Primovist 0.25 mmol/ml, solution for injection
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:
Gadoxetic acid, disodium
Available from:
Bayer Limited
ATC code:
V08CA; V08CA10
INN (International Name):
Gadoxetic acid, disodium
Dosage:
0.25 millimole(s)/millilitre
Pharmaceutical form:
Solution for injection
Prescription type:
Product subject to Restricted Prescription (C)
Therapeutic area:
Paramagnetic contrast media; gadoxetic acid
Authorization status:
Not marketed
Authorization date:
2004-11-19
Patient Information leaflet
BP22036_REC30610
1
PACKAGE LEAFLET: INFORMATION FOR THE USER
PRIMOVIST
0.25 MMOL/ML, SOLUTION FOR INJECTION
Gadoxetate disodium
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 giving you
Primovist
-
If you get any side effects talk to your doctor. This includes any
possible side effects not listed in this
leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Primovist is and what it is used for
2.
What you need to know before you are given Primovist
3.
How to use Primovist
4.
Possible side effects
5.
How to store Primovist
6.
Contents of the pack and other information
1.
WHAT PRIMOVIST IS AND WHAT IT IS USED FOR
Primovist is a contrast medium for magnetic resonance imaging (MRI) of
the liver. It is used to help detect
and diagnose changes that may be found in the liver. Abnormal signs
within the liver can be better evaluated
as to number, size, and distribution. Primovist can also help the
doctor determine the nature of any
abnormalities, thereby increasing the confidence in the diagnosis.
It is provided as a solution for intravenous injection. This medicine
is for diagnostic use only.
MRI is a form of medical diagnostic imaging that forms pictures after
water molecules have been detected in
normal and abnormal tissues. This is done using a complex system of
magnets and radio waves.
2.
WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN PRIMOVIST
DO NOT USE PRIMOVIST
-
if you are allergic to gadoxetate disodium or any of the other
ingredients of this medicine (listed in
section 6).
WARNINGS AND PRECAUTIONS
Talk to your doctor before you are given Primovist if you have:
-
or have had asthma or an allergy such as hay fever, nettle-rash
-
had a previous reaction to contrast media
-
reduced kidney function
The use of some gadolinium-containing contrast agents in patients with
these conditions has been
associated with a disease called Nephroge
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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
Primovist 0.25 mmol/ml, solution for injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains 0.25mmol gadoxetate disodium (Gd‑EOB‑DTPA
disodium), equivalent to 181.43 mg gadoxetate disodium
1 injection vial with 5.0 ml contains 907 mg gadoxetate disodium,
1 injection vial with 7.5 ml contains 1361 mg gadoxetate disodium,
1 injection vial with 10.0 ml contains 1814 mg gadoxetate disodium.
Excipients with known effect: 11.7 mg sodium/ ml.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection:
Clear, colourless to pale yellow liquid free from visible particles.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Primovist is indicated for the detection of focal liver lesions and
provides information on the character of lesions in
T1-weighted magnetic resonance imaging (MRI).
Primovist should be used only when diagnostic information is essential
and not available with unenhanced magnetic resonance
imaging (MRI) and when delayed phase imaging is required.
This medicinal product is for diagnostic use by intravenous
administration only_._
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
METHOD OF ADMINISTRATION
Primovist is a ready-to-use aqueous solution to be administered
undiluted as an intravenous bolus injection at a flow rate of
about 2 ml/sec. After the injection of the contrast medium the
intravenous cannula/ line should be flushed using sterile 9
mg/ml (0.9 %) saline solution.
For detailed imaging information refer to section 5.1.
For additional instructions see section 6.6.
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.
The recommended dose of Primovist is:
Adults:
0.1 ml per kg body weight Primovist.
H
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