Država: Izrael
Jezik: engleski
Izvor: Ministry of Health
IOPROMIDE
BAYER ISRAEL LTD
V08AB05
SOLUTION FOR INJECTION
IOPROMIDE 623.4 MG / 1 ML
I.V, INTRA-ARTERIAL
Required
BAYER AG, GERMANY
IOPROMIDE
IOPROMIDE
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.
2014-05-31
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 Pročitajte cijeli dokument
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 Pročitajte cijeli dokument