OMNISCAN 0.5 mMol/ml Solution for Injection

Land: Irland

Språk: engelsk

Kilde: HPRA (Health Products Regulatory Authority)

Aktiv ingrediens:

GADODIAMIDE

Tilgjengelig fra:

GE Healthcare AS

ATC-kode:

V08CA03

INN (International Name):

GADODIAMIDE

Dosering :

0.5 mMol/ml

Legemiddelform:

Solution for Injection

Resept typen:

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

Terapeutisk område:

Paramagnetic contrast media

Autorisasjon status:

Authorised

Autorisasjon dato:

2007-06-29

Informasjon til brukeren

PACKAGE LEAFLET: INFORMATION FOR THE USER
OMNISCAN 0.5 MMOL/ML SOLUTION FOR INJECTION
OMNISCAN 0.5 MMOL/ML SOLUTION FOR INJECTION, PRE-FILLED SYRINGE
GADODIAMIDE
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN OMNISCAN
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.
-
If you get any side effects, talk to you doctor. This includes any
possible side effects not listed in
this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What OMNISCAN is and what it is used for
2.
What you need to know before you are given Omniscan
3.
How to use Omniscan
4.
Possible side effects
5.
How to store Omniscan
6.
Contents of the pack and other information
1.
WHAT OMNISCAN IS AND WHAT IT IS USED FOR
THIS MEDICINE IS FOR DIAGNOSTIC USE ONLY.
Omniscan is a contrast medium which is used in Magnetic Resonance
Imaging (MRI) examinations
of the brain or spine, and for whole body examinations like the head
and neck region, the thoracic
cavity including the heart, extremities (arms and legs), organs in the
abdominal cavity (prostate,
urinary bladder, pancreas and liver), kidney, female breast,
musculoskeletal system and blood vessels.
Omniscan can help some medical conditions to be seen more clearly.
This helps the doctor to find
and examine these conditions more easily, and can improve the
information needed to make a
diagnosis.
2.
WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN OMNISCAN
DO NOT USE OMNISCAN
-
if you are allergic (hypersensitive) to gadodiamide or any of the
other ingredients of Omniscan
(listed in section 6)
You should not be given Omniscan if you suffer from severe and/or
acute kidney problems, or if you
are a patient who is about to have or has recently had a liver
transplant, as use of Omniscan in
patients with these conditions has been associated with a disease
called nephrogenic systemic fibrosis
(NSF). NSF is a disease involving thickening of the skin and
connective tissues. NSF may result in
severe joint

Preparatomtale

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Omniscan 0.5 mmol/ml Solution for Injection, glass vial/bottles
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml contains: Gadodiamide 287 mg (0.5 mmol)
5 ml contains: Gadodiamide 1.44 g (2.5 mmol)
10 ml contains: Gadodiamide 2.87 g (5.0 mmol)
15 ml contains: Gadodiamide 4.31 g (7.5 mmol)
20 ml contains: Gadodiamide 5.74 g (10.0 mmol)
100 ml contains: Gadodiamide 28.70 g (50.0 mmol)
Excipient(s) with known effect:
Total sodium content: 0.62 mg/ml
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection.
A clear, colourless to slightly yellow aqueous solution.
Osmolality at 37°C:
780 (mOsm/kg H
2
O)
pH:
6.0 -7.0
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
This medicinal product is for diagnostic use only.
Omniscan is a contrast medium for cranial and spinal magnetic
resonance imaging (MRI). Omniscan is also indicated
for whole body MRI including head and neck region, thoracic space
including the heart, extremities, abdomen and
pelvis (prostate and bladder), female breast, abdomen (pancreas and
liver), retroperitoneal space (kidney),
musculosceletal system and vessels (angiography) by intravenous
administration.
Omniscan facilitates visualisation of abnormal structures or lesions
and helps in the differentiation between healthy and
pathological tissue.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Omniscan should be drawn into the syringe immediately before use. All
the recommended doses below can be
administered as bolus intravenous injections. To ensure complete
injection of Omniscan, the intravenous line may be
flushed with 5 ml sodium chloride 9 mg/ml (0.9 %) solution for
injection after injection.
_CNS examinations_
The recommended dosage to adults and children is 0.2 ml/kg body weight
(b.w.) (0.1 mmol/kg b.w.) up to 100 kg.
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