MAGNEVIST 469 Micromol Solution for Injection
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Patient Information leaflet
(PIL)
22-10-2015
Summary of Product characteristics
(SPC)
11-08-2017
Active ingredient:
GADOPENTETATE DIMEGLUMINE
Available from:
Bayer Limited
ATC code:
V08CA01
INN (International Name):
GADOPENTETATE DIMEGLUMINE
Dosage:
469 Micromol
Pharmaceutical form:
Solution for Injection
Prescription type:
Product subject to Restricted Prescription (C)
Therapeutic area:
Paramagnetic contrast media
Authorization status:
Authorised
Authorization date:
2008-07-25
Patient Information leaflet
Bayer Limited
The Atrium
Blackthorn Road
Dublin 18
Telephone:
+353 1 2999313
Fax:
+353 1 2061456
www.bayer.ie
15158
PATIENT LEAFLET:
Information for the user
MAGNEVIST
®
0.5 MMOL/ML
SOLUTION FOR INJECTION, IN
PRE-FILLED SYRINGE
Gadopentetate dimeglumine
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
7. INFORMATION FOR HEALTHCARE
PROFESSIONALS ONLY
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 to
help make an MRI scan of the area of
your body that your doctor wants to
investigate 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 radiowaves 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 to
see and investigate the difference
Read the complete document
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Magnevist 0.5mmol/ml Solution for Injection, in pre-filled syringe.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains 0.5 mmol gadopentetate dimeglumine (equivalent to
469.01 mg gadopentetate dimeglumine).
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection.
Clear, colourless to pale yellow solution.
The physico-chemical properties of Magnevist listed below are:
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
This medicinal product is for diagnostic use only.
•
Cranial and spinal magnetic resonance imaging (MRI)
In particular for the demonstration of tumours and for further
differential-diagnostic clarification in suspected
meningioma, (acoustic) neurinoma, invasive tumours (e.g. glioma) and
metastases; for the demonstration of small
and/or isointense tumours; in suspected recurrence after surgery or
radiotherapy; for the differentiated demonstration of
rare neoplasms such as haemangioblastomas, ependymomas and small
pituitary adenomas; for improved determination
of the spread of tumours not of cerebral origin.
Additionally in spinal MRI: Differentiation of intra- and
extramedullary tumours; demonstration of solid tumour areas
in known syrinx; determination of intramedullary tumour spread.
•
Whole body MRI
Including the facial skull, the neck region, the thoracic space
including the heart and abdominal space, the female
breast, the pelvis and the active and passive musculoskeletal system,
and imaging of vessels throughout the body.
In particular, Magnevist permits diagnostic information:
For the demonstration or exclusion of tumours, inflammation and
vascular lesions;
For determination of the spread and demarcation of these lesions;
For the differentiation of the internal structure of lesions;
OSMOLALITY (OSM/KG H
2
O)
At 37ºC
1.96
VISCOSITY (MPA·S)
At 20ºC
4.9
At 37ºC
2.9
PH-VALUE
7.0 – 7.9
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