ULTRAVIST 300 INJECTION 300 mg Iodineml

Land: Singapúr

Tungumál: enska

Heimild: HSA (Health Sciences Authority)

Virkt innihaldsefni:

IOPROMIDE EQV IODINE

Fáanlegur frá:

BAYER (SOUTH EAST ASIA) PTE LTD

ATC númer:

V08AB05

Skammtar:

623.40 mg

Lyfjaform:

INJECTION

Samsetning:

IOPROMIDE EQV IODINE 300 mg/ml

Stjórnsýsluleið:

INTRAVENOUS, INTRAVASCULAR, INTRACAVITARY, INTRA-ARTERIAL

Gerð lyfseðils:

Prescription Only

Framleitt af:

Bayer AG (Berlin, Müllerstraße)

Leyfisstaða:

ACTIVE

Leyfisdagur:

1991-05-14

Upplýsingar fylgiseðill

 
Ultravist PI_SG_CCDS 13_27 June 2013 
1.  NAME OF THE MEDICINAL PRODUCT 

Ultravist 300/370, solution for injection  

2.  QUALITATIVE AND QUANTITATIVE COMPOSITION  

Ultravist 300: 1ml
contains 623 mg iopromide (equivalent to 300 mg iodine)  
Ultravist 370: 1ml
contains 769 mg iopromide (equivalent to 370 mg iodine)  

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

3.  PHARMACEUTICAL FORM 

Solution for injection 

Clear, colourless to pale yellow solution.  

The physico-chemical properties of Ultravist
at the concentrations listed below are:  

Iodine concentration (mg/ml)  
300  
370  
Osmolality (osm/kg H
2
O) at 37
0
C  0.61  
0.77  
Viscosity (mPa.s)  

at 20
0
C 
8.7  
20.1  
at 37
0
C  
4.6  
9.5  
Density (g/ml) 

at 20
0
C 
1.328 
1.409 
at 37
0
C  
1.322 
1.399 
pH-value 
6.5 
– 8.0  6.5 – 8.0 

4.  CLINICAL PARTICULARS 

4.1 
INDICATIONS 

This medicinal product is for diagnostic use only.   

Ultravist 300:  
Contrast enhancement in computerized tomography (CT), digital
subtraction angiography 
(DSA),
intravenous urography, phlebography of the extremities, venography, arteriography, 
visualization of body cavities (e.g. arthrography, hysterosalpingography, fistulography) WITH 
THE EXCEPTION OF MYELOGRAPHY, VENTRICULOGRAPHY, CISTERNOGRAPHY.  

Ultravist 370:  
Contrast enhancement in computerized tomography (CT), digital
subtraction angiography 
(DSA), intravenous urography, arteriography and especially angiocardiography, visualization 
of body cavities (e.g. arthrography, fistulography) WITH
THE EXCEPTION OF MYELOGRAPHY, 
VENTRICULOGRAPHY, CISTERNOGRAPHY.  

Ultravist PI_SG_CCDS 13_27 June 2013 
4.2 DOSAGE AND METHOD OF ADMINISTRATION  

4.2.1 GENERAL INFORMATION  

Contrast media which are
warmed to 

Vara einkenni

Ultravist PI_SG_CCDS 18_01 Aug2022
1.
NAME OF THE MEDICINAL PRODUCT
Ultravist 300/370, solution for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Ultravist 300: 1ml contains 623 mg iopromide (equivalent to 300 mg
iodine)
Ultravist 370: 1ml contains 769 mg iopromide (equivalent to 370 mg
iodine)
For a full list of excipients, see section ‘List of excipients’.
3.
PHARMACEUTICAL FORM
Solution for injection
Clear, very slightly brown, very slightly brownish-yellow or very
slightly yellow solution.
The physico-chemical properties of Ultravist at the concentrations
listed below are:
Iodine concentration (mg/ml)
300
370
Osmolality (osm/kg H
2
O) at 37
0
C
0.61
0.77
Viscosity (mPa.s)
at 20
0
C
8.7
20.1
at 37
0
C
4.6
9.5
Density (g/ml)
at 20
0
C
1.328
1.409
at 37
0
C
1.322
1.399
pH-value
6.5 – 8.0
6.5 – 8.0
4.
CLINICAL PARTICULARS
4.1
INDICATIONS
This medicinal product is for diagnostic use only.
Ultravist 300:
Contrast enhancement in computerized tomography (CT), digital
subtraction
angiography (DSA), intravenous urography, phlebography of the
extremities,
venography, arteriography, visualization of body cavities (e.g.
arthrography,
hysterosalpingography, fistulography) WITH THE EXCEPTION OF
MYELOGRAPHY,
VENTRICULOGRAPHY, CISTERNOGRAPHY.
Ultravist 370:
Contrast enhancement in computerized tomography (CT), digital
subtraction
angiography (DSA), intravenous urography, arteriography and especially
angiocardiography, visualization of body cavities (e.g. arthrography,
fistulography)
WITH THE EXCEPTION OF MYELOGRAPHY, VENTRICULOGRAPHY, CISTERNOGRAPHY.
Ultravist PI_SG_CCDS 18_01 Aug2022
4.2
DOSAGE AND METHOD OF ADMINISTRATION
4.2.1 GENERAL INFORMATION
Contrast media which are warmed to body temperature before
administration are
better tolerated and can be injected more easily because of reduced
viscosity.
For additional instructions, see section ‘Instructions for
use/handling’.
4.2.2 DOSAGE REGIMEN
_INTRAVENOUS UROGRAPHY _
_ _
ADULTS
The dose should not be less than 1 ml Ultravist 300 (0.8 ml Ultravist
370)/