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

Land: Irland

Språk: engelsk

Kilde: HPRA (Health Products Regulatory Authority)

Aktiv ingrediens:

Gadoteric acid

Tilgjengelig fra:

Guerbet

ATC-kode:

V08CA; V08CA02

INN (International Name):

Gadoteric acid

Dosering :

279.32 milligram(s)/millilitre

Legemiddelform:

Solution for injection in pre-filled syringe

Resept typen:

Product subject to Restricted Prescription (C)

Terapeutisk område:

Paramagnetic contrast media; gadoteric acid

Autorisasjon status:

Not marketed

Autorisasjon dato:

1996-06-10

Informasjon til brukeren

PACKAGE LEAFLET: INFORMATION FOR THE USER
DOTAREM 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 pharmacist.
•
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side effects not
listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
:
1.
What Dotarem is and what it is used for
2.
What you need to know before you are given Dotarem
3.
How you will be given Dotarem
4.
Possible side effects
5.
How to store Dotarem
6.
Contents of the pack and other information
1.
WHAT DOTAREM IS AND WHAT IS IT USED FOR
Dotarem is a diagnostic agent used in adults and children. It belongs
to the group of contrast agents used for
magnetic resonance imaging (MRI).
Dotarem is used to enhance the contrast of the images obtained during
MRI examinations. This contrast
enhancement improves the examination of some areas of the body.
This medicine is for diagnostic use only.
2.
WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN DOTAREM
YOU SHOULD NOT BE GIVEN DOTAREM
•
if you are allergic to the active substance or any of the other
ingredients of this medicine (listed in section
6)
•
if you are allergic to medicines containing gadolinium (like other
contrast agents used for MRI).
WARNINGS AND PRECAUTIONS
Inform your doctor or radiologist if the following applies to you:
•
you have previously reacted to a contrast agent during an examination
•
you have asthma
•
you have a history of allergy (such as seafood allergy, urticaria, hay
fever)
•
you are being treated with a beta-blocker (medicine for heart and
blood pressure disorders, such as
metoprolol)
•
your kidneys do not work properly
•
you have recently had, or soon expect to have, a liver transplant
•
you have a disease affecting your heart or your blood vessels
•
you have ha

Preparatomtale

Health Products Regulatory Authority
15 November 2023
CRN00DYHZ
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Dotarem 279.32 mg/ml solution for injection in pre-filled syringe
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Name of ingredient
Formula per ml
Gadoteric acid*
279.32 mg (equivalent to 0.5 mmol/ml)
*Gadoteric acid is formed in situ during manufacture from DOTA and
gadolinium oxide.
Gadoteric acid: 1, 4, 7, 10-tetraazacyclododecane-N, N’, N’’,
N’’’, tetraacetic acid (or DOTA) gadolinium complex
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection.
Clear colourless or slightly yellow solution in a prefilled syringe
Osmolality: 1350 mOsm/kg
-1
Viscosity at 20 °C: 3.2 mPa.s
Viscosity at 37 °C: 2.0 mPa.s
pH: 6.5 to 8.0
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
This medicinal product is for diagnostic use only.
Dotarem should be used only when diagnostic information is essential
and not available with unenhanced magnetic resonance
imaging (MRI).
Enhancement ofc ontrast in Magnetic Resonance Imaging:
In adults and paediatric population (0-18 years):
* MRI of the brain and spine: brain tumours, tumours of the spine and
the surrounding tissue, intravertebral disk prolapse,
infectious diseases.
* Wholebody MRI:
Abdominal diseases: primary and secondary hepatic tumours, pancreatic
tumours.
Renal diseases: renal tumours and cysts, follow-up of kidney
transplants.
Pelvic diseases: uterine and ovarian tumours.
Cardiac diseases: follow-up of infarction and heart transplants.
Breast diseases: breast tumours, follow-up of implants.
Osteo-articular diseases: bone and soft tissue tumours.
In adults only:
*Vascular pathology (angiography)
Health Products Regulatory Authority
15 November 2023
CRN00DYHZ
Page 2 of 7
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
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 should n