IOMERON 400

Country: Iżrael

Lingwa: Ingliż

Sors: Ministry of Health

Ingredjent attiv:

IOMEPROL

Disponibbli minn:

DEXCEL LTD, ISRAEL

Kodiċi ATC:

V08AB

Għamla farmaċewtika:

SOLUTION FOR INJECTION

Kompożizzjoni:

IOMEPROL 816.5 MG/ML

Rotta amministrattiva:

I.V, INTRA-ARTERIAL

Tip ta 'preskrizzjoni:

Required

Manifatturat minn:

BRACCO IMAGING S.P.A., ITALY

Grupp terapewtiku:

WATERSOLUBLE, NEPHROTROPIC, LOW OSMOLAR X-RAY CONTRAST MEDIA

Indikazzjonijiet terapewtiċi:

Contrast medium for diagnostic radiography. Intravenous urography (in adults ,including those with renal impairment or diabetes), CT (body), conventional angiography, intraarterial DSA, angiocardiography (in adults and pediatrics), conventional selective coronary arteriography, interventional coronary , arthrography, fistulography, galactography, dacryocystography, sialography.

Data ta 'l-awtorizzazzjoni:

2021-12-31

Fuljett ta 'informazzjoni

_ _
ינוי
2022
IOMERON 300, 350, 400 MG, SOLUTION FOR INJECTION
,דבכנ יאופר תווצ
תרבח
מ"עב לסקד
ןוכדע לע םכעידוהל תשקבמ
ןולעב
אפורל
רישכתה לש
םי
:
א
ןורמוי
300
,
350
,
400
.
העדוהב
וז
םינוכדעה םיטרופמ
דבלב יתוחיטבה עדימב הרמחה םיווהמה
.
ןייעל שי ,אלמ עדימל
ןולעב
.
אפורל ןולעה
ופורתה רגאמב םוסרפל חלשנ
לבקל ןתינו תואירבה דרשמ רתאבש ת
ו
ספדומ
לעבל היינפ י"ע
:םושירה
לסקד
מ"עב
לסקד 'חר ,
1
אביקע רוא ,
3060000
:'לט ,לארשי ,
04-6364000
. בכרה
:רישכתה
.
respectively
iomeprol 61.24 g, 71.44 g, 81.65 g
Each 100 ml of solution contains
יוותה
תו
רשואמ
ו
:ת
Contrast medium for diagnostic radiology.
IOMERON 300: Intravenous urography (in adults and paediatrics),
peripheral phlebography,
CT (brain and body), cavernosography, intravenous DSA, conventional
angiography,
intraarterial DSA, angiocardiography (in adults and paediatrics),
conventional selective
coronary arteriography, interventional coronary arteriography, ERCP,
arthrography,
hysterosalpingography, fistulography, discography, galactography,
chloangiography,
dacryocystography, sialography, retrograde urethrography, retrograde
pyelo-ureterography.
IOMERON 350:
Intravenous urography (in adults and paediatrics), CT (body),
intravenous
DSA, conventional angiography, intraarterial DSA, angiocardiography
(in adults and
paediatrics), conventional selective coronary arteriography,
interventional coronary
arteriography, arthrography, hysterosalpingography, fistulography,
galactography,
retrograde cholangiography, dacryocystography, sialography.
IOMERON 400: Intravenous urography (in adults including those with
renal impairment or
diabetes), CT (body), conventional angiography, intraarterial DSA,
angiocardiography (in
adults and paediatrics), conventional selective coronary
arteriography, interventional
co

Karatteristiċi tal-prodott

SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
IOMERON
® 300
IOMERON
® 350
IOMERON
® 400
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
IOMERON
®
300
100 ml of solution contains:
Active ingredient: Iomeprol: 61.24 g
IOMERON
®
350
100 ml of solution contains:
Active ingredient: Iomeprol: 71.44 g
IOMERON
®
400
100 ml of solution contains:
Active ingredient: Iomeprol: 81.65 g
For the full list of excipients, see section 6.1
3.
PHARMACEUTICAL FORM
IOMEPROL,
N,
N’
-bis(2,
3-dihydroxypropyl)-5[(hydroxyacetyl)methylamino]-2,
4,
6-triiodo-1,
3-
benzenedicarboxamide, the active component of lomeron
®
, is a triiodinated, non-ionic, water soluble,
nephrotropic, low-osmolality X-ray contrast medium with a molecular
weight of 777.09, formulations of which
yield contrast media of particularly low osmolality and viscosity in
comparison with other non-ionic media.
lomeprol has been formulated in a wide range of concentrations (up to
400 mg iodine/ml). All have proved to
be extremely stable both to heat sterilization and prolonged room
temperature storage, without the chelator
(EDTA salt) required by other contrast agents.
Solution for injection displaying the following physico-chemical
characteristics by Iodine strengths as
below:
_Iodine _
_concentration _
_mgI/mL _
_Osmolality _
_mOsmol/kg water _
_(x _

_ s_

_t95)* _
_Viscosity _
_mPa_

_s _
_(x _

_ s_

_t95)* _
_ _
_37° C _
_20°C _
_37° C _
300
521

24
8.1

0.7
4.5

0.4
350
618

29
14.5

1.1
7.5

0.6
400
726

34
27.5

2.3
12.6

1.1
*Steam pressure method
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Contrast medium for diagnostic radiology.
IOMERON 300
Intravenous urography (in adults and paediatrics), peripheral
phlebography, CT (brain and
body), cavernosography, intravenous DSA, conventional angiography,
intraarterial DSA,
angiocardiography (in adults and paediatrics), conventional selective
coronary
arteriography, interventional coronary arteriography, ERCP,
arthrography,
hysterosalpingograph