Omniscan 0.5 mmol/ml solution for injection

Riik: Malta

keel: inglise

Allikas: Malta Medicines Authority

Toimeaine:

GADODIAMIDE

Saadav alates:

GE Healthcare AS Nycoveien 1, NO-0485 Oslo, Norway

ATC kood:

V08CA03

INN (Rahvusvaheline Nimetus):

GADODIAMIDE

Ravimvorm:

SOLUTION FOR INJECTION

Koostis:

GADODIAMIDE

Retsepti tüüp:

POM

Terapeutiline ala:

CONTRAST MEDIA

Volitamisolek:

Suspended

Loa andmise kuupäev:

2006-09-20

Infovoldik

PACKAGE LEAFLET:INFORMATION FOR THE USER
OMNISCAN 0.5 MMOL/ML SOLUTION FOR INJECTION
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 any 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 thickening of the skin and connective tissues. NSF may
result in severe joint immobility, muscle
weakness or may affect the normal work

Toote omadused

Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE PROPRIETARY MEDICINAL PRODUCT
OMNISCAN™ 0.5 mmol/ml solution for injection
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active ingredient
Content per ml
Function
GADODIAMIDE
(GdDTPA-BMA)
287 mg
(equiv. 0.5 mmol)
MRI-contrast agent
OMNISCAN injection is a non-ionic paramagnetic contrast medium with
the following
physicochemical properties:
Osmolality (mOsm/kg H
2
O) at 37 °C
780
Viscosity (mPa·s) at 20 °C
2.8
Viscosity (mPa·s) at 37 °C
1.9
Density at 20 °C (kg/l)
1.15
Molar relaxivity
_r_
_1 _
(mM
-1
· s
-1
) at 20 MHz and 37 °C
3.9
_r_
_1 _
(mM
-1
· s
-1
) at 10 MHz and 37 °C
4.6
_r_
_2 _
(mM
-1
· s
-1
) at 10 MHz and 37 °C
5.1
pH 6.0 - 7.0
Gadodiamide is freely soluble in water.
Excipient(s) with known effect:
Omniscan also contains sodium 0.62mg/ml
For the full list of excipients, see section 6.1
3
PHARMACEUTICAL FORM
Solution for injection.
The product is a clear, colourless to slightly yellow aqueous
solution.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Contrast medium for cranial and spinal magnetic resonance imaging
(MRI) and for general MRI of the
Page 2 of 9
body after intravenous administration.
The product provides contrast enhancement and facilitates
visualisation of abnormal structures or
lesions in various parts of the body including the CNS.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
No special preparation of the patient is required. OMNISCAN should be
drawn into the syringe
immediately before use.
For intravenous use. For both adults and children the required dose
should be administered as a single
intravenous injection. To ensure complete injection of the contrast
medium, the intravenous line may be
flushed with sodium chloride injection 0.9%.
CNS
Dosage for adults and children
The recommended dosage is 0.1 mmol/kg body weight (equivalent to 0.2
ml/kg b.w.) up to 100 kg.
Above 100 kg body weight 20 ml is usually sufficient to provide
diagnostically adequate contrast.
Adults only
When brain metastases are suspected, a do