Dotagraf 279.32 mg/ml solution for injection

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Gadolinium oxide; DOTA ACID; Meglumine; Gadoteric acid

Available from:

Bayer Limited

ATC code:

V08CA; V08CA02

INN (International Name):

Gadolinium oxide; DOTA ACID; Meglumine; Gadoteric acid

Dosage:

279.32 milligram(s)/millilitre

Pharmaceutical form:

Solution for injection

Prescription type:

Product subject to Restricted Prescription (C)

Therapeutic area:

Paramagnetic contrast media; gadoteric acid

Authorization status:

Not marketed

Authorization date:

2016-12-16

Patient Information leaflet

BP22036_REC30610
1
PACKAGE LEAFLET: INFORMATION FOR THE USER DOTAGRAF 279.32 MG/ML
SOLUTION FOR INJECTION
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.
•
If you get any side effects, talk to your doctor, radiologist or
pharmacist. This includes any
possible side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Dotagraf is and what it is used for
2.
What you need to know before Dotagraf is used
3.
How Dotagraf is used
4.
Possible side effects
5.
How to store Dotagraf
6.
Contents of the pack and other information
1.
WHAT DOTAGRAF IS AND WHAT IT IS USED FOR
Dotagraf is a contrast agent that contains gadoteric acid. It is for
diagnostic use only.
Dotagraf is used to enhance the contrast of the images obtained in
examinations with Magnetic
Resonance Imaging (MRI). This contrast enhancement improves the
visualisation and delineation in:
_ _
_Adult and paediatric population (0-18 years) _
•
MRI of the Central Nervous System including defects (lesions) in
brain, spinal cord and
adjacent tissue;
•
Whole body MRI including defects (lesions) in liver, kidneys,
pancreas, pelvis, lungs, heart,
breast and musculoskeletal system.
_Adult population_
•
MR angiography including defects (lesions) and narrowing (stenosis) in
arteries, except in
coronary arteries.
2.
WHAT YOU NEED TO KNOW BEFORE DOTAGRAF IS USED
YOU SHOULD NOT BE GIVEN DOTAGRAF
•
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
magnetic resonance imaging).
BP22036_REC30610
2
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

Summary of Product characteristics

Health Products Regulatory Authority
14 November 2022
CRN00D827
Page 1 of 8
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Dotagraf 279.32 mg/ml solution for injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml solution for injection contains 279.32 mg gadoteric acid (as
meglumine salt), equivalent to 0.5 mmol.
10 ml solution for injection contain 2793.2 mg gadoteric acid (as
meglumine salt), equivalent to 5 mmol.
15 ml solution for injection contain 4189.8 mg gadoteric acid (as
meglumine salt), equivalent to 7.5 mmol.
20 ml solution for injection contain 5586.4 mg gadoteric acid (as
meglumine salt), equivalent to 10 mmol.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection.
Clear, colourless to yellow solution.
Contrast medium concentration279.32 mg/ml
0.5 mmol/ml
Osmolality at 37°C
1.35 Osm/kg
H
2
O
Viscosity at 37°C
1.8 mPas
pH value
6.5 – 8.0
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
This medicinal product is for diagnostic use only.
Dotagraf is a contrast agent indicated for enhancement of the contrast
in Magnetic Resonance Imaging (MRI) for a better
visualization/delineation in:
_Adult and paediatric population (0-18 years)_
● MRI of the CNS including lesions of the brain, spine, and
surrounding tissues
● Whole body MRI including lesions of the liver, kidneys, pancreas,
pelvis, lungs, heart, breast, and musculoskeletal system.
_Adult population_
● MR angiography including lesions or stenoses of the non-coronary
arteries.
Dotagraf should be used only when diagnostic information is essential
and not available with unenhanced MRI.
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 not exceed the
recommended dose per kilogram of body weight detailed in
this section.
_Encephalic and spinal MRI_
Health Products Regulatory Authority
14 November 2022
CRN00D827
Pa