CYCLOLUX 0.5 MMOL/ML SOLUTION FOR INJECTION - patient leaflet, side effects, dosage

Cyclolux

0.5 mmol/ml solution for injection

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.

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What is in this leaflet:

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• 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 contrast agent that contains gado-teric acid. It is for diagnostic use only.

Cyclolux is used to enhance the contrast of the images obtained in examinations with Magnetic Resonance Imaging (MRI). This contrast enhancement improves the visualisation and delineation in:

Adult and paediatric population (0–18 years)

• MRI of the Central Nervous System 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.

Adult population

• MR angiography including defects (lesions) and narrowing (stenosis) in arteries, except in coronary arteries.

2. what you need to know before cyclolux is used

Cyclolux

0.5 mmol/ml solution for injection

The following information is intended for medical or healthcare professionals only:

Posology

The lowest dose that provides sufficient enhancement for diagnostic purposes should be used. The dose should be calculated based on the patient’s body weight, and should not exceed the recommended dose per kilogram of body weight detailed in this section.

• Encephalic 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.
• Whole body MRI and 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.

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.

• Paediatric population: MRI of brain and spine/whole-body MRI: the recommended and maximum dose of Cyclolux is 0.1 mmol/ kg BW. More than one dose should not be used during a scan. 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.

Cyclolux is not recommended for angiography in children under 18 years of age due to insufficient data on efficacy and safety in this indication.

• 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. Do not use by intrathecal route. Take care to maintain strictly intravenous injection: extravasation may result in local intolerance reactions, requiring the usual local care. 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

Size: 520 × 224 mm (gefaltet auf 150 × 38 mit 2 Etiketten)

Fontsize: 10 Pt

Colour: Pantone 280 C, Pantone 116 C, Black (100%, 70%, 50%)

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.

Paediatric population

Depending on the amount of Cyclolux to be given to the child, it is preferable to use Cyclolux 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.

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 gadolinium- containing 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 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 and Method of administration, Paediatric population.

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.

4. 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
• swelling of hands or feet
• lightheadedness (low blood pressure)
• breathing difficulties
• whistling respiration
• coughing
• itching
• runny nose
• sneezing
• eye irritation
• hives
• skin rash

Uncommon side effects

(may affect up to 1 in 100 people)

• hypersensitivity (allergic reaction)
• headaches
• unusual taste in the mouth
• dizziness
• somnolence (sleepiness)
• sensation of tingling, warmth/burning, cold and/or pain
• low or high blood pressure
• nausea (feeling sick)
• stomach pain
• rash
• feeling hot, feeling cold
• asthenia (loss of energy; weakness)
• injection site discomfort, injection site reaction, injection site coldness, injection site swelling, diffusion of the product outside of blood vessels that can lead to inflammation (redness and local pain)

Rare side effects

(may affect up to 1 in 1,000 people)

• anxiety, faintness (dizziness and feeling of imminent loss of consciousness)
• eyelid swelling
• palpitations
• sneezing
• vomiting (being sick)
• diarrhoea
• increased saliva secretion
• hives, itching, sweating
• chest pain, chills

Very rare side effects

(may affect up to 1 in 10,000 people)

• anaphylactic or anaphylactic-like reactions (a serious, potentially life-threatening allergic reaction)
• agitation
• coma, seizures, syncope (brief loss of consciousness), disorder of smell (perception of often unpleasant odours), tremor
• conjunctivitis, red eye, blurred vision, increased tear secretion
• cardiac arrest, accelerated or slow heart beat, irregular heart beat, vascular dilatation, pallor
• respiratory arrest, pulmonary oedema, breathing difficulties, wheezing, stuffy nose, cough, dry throat, throat constriction with feeling of suffocation, respiratory spasms, throat swelling
• eczema, redness of the skin, swelling of the lips and localized in the mouth
• muscle cramps, muscle weakness, back pain
• malaise, chest discomfort, fever, swelling of the face, diffusion of the product outside of blood vessels that can lead to 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-con-taining 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

Website:

or search for MHRA Yellow Card in the Google Play or Apple App Store

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 than 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 informationwhat 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,1,4,7,10-tetraazacyclo­dodecane-1,4,7,10-tetraacetic acid (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 and Manufacturer Sanochemia Pharmazeutika GmbH

Landegger StraBe 7

2491 Neufeld an der Leitha, Austria

This medicine is authorised in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following name:

Germany:

Cyclolux 0.5 mmol/ml Injektionslosung

Austria:

Cyclolux 0,5 mmol/ml

Injektionslosung im Einzeldosisbe­haltnis

Czech Republic:

Cyclolux 279 mg/ml injekcm roztok

Greece:

Cyclolux 0,5 mmol eveoipo SidXupa

Poland:

Cyclolux, 0,5 mmol/ml, roztwor do wstrzykiwan