Gadovist 1.0mmol/ml Solution for Injection in pre-filled syringe/cartridge

Држава: Малта

Језик: Енглески

Извор: Medicines Authority

Активни састојак:

GADOBUTROL

Доступно од:

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

АТЦ код:

V08CA09

INN (Међународно име):

GADOBUTROL 1.0 mmol/ml

Фармацеутски облик:

SOLUTION FOR INJECTION IN A PRE-FILLED SYRINGE

Састав:

GADOBUTROL 1.0 mmol/ml

Тип рецептора:

POM

Терапеутска област:

CONTRAST MEDIA

Статус ауторизације:

Authorised

Датум одобрења:

2016-07-04

Информативни летак

1
PACKAGE LEAFLET
for
Gadovist 1.0 mmol/ml solution for injection in prefilled
syringes/cartridges
2
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
GADOVIST
1.0 MMOL/ML SOLUTION FOR INJECTION IN PREFILLED SYRINGE/CARTRIDGE
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 Gadovist (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 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 ARE GIV

Карактеристике производа

1
SUMMARY OF PRODUCT CHARACTERISTICS,
LABELLING AND PACKAGE LEAFLET
for
Gadovist 1.0 mmol/ml solution for injection in prefilled
syringes/cartridges
2
_ _
SUMMARY OF PRODUCT CHARACTERISTICS,
LABELLING AND PACKAGE LEAFLET
3
SUMMARY OF PRODUCT CHARACTERISTICS
4
1.
NAME OF THE MEDICINAL PRODUCT
Gadovist 1.0 mmol/ml solution for injection in prefilled
syringe/cartridge
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 prefilled syringe with 5.0 ml contains 3023.6 mg gadobutrol,
1 prefilled syringe with 7.5 ml contains 4535.4 mg gadobutrol,
1 prefilled syringe with 10 ml contains 6047.2 mg gadobutrol,
1 prefilled syringe with 15 ml contains 9070.8 mg gadobutrol,
1 prefilled syringe with 20 ml contains 12094.4 mg gadobutrol.
1 cartridge with 15 ml contains 9070.8 mg gadobutrol,
1 cartridge with 20 ml contains 12094.4 mg gadobutrol,
1 cartridge with 30 ml contains 18141.6 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 in prefilled syringe/cartridge
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 a