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MAGNETOLUX 500 MICROMOL/ML SOLUTION FOR INJECTION

Active substance(s): DIMEGLUMINE GADOPENTETATE

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PACKAGE LEAFLET: INFORMATION FOR THE USER
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.
2.
3.
4.
5.
6.

What Magnetolux is and what it is used for
Before you are given Magnetolux
How to use Magnetolux
Possible side effects
How to store Magnetolux
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).

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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.

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3.

HOW TO USE MAGNETOLUX

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:

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Very common
Common
Uncommon
Rare
Very rare
Not known

affects more than 1 user in 10
affects 1 to 10 users in 100
affects 1 to 10 users in 1,000
affects 1 to 10 users in 10,000
affects less than 1 user in 10,000
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
Gastrointestinal
Disorders
General Disorders and
Administration Site
Conditions
Blood and Lymphatic
System Disorders:
Immune System
Disorders

dizziness, numbness (paraesthesia),
headache
nausea, vomiting

Rare

sensation of heat

short term increase in blood iron

Nervous 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
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

Respiratory, Thoracic
and Mediastal
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
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
swelling of eyelids, face or lips, redness of the
skin, itchiness

Skin and
Subcutaneous Tissue

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Disorders
Musculoskeletal and
Connective Tissue
Disorders
Renal and Urinary
Disorders
General Disorders and
Administration Site
Conditions

Not known

General Disorders and
Administration Site
Conditions

back pain or joint pain
urinary incontinence (urine leaking) or
urgency, short term changes in kidney function
values or acute renal failure in patients with
disturbed kidney function
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
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.

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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

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This medicinal product is authorised in the Member States of the EEA under the following
names:
Austria

Magnetolux 500 mikromol/ml Injektionslösung

Bulgaria

Magnetolux 500 µmol/ml Инжекционен разтвор

Czech Republic

Magnetolux 500 mikromol/ml Injekční roztok

Germany

Magnetolux 500 mikromol/ml Injektionslösung

Greece

Magnetolux 500 micromol/ml Ενέσιμο διάλυμα

Spain

Magnetolux 500 micromol/ml solución inyectable

Hungary

Magnetolux 500 μmol/ml Oldatos injekció

Ireland

Magnetolux 500 micromol/ml solution for injection

Italy

Magnetolux 500 micromol/ml soluzione iniettabile

Portugal

Magnetolux 500 micromol/ml solução injectável

Romania

Magnetolux 500 micromol/ml solutie injectabilă

Slovakia

Magnetolux 500 mikromol/ml Injekčný roztok

United Kingdom

Magnetolux 500 micromol/ml solution for injection

This leaflet was last approved in 03/2010

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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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