Gadovist Solution for Injection 1.0mmol/mml

Država: Malta

Jezik: engleski

Izvor: Medicines Authority

Aktivni sastojci:

GADOBUTROL

Dostupno od:

Bayer PLC

ATC koda:

V08CA09

INN (International ime):

GADOBUTROL

Farmaceutski oblik:

SOLUTION FOR INJECTION

Sastav:

GADOBUTROL 1 mmol/ml

Tip recepta:

POM

Područje terapije:

CONTRAST MEDIA

Status autorizacije:

Authorised

Uputa o lijeku

PACKAGING TECHNOLOGY BERLIN SGMGJ
page 1
Bayer Pharma AG
client: 0021
item-no.: 84250554
PZ: 2698O-3
code-no.:
name: LF-OUTS-GADOVIST 1,0 VL
country: GB/-/BPH
colors: BLACK
version: 06.07.2015/03
approval:
dimension: 210 X 462 MM
84250554
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU
ARE GIVEN THIS MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
R Keep this leaflet. You may need to read it
again.
R If you have any further questions, please ask
your doctor or the person giving you
Gadovist (the radiologist) or the hospital/
MRI-centre personnel.
R If you get any side effects talk to your doctor
or radiologist. This includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1. What Gadovist is and what it is used for
2. What you need to know before you are given
Gadovist
3. How Gadovist will be given
4. Possible side effects
5. How to store Gadovist
6. Contents of the pack and other information
1. WHAT GADOVIST IS AND WHAT IT IS
USED FOR
Gadovist is a contrast medium for magnetic
resonance imaging (MRI) used for diagnostics of
the brain, spine and vessels. Gadovist can also
help the doctor find out the kind (benign or
malignant) of known or suspected abnormalities
in the liver and kidneys.
Gadovist can also be used for MRI of
abnormalities of other body regions.
It facilitates visualisation of abnormal structures
or lesions and helps in the differentiation
between healthy and diseased tissue.
It is for use in adults and children of all ages
(including term newborn infants).
HOW GADOVIST WORKS
MRI is a form of medical diagnostic imaging that
uses the behaviour of water molecules in normal
and abnormal tissues. This is done by a complex
system of magnets and radio waves. Computers
record the activity and translate that into images.
Gadovist is given as an injection into your vein.
This medicine is for diagnostic use only and will
only be administered by healthcare professionals
experienced in the field of clinical MRI practice.
2. WHAT YOU NEED TO KNOW BEFORE YOU

Svojstava lijeka

Page 1 of 11
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Gadovist 1.0 mmol/ml solution for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 mlof solution for injection contains 604.72 mg gadobutrol
(equivalent to 1.0 mmol gadobutrol containing
157.25 mg gadolinium).
1 vial with 2 ml contains 1209.44 mg gadobutrol,
1 vial with 7.5 ml contains 4535.4 mg gadobutrol,
1 vial with 15 ml contains 9070.8 mg gadobutrol,
1 vial with 30 ml contains 18141.6 mg gadobutrol.
1 bottle with 65 ml contains 39306.8 mg gadobutrol.
Excipient with known effect: 1 ml contains 0.00056 mmol (equivalent to
0.013 mg) of sodium (see
section 4.4).
_ _
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection
Clear, colourless to pale yellow liquid.
Physico-chemical properties:
Osmolality at 37 °C: 1603 mOsm/kg H
2
O
Viscosity at 37 °C: 4.96 mPa·s
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
This medicinal product is for diagnostic use only. Gadovist is
indicated in adults and children of all ages
(including term neonates) for:

Contrast enhancement in cranial and spinal magnetic resonance imaging
(MRI).

Contrast enhanced MRI of liver or kidneys in patients with high
suspicion or evidence of having focal
lesions to classify these lesions as benign or malignant.

Contrast enhancement in magnetic resonance angiography (CE-MRA).
Gadovist can also be used for MR Imaging of pathologies of the whole
body.
It facilitates visualisation of abnormal structures or lesions and
helps in the differentiation between healthy
and pathological tissue.
Page 2 of 11
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
GADOVIST SHOULD ONLY BE ADMINISTERED BY HEALTHCARE
PROFESSIONALSEXPERIENCED IN THE FIELD OF CLINICAL
MRI PRACTICE.
Method of administration
This medicinal product is for intravenous administration only.
The dose required is administered intravenously as a bolus injection.
Contrast-enhanced MRI can commence
immediately afterwards (shortly after the injection depending on t