Quốc gia: Israel
Ngôn ngữ: Tiếng Anh
Nguồn: Ministry of Health
IOMEPROL
DEXCEL LTD, ISRAEL
V08AB
SOLUTION FOR INJECTION
IOMEPROL 816.5 MG/ML
I.V, INTRA-ARTERIAL
Required
BRACCO IMAGING S.P.A., ITALY
WATERSOLUBLE, NEPHROTROPIC, LOW OSMOLAR X-RAY CONTRAST MEDIA
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.
2021-12-31
_ _ 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 Đọc toàn bộ tài liệu
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 Đọc toàn bộ tài liệu