Magnevist 0.5mmol/ml solution for injection 20ml vials

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Meglumine gadopentetate

Available from:

Bayer Plc

INN (International Name):

Meglumine gadopentetate

Dosage:

.5mmol/1ml

Pharmaceutical form:

Solution for injection

Administration route:

Intravenous

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: ; GTIN: 5016703001379

Patient Information leaflet

MagnevistCombined PIL v018_0
Page 1 of 8
Due to regulatory changes, the content of the following Patient
Information Leaflet may vary from the one found in your medicine pack.
Please compare the 'Leaflet prepared/revised date' towards the end of
the leaflet to establish if there have been any changes.
If you have any doubts or queries about your medication, please
contact
your doctor or pharmacist.
_ _
PATIENT LEAFLET: INFORMATION FOR THE USER
MAGNEVIST
®
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
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.
MagnevistCombined PIL v018_0
Page 2 of 8
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
pictur

Summary of Product characteristics

MAGNEVIST
Summary of Product Characteristics Updated 10-Oct-2017 | Bayer plc
1. Name of the 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 by 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
Prefilled syringe:
The prefilled syringe must be taken from the pack and prepared for the
injection immediately before the
examination.
The tip cap should be removed from the prefilled syringe immediately
before use.
After the pre-filled syringe has been prepared for use, Magnevist
remains stable for an examination day.
The time indicated does not refer to the physicochemical stability,
but to the possibility of microbial
contamination.
Vials:
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