:
- anticonvulsants (antiepileptic drug)
- cyclopropane (anaesthetic drug)
- bisulphite compounds
(preservative)
- haloperidol (antipsychotic drug)

- morphine (severe pain relieving drug)
- nitrofurantoin (antibiotic)
- opium alkaloids (anti-diarrhoea drug)
- phenobarbital (anti-epileptic and

- diamorphine (narcotic drug)
- pethidine (severe pain relieving
drug)
- metamizole (pain relieving drug)
- methadone (drug for substitution
treatment of opioid addicts)

anaesthetic drug)
- phenylbutazone (pain relieving drug)
- probenecid (drug for gout therapy)
- rifamycin (antibiotic)
- any injections containing sodium
bisulphite (preservative).

Please tell your doctor or pharmacist if you are taking or have recently taken
any other medicines, including medicines obtained without a prescription.
Pregnancy and breast-feeding
Tell your doctor before you receive ICG-PULSION if you are pregnant, think
you may be pregnant or if you are breast-feeding. Your doctor will decide if
it is appropriate to give you this medicine.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
No studies of 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.
3.
HOW TO USE ICG-PULSION
The injection is given only under the supervision of a doctor.

Only water for injections is used to dissolve the indocyanine green.
 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 depends 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).
Recommended dosages (mg/kg = milligrams of medicine for each
kilogram you weigh)
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 choroids), 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 use more of this medicine than you should
Please tell your doctor if you think you have been given too much of the
medicine.
If you have any further questions on the use of this medicinal product, ask
your doctor or pharmacist.
4.
POSSIBLE SIDE EFFECTS
Like all medicines, ICG-PULSION can cause side effects, although not
everybody gets them.
Severe allergic reaction: Very rare (affects fewer than one in every 10,000
patients):
The symptoms are:
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 heart beat
a fall in blood pressure and shortness of breath
heart failure (cardiac arrest)
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.
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.
Reporting of side effects
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. You can also
report side effects directly via the national reporting system Yellow Card
Scheme, Website: www.mhra.gov.uk/yellowcard
By reporting side effects, you can help provide more information on the
safety of this medicine.

5.

HOW TO STORE ICG-PULSION

Keep this medicine out of the reach and sight of children.
Do not store above 30°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 ICG-PULSION 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.
Do not throw away any medicines via waste water or household waste. Ask
your pharmacist how to throw away medicines you no longer use. These
measures will help protect the environment.
6.

CONTENTS OF THE PACK AND OTHER INFORMATION

What ICG-PULSION 5 mg/ml Injection contains
The active substance is indocyanine green.
Each amber glass 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).
What ICG-PULSION 5mg/ml Injection looks like and contents of the
pack
ICG-PULSION powder for solution for injection is available in two package
sizes: 5 vials containing either 25 mg or 50 mg of the active ingredient
indocyanine green.
The container is sealed with a grey rubber stopper and fixed with an
aluminium cap covered by a blue polypropylene cap.
Marketing Authorisation Holder and Manufacturer
PULSION Medical Systems SE, Hans-Riedl-Str. 21, 85622 Feldkirchen,
Germany; E-mail: Info@PULSION.com
Tel: +49-(0)89-459914-0, Fax: +49-(0)89-459914-18
This medicinal product is authorised in the Member States of the EEA
under the following names:
Austria:
ICG-PULSION
Belgium:
Indocyanine green PULSION 25 mg;
Indocyanine green PULSION 50 mg
Italy:
Verde indocianina PULSION
The Netherlands: ICG-PULSION 25 mg; ICG-PULSION 50 mg
Portugal:
Indocianina verde PULSION
Sweden:
Indocyaningrön Pulsion
United Kingdom: ICG-PULSION 5 mg/ml injection
This leaflet was last revised in 03/2015.
The following information is only intended for medical or healthcare
professionals only:
Handling instructions
This medicinal product should be reconstituted immediately prior to use.
This medicinal product is reconstituted by addition of 5 ml water for
injections to the vial containing 25 mg of active substance or 10 ml water for
injections to the vial containing 50 mg of active substance, respectively,
giving in both cases a dark-green solution for injection with a concentration
of 5 mg/ml (0.5 % w/v).
If an incompatibility is noted in the form of unclear solution then the
reconstituted solution should be discarded.
Visually inspect the reconstituted solution. Only use clear solutions free
from visible particles.
This medicinal product is for single use only.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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