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CYCLOLUX 0.5 MMOL/ML SOLUTION FOR INJECTION

Active substance(s): GADOTERIC ACID

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Package leaflet: Information for the user
CYCLOLUX 0.5 mmol/ml
Solution for injection
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.
• If you get any side effects, talk to your doctor, radiologist or pharmacist. This includes any possible
side effects not listed in this leaflet. See section 4.

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

WHAT CYCLOLUX IS AND WHAT IT IS USED FOR

Cyclolux is a diagnostic agent. It belongs to the group of contrast agents used for magnetic resonance imaging
(MRI).
Cyclolux is used to enhance the contrast of the images obtained during MRI examination techniques. This
contrast enhancement improves the visualisation and delineation of:
• MRI of the CNS including defects (lesions) in brain, spinal cord and adjacent tissue;
• Whole body MRI including defects (lesions) in liver, kidneys, pancreas, pelvis, lungs, heart, breast and
musculoskeletal system;
• MR angiography including defects (lesions) and narrowing (stenosis) in arteries, except in coronary
arteries.
This medicine is for diagnostic use only.
2.

WHAT YOU NEED TO KNOW BEFORE CYCLOLUX IS USED

The information in this section should be read carefully.
The information given should be taken into consideration by you and your doctor or radiologist before you are
given Cyclolux.
You should NOT be given Cyclolux
• if you are allergic to the active substance or any of the other ingredients of this medicine (listed in
section 6).
• if you are allergic to medicines containing gadolinium (like other contrast agents used for magnetic
resonance imaging).
Warnings and precautions
Inform your doctor or radiologist if the following applies to you:
• you have previously reacted to a contrast agent during an examination
• you have asthma
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you have a history of allergy (such as seafood allergy, urticaria, hay fever)
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, or soon expect to have, a liver transplant
you have a disease affecting your heart or your blood vessels
you have had convulsions or you are being treated for epilepsy.

In all these cases, your doctor or radiologist will assess the benefit-to-risk ratio and decide whether you should
be given Cyclolux. If you are given Cyclolux, your doctor or radiologist will take the precautions necessary and
the administration of Cyclolux will be carefully monitored.
Your doctor or radiologist may decide to take a blood test to check how well your kidneys are working before
making the decision to use Cyclolux, especially if you are 65 years of age or older.
Neonates and infants
As kidney function is immature in babies up to 4 weeks of age and infants up to 1 year of age, Cyclolux will
only be used in these patients after careful consideration by the doctor.
Remove all metallic objects you may wear before the examination. Inform your doctor or radiologist if you
have:
• a pacemaker
• a vascular clip
• an infusion pump
• a nerve stimulator
• a cochlear implant (implant in the inner ear)
• any suspected metallic foreign bodies, particularly in the eye.
This is important as these can result in serious problems, as magnetic resonance imaging devices use very
strong magnetic fields.
Other medicines and Cyclolux
Tell your doctor or radiologist if you are taking or have recently taken any other medicines. In particular, please
inform your doctor, radiologist or pharmacist if you are taking or have recently taken medicines for heart and
blood pressure disorders such as beta-blocking agents (such as metoprolol), vasoactive substances (such as
doxazosin), angiotensin-converting enzyme inhibitors (such as ramipril), angiontensin II receptor antagonists
(such as valsartan).
Cyclolux with food, drink and alcohol
There are no known interactions between Cyclolux and food and drinks. However, please check with your
doctor, radiologist or pharmacist if it is required not to eat or drink before the examination.
Pregnancy, breastfeeding and fertility
If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor
or radiologist for advice before taking this medicine.
Pregnancy
Cyclolux should not be used during pregnancy unless strictly necessary.
Breastfeeding
Your doctor or radiologist will discuss whether you should continue breast-feeding or interrupt breast-feeding
for a period of 24 hours after you receive Cyclolux.
Driving and using machines
No data are available on the effects of Cyclolux on the ability to drive. If you feel unwell after the examination,
you should not drive or use machines.
3.

HOW CYCLOLUX IS USED

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Cyclolux will be administered to you by intravenous injection.
During the examination, you will be under the supervision of a doctor or radiologist. A needle will be left in
your vein; this will allow the doctor or radiologist to inject you with appropriate emergency drugs if necessary.
If you experience an allergic reaction, the administration of Cyclolux will be stopped.
Cyclolux can be administered by hand or by the mean of an automatic injector. In children, the product will
only be administered by hand.
The procedure will be carried out in a hospital, clinic or private practice. The attending staff know what
precautions have to be taken for the examination. They are also a ware of the possible complications that can
occur.
Dosage
Your doctor or radiologist will determine the dose you will receive and supervise the injection.
Dosage in special patient groups
The use of Cyclolux is not recommended in patients with severe kidney problems and patients who have
recently had, or soon expect to have, a liver transplant. However if use is required you should only receive one
dose of Cyclolux during a scan and you should not receive a second injection for at least 7 days.
Neonates, infants, children and adolescents
As kidney function is immature in babies up to 4 weeks of age and infants up to 1 year of age, Cyclolux will
only be used in these patients after careful consideration by the doctor. Neonates and infants should only
receive one dose of Cyclolux during a scan and should not receive a second injection for at least 7 days.
Use for angiography is not recommended in children less than 18 years of age.
Use for whole body MRI is not recommended in children less than 6 months of age.
Elderly
It is not necessary to adjust your dose if you are 65 years of age or older but you may have a blood test to check
how well your kidneys are working.
If too much Cyclolux has been administered to you
It is highly unlikely that you will be given an overdose. You will be given Cyclolux in a medical setting by a
trained person. In the real case of overdose, Cyclolux can be removed from the body by haemodialysis (blood
cleaning).
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 seven days after Cyclolux injection.
There is a small risk that you may have an allergic reaction to Cyclolux. Such reactions can be severe and
result in shock (case of allergic reaction that could put your life in danger). The following symptoms may be
the first signs of a shock. Inform immediately your doctor, radiologist or health professional if you feel any of
them:
• swelling of the face, mouth or throat which may cause you difficulties in swallowing or breathing
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swelling of hands or feet
lightheadedness (hypotension)
breathing difficulties
whistling respiration
coughing
itching
runny nose
sneezing
eye irritation
hives
skin rash

Very common side effects (may affect more than 1 in 10 people)
• headaches
• tingling sensation
Common side effects (may affect up to 1 in 10 people)
• sensation of warmth or cold and/or pain at the injection site
• nausea (feeling sick)
• vomiting (being sick)
• redness of the skin, itching and rash
Uncommon side effects (may affect up to 1 in 100 people)
• allergic reactions
Rare side effects (may affect up to 1 in 1,000 people)
• unusual taste in the mouth
• hives, increased perspiration
Very rare side effects (may affect up to 1 in 10,000 people)
• agitation, 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, accelered or slow heart beat, irregular heart beat, palpitations, low or high blood
pressure, vascular dilatation, pallor
• respiratory arrest, pulmonary oedema, breathing difficulties, feeling of tight throat, wheezing, stuffy
nose, sneezing, cough, dry throat
• diarrhoea, stomach pain, increased saliva secretion
• eczema
• muscle contractures, muscle weakness, back pain
• malaise, chest pain, chest discomfort, fever, chills, swelling of the face, fatigue, injection site
discomfort, injection site reaction, injection site swelling, diffusion of the product outside of blood
vessels that can lead to inflammation (redness and local pain) or tissue dying off at the injection site,
inflammation of a vein
• decrease in oxygen level in blood
There have been reports of nephrogenic systemic fibrosis (which causes hardening of the skin and may affect
also soft tissue and internal organs), most of which were in patients who received Cyclolux together with other
gadolinium-containing contrast agents. If, during the weeks following the MRI examination, you notice
changes in the colour and/or thickness of your skin in any part of your body, inform the radiologist who
performed the examination.
Reporting of side effects
If you get any side effects, talk to your radiologist, pharmacist, doctor or nurse. This includes any possible side
effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at:
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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 CYCLOLUX

Keep this medicine out of the sight and reach of children.
This medicinal product does not require any special precaution for storage.
Chemical and physical in-use stability has been demonstrated 72 hours at room temperature. From a
microbiological point of view, the product should be used immediately. If not used immediately, in-use storage
times and conditions prior to use are the responsibility of the user and would normally not be longer that 24
hours at 2 to 8°C, unless opening has taken place in controlled and validated aseptic conditions.
Do not use this medicine after the expiry date which is stated on the vial 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 Cyclolux contains
• The active substance is gadoteric acid. One millilitre of solution for injection contains 279.32 mg of
gadoteric acid (as meglumine salt), equivalent to 0.5 mmol of gadoteric acid (as meglumine salt).
• The other ingredients are meglumine, DOTA and water for injection.
What Cyclolux looks like and contents of the pack
Cyclolux is a clear, colourless to yellow solution for intravenous injection.
The Cyclolux pack contains one or ten vials with 10, 15 and 20 ml of solution for injection.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Sanochemia Pharmazeutika AG
Boltzmanngasse 11
1090 Vienna, Austria
Manufacturer
Sanochemia Pharmazeutika AG
Landeggerstrasse 7
2491 Neufeld/Leitha, Austria
This leaflet was last revised in June 2015.
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The following information is intended for medical or healthcare professionals only:
Posology
• Brain and spinal MRI: In neurological examinations, the dose can vary from 0.1 to 0.3 mmol/kg BW,
corresponding to 0.2 to 0.6 ml/kg BW. After administration of 0.1 mmol/kg BW to patients with brain
tumours, the additional dose of 0.2 mmol/kg BW may improve tumour characterisation and facilitate
therapeutic decision- making.
• MRI of other organs and Angiography: The recommended dose for intravenous injection is 0.1
mmol/kg (i.e. 0.2 ml/kg) to provide diagnostically adequate contrast.
• Angiography: 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, equivalent to
0.2 ml/kg BW may be justified. However, if the use of 2 consecutive doses of Cyclolux is anticipated
prior to commencing angiography, use of 0.05 mmol/kg BW, equivalent to 0.1ml/kg BW for each dose
may be of benefit, depending on the imaging equipment available.
• Children: The 0.1 mmol/kg BW dose applies to all indications except angiography due to insufficient
data on efficacy and safety in this indication.
Due to immature renal function in neonates up to 4 weeks of age and infants up to 1 year of age,
Cyclolux 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, Cyclolux injections should not be repeated unless the interval
between injections is at least 7 days.
In neonates and infants the required dose should be administered by hand.
• Patients with renal impairment: The adult dose applies to patients with mild to moderate renal
impairment (GFR ≥ 30 ml/min/1.73m2). See also below “Impaired renal function”.
• Patients with hepatic impairment: The adult dose applies to these patients. Caution is recommended,
especially in the case of perioperative liver transplantation period.
Method of administration
Cyclolux is indicated for intravenous administration only. Cyclolux must not be administered by subarachnoid
(or epidural) injection.
Infusion rate: 3-5 ml/min (for angiographic procedures, higher infusion rates up to 120 ml/min, i.e. 2 ml/sec,
may be used for angiographic procedures)
Optimal imaging: within 45 minutes after injection
Optimal image sequence: T1-weighted
Intravascular administration of contrast media should, if possible, be done with the patient lying down. After
the administration, the patient should be kept under observation for at least half an hour, since experience shows
that the majority of undesirable effects occur within this time.
Prepare a syringe with a needle. Remove the plastic disk. 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.
For single use only, any unused solution should be discarded.
The solution for injection should be inspected visually prior to use. Only clear solutions free of visible particles
should be used.
Impaired renal function
Prior to administration of Cyclolux, 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 gadoliniumcontaining contrast agents in patients with acute or chronic severe renal impairment (GFR < 30ml/min/1.73m2).
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 Cyclolux, it should therefore only be used in
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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. If it is necessary to use Cyclolux, 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,
Cyclolux injections should not be repeated unless the interval between injections is at least 7 days.
Haemodialysis shortly after Cyclolux administration may be useful at removing Cyclolux 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.
Elderly
As the renal clearance of gadoteric acid may be impaired in the elderly, it is particularly important to screen
patients aged 65 years and older for renal dysfunction.
Neonates and infants
See under Posology, Children
Pregnancy and lactation
Cyclolux 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 Cyclolux, should be
at the discretion of the doctor and lactating mother.
Instructions on handling
The peel-off tracking label on the vials 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.

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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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