ULTRAVIST 300

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

IOPROMIDE

Available from:

BAYER ISRAEL LTD

ATC code:

V08AB05

Pharmaceutical form:

SOLUTION FOR INJECTION

Composition:

IOPROMIDE 623.4 MG / 1 ML

Administration route:

I.V, INTRA-ARTERIAL

Prescription type:

Required

Manufactured by:

BAYER AG, GERMANY

Therapeutic group:

IOPROMIDE

Therapeutic area:

IOPROMIDE

Therapeutic indications:

Contrast enhancement in computerized tomography (CT) , digital subtraction angiography (DSA), intravenous urography, arteriography ,phlebography of the extremities, venography, visualization of body cavities (e.g. arthrography, hysterosalpingography,fistulography) with the exception of myelography, ventriculography, cisternography.

Authorization date:

2014-05-31

Patient Information leaflet

העדוה
העדוה
לע
לע
הרמחה
הרמחה
(
(
עדימ
עדימ
ןולעב )תוחיטב
ןולעב )תוחיטב
ל
ל
אפור
אפור
ןכדועמ(
ןכדועמ(
05.2013
05.2013
)
)
ךיראת
22.7.2013
םש
רישכת
תילגנאב
רפסמו
( :םושירה
ULTRAVIST 300 ( 064-18-27492-00
ULTRAVIST 370 (064-19-27493-00)
__
םש
לעב
םושירה
_____
BAYER ISRAEL
LTD
.
_______________________________
! דבלב תורמחהה טורפל דעוימ הז ספוט
תורמחהה
תושקובמה
קרפ
ןולעב
טסקט
יחכונ
טסקט
שדח
4.2 POSOLOGY AND METHOD
OF ADMINISTRATION

Dietary suggestions
Normal diet may be maintained up to
two hours prior to the examination.
During the last two hours the patient
should refrain from eating.

Hydration
Adequate hydration must be assured
before and after intravascular and
intrathecal contrast medium
administration. This applies especially
to patients with multiple myeloma,
diabetes mellitus, polyuria, oliguria,
hyperuricemia, as well as to newborns,
infants, small children and elderly
patients.

Newborns (

1 month) and infants
(1 month -2 years)
Young infants (age < 1 year) and
especially newborns are susceptible to
electrolyte imbalance and
hemodynamic alterations. Care should
be taken regarding: the dose of contrast
medium to be given, the technical
performance of the radiological
procedure and the patient status.

Anxiety

Pronounced states of excitement,
anxiety and pain may increase the
risk of side effects or intensify
contrast medium-related reactions.
These patients may be given a
sedative.

Warming prior to use

Contrast media which are warmed
to body temperature before
Experience shows that contrast medium is
tolerated better if it is warmed to
body temperature
.
Intravenous urography
Adults: The minimum dose is 0.8ml/kg body
weight Ultravist 370, (1ml/kg Ultravist 300).
These doses should provide adequate filling
of the ureters. It may be necessary to
increase the dose in individual cases.
Children: The po

Summary of Product characteristics

1.
NAME OF THE MEDICINAL PRODUCT
Ultravist 300
Ultravist 370
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Ultravist 300: 1 mL contains 623 mg iopromide (equivalent to 300 mg
iodine).
Ultravist 370: 1 mL contains 769 mg iopromide (equivalent to 370 mg
iodine).
For the full list of excipients, see section 6.1.
The physical and chemical properties of the Ultravist solutions for
injection at the concentrations
indicated below are as follows:
Ultravist 300
Ultravist 370
Iodine content (mg/mL)
300
370
Iodine content (g) per:
10 mL vial
20 mL vial
50 mL bottle
100 mL bottle
150 mL bottle
200 mL bottle
500 mL bottle
3.0
6.0
15.0
30.0
45.0
60.0
150.0
-
-
18.5
37.0
55.5
74.0
185.0
Contrast medium content
(mg/mL)
623
769
Contrast medium content (g) per:
10mL vial
20mL vial
50mL bottle
100mL bottle
150mL bottle
200mL bottle
500mL bottle
6.2
12.5
31.2
62.3
93.5
124.7
311.7
-
-
38.4
76.9
115.3
153.8
384.4
Osmolality (osm/kg H
2
O)
at 37 °C
0.59
0.77
Viscosity (mPa·s)
at 20 °C
at 37 °C
8.9
4.7
22.0
10.0
Density (g/mL)
at 20 °C
1.328
1.409
at 37 °C
1.322
1.399
pH
6.5-8.0
6.5-8.0
3.
PHARMACEUTICAL FORM
Solution for injection and infusion.
Clear, free of particles solution.
4.
CLINICAL PARTICULARS
4.1
Therapeutic indications
This medicinal product is for diagnostic use only.
Ultravist 300:
Contrast enhancement in computerized tomography (CT), digital
subtraction angiography (DSA),
intravenous urography, arteriography, phlebography of the extremities,
venography, 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.
4.2
Posology and method of administration
•
General information
Experience shows that contrast mediu