Skip to Content

CLARISCAN 0.5 MMOL/ML SOLUTION FOR INJECTION

Active substance(s): GADOTERIC ACID

PDF options:  View Fullscreen   Download PDF

PDF Transcript

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
Clariscan 0.5 mmol/mL solution for injection
Clariscan 0.5 mmol/mL solution for injection in pre-filled syringe
Gadoteric acid
Read all of this leaflet carefully before you start using this medicine because it contains
important information for you.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or radiologist or pharmacist.
• If you get any of the side effects, talk to your doctor, radiologist or pharmacist. This includes any
possible side effects not listed in this leaflet. See section 4.
In this leaflet:
1. What Clariscan is and what it is used for
2. What you need to know before you are given Clariscan
3. How you will be given Clariscan
4. Possible side effects
5. How to store Clariscan
6. Contents of the pack and other information
1.

What Clariscan is and what it is used for

What Clariscan is
Clariscan contains the active substance gadoteric acid. It belongs to a group called “contrast agents”
used for magnetic resonance imaging” (MRI).
Clariscan is used to enhance the contrast of the images obtained during MRI examinations.
What Clariscan is used for
In adults and in children and adolescents 0-18 years old:

MRI of the CNS including of defects (lesions) in brain, spine, and surrounding tissues
In adults and in children and adolescents 6 months – 18 years old:

Whole body MRI including defects (lesions)
In adults only:

MR angiography including defects (lesions) or narrowing (stenosis) in arteries, except in
coronary arteries.
This medicine is for diagnostic use only
How Clariscan works
Clariscan makes the pictures on an MRI scanner easier to see. It does this by increasing the contrast
between the part of the body being looked at and the rest of the body. This allows doctors or
radiologists to see different areas of the body better.
2. What you need to know before you are given Clariscan
You should not be given Clariscan:


if you are allergic to gadoteric acid or any of the other ingredients of this medicine (listed in
section 6)

if you are allergic to medicines which contain gadolinium or other contrast agents used for
MRI.

Warnings and precautions
Remove all metallic objects you may wear before examination.
Talk to your doctor or radiologist before being given Clariscan if:

you have previously reacted to a contrast agent during an examination

you have asthma

you have a history of allergy - such as a seafood allergy, hay fever, urticaria (severe itching)

you are being treated with a beta-blocker (medicine for heart and blood pressure disorders,
such as metoprolol

your kidneys do not work properly

you have recently had a liver transplant – or expect to have one soon

you have had fits (seizures or convulsions) or you are being treated for epilepsy

you have a severe heart problem.

you have a disease affecting your heart or your blood vessels

you have a heart pacemaker, an iron-based (ferromagnetic) clip an implant or an insulin pump,
or any suspected metallic foreign bodies, particularly in the eye please. It is a condition where MRI is
not suitable.
Talk to your doctor or radiologist if any of the above apply to you before being given Clariscan.
Risk of serious side effects
As with all MRI contrast agents, there is a risk of side effects. The side effects are usually minor and
temporary but cannot be predicted. However, there is a risk they could endanger your life:

possible serious side effects may happen immediately or within one hour of being given the
medicine

side effects may happen up to 7 days after treatment. Side effects are more likely if you have
ever had a reaction to an MRI contrast agent in the past (see section 4 “Possible side effects”):

Tell your doctor or radiologist before being given Clariscan if you have had a reaction in the
past. Your doctor or radiologist will only give you Clariscan if the benefits outweigh the risks. If you
are given Clariscan, you will be carefully monitored by your doctor or radiologist.
Tests and checks
Your doctor or radiologist may decide to do a blood test before you are given Clariscan, especially if
you are over 65 years old. This is to check how well your kidneys are working.
Children and adolescents:
Use for angiography is not recommended in children less than 18 years of age.
New borns and infants
Your doctor or radiologist will carefully consider whether your baby can be given Clariscan. This is
because the kidneys are immature in babies up to up to 4 weeks and infants up to 1 year.
Use for whole body MRI is not recommended in children less than 6 months of age.
Other medicines and Clariscan

Tell your doctor or radiologist if you are taking, have recently taken or might take any other
medicines.
In particular, tell your doctor or radiologist if you are taking or have recently taken any of these
medicines for heart and high blood pressure:

a beta-blocker medicine – Medicines that slow your heart rate (such as metoprolol)

medicines enlarge (dilate) your blood vessels and decrease blood pressure: vasoactive
substances (such as doxazosin), angiotensin-converting enzyme (ACE) inhibitors (such as ramipril),
angiotensin II receptor antagonist (such as valsartan).
Tell your doctor or radiologist if you are taking or have recently taken any of the medicines listed
above.
Clariscan with food and drink
Nausea and vomiting are known possible undesirable effects when using MRI contrast agents. The
patient should therefore refrain from eating for 2 hours prior to the investigation.
Pregnancy and breast-feeding
Pregnancy
You must tell your doctor or radiologist if you are pregnant, think you may be pregnant or might
become pregnant. This is because Clariscan should not be given during pregnancy unless your doctor
decides it is necessary.
Breast-feeding
Tell your doctor or radiologist if you are breast-feeding or about to start breast-feeding. Your doctor
or radiologist will discuss with you whether you should continue breast-feeding. You may need to
stop breast-feeding for 24 hours after you have been given Clariscan.
Driving and using machines
No data are available on the effects of Clariscan on the ability to drive. However, while driving or
operating machines you should take into account dizziness (symptom of low blood pressure) and
nausea. If you feel unwell after the examination, you should not drive or use machines.
3.

How you will be given Clariscan

How Clariscan is given
Clariscan will be given to you by intravenous injection.
This will happen in a hospital, clinic or private practice.
Medical staff know the precautions that need to be taken.
They also know the possible complications that can happen.
During the examination, you will be supervised by your doctor or radiologist.

A needle will be left in your vein.

This will allow the doctor or radiologist inject you with emergency drugs if needed.

If you have an allergic reaction, the doctor or radiologist will stop giving you Clariscan.
How much you will be given
Your doctor or radiologist will decide how much Clariscan you will be given and supervise the
injection.
People with liver or kidney problems
The use of Clariscan is not recommended in patients with severe kidney problems or patients who
have recently had a liver transplant – or expect to have one soon.
However, if your doctor or radiologist decides to give you Clariscan:

you must only be given one dose of Clariscan during an MRI and

you must not be given a second injection for at least 7 days.
New borns, infants, children and teenagers
Clariscan will only be used in these patients after careful consideration by the doctor or radiologist.
However, if your doctor or radiologist decides to give your child Clariscan:

they must only be given one dose of Clariscan during an MRI scan and

they must not be given a second injection for at least 7 days.
Use for whole body MRI is not recommended in children less than 6 months of age.
Use for angiography is not recommended in children less than 18 years of age.
The elderly
Your dose will not be changed if you are 65 years of age or older. However, you may have a blood
test first to check how well your kidneys are working.
If too much Clariscan has been given to you
It is very unlikely that you will be given an overdose. This is because you will be given Clariscan in a
medical setting by a trained person.
In a real case of overdose, Clariscan can be removed from the body by cleaning your blood
(“haemodialysis”).
Additional information regarding the use and handling by the medical or healthcare professional is
given at the end of this leaflet.
If you have any further questions on the use of this medicine, ask your doctor or radiologist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
After the administration, you will be kept under observation for at least half an hour.
Most side effects occur immediately or sometimes delayed. Some effects can occur up to several days
after being given the Clariscan injection.

There is a small risk (rare) that you may have an allergic reaction to Clariscan. Such reactions
can be severe and exceptionally result in “shock” (a very rare case of allergic reaction that could put
your life in danger). Any of the symptoms listed below may be the first signs of shock.
Tell your doctor, radiologist or healthcare professional straight away if you have any of the
following signs – you may need urgent medical treatment:

swelling of the face, mouth or throat which may cause difficulties in swallowing or breathing

swelling of hands or feet

low blood pressure (hypotension- feeling faint)

breathing problems including breathing which sounds like a whistle

cough

itching

runny nose

sneezing or irritated eyes

patches of red skin, severe itching (urticaria)

Other side effects
Tell your doctor or radiologist if you notice any of the following side effects:
Very common: may affect more than 1 in 10 people

headaches

tingling sensation
Common: may affect up to 1 in 10 people

sensation of warmth or cold or pain where the injection was given

nausea (feeling sick)) vomiting (being sick)

redness of the skin, itching and rash
Uncommon: may affect up to 1 in 100 people

allergic reactions
Rare: may affect up to 1 in 1,000 people

unusual taste in the mouth

hives (patches of red skin, severe itching (urticaria))

increased sweating
Very rare: may affect up to 1 in 10,000 people

feeling agitated or anxiety

coma, seizures, syncope (brief loss of consciousness), faintness (dizziness and feeling of
imminent loss of consciousness), dizziness, disorder of smell (perception of often unpleasant odours),
tremor

conjunctivitis, red eye, blurred vision, increased tear secretion, eye swelling

cardiac arrest, accelerated or slow heartbeat, irregular heartbeat, palpitations, low or high
blood pressure, enlargement or relaxation of your blood vessels (vascular dilatation) leading to
lowering in your blood pressure and slow heartbeat, pallor

breathing stops suddenly (respiratory arrest), fluid on the lungs (pulmonary oedema),
breathing difficulties, feeling of tight throat, wheezing, feeling of blocked nose, sneezing, cough,
feeling of dry throat

diarrhoea, stomach pain, producing more saliva

eczema, other skin reactions (for example red skin)

muscle contractures, muscle weakness, back pain


feeling tired (malaise or fatigue)

chest pain or discomfort

fever or rigors

swelling of the face

swelling or a reaction or discomfort around the injection site, redness and pain, oozing of the
medicine outside the veins can lead to inflammation or death of the skin cells (necrosis) at the
injection site, blood clot in the vein which causes inflammation (superficial phlebitis)

less oxygen in the blood

Unknown: it is not known how often these happen
Nephrogenic Systemic Fibrosis
This is a disease which hardens the skin and may affect soft tissue and internal organs. This has been
mostly in patients who were given Clariscan together with other gadolinium containing contrast
agents.
Tell your doctor or radiologist if you notice any changes in the colour or thickness of your skin in any
part of your body as this may be a sign of the condition listed above.
The following side effects have occurred with other similar contrast agents for MRI: destruction of
your red blood cells (haemolysis), confusion, temporary blindness, eye pain, ringing in the ears
(tinnitus), ear pain, asthma, dry mouth, blister- like eczema of the skin, inability to control urine
(incontinence), kidney damage, acute renal failure, changes in electrocardiogram measurements of
your heart, changes in blood tests (increase in blood iron, increased bilirubin), abnormal liver tests.
Reporting of side effects
If you get any side effects, talk to your doctor or radiologist.
This includes any possible side effects not listed in this leaflet.
You can also report side effects directly via the national reporting system:
UK
The Yellow Card Scheme (Website: www.mhra.gov.uk/yellowcard).
Ireland
HPRA Pharmacovigilance
Earlsfort Terrace
IRL - Dublin 2
Tel: +353 1 6764971
Fax: +353 1 6762517
Website: www.hpra.ie
e-mail: medsafety@hpra
By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Clariscan
Keep this medicine out of the sight and reach of children.

The vials do not require any special storage conditions.
The pre-filled syringe must not be frozen.
Do not use this medicine after the expiry date which is stated on the vial or bottle or the pre-filled
syringe and on the carton, after the abbreviation “Exp”.
The expiry date refers to the last day of that month.
6. Contents of the pack and other information
What Clariscan contains

The active substance is gadoteric acid. One mL of solution for injection contains 279.3mg of
gadoteric acid (as gadoterate meglumine), equivalent to 0.5 mmol of gadoteric acid.

The other ingredients are meglumine, tetraxetan (DOTA) and water for injection.
What Clariscan looks like and contents of the pack
Clariscan is a clear, colourless to slightly yellow solution for intravenous injection.
Clariscan is available in the following containers:
Glass vials (Type 1, colourless) filled to 5, 10, 15 and 20 mL
Polymer pre-filled syringes filled to 10, 15 and 20 mL.
Glass bottles (Type 1, colourless) and polypropylene bottles filled to 50 and 100 mL.
All containers are packed in an outer box of 1 and 10 units.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
GE Healthcare AS
Nycoveien 1-2
P.O. Box 4220 Nydalen
NO-0401 OSLO
NORWAY
This leaflet was last revised in February 2017

The following information is intended for medical or healthcare professionals only:
Posology
Adults
MRI of brain and spine
The recommended dose is 0.1 mmol/kg, i.e. 0.2 mL/kg BW. In patients with brain tumours, an
additional dose of 0.2 mmol/kg BW, i.e. 0.4 mL/kg BW, may improve tumor characterisation and
facilitate therapeutic decision making.
Whole body MRI (including lesions of the liver, kidneys, pancreas, pelvis, lungs, heart, breast,
and musculoskeletal system)
The recommended dose is 0.1 mmol/kg BW, i.e. 0.2 mL/kg BW to provide diagnostically adequate
contrast.
For angiography: The recommended dose for intravenous injection is 0.1 mmol/kg BW, i.e. 0.2 mL/
kg BW to provide diagnostically adequate contrast.
In exceptional circumstances (e.g. failure to gain satisfactory images of an extensive vascular territory)
administration of a second consecutive injection of 0.1 mmol/kg BW, i.e. 0.2 mL/kg may be justified.
However, if the use of 2 consecutive doses of Clariscan are anticipated prior to commencing
angiography, the use of 0.05 mmol/kg BW (i.e. 0.1 mL/kg) for each dose may be of benefit,
depending on the imaging equipment available.
Special populations
Impaired renal function
Clariscan should only be used in patients with severe renal impairment (GFR < 30 mL/min/1.73m2)
and in patients in the perioperative liver transplantation period after careful risk/benefit assessment
and if the diagnostic information is essential and not available with non-contrast enhanced MRI. If it
is necessary to use Clariscan the dose should not exceed 0.1 mmol/kg body weight.
More than one dose should not be used during a scan. Because of the lack of information on repeated
administration, Clariscan injections should not be repeated unless the interval between injections is at
least 7 days.
Elderly (aged 65 years and above)
No dosage adjustment is considered necessary. Caution should be exercised in elderly patients.
Impaired hepatic function
The adult dose applies to these patients. Caution is recommended, especially in the case of
perioperative liver transplantation period (see above impaired renal function).
Paediatric population (aged 0-18 years)
Encephalic and Spinal MRI, Whole body MRI:
The recommended and maximum dose of Clariscan is 0.1 mmol/kg body weight. More than one dose
should not be used during a scan.

Use for whole body MRI is not recommended in children less than 6 months of age
Due to immature renal function in neonates up to 4 weeks of age and infants up to 1 year of age,
Clariscan should only be used in these patients after careful consideration, at a dose not exceeding 0.1
mmol/kg body weight. More than one dose should not be used during a scan. Because of the lack of
information on repeated administration, Clariscan injections should not be repeated unless the interval
between injections is at least 7 days.
Angiography:
Clariscan is not recommended for angiography in children under 18 years of age due to insufficient
data on its efficacy and safety in this indication.
Method of administration
The product is indicated for intravenous administration only.
Infusion rate: 3-5 mL/min (higher infusion rates up to 120 mL/min, i.e. 2 mL/sec, may be used for
angiographic procedures). For instructions on preparation and disposal.
Paediatric population (0-18 years). Depending on the amount of Clariscan to be given to the child, it is
preferable to use Clariscan vials with a single use syringe of a volume adapted to this amount in order
to have a better precision of the injected volume.
In neonates and infants, the required dose should be administered by hand.
Special warnings and precautions for use
Impaired renal function
Prior to administration of Clariscan it is recommended that all patients are screened for renal
dysfunction by obtaining laboratory tests.
There have been reports of nephrogenic systemic fibrosis (NSF) associated with use of some
gadolinium-containing contrast agents in patients with acute or chronic severe renal impairment
(GFR< 30mL/min /1.73 m2). Patients undergoing liver transplantation are at particular risk since the
incidence of acute renal failure is high in this group. As there is a possibility that NSF may occur with
Clariscan
It should therefore only be used in patients with severe renal impairment and in patients in the
perioperative liver transplantation period after careful risk/benefit assessment and if the diagnostic
information is essential and not available with non-contrast enhanced MRI.
As the renal clearance of Clariscan may be impaired in the elderly, it is particularly important to
screen patients aged 65 years and older for renal dysfunction.
Haemodialysis shortly after Clariscan administration may be useful at removing Clariscan from the
body. There is no evidence to support the initiation of haemodialysis for prevention or treatment of
NSF in patients not already undergoing haemodialysis.
Pregnancy and lactation
Clariscan should not be used during pregnancy unless the clinical condition of the woman requires use
of gadoteric acid.

Continuing or discontinuing breast feeding for a period of 24 hours after administration of Clariscan,
should be at the discretion of the doctor or radiologist and lactating mother.
Precautions for use and handling
For single use
The solution for injection should be inspected visually prior to use. Only clear solutions free of visible
particles should be used.
Vials and bottles: - Prepare a syringe with a needle. For vials, remove the plastic disk. For
polypropylene bottles remove the plastic screw cap or top plastic lid by pulling the top ring. After
cleaning the stopper with a pad soaked in alcohol, puncture the stopper with the needle. Withdraw the
quantity of product required for the examination and inject it intravenously.
Prefilled syringes: Inject intravenously the quantity of product required for the examination.
The remaining contrast medium in the vial/bottle, the connecting lines and all disposable components
in the injector system must be discarded after the examination
The peel-off tracking label: The peel-off tracking label on the syringes/vials/bottles should be stuck
onto the patient record to enable accurate recording of the gadolinium contrast agent used. The dose
used should also be recorded. If electronic patient records are used, the name of the product, the batch
number and the dose should be entered into the patient record.
Any unused medicinal product or waste material should be disposed of in accordance with local
requirements.

+ Expand Transcript

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Hide