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, musculosceletal 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 thic

Preparatomtale

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Omniscan 0.5 mmol/ml Solution for Injection, pre-filled syringe
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml contains: Gadodiamide 287 mg (0.5 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)
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, pre-filled syringe
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.
Above 100 kg bod