Clariscan 279.32 mg/ml solution for injection in pre-filled syringe

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Gadoteric acid

Available from:

GE Healthcare AS

ATC code:

V08CA; V08CA02

INN (International Name):

Gadoteric acid

Dosage:

279.3 milligram(s)/millilitre

Pharmaceutical form:

Solution for injection in pre-filled syringe

Prescription type:

Product subject to prescription which may not be renewed (A)

Therapeutic area:

Paramagnetic contrast media; gadoteric acid

Authorization status:

Marketed

Authorization date:

2017-12-22

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
CLARISCAN 279.32 MG/ML SOLUTION FOR INJECTION
CLARISCAN 279.32 MG/ML SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE
GADOTERIC ACID
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING 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, ask your doctor or radiologist or
pharmacist.
•
If you get any of the side effects, talk to your doctor, radiologist
or pharmacist. This includes any
possible side effects not listed in this leaflet. See section 4.
IN THIS LEAFLET
:
1. What Clariscan is and what it is used for
2. What you need to know before you are given Clariscan
3. How you will be given Clariscan
4. Possible side effects
5. How to store Clariscan
6. Contents of the pack and other information
1.
WHAT CLARISCAN IS AND WHAT IT IS USED FOR
WHAT CLARISCAN IS
Clariscan contains the active substance gadoteric acid. It belongs to
a group called “contrast agents”
used for magnetic resonance imaging” (MRI).
WHAT CLARISCAN IS USED FOR
Clariscan is used to enhance the contrast of the images obtained
during MRI examinations.
In adults and in children and adolescents 0-18 years old:
•
MRI of the CNS including of defects (lesions) in brain, spine, and
surrounding tissues
In adults and in children and adolescents 6 months – 18 years old:
•
Whole body MRI including defects (lesions)
In adults only:
•
MR angiography including defects (lesions) or narrowing (stenosis) in
arteries, except in
coronary arteries.
This medicine is for diagnostic use only
HOW CLARISCAN WORKS
Clariscan makes the pictures on an MRI scanner easier to see. It does
this by increasing the contrast
between the part of the body being looked at and the rest of the body.
This allows doctors or
radiologists to see different areas of the body better.
2.
WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN CLARISCAN
YOU SHOULD NOT BE GIVEN CLARISCAN:
•
if you are allergic to gadoteric acid or any of the oth

Summary of Product characteristics

Health Products Regulatory Authority
19 February 2024
CRN00DXDL
Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Clariscan 279.32 mg/ml solution for injection in pre-filled syringe
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 mL solution for injection contains 279.32 mg gadoteric acid* (as
gadoterate meglumine) equivalent to 0.5 mmol
Tetraxetan (DOTA) 202.46 mg
Gadolinium oxide 90.62 mg
* Gadoteric acid: gadolinium complex with1,4,7,10
tetraazacyclododecane N,N’,N”,N’’’ tetraacetic acid
(tetraxetan (DOTA))
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection in prefilled syringe
Clear, colourless to slightly yellow solution
Contrast medium concentration279.32 mg/mL equivalent to 0.5 mmol/mL
Osmolality at 37 °C
1350 mOsm.kg
-1
Viscosity at 20 °C
3.0 mPa.s
Viscosity at 37 °C
2.1 mPa.s
pH value
6.5 – 8.0
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
This medicinal product is for diagnostic use only.
Clariscan should be used only when diagnostic information is essential
and not available with unenhanced magnetic resonance
imaging (MRI).
Clariscan is a contrast agent indicated for enhancement of the
contrast in Magnetic Resonance Imaging for a better
visualization/delineation.
Adult population and paediatric population (0-18 years):

lesions of the brain, spine, and surrounding tissues

whole body MRI (see section 4.2)
Use for whole body is not recommended in children under 6 months.
In adults only:

lesions or stenoses of the non-coronary arteries (MR Angiography).
Health Products Regulatory Authority
19 February 2024
CRN00DXDL
Page 2 of 9
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
This medicinal product should only be administered by trained
healthcare professionals with technical expertise in performing
and interpreting gadolinium enhanced MRI.
POSOLOGY
The lowest dose that provides sufficient enhancement for diagnostic
purposes should be used. The dose should be calculated
based on the patient's body weight, and sho