MAGNEVIST INJECTION 469 mgml

País: Singapur

Idioma: anglès

Font: HSA (Health Sciences Authority)

ingredients actius:

GADOPENTETIC ACID, DIMEGLUMINE SALT

Disponible des:

BAYER (SOUTH EAST ASIA) PTE LTD

Codi ATC:

V08CA01

Dosis:

469 mg/ml

formulario farmacéutico:

INJECTION

Composición:

GADOPENTETIC ACID, DIMEGLUMINE SALT 469 mg/ml

Vía de administración:

INTRAVENOUS

tipo de receta:

Prescription Only

Fabricat per:

BAYER AG

Estat d'Autorització:

ACTIVE

Data d'autorització:

1990-04-27

Informació per a l'usuari

Magnevist PI_SG_CCDS 9 _7June 2013 

1.NAME OF THE MEDICINAL PRODUCT 

Magnevist 0.5 mmol per ml solution for injection. 

2. QUALITATIVE AND QUANTITATIVE COMPOSITION 

Each ml contains 0.5 mmol gadopentetate dimeglumine (equivalent to 469.01 mg 
gadopentetate dimeglumine) as active ingredient. 

For full list of excipients, see section 
‘List of excipients’. 

3. PHARMACEUTICAL FORM 
Solution for injection. 

Clear, colourless to pale yellow solution. 
The physio-chemical properties of Magnevist listed below are: 

Osmolarity at 37 ºC (osm/l solution) 
1.44 
Osmolality at 37 ºC (osm/kg H
2
O) 
1.96 
Osmot. pressure at 37 ºC 
(atm) 
49.8 
(mPa) 
5.06 

Viscosity (mPa · s or cP) 
at 20 ºC 
4.9 
at 37 ºC 
2.9 

pH 
7.0-7.9 

4. CLINICAL PARTICULARS 

4.1 INDICATION(S) 

This medicinal product is for diagnostic use only. 

• Cranial and spinal magnetic resonance imaging (MRI) 

In
particular for the demonstration of tumours and for further differential-diagnostic 
clarification in suspected meningioma, (acoustic) neurinoma, invasive tumours (e. g. 
glioma) and metastases; for the demonstration of small and/or isointense 
tumours; in suspected recurrence after surgery or radiotherapy; for the differentiated 
demonstration of rare neoplasms such
as haemangioblastomas, ependymomas and 
small pituitary adenomas; for improved determination of the spread of tumours 
not of cerebral origin. 

Additionally in spinal MRI: Differentiation of intra and
extramedullary tumours; 
demonstration of solid tumour areas in known
syrinx; determination of intramedullary 
tumour spread. 

• Whole body MRI 

Including the facial skull, the neck region, the thoracic and abdominal space, the female 
Magnevist PI_SG_CCDS 9 _7June 2013 

breast, the 

Fitxa tècnica

Magnevist PI_CCDS 9 _13 Apr 2018
1.NAME OF THE MEDICINAL PRODUCT
Magnevist 0.5 mmol per ml solution for injection.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains 0.5 mmol gadopentetate dimeglumine (equivalent to
469.01 mg
gadopentetate dimeglumine) as active ingredient.
For full list of excipients, see section ‘List of excipients’.
3. PHARMACEUTICAL FORM
Solution for injection.
Clear, colourless to pale yellow solution.
The physio-chemical properties of Magnevist listed below are:
Osmolarity at 37 ºC (osm/l solution)
1.44
Osmolality at 37 ºC (osm/kg H
2
O)
1.96
Osmot. pressure at 37 ºC
(atm)
49.8
(mPa)
5.06
Viscosity (mPa · s or cP)
at 20 ºC
4.9
at 37 ºC
2.9
pH
7.0-7.9
4. CLINICAL PARTICULARS
4.1 INDICATION(S)
This medicinal product is for diagnostic use only.
• Cranial and spinal magnetic resonance imaging (MRI)
In particular for the demonstration of tumours and for further
differential-diagnostic
clarification in suspected meningioma, (acoustic) neurinoma, invasive
tumours (e. g.
glioma) and metastases; for the demonstration of small and/or
isointense
tumours; in suspected recurrence after surgery or radiotherapy; for
the differentiated
demonstration of rare neoplasms such as haemangioblastomas,
ependymomas and
small pituitary adenomas; for improved determination of the spread of
tumours
not of cerebral origin.
Additionally in spinal MRI: Differentiation of intra and
extramedullary tumours;
demonstration of solid tumour areas in known syrinx; determination of
intramedullary
tumour spread.
• Whole body MRI
Including the facial skull, the neck region, the thoracic and
abdominal space, the female
Magnevist PI_CCDS 9 _13 Apr 2018
breast, the pelvis and the active and passive locomotive apparatus.
In particular, Magnevist permits diagnostic information:
- For the demonstration or exclusion of tumours, inflammations and
vascular lesions;
- For determination of the spread and demarcation of these lesions;
- For the differentiation of the internal structure of lesions;
- For assessment of th