CLARICYCLIC 0,5 MMOL/ML Roztwór do wstrzykiwań

Treść ulotki

1. Claricyclic 0.5 mmol/mL injectable solution
   1. What is Claricyclic and what is it used for
   2. What you need to know before using Claricyclic
   3. How to use Claricyclic
   4. Possible side effects
   5. How to store Claricyclic
   6. Contents of the pack and other information

Claricyclic 0.5 mmol/mL injectable solution

Claricyclic 0.5 mmol/mL injectable solution in pre-filled syringe
Gadoteric acid
Generic Medicine
contains important information for you.

• If you have any doubts, ask your doctor, radiologist or pharmacist.
• If you experience any side effects, including those not listed in this leaflet, ask your doctor, radiologist or pharmacist. See section 4.
• 1. What is Claricyclic and what it is used for
• 2. What you need to know before using Claricyclic
• 3. How to use Claricyclic
• 4. Possible side effects
• 5. How to store Claricyclic
• 6. Contents of the pack and other information

1. What is Claricyclic and what is it used for

What is Claricyclic
Claricyclic contains the active substance gadoteric acid. It belongs to a group called “contrast agents” and is used for magnetic resonance imaging (MRI).

What is Claricyclic used for
Claricyclic is used to improve the contrast of images obtained during MRI scans.
In adults and in children and adolescents from 0 to 18 years of age:

• MRI of the CNS including defects (lesions) of the brain, spinal cord and adjacent tissue; In adults and in children and adolescents from 6 months to 18 years of age:
• MRI of the whole body including defects (lesions)

For adults only

• MR angiography including defects (lesions) or narrowing (stenosis) of the arteries, except for the coronary arteries. This medicine is for diagnostic use only.

How Claricyclic works
Claricyclic facilitates the visualization of images on an MRI scanner, increasing the contrast between
the area being observed and the rest of the body. This allows the doctor or radiologist to better observe the
different areas of the body.

2. What you need to know before using Claricyclic

Do not use Claricyclic:

• 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 that contain gadolinium or other contrast agents used for MRI.

Warnings and precautions
Before the examination, remove all metallic objects you are wearing.
Consult your doctor or radiologist before receiving Claricyclic if:

• you have had a reaction to a contrast agent during a previous examination.
• you suffer from asthma
• you have a history of allergy, such as allergy to seafood, hay fever, urticaria (severe itching)
• you are taking a beta-blocker (medicine for heart problems or blood pressure such as metoprolol)
• your kidneys are not working properly
• you have recently undergone a liver transplant or are planning to undergo one in the near future
• you have suffered from seizures (epilepsy or convulsions) or are being treated for epilepsy
• you suffer from serious heart disorders.
• you suffer from disorders of the heart or blood vessels.
• you have a cardiac pacemaker implant, an iron-based (ferromagnetic) clip, a device or a pump for insulin or presumed metallic foreign bodies, especially in the eye. This is a condition not suitable for MRI.

Inform your doctor or radiologist if you fall into any of the above cases before receiving Claricyclic.

Risk of serious adverse effects
As with all MRI contrast agents, there is a risk of adverse effects. These adverse effects
are generally mild and temporary, but unpredictable. However, they may be life-threatening:

• possible serious adverse effects may occur immediately or within one hour of administration of the medicine
• adverse effects may occur up to 7 days after treatment. Adverse effects are more likely if you have had a reaction to another contrast agent in the past (see section 4 “Possible adverse effects”)
• Inform your doctor or radiologist if you have had a reaction in the past. The doctor or radiologist will only administer Claricyclic if the benefits outweigh the risks. If Claricyclic is administered, you will be carefully monitored by the doctor or radiologist.

Tests and checks
The doctor or radiologist may decide to perform a blood test before administering
Claricyclic, especially if you are over 65 years of age. This is to check how your
kidneys are functioning.

Children and adolescents
Use in angiography is not recommended in children under the age of 18 years.

Infants and toddlers
The doctor or radiologist will carefully assess whether your child can take Claricyclic, because the
kidneys are immature in newborns up to 4 weeks of age and in children up to 1 year of age.
Use in whole-body MRI is not recommended in children under 6 months of age.

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

• beta-blockers - medicines that slow down the heartbeat (e.g. metoprolol), medicines that widen (dilate) blood vessels and reduce blood pressure: vasoactive substances (e.g. doxazosin), angiotensin converting enzyme (ACE) inhibitors (e.g. ramipril), angiotensin II receptor antagonists (e.g. valsartan).

Inform your doctor or radiologist if you are taking or have recently taken any of the
above medicines.

Claricyclic with food and drink
Nausea and vomiting are known to be possible adverse effects resulting from the use of
MRI contrast agents. The patient should therefore refrain from eating food in the 2 hours preceding the examination.

Pregnancy and breastfeeding
Pregnancy
Inform your doctor or radiologist if you are pregnant, suspect you are pregnant or are planning a pregnancy.
Claricyclic should not be administered during pregnancy unless your doctor considers it
necessary.

Breastfeeding
Inform your doctor or radiologist if you are breastfeeding or intend to do so. The doctor or radiologist
will assess with you whether to continue or discontinue breastfeeding. It may be necessary
to interrupt breastfeeding for 24 hours after receiving Claricyclic.

Driving and operating machinery
There is no data available on the ability to drive vehicles. However, when driving or using
machinery, the onset of dizziness (symptom of a lowering of pressure) and nausea should be considered. If you do not feel well after the examination, do not drive vehicles and do not use tools or
machinery.

3. How to use Claricyclic

How to use Claricyclic
Claricyclic is administered via intravenous injection.
The injection is performed in a hospital, clinic, or private practice.
Medical personnel are aware of the precautions that must be taken.
Medical personnel are also aware of the complications that may occur.
During the examination, you will remain under the control of the doctor or radiologist.

• A needle will be left in your vein.
• This will allow the doctor or radiologist to inject you with emergency medications, if necessary.

In case of an allergic reaction, the doctor or radiologist will stop the administration of Claricyclic.

Quantity administered
The doctor or radiologist will decide the amount of Claricyclic that will be administered to you and will monitor
the injection.

Patients with liver or kidney problems
The use of Claricyclic is not recommended in patients with severe kidney problems or who have
recently undergone a liver transplant or are planning to undergo one in the immediate
future.
In any case, if the doctor or radiologist decides to administer Claricyclic to you:

• you must receive a single dose of Claricyclic during the MRI examination and
• you must not receive a second injection before at least 7 days have passed.

Infants, children, and adolescents
Claricyclic will be used in these patients only after careful evaluation by the doctor or
radiologist. In any case, if the doctor or radiologist decides to administer Claricyclic to your child:

• your child must receive a single dose of Claricyclic during the MRI examination and
• your child must not receive a second injection before at least 7 days have passed.

Use in whole-body MRI is not recommended in children under 6 months of age.
Use for angiography is not recommended in children under 18 years of age.

Elderly
The dosage does not change if you are 65 years of age or older. However, a blood test may be performed to verify if the patient's kidneys are functioning properly.

What to do if you have received an overdose of Claricyclic
It is very unlikely that the patient will receive an overdose, because Claricyclic is administered
in a medical environment by a qualified person.
In the event of an actual overdose, Claricyclic can be removed from the body with a blood wash (“hemodialysis”).
Further information on use and treatment from the specialist or healthcare personnel is
If you have any further questions about the use of this medicine, please ask your doctor or radiologist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

After administrationyou will be kept under observation for at least half an hour.
Most side effects occur immediately or shortly after the
administration of the medicine. Some effects may appear up to several days after
the injection of Claricyclic.

There is a modest risk (rare) of developing an allergic reaction to Claricyclic.These reactions
can be serious and exceptionally cause “shock”(a very rare case of allergic reaction
that can endanger the patient's life). The symptoms listed below may be the first signs
of shock.
Immediately inform the radiologist or healthcare professional if you experience any of the following signs–
urgent medical treatment may be necessary:

• swelling of the face, mouth or throat that may cause difficulty swallowing or breathing
• swelling of the hands or feet
• low blood pressure (hypotension - feeling of weakness)
• breathing problems, including wheezing
• cough
• itching
• runny nose
• sneezing and irritated eyes
• red spots on the skin, severe itching (urticaria)

Other side effects
Inform your doctor or radiologist if you notice any of the following side effects:

Very common: may affect more than 1 in 10 people

• headache
• tingling sensation

Common: may affect up to 1 in 10 people

• feeling of warmth, cold or pain at the injection site
• nausea (feeling unwell), vomiting (feeling sick)
• skin redness, itching and rash

Uncommon: may affect up to 1 in 100 people

• allergic reactions

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

• strange taste in the mouth
• urticaria (red spots on the skin, severe itching (urticaria)).
• increased sweating

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

• feeling of agitation or anxiety
• coma, convulsions, syncope (brief loss of consciousness), weakness (dizziness and feeling of impending loss of consciousness), dizziness, changes in smell (frequent perception of unpleasant odors), tremor
• conjunctivitis, red eyes, blurred vision, increased tearing, swollen eyes
• cardiac arrest, fast or slow heartbeat, irregular heartbeat, palpitations, low or high blood pressure, widening or relaxation of blood vessels (vasodilation) leading to a drop in blood pressure and a slowing of the heartbeat, paleness
• sudden stopping of breathing (respiratory arrest), fluid accumulation in the lungs (pulmonary edema), difficulty breathing, feeling of a lump in the throat, labored breathing, stuffy nose, sneezing, coughing, dry throat
• diarrhea, stomach pain, increased salivation
• eczema, other skin reactions (e.g., skin redness)
• muscle cramps, muscle weakness, back pain
• feeling tired (malaise or fatigue)
• chest pain or discomfort
• fever or chills
• swelling of the face
• swelling or reaction or discomfort around the injection site, redness and pain, leakage of the medicine from the veins which can lead to inflammation or death of the skin cells (necrosis) at the injection site, blood clot in the vein causing inflammation (superficial thrombophlebitis)
• decreased oxygen in the blood

Not known: frequency cannot be estimated
Nephrogenic systemic fibrosis
This is a disease that hardens the skin and can affect soft tissues and internal organs. It has been
observed mainly in patients who have received Claricyclic together with other contrast agents containing gadolinium.
Inform your doctor or radiologist if you notice any changes in the color or thickness of the skin in
any part of the body as this may be a sign of the conditions listed.
The following side effects have occurred with other similar MRI contrast agents: destruction
of red blood cells (hemolysis), confusion, temporary blindness, eye pain, ringing in the ears
(tinnitus), ear pain, asthma, dry mouth, blistering skin eczema, inability
to retain urine (incontinence), kidney damage, acute renal failure, changes in the electrocardiogram tracing, changes in blood tests (increased iron, increased
bilirubin), altered liver tests.

Reporting of side effects
consult your doctor or radiologist.
You can also report side effects directly through the national reporting system
at www.agenziafarmaco.gov.it/it/responsabili. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

5. How to store Claricyclic

Keep this medicine out of the sight and reach of children.
The vials/bottles do not require any particular 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, the bottle or the
pre-filled syringe after “Exp.”.
The expiry date refers to the last day of that month.
Chemical and physical stability during use has been demonstrated for 48 hours at room temperature. From a
microbiological point of view, the product must be administered immediately. If not used
immediately, the storage times and conditions prior to use are the responsibility of
the user and should normally not exceed 24 hours at 2-8 ° C, unless the opening takes place
under controlled and validated aseptic conditions.

6. Contents of the pack and other information

What Claricyclic contains

• The active substance is gadoteric acid. 1 mL of injectable solution contains 279.3 mg of gadoteric acid (as gadoterate meglumine), equivalent to 0.5 mmol of gadoteric acid.
• The other components are meglumine, tetraxetane (DOTA) and water for injections.

What Claricyclic looks like and contents of the pack
Claricyclic is a clear, colourless to slightly yellow solution for intravenous injection.
Claricyclic is available in the following containers:
Glass vials (Type 1, colourless) filled with 5, 10, 15, 20 mL.
Prefilled polymer syringes of 10, 15 or 20 mL.
Glass vials (Type 1, colourless) and polypropylene vials filled with 50 and 100 mL.
All containers are packaged in an outer carton 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

The following information is intended for healthcare professionals only:
Dosage

Adults
MRI of the brain and spinal cord.
The recommended dose is 0.1 mmol/kg of body weight, which is 0.2 mL/kg of body weight. In
patients with brain tumours, a further dose of 0.2 mmol/kg of body weight, which is 0.4 mL/kg of
body weight, may improve tumour characterisation and facilitate therapeutic decision-making.

MRI of the whole body (including lesions of the liver, kidneys, pancreas, pelvis, lungs, heart, breast and musculoskeletal system)
The recommended dose is 0.1 mmol/kg of body weight, which is 0.2 mL/kg of body weight for
ensuring adequate diagnostic contrast.
For angiography: The recommended dose for intravenous injection is 0.1 mmol/kg of body weight,
which is 0.2 mL/kg of body weight, for ensuring adequate diagnostic contrast.
In exceptional circumstances (e.g. inability to obtain satisfactory images of a large vascular area), the administration of a second consecutive injection of 0.1 mmol/kg of body weight, which is 0.2 mL/kg, may be justified. However, if the use of 2 consecutive doses of Claricyclic is anticipated before starting angiography, the use of 0.05 mmol/kg of body weight (which is 0.1
mL/kg) per dose may be beneficial, depending on the diagnostic imaging equipment
available.

Special populations
Renal impairment
Claricyclic must be used in patients with severe renal insufficiency (GFR <30 mL/min/1.73m )
and in the perioperative period of a liver transplant only after a careful assessment of the risk/benefit ratio and if the diagnostic information is essential and not available with MRI without
contrast agent. If Claricyclic is necessary, the dose should not exceed 0.1 mmol/kg of
body weight.
No more than one dose should be used during a scan. No information is available
regarding repeated administration, therefore the use of Claricyclic should not be repeated unless
with an interval of at least 7 days between injections.
Elderly (65 years of age or older)
No dose adjustment is considered necessary. Caution is advised in elderly patients
Hepatic impairment
The adult dose applies to these patients. Caution is recommended, especially in the perioperative
period of a liver transplant (see above, renal impairment).
Paediatric population (0-18 years of age)
MRI of the brain and spinal cord, MRI of the whole body:
The maximum recommended dose of Claricyclic is 0.1 mmol/kg of body weight. No more than one dose should be used
during a scan.
Use in whole-body MRI is not recommended in children under 6 months of age.
Given the immaturity of renal function in infants up to 4 weeks of age and in children up to 1 year of
age, Claricyclic should be used in these patients only after careful assessment, at a dose
not exceeding 0.1 mmol/kg of body weight. Do not administer more than one dose during a
scan. No information is available regarding repeated administration, therefore the use of
Claricyclic should not be repeated unless with an interval of at least 7 days between
injections.
Angiography: Claricyclic is not recommended for angiography in children under 18 years of
age as there are no data on efficacy and safety in this indication.

Route of administration
The product is indicated only for intravenous administration.
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, see the following paragraph Precautions for use

and handling.
Paediatric population (0-18 years). Depending on the amount of Claricyclic to be administered to
the child, it is preferable to use the Claricyclic vials with a single-use syringe of appropriate volume to
this amount for better accuracy of the injected volume.
In neonates and children, the required dose should be administered manually.

Special warnings and precautions for use
Renal impairment
Screening for renal dysfunction by laboratory tests is recommended before administering Claricyclic to all patients.
Cases of nephrogenic systemic fibrosis (NSF) have been reported in association with the use of some gadolinium-containing contrast agents in patients with acute or chronic severe renal insufficiency (GFR <30
mL/min/1.73m ). Patients undergoing liver transplantation are particularly at risk as
the incidence of acute renal insufficiency is high in this group. Since there is a possibility that
NSF may occur with Claricyclic, this medicinal product must be used in patients with severe renal
insufficiency and in the perioperative period of a liver transplant only after a careful assessment of the
risk/benefit ratio and when the diagnostic information is essential and not available
with MRI without contrast agent.
Since renal clearance of gadoteric acid may be impaired in the elderly, it is
particularly important to screen patients aged 65 years or older for
renal dysfunction.
Haemodialysis shortly after the administration of Claricyclic may be helpful in removing Claricyclic
from the body. There is no evidence to support the use of haemodialysis for the prevention or
treatment of NSF in patients not yet undergoing haemodialysis.

Pregnancy and breastfeeding
Claricyclic should not be used during pregnancy unless the patient’s clinical condition
requires the use of gadoteric acid.
Continuation or interruption of breastfeeding for a period of 24 hours after the
administration of Claricyclic should be at the discretion of the doctor or radiologist and the mother.

Precautions for use and handling
Single use
The injectable solution must be visually inspected before use. Only clear solutions free from visible particles must be used.

Vials and Vials: - Prepare a syringe with a needle. Vials: remove the plastic disc.
Polypropylene vials: remove the plastic screw cap or the plastic lid by lifting the upper ring.
After cleaning the stopper with an alcohol swab, puncture the stopper with the needle.
Withdraw the amount of product necessary for the examination and inject it intravenously.

Prefilled syringes: Inject the amount of product necessary for the examination intravenously
The contrast agent remaining in the vials/vials, the connecting material and all disposable components of the system must be discarded after the examination.
Removable traceability label: the removable traceability label on syringes/vials/vials
must be applied to the patient's medical record to allow accurate recording of
gadolinium used as a contrast agent. The dose used must be recorded. If electronic medical records are used, the product name, batch number and dose must be entered into the
patient’s medical record.
Unused medicinal product or waste material must be disposed of in accordance with local regulations.