Imstello 1.0 mmol/ml solution for injection in pre-filled syringe

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

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

Therapeutic area:

Paramagnetic contrast media; gadobutrol

Authorization status:

Not marketed

Authorization date:

2019-11-22

Patient Information leaflet

BP22036_REC30610
1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
IMSTELLO 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 Imstello (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 Imstello is and what it is used for
2.
What you need to know before you are given Imstello
3.
How Imstello will be given
4.
Possible side effects
5.
How to store Imstello
6.
Contents of the pack and other information
1.
WHAT IMSTELLO IS AND WHAT IT IS USED FOR
Imstello is a contrast medium for magnetic resonance imaging (MRI)
used for diagnostics of the brain, spine
and vessels. Imstello an also help the doctor find out the kind
(benign or malignant) of known or suspected
abnormalities in the liver and kidneys.
Imstello 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 IMSTELLO 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.
Imstello 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 IMSTELLO
DO NOT USE IMSTELLO IF YOU
•
are allergic to gadobutrol or any of the other ingredients of this
medi

Summary of Product characteristics

Health Products Regulatory Authority
14 November 2022
CRN00D827
Page 1 of 10
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Imstello 1.0 mmol/ml solution for injection in pre-filled 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.
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
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. Imstello 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).
Imstello 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.
Imstello 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
IMSTELLO SHOULD ONLY BE ADMINISTERED BY HEALTHCARE PROFESSIONALS
EXPERIENCED IN THE FIELD OF CLINICAL MRI PRACTICE.
Method of administration
This med