Magnetolux 500 Micromol/Ml Solution For Injection
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Magnetolux 500 micromol/ml, solution for injection
Gadopentetate dimeglumine
Read all of this leaflet carefully before you start using this medicine.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or your pharmacist.
- This medicine has been prescribed for you personally and you should not pass it on to others. It may harm them, even if their symptoms are the same as yours.
- If any of the side effects get serious, or if you notice any side effects not listed in this leaflet please tell your doctor or pharmacist.
In this leaflet:
1. What Magnetolux is and what it is used for
2. Before you are given Magnetolux
3. How to use Magnetolux
4. Possible side effects
5. How to store Magnetolux
6. Further information
1. WHAT MAGNETOLUX IS AND WHAT IT IS USED FOR
Magnetolux contains gadopentetate dimeglumine, a product which enhances contrast.
This medicine is for diagnostic use only.
Magnetolux is used in examinations with Magnetic Resonance Imaging (MRI).
Magnetolux is used during cranial (head), spinal and whole body MRI scans including head and neck region, the chest including heart and female breast, the belly including pancreas and liver, the kidneys, the pelvis including prostatic gland, bladder and womb, the muscles and the bones.
It may be used to facilitate the visualization, detection and characterisation of several different types of tumours (growths) or lesions in the head, spine and various sites of the body.
In addition the visualisation of all blood vessels (MR-angiography) is possible (with exception of the arteries of the heart), especially for diagnosis of narrowing or obstructions of the vessels.
The blood supply to the heart muscle under stress conditions, for example induced by drugs, can be measured and viability of the heart muscle can be diagnosed ("delayed enhancement").
2. BEFORE YOU ARE GIVEN MAGNETOLUX Do not take Magnetolux
- if you are allergic (hypersensitive) to gadopentetate dimeglumine or any of the other ingredients of Magnetolux
- if you suffer from severe renal impairment (GFR < 30 ml/min/1.73 m2).
Take special care with Magnetolux
- if you have a heart pacemaker, an iron-based (ferromagnetic) clip or an implant or an insulin pump, please inform your radiologist/doctor about this. It is a condition where MRI is not suitable.
- because Magnetolux may trigger allergic or other specific individual reactions that may have consequences on your heart, on your respiratory tract or on your skin.
If an allergic reaction occurs, the radiologist/doctor will stop the administration of the contrast medium at once and, if necessary, will start appropriate treatment of the allergic reactions. Therefore, it is recommended that you have a flexible in-dwelling catheter during the examination, to enable immediate action in case of emergencies.
Very rarely severe reactions, including shock, may occur. Therefore, you should read the following very carefully:
• if you have, or if you have ever had, bronchial asthma or other allergies or a previous allergic reaction to contrast media you may be more likely to have an allergic reaction during the examination. Tell your radiologist/doctor if you suffer from these conditions. You may be given another medicine before the examination to prevent them.
• if you are taking a beta-blocker (medicines used against high blood pressure, heart problems and other conditions) you should tell your radiologist/doctor. Patients treated with beta-blockers do not necessarily respond to other medicines usually used for the treatment of allergic reactions.
• if you have any heart problems (e. g. severe heart failure, coronary artery disease) you are more susceptible to serious or even fatal outcomes of severe allergic reactions.
- if you have fits or seizures you may have an increased risk of suffering from one during the examination.
- if you suffer from moderate renal impairment (GFR 30 - 59 ml/min/1.73 m2) you should tell your radiologist/doctor. Your doctor will screen your renal function before administering Magnetolux.
Using Magnetolux with food and drink
It is very important that you do not eat anything for 2 hours prior to the investigation.
Using other medicines
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Especially: Beta blockers (medicines used for high blood pressure, heart problems and other conditions)
Pregnancy and breast-feeding
The potential risk to the baby if given during pregnancy is unknown. Therefore Magnetolux should only be used during pregnancy if clearly necessary.
Magnetolux passes into breast milk in very small amounts, but at the doses used for examination no effects for the suckling child are anticipated. Magnetolux can be used during breast-feeding.
Driving and using machines
Your injection is unlikely to affect your ability to drive a car or to operate machinery.
However, while driving vehicles or operating machinery you should take account that nausea or low blood-pressure may incidentally occur.
Magnetolux will be given by an authorised healthcare professional directly into a vein (intravenously).
Ideally you should be recumbent during administration, and you will be kept under supervision for at least 30 minutes after the injection by your radiologist/doctor. This is the time where most undesired reactions (e. g. allergic reactions) may occur. However, in rare cases, reactions may occur after hours or days.
If this medicinal product is intended to be used with an automatic application system, its suitability for the intended use has to be demonstrated by the manufacturer of the medical device. Instructions for use of the medical device must be followed absolutely.
This medicinal product is for single use only.
Adults, adolescents and children (over the age of two years):
The dose for cranial, spinal and whole body MRI used will depend on the type of lesion that is being investigated but it is usually between 0.2 and 0.6 ml/kg body weight for adults and between 0.2 and 0.4 ml/kg body weight for children.
New-born infants, infants and toddlers (under the age of two years):
The dose is 0.2 ml/kg body weight in children under the age of 2 years.
Patients with moderate renal impairment [if the value for assessment of renal function, the GFR (glomerular filtration rate) is 30 - 59 ml/min/1.73 m2]:
The use of Magnetolux must be carefully evaluated in patients with moderate renal impairment. The medicine will remain longer in the body of those patients than in patients without impaired renal function.
The doctor will screen you to see, if your kidneys are working properly.
Newborns and infants:
In newborns and infants up to 1 year of age Magnetolux should only be used after careful consideration because the proper function of the kidneys is not fully developed in this age group.
If you are given more Magnetolux than you should
This medicine will be given to you by a healthcare professional. If you think that you have received too much medicine please tell your doctor or nurse immediately.
If you have any further questions on the use of this product, ask your doctor or radiographer or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Magnetolux can cause side effects, although not everybody gets them.
The most commonly reported side effects with Magnetolux are nausea, vomiting, headache, dizziness, pain and a feeling of warmth or coldness at the injection site or a feeling of warmth in general.
Other side effects that may occur have been listed by organ system and frequency. Frequencies are reported as:
|
Very common |
affects more than 1 user in 10 |
|
Common |
affects 1 to 10 users in 100 |
|
Uncommon |
affects 1 to 10 users in 1,000 |
|
Rare |
affects 1 to 10 users in 10,000 |
|
Very rare |
affects less than 1 user in 10,000 |
|
Not known |
frequency cannot be estimated from the available data |
Reactions for which no frequency rate can be provided due to lack of clinical data, have been entered with "Not known”.
|
Frequency |
Organ system |
Adverse reaction |
|
Uncommon |
Nervous System Disorders |
dizziness, numbness (paraesthesia), headache |
|
Gastrointestinal Disorders |
nausea, vomiting | |
|
General Disorders and Administration Site Conditions |
sensation of heat | |
|
Rare |
Blood and Lymphatic System Disorders: |
short term increase in blood iron |
|
Immune System Disorders |
Hypersensivity/anaphylactic reaction: angiooedema, inflammation of the eye (conjunctivitis), coughing, itching, runny nose, sneezing, skin rashes (urticaria), wheeziness, tightness of the voicebox (larynx), swelling of the voice box (larynx) and the throat (pharynx), low blood pressure, shock | |
|
Nervous System Disorders |
agitation, confusion, speech, or smelling disturbance, fits, tremor, coma, sleepiness | |
|
Eye Disorders |
eye pain, sight disturbance, eyes watering | |
|
Ear and Labyrinth Disorders |
pain of the ear, hearing disturbance | |
|
Cardiac Disorders |
changes in heart rate or rhythm, blood pressure changes, heart stops beating | |
|
Vascular Disorders |
widening of the blood vessels and changes in blood flow causing low blood pressure followed by fainting, fast heart rate (tachycardia), difficulties in breathing and turning blue possibly leading to unconsciousness and shock | |
|
Respiratory, Thoracic and Mediastal Disorders |
short term changes in breathing rate, shortness of breath, difficulty in breathing, stopping breathing, fluid in the lungs | |
|
Gastrointestinal Disorders |
abdominal pain, diarrhoea, taste disturbance, dry mouth, excess saliva | |
|
Hepatobiliary Disorders |
short-term increase in liver enzymes and bilirubine value | |
|
Skin and Subcutaneous Tissue |
swelling of eyelids, face or lips, redness of the skin, itchiness |
|
Disorders | ||
|
Musculoskeletal and Connective Tissue Disorders |
back pain or joint pain | |
|
Renal and Urinary Disorders |
urinary incontinence (urine leaking) or urgency, short term changes in kidney function values or acute renal failure in patients with disturbed kidney function | |
|
General Disorders and Administration Site Conditions |
chest pain, chills, sweating, changes in body temperature, fever; pain at the administration site, feeling of coldness or warmth, swelling, inflammation, degeneration of tissue (tissue necrosis), inflammation of the veins at the injection site | |
|
Not known |
General Disorders and Administration Site Conditions |
cases of nephrogenic systemic fibrosis/ nephrogenic fibrosing dermophathy (a condition in patients with kidney disease with hardening of the skin and other organs) |
Some people may find they have an allergic reaction to Magnetolux. Tell your doctor immediately if any of the following rare severe allergy symptoms occur:
- sudden wheeziness and tightness of the chest
- swelling of eyelids, face or lips
- skin rashes (urticaria), itchiness, fever
- collapse
- turning blue (cyanosis)
If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
5. HOW TO STORE MAGNETOLUX
Keep out of the reach and sight of children.
Do not use Magnetolux after the expiry date that is stated on the label. The expiry date refers to the last day of that month.
Keep the vial / bottle in the outer carton in order to protect from light.
Do not store above 30 °C.
Chemical and physical in-use stability has been demonstrated 24 hours at 25 °C. From a microbiological point of view, the product should be used immediately. If not used immediately, inuse 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.
Do not use Magnetolux if you notice any visible signs of deterioration (such as particles in the solution or fissures in the vial).
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. FURTHER INFORMATION
What Magnetolux contains
The active substance is:
gadopentetate dimeglumine.
1 ml of solution for injection contains 469 mg of gadopentetate dimeglumine equivalent to 500 micromol/ml, equivalent to 78.63 mg gadolinium.
5 ml of solution for injection contain 2,345 mg of gadopentetate dimeglumine equivalent to 500 micromol/ml, equivalent to 393.15 mg gadolinium.
10 ml of solution for injection contain 4,690 mg of gadopentetate dimeglumine equivalent to 500 micromol/ml, equivalent to 786.30 mg gadolinium.
15 ml of solution for injection contain 7,035 mg of gadopentetate dimeglumine equivalent to 500 micromol/ml, equivalent to 1,179.45 mg gadolinium.
20 ml of solution for injection contain 9,380 mg of gadopentetate dimeglumine equivalent to 500 micromol/ml, equivalent to 1,572.60 mg gadolinium.
30 ml of solution for injection contain 14,070 mg of gadopentetate dimeglumine equivalent to 500 micromol/ml, equivalent to 2,358.90 mg gadolinium.
100 ml of solution for injection contain 46,900 mg of gadopentetate dimeglumine equivalent to 500 micromol/ml, equivalent to 7,863.00 mg gadolinium.
The other ingredients are:
meglumine, pentetic acid, water for injections
What Magnetolux looks like and contents of the pack
Solution for injection. Clear solution.
Clear glass vial (type I glass) or bottle (type II glass) with a rubber stopper and aluminium cap that is packed into a carton.
Magnetolux is presented in the following packs:
packs of 1 vial of 5, 10, 15, 20, 30 ml packs of 1 bottle of 100 ml
packs of 5 vials of 5, 10, 15, 20, 30 ml packs of 5 bottles of 100 ml
packs of 10 vials of 5, 10, 15, 20, 30 ml packs of 10 bottles of 100 ml
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Sanochemia Pharmazeutika AG Boltzmanngasse 11 A-1090 Vienna Austria
This medicinal product is authorised in the Member States of the EEA under the following names:
|
Austria |
Magnetolux 500 mikromol/ml Injektionslosung |
|
Bulgaria |
Magnetolux 500 gmol/ml MHwe^uoHeH pa3TBop |
|
Czech Republic |
Magnetolux 500 mikromol/ml Injekcni roztok |
|
Germany |
Magnetolux 500 mikromol/ml Injektionslosung |
|
Greece |
Magnetolux 500 micromol/ml Eveaigo SiaAuga |
|
Spain |
Magnetolux 500 micromol/ml solucion inyectable |
|
Hungary |
Magnetolux 500 gmol/ml Oldatos injekcio |
|
Ireland |
Magnetolux 500 micromol/ml solution for injection |
|
Italy |
Magnetolux 500 micromol/ml soluzione iniettabile |
|
Portugal |
Magnetolux 500 micromol/ml solugao injectavel |
|
Romania |
Magnetolux 500 micromol/ml solutie injectabila |
|
Slovakia |
Magnetolux 500 mikromol/ml Injekcny roztok |
|
United Kingdom |
Magnetolux 500 micromol/ml solution for injection |
This leaflet was last approved in 03/2010
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