Optimark
Land: Europäische Union
Sprache: Englisch
Quelle: EMA (European Medicines Agency)
Gebrauchsinformation
(PIL)
08-05-2017
Fachinformation
(SPC)
08-05-2017
Öffentlichen Beurteilungsberichts
(PAR)
16-06-2016
Wirkstoff:
gadoversetamide
Verfügbar ab:
Mallinckrodt Deutschland GmbH
ATC-Code:
V08CA06
INN (Internationale Bezeichnung):
gadoversetamide
Therapiegruppe:
Contrast media
Therapiebereich:
Magnetic Resonance Imaging
Anwendungsgebiete:
This medicinal product is for diagnostic use only.Optimark is indicated for use with magnetic resonance imaging (MRI) of the central nervous system (CNS) and liver. It provides contrast enhancement and facilitates visualisation and helps with the characterisation of focal lesions and abnormal structures in the CNS and liver in patients with known or highly suspected pathology.
Produktbesonderheiten:
Revision: 14
Berechtigungsstatus:
Withdrawn
Berechtigungsdatum:
2007-07-23
Gebrauchsinformation
32
B. PACKAGE LEAFLET
Medicinal product no longer authorised
33
PACKAGE LEAFLET: INFORMATION FOR THE USER
OPTIMARK 500 MICROMOL/ML SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE
Gadoversetamide
This medicine is subject to additional monitoring. This will allow
quick identification of new
safety information. You can help by reporting any side effects you may
get. See the end of section 4
for how to report side effects.
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE BEING 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, 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 Optimark is and what it is used for
2.
What you need to know before you are given Optimark
3.
How Optimark is given
4.
Possible side effects
5.
How to store Optimark
6.
Contents of the pack and other information
1.
WHAT OPTIMARK IS AND WHAT IT IS USED FOR
Optimark contains the active substance gadoversetamide.
Gadoversetamide is used as a ‘contrast
agent’ in magnetic resonance imaging.
Optimark is for diagnostic use, only. It is used in adult patients and
children of two years and older,
who are undergoing magnetic resonance imaging (MRI), a type of scan
where images of the internal
organs are taken. Optimark is used to obtain a clearer scan in
patients who have or are thought to have
abnormalities in the brain, spine or liver.
2.
WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN OPTIMARK
DO NOT USE OPTIMARK
if you are allergic
•
to the active substance gadoversetamide or
•
to any of the other ingredients of Optimark (see section 6), or
•
to other gadolinium contrast agents.
You must not be given Optimark if
•
you suffer from severe and/or acute kidney impairment, or
•
if you are a patient who is about to have or has had a liver
transplant as use of Optimark in
patients with
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Fachinformation
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
Medicinal product no longer authorised
2
This medicinal product is subject to additional monitoring. This will
allow quick identification of
new safety information. Healthcare professionals are asked to report
any suspected adverse reactions.
See section 4.8 for how to report adverse reactions.
1.
NAME OF THE MEDICINAL PRODUCT
Optimark 500 micromol/ml solution for injection in pre-filled syringe
Optimark 500 micromol/ml solution for injection in vial
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Pre-filled syringe
1 ml contains 330.9 mg gadoversetamide, equivalent to 500 micromol.
Each 10 ml syringe contains 3309 mg gadoversetamide equivalent to 5
millimol.
Each 15 ml syringe contains 4963.5 mg gadoversetamide equivalent to
7.5 millimol.
Each 20 ml syringe contains 6618 mg gadoversetamide equivalent to 10
millimol.
Each 30 ml syringe contains 9927 mg gadoversetamide equivalent to 15
millimol.
Excipient(s) with known effect:
20 ml of the solution contain 28.75 mg sodium.
30 ml of the solution contain 43.13 mg sodium.
For the full list of excipients, see section 6.1.
Vial
1 ml contains 330.9 mg gadoversetamide, equivalent to 500 micromol.
Each 10 ml vial contains 3309 mg gadoversetamide equivalent to 5
millimol.
Each 15 ml vial contains 4963.5 mg gadoversetamide equivalent to 7.5
millimol.
Each 20 ml vial contains 6618 mg gadoversetamide equivalent to 10
millimol.
Excipient(s) with known effect:
20 ml of the solution contain 28.75 mg sodium.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Pre-filled syringe
Solution for injection in pre-filled syringe.
Vial
Solution for injection in vial.
Clear, colourless to pale yellow solution.
pH: 6.0 – 7.5
Osmolality (37°C): 1000 – 1200 mOsm/kg
Medicinal product no longer authorised
3
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
This medicinal product is for diagnostic use only.
Optimark is indicated for use with magnetic resonance imaging (MRI) of
the central nervous system
(CNS) and liver. It pro
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