Magnevist 2mmol/litre solution for injection 20ml pre-filled syringes

Country: Велика Британија

Језик: Енглески

Извор: MHRA (Medicines & Healthcare Products Regulatory Agency)

Активни састојак:

Meglumine gadopentetate

Доступно од:

Bayer Plc

INN (Међународно име):

Meglumine gadopentetate

Дозирање:

.002mmol/1ml

Фармацеутски облик:

Solution for injection

Пут администрације:

Intraarticular

Класа:

No Controlled Drug Status

Тип рецептора:

Valid as a prescribable product

Резиме производа:

BNF: ; GTIN: 5016703008682

Информативни летак

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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.
_ _
PACKAGE LEAFLET: INFORMATION FOR THE USER
MAGNEVIST
®
2 MMOL/L SOLUTION FOR INJECTION
DIMEGLUMINE GADOPENTETATE
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN THIS MEDICINE
BECAUSE IT
CONTAINS IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, please ask the doctor giving you
Magnevist 2
mmol/l (the radiologist) or the hospital/MRI-centre staff.
-
If you get any side effects, talk to your doctor, radiologist or the
hospital/MRI-
centre staff. This includes any possible side effects not listed in
this leaflet. See
section 4.
WHAT IS IN THIS LEAFLET
1.
What Magnevist 2 mmol/l is and what it is used for
2.
What you need to know before you are given Magnevist 2 mmol/l
3.
How you will be given Magnevist 2 mmol/l
4.
Possible side effects
5.
How to store Magnevist 2 mmol/l
6.
Contents of the pack and other information
1. WHAT MAGNEVIST 2 MMOL/L
IS AND WHAT IT IS USED FOR
Magnevist 2 mmol/l is used together with a technique called Magnetic
Resonance
Imaging (MRI) to create artificial contrast or enhancement to help
make an MRI scan
of your joints 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
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black and white picture which can help your doctor see and investigate
the
differences between normal and abnormal tissue.
Sometimes MRI is used

Карактеристике производа

OBJECT 1
MAGNEVIST 2MMOL/L SOLUTION FOR INJECTION
Summary of Product Characteristics Updated 16-Jan-2018 | Bayer plc
1. Name of the medicinal product
Magnevist 2 mmol/l solution for injection
2. Qualitative and quantitative composition
1 ml aqueous solution contains 1.876 mg gadopentetic acid, dimeglumine
salt as active ingredient
(equivalent to 0.002 mmol gadopentetic acid, dimeglumine, containing
0.32 mg gadolinium).
Excipient with known effect: sodium chloride
Magnevist 2 mmol/l contains 3.4 mg sodium per ml
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Solution for injection.
4. Clinical particulars
4.1 Therapeutic indications
For contrast enhancement in direct magnetic resonance arthrography.
This medicinal product is for diagnostic use by intraarticular
administration only.
Magnevist 2 mmol/l should be used only when diagnostic information is
essential and not available with
unenhanced magnetic resonance imaging (MRI) and when another
authorised product cannot be used.
4.2 Posology and method of administration
The usual precautions for MRI (e.g. exclusion of cardiac pacemakers
and other ferro-magnetic objects
including vascular clips etc) must be observed.
Posology
The recommendations for the use of Magnevist 2 mmol/l apply to a field
strength between 0.2 Tesla and
1.5 Tesla.
Intraarticular administrations of contrast agents are to be given with
the patient lying or sitting. After the
end of the injection, the patient should be kept under supervision for
at least half an hour.
The lowest dose that provides sufficient enhancement for diagnostic
purposes should be used.
ADULTS:
In general, for all joints the administration of up to 20 ml (knee
joint up to 50 ml) Magnevist 2 mmol/l is
sufficient for good opacification and to answer all the relevant
clinical questions. A volume leading to a
slight distension of the joint capsule should be injected. Only so
much contrast medium should be injected
until discrete resistance is felt and/or the patient experiences a
mild feeling of pressur