Gadovist 1.0 mmol/ml solution for injection in prefilled syringe
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Patient Information leaflet
(PIL)
10-11-2022
Summary of Product characteristics
(SPC)
10-11-2022
Active ingredient:
Gadobutrol
Available from:
Bayer Limited
ATC code:
V08CA; V08CA09
INN (International Name):
Gadobutrol
Dosage:
1.0 millimole(s)/millilitre
Pharmaceutical form:
Solution for injection in pre-filled syringe
Prescription type:
Product subject to Restricted Prescription (C)
Therapeutic area:
Paramagnetic contrast media; gadobutrol
Authorization status:
Marketed
Authorization date:
2001-04-20
Patient Information leaflet
1
BP22036_REC30610
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
GADOVIST
1.0 MMOL/ML SOLUTION FOR INJECTION IN PREFILLED SYRINGE
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 GIVEN GADOVIST
DO NOT USE GADOVIST IF YOU
•
are allergic to gadobutrol or any of the other in
Read the complete document
Summary of Product characteristics
Health Products Regulatory Authority
10 November 2022
CRN00D61K
Page 1 of 10
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Gadovist 1.0 mmol/ml solution for injection in prefilled syringe
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.
Excipient with known effect: 1 ml contains 0.00056mmol (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
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.
Gadovist 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
GADOVIST SHOULD ONLY BE ADMINISTERED BY HEALTHCARE PROFESSIONALS
EXPERIENCED IN THE FIELD OF
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