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MAGNEGITA 500 MICROMOL/ML SOLUTION FOR INJECTION

Active substance(s): DIMEGLUMINE GADOPENTETATE

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UK
PACKAGE LEAFLET:
INFORMATION FOR THE USER

MAGNEGITA 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.
Ÿ
Ÿ
If you have any further questions, ask your doctor or your
pharmacist.
Ÿ
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.
Ÿ
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. See section 4.
In this leaflet:
1. What Magnegita is and what it is used for
2. Before you are given Magnegita
3. How to use Magnegita
4. Possible side effects
5. How to store Magnegita
6. Further information

1

WHAT MAGNEGITA IS AND WHAT IT IS USED FOR

Magnegita contains gadopentetate dimeglumine, a product which enhances
contrast.
This medicine is for diagnostic use only.
Magnegita is used in examinations with Magnetic Resonance Imaging (MRI).
Magnegita 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 MAGNEGITA

Do not take Magnegita

Ÿ
if you are allergic (hypersensitive) to gadopentetate dimeglumine or any

of the other ingredients of Magnegita

Ÿ
if you suffer from severe renal impairment

(GFR < 30 ml/min/1.73 m2).

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Take special care with Magnegita
Ÿ
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.
Ÿ
because Magnegita may trigger allergic or other specific individual
reactions that may have consequences on your heart, on your respiratory
tract or on your skin.
You should not be given Magnegita if you suffer from severe kidney problems,
or if you are a patient who is about to have or has recently had a liver
transplant, as use of Magnegita in patients with these conditions has been
associated with a disease called nephrogenic systemic fibrosis (NSF). NSF is a
disease involving thickening of the skin and connective tissues. NSF may result
in severe joint immobility, muscle weakness or may affect the normal working of
internal organs which may potentially be life threatening.
Magnegita should also not be given to newborn babies up to age of 4 weeks.
Tell your doctor if:
Ÿ
your kidneys do not work properly
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you have recently had, or soon expect to have, a liver transplant.

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:
Ÿ
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.
Ÿ
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.
Ÿ
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.
Ÿ
if you have fits or seizures you may have an increased risk of suffering from
one during the examination.
Ÿ
if you suffer from moderate renal impairment (GFR 30-59 ml/min/1.73 m2)
you should tell your radiologist/doctor. Before you receive Magnegita, you
will need to have a blood test to check how well your kidneys are working.
Magnegita should not be used in newborn babies up to the age of 4 weeks. As
kidney function is immature in infants up to 1 year of age, Magnegita will only
be used in infants after careful consideration by the doctor.
Using Magnegita 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
Ask your doctor for advice before taking any medicine.
Pregnancy
You must tell your doctor if you think you are or might become pregnant as
Magnegita should not be used during pregnancy unless strictly necessary.

Breast-feeding
Tell your doctor if you are breast-feeding or about to start breast-feeding.
Breast-feeding should be discontinued for at least 24 hours after you receive
Magnegita.
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.

3

HOW TO USE MAGNEGITA

Magnegita 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.
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.
Dosage in special patient groups
Neonates up to 4 weeks of age and infants up to 1 year of age
Magnegita should not be used in newborn babies up to the age of 4 weeks.
As kidney function is immature in infants up to 1 year of age, infants should only
receive one dose of Magnegita during a scan and should not receive a second
injection for at least 7 days. In infants up to 1 year of age Magnegita should
only be used after careful consideration because the proper function of the
kidneys is not fully developed in this age group.
Toddlers (from 1 - 2 years)
The dose is 0.2 ml/kg body weight in children under the age of 2 years.
Elderly (aged 65 years and above)
It is not necessary to adjust your dose if you are 65 years of age or older but you
will have a blood test to check how well your kidneys are working.
Patients with impaired renal function
You should not be given Magnegita if you suffer from severe kidney problems
or if you are a patient who is about to have or has recently had a liver
transplant.
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 Magnegita 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.
If you have moderate kidney problems, you should only receive one dose of
Magnegita during a scan and you should not receive a second injection for at
least 7 days.

The following information is intended for medical or
healthcare professionals only:
Prior to administration of Magnegita, all patients should
be screened for renal dysfunction by obtaining laboratory
tests.
There have been reports of nephrogenic systemic fibrosis (NSF)
associated with use of Magnegita and some other gadoliniumcontaining contrast agents in patients with acute or chronic severe renal
impairment (GFR < 30 ml/min/1.73m2). Patients undergoing liver
transplantation are at particular risk since the incidence of acute renal
failure is high in this group. Therefore Magnegita must not be used in
patients with severe renal impairment, in patients in the perioperative
liver transplantation period.
Magnegita should also not be given to newborn babies up to the age
of 4 weeks.
The risk for development of NSF in patients with moderate renal
impairment (GFR 30–59 ml/min/1.73m2) is unknown, therefore,
Magnegita should be only used after careful risk-benefit evaluation in
patients with moderate renal impairment at a dose not exceeding 0.2
ml/kg body weight. More than one dose should not be used during a
scan. Because of the lack of information on repeated administration,
Magnegita injections should not be repeated unless the interval
between injections is at least 7 days.
Due to immature renal function in infants up to 1 year of age,
Magnegita should only be used in these patients after careful
consideration at a dose not exceeding 0.2 ml/kg body weight. More
than one dose should not be used during a scan. Because of the lack of
information on repeated administration, Magnegita injections should
not be repeated unless the interval between injections is at least 7 days.
Magnegita should not be given to newborn babies up to age of 4
weeks.
As the renal clearance of gadopentetate dimeglumine may be impaired
in the elderly, it is particularly important to screen patients aged 65
years and older for renal dysfunction.
Haemodialysis shortly after Magnegita administration may be useful at
removing Magnegita 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.

If you are given more Magnegita 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, Magnegita can cause side effects, although not everybody
gets them.
The most commonly reported undesirable effects with Magnegita are nausea,
vomiting, headache, dizziness, pain and a feeling of warmth or coldness at the
injection site or a feeling of warmth in general.
There have been reports of nephrogenic systemic fibrosis (which causes
hardening of the skin and may affect also soft tissue and internal organs).
Other undesirable effects that may occur have been listed by organ system and
frequency. Frequencies are reported as:
Very common (more than 1 in 10 people)
Common
(more than 1 in 100 people and less than 1 in 10 people)
Uncommon (more than 1 in 1,000 people and less than 1 in 100 people)
Rare
(more than 1 in 10,000 people and less than 1 in 1,000 people)
Very rare
(less than 1 in 10,000 people)
Reactions for which no frequency rate can be provided due to lack of clinical
data, have been entered with “Not known”.
Blood Disorders
Rare
short term increase in blood iron
Nervous System Disorders
Uncommon dizziness, numbness (paraesthesia), headache
Rare
agitation, confusion, speech, or smelling disturbance, fits,
tremor, coma, sleepiness
Eye Disorders
Rare
eye pain, sight disturbance, eyes watering
Ear Disorders
Rare
pain of the ear, hearing disturbance

Skin Disorders
Rare
swelling of eyelids, face or lips, redness of the skin, itchiness
Musculoskeletal Disorders
Rare
back pain or joint pain
Kidney Disorders
Rare
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
Uncommon sensation of heat
Rare
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 cases of nephrogenic systemic fibrosis/nephrogenic fibrosing
dermophathy (a condition in patients with kidney disease with
hardening of the skin and other organs)
Immune System Disorders
Rare
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
Some people may find they have an allergic reaction to Magnegita. Tell your
doctor immediately if any of the following rare severe allergy symptoms occur:
Ÿ
Sudden wheeziness and tightness of the chest
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Swelling of eyelids, face or lips
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Skin rashes (urticaria), itchiness, fever
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Collapse
Ÿ
Turning blue (cyanosis)
Reporting of side effects
If you get any side effects, talk to your 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: 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 MAGNEGITA

Heart Disorders
Rare
changes in heart rate or rhythm, blood pressure changes, heart
stops beating

Keep out of the reach and sight of children.
Do not use Magnegita after the expiry date that is stated on the label. The
expiry date refers to the last day of that month.
This medicinal product does not require any special storage conditions.

Breast-feeding should be discontinued for at least 24 hours after the
administration of Magnegita.

Vascular Disorders
Rare
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

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.

Respiratory, Thoracic and Mediastinal Disorders
Rare
short term changes in breathing rate, shortness of breath,
difficulty in breathing, stopping breathing, fluid in the lungs

Magnegita should not be used during pregnancy unless the clinical
condition of the woman requires use of gadopentetate dimeglumine.

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Gastrointestinal Disorders
Uncommon nausea, vomiting
Rare
abdominal pain, diarrhoea, taste disturbance, dry mouth,
excess saliva
Hepatobiliary Disorders
Rare
short-term increase in liver enzymes and bilirubine value

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, 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.
Do not use Magnegita 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 Magnegita contains
Ÿ
The active substance is gadopentetate dimeglumine.
Ÿ
1 ml Magnegita solution for injection contains 469 mg of

gadopentetate dimeglumine (corresponding to 500 micromol,
corresponding to 78.63 mg gadolinium).
Ÿ
The other ingredients are pentetic acid, meglumine and water for
injection
What Magnegita looks like and contents of the pack
Solution for injection.
Your medicinal product comes in a clear glass vial with a rubber stopper
and aluminium cap that is packed into a carton along with this patient
information leaflet (package leaflet).
The vial contains a clear, particle free solution for injection.
Magnegita is presented in the following packs:
1 vial with 5, 10, 15, 20, 30 and 100 ml solution for injection
10 vials with 5, 10, 15, 20, 30 and 100 ml solution for injection
Not all pack sizes may be marketed.
Marketing authorisation holder and manufacturer
Marketing authorisation holder:
Agfa HealthCare Imaging Agents GmbH
Am Coloneum 4
50829 Köln, Germany
Tel: + 49 221 5717-660
Fax: + 49 221 5717-1051
E-mail: imagingagents@agfa.com
Manufacturer:
Biokanol Pharma GmbH
Kehler Straße 7
76437 Rastatt, Germany
This leaflet was last
approved in MM/YYYY.

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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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