Magnevist

Land: Malta

Språk: engelsk

Kilde: Medicines Authority

Aktiv ingrediens:

GADOPENTATE DIMEGLUMINE

Tilgjengelig fra:

Bayer Public Limited Company 400 South Oak Way, Reading Berkshire RG2 6AD, United Kingdom

ATC-kode:

V08CA01

INN (International Name):

GADOPENTATE DIMEGLUMINE

Legemiddelform:

SOLUTION FOR INJECTION

Sammensetning:

GADOPENTATE DIMEGLUMINE

Resept typen:

POM

Terapeutisk område:

CONTRAST MEDIA

Autorisasjon status:

Withdrawn

Autorisasjon dato:

2008-09-15

Informasjon til brukeren

81853312
PACK
AGING T
ECHNOLOGY BERLIN PEWI

page 1 
Bayer Pharma AG
client: 
0021
 itemno.: 
81853312
 PZ: 
2663O-3 
code-no.: 
0
name: 
LF-OUTS-MAGNEVIST VL
 countr
y: 
GB BPH
colors: 
BLACK
version: 
03.04.2014/03
 approval: 
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU 
ARE GIVEN THIS MEDICINE.


Keep this leaflet. You may need to read it 
again.


If you have any further questions, please ask 
the doctor giving you Magnevist (the 
radiologist) or the hospital/MRI-centre staff.


If any of the side effects gets serious, or if 
you notice any side effects not listed in this 
leaflet, please tell your doctor, radiologist or 
the hospital/MRI-centre staff.
IN THIS LEAFLET:
1. What Magnevist is and what it is used for
2. Before you are given Magnevist 
3. How you will be given Magnevist
4. Possible side effects
5. How to store Magnevist 
6. Further information
1. WHAT MAGNEVIST IS AND WHAT IT IS 
USED FOR
Magnevist is used together with a technique 
called Magnetic Resonance Imaging (MRI) to 
create artificial contrast or enhancement, this 
can help make the MRI scan of the brain, spine, 
vessels, or other area of your body that your 
doctor wants to investigate look clearer.
MRI is a modern scanning technique which 
produces very high quality pictures of various 
parts of your body without using X-rays.  The 
use of MRI can provide a quick, early and 
accurate diagnosis.
The scanner uses a strong magnetic field and 
radio waves to measure the magnetic properties 
of body tissues.  Using a computer, this 
information is converted into a black and white 
picture which can help your doctor see and 
investigate the differences between normal and 
abnormal tissue.
Sometimes MRI is used in areas where it cannot 
produce a clear black and white picture.  This is 
when Magnevist is used. Magnevist produces a 
clearer image and allows the doctor to see the 
area of interest better.  Sometimes several scans 
will be taken b

Preparatomtale

Page 1 of 11
SUMMARY OF PRODUCT CHARACTERISTICS
1.
TRADE NAME OF MEDICINAL PRODUCT
Magnevist
®
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains 0.5 mmol gadopentetate
dimeglumine (equivalent to 469.01 mg gadopentetate dimeglumine).
For full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
This medicinal product is for diagnostic use only as a paramagnetic
contrast medium in cranial, spinal
and whole body magnetic resonance imaging (MRI).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
METHOD OF ADMINISTRATION
Magnevist is to be administered only be intravenous injection.
Nausea and vomiting are known possible adverse reactions of all
extracellular MRI contrast media. The
patient should therefore refrain from eating for 2 hours prior to
investigation to avoid aspiration. The
usual precautions for MRI (e.g. exclusion of cardiac pacemakers and
other ferro-magnetic objects
including vascular clips etc) must be observed.
INSTRUCTIONS FOR USE/HANDLING
Magnevist should only be drawn up into the syringe immediately before
use.
The rubber stopper should never be pierced more than once.
Any contrast medium not used in one examination must be discarded.
Contrast-enhanced MRI can start immediately after administration of
the medium. T
1
- weighted
scanning sequences are particularly suitable for contrast-enhanced
examinations with Magnevist.
Ideally the patient should be recumbent during administration, and
should be kept under supervision for
at least 30 minutes after the injection.
POSOLOGY
The recommended doses are given in ml of Magnevist per kg body weight.
Page 2 of 11
ADULTS:
CRANIAL AND SPINAL MRI
In general, the administration of 0.2ml Magnevist per kg body weight
(equivalent to 0.1mmol
gadopentetate dimeglumine per kg body weight) is sufficient to provide
diagnostically adequate
contrast.
If a strong clinical suspicion of a lesion persists despite a normal
scan, a further injection of 0.2ml or
even 0.4ml Magnevist per kg b