Gadograf 1.0 mmol/ml solution for injection - 15ml vial

País: Malta

Língua: inglês

Origem: Medicines Authority

Ingredientes ativos:

GADOBUTROL

Disponível em:

Bayer Hellas S.A 6-8 Agisilaou Street 151 23 Marousi Attiki, , Greece

Código ATC:

V08CA09

DCI (Denominação Comum Internacional):

GADOBUTROL 1 mmol/ml

Forma farmacêutica:

SOLUTION FOR INJECTION

Composição:

GADOBUTROL 1 mmol/ml

Tipo de prescrição:

POM

Área terapêutica:

CONTRAST MEDIA

Status de autorização:

Withdrawn

Data de autorização:

2019-07-09

Folheto informativo - Bula

Page 1 of 10
Version 09/2020
PACKAGE LEAFLET
for
Gadograf 1.0 mmol/ml solution for injection
Page 2 of 10
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
GADOGRAF
1.0 MMOL/ML SOLUTION FOR INJECTION
gadobutrol
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 your doctor or the
person giving you Gadograf (the
radiologist) or the hospital/MRI-centre personnel.
-
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 Gadograf is and what it is used for
2.
What you need to know before you are given Gadograf
3.
How Gadograf will be given
4.
Possible side effects
5.
How to store Gadograf
6.
Contents of the pack and other information
1.
WHAT GADOGRAF IS AND WHAT IT IS USED FOR
Gadograf is a contrast medium for magnetic resonance imaging (MRI)
used for diagnostics of the brain,
spine and vessels. Gadograf can also help the doctor find out the kind
(benign or malignant) of known or
suspected abnormalities in the liver and kidneys.
Gadograf 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 GADOGRAF 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.
Gadograf 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 ARE GIVEN GADOGRAF
DO NOT USE GAD

Características técnicas

Page 1 of 13
Version 09/2020
SUMMARY OF PRODUCT CHARACTERISTICS
Page 2 of 13
1.
NAME OF THE MEDICINAL PRODUCT
Gadograf 1.0 mmol/ml solution for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml of solution for injection contains 604.72 mg gadobutrol
(equivalent to 1.0 mmol gadobutrol containing
157.25 mg gadolinium).
1 vial with 15 ml contains 9070.8 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. Gadograf 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).
Gadograf 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.
Gadograf should be used only when diagnostic information is essential
and not available with unenhanced
magnetic resonance imaging (MRI).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
GADOGRAF SHOULD ONLY BE ADMINISTERED BY HEALTHCARE PROFESSIONALS_
_EXPERIENCED IN THE FIELD OF CLINICAL
MRI PRACTICE.
Page 3 of 13
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 the
pulse sequences used and th