Land: Israel
Sprog: engelsk
Kilde: Ministry of Health
IOBITRIDOL
PROMEDICO LTD
V08AB11
SOLUTION FOR INJECTION
IOBITRIDOL 250 MG/ML
I.V
Required
GUERBET, FRANCE
IOBITRIDOL
IOBITRIDOL
For adults and children undergoing: phlebography, chest CT scan, intra - arterial digital subtraction angiography.
2022-03-31
אפורל ןולעב )תוחיטב עדימ ( הרמחה לע העדוה :ךיראת 7.2013 :םושירה רפסמו תילגנאב רישכת םש XENETIX 250 )105-07-28746-00(, XENETIX 300 )105-08-28747-00(, XENETIX 350 )105-09-28748-00( :םושירה לעב םש PROMEDICO LTD ! דבלב תורמחהה טורפל דעוימ הז ספוט תושקובמה תורמחהה ןולעב קרפ יחכונ טסקט שדח טסקט 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Excipient with known effect: sodium (up to 3.5 mg per 100 mL). 4.3. CONTRAINDICATIONS CONTRA-INDICATIONS Xenetix is contraindicated in patients hypersensitive to the product. A history of sensitivity to iodine contraindicates the use of Xenetix (see Warnings). In the absence of specific studies, iobitridol is not indicated for myelography. 4.3. CONTRAINDICATIONS Hypersensitivity to iobitridol or any of the excipients. History of a major immediate reaction or delayed skin reaction (see Section 4.8) to a Xenetix injection. Manifest thyrotoxicosis 4.4. SPECIAL WARNINGS AND SPECIAL PRECAUTIONS FOR USE SPECIAL WARNINGS AND PRECAUTIONS FOR USE WARNINGS As in the case of all iodinated contrast agents, non-ionic water soluble tri-iodinated products may induce mild, severe or fatal intolerance reactions, often of early onset but sometimes delayed. These reactions cannot be predicted but are more frequent in patients with a history of allergy (hives, asthma, hay-fever, eczema, various food and drug allergies) or who have shown particular sensitivity during a previous examination with an iodinated contrast medium. 2 Risk-benefit should be considered when dehydration exists, especially when associated with pre-existing renal or hepatic disease, advanced vascular disease, and diabetes mellitus, in infants, young children and elderly patients. Screening for these reactions by means of iodine reaction tests or any other tests currently available is not possible. Precautions for use During the examination, the following are required: surveillance by Læs hele dokumentet
1 N AME OF THE M EDICINAL P RODUCT XENETIX 250, 300, 350 solution for injection (250, 300, 350 mg iodine/mL) 2 QUALITATIVE AND QUANTITATIVE COMPOSITION PER 100 M L Xenetix 250 Xenetix 300 Xenetix 350 Iobitridol ................................ 54.8400 g ................ 65.8100 g ................ 76.7800 g Equivalent to iodine ................. 25.0000 g ............. 30.0000 g ................ 35.0000 g Excipients: Edetate calcium disodium; Tromethamine hydrochloride Tromethamine; Hydrochloric acid or sodium hydroxide; Water for injection 3 PHARMACEUTICAL FORM Solution for injection 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Xenetix 250 For adults and children undergoing: • phlebography • chest CT-scan • intra-arterial digital subtraction angiography Xenetix 300, 350 For adults and children undergoing: • intravenous urography • brain or whole-body CT scan • intravenous digital subtraction angiography • arteriography • angiocardiography 4.2 Dosage and method of administration Doses will be adjusted as a function of the examination and the regions of interest as well as to body weight, and the renal function of the subject, particularly in children. The recommended mean doses are as follows: XENETIX 250 Indications Mean dose (mL/kg) Total volume (min.-max.) mL Phlebography 2.6 150-220 Chest CT-scan 2.0 95-170 Intra-arterial digital subtraction angiography 3.1 75-360 XENETIX 300 Indications Mean dose (mL/kg) Total volume (min.-max.) mL Intravenous urography: • fast injection: • slow injection: 1.2 1.6 50-100 100 CT-scan • Brain • whole-body 1.4 1.9 20-100 20-150 Intravenous digital subtraction angiography 1.7 40-270 Arteriography • Brain • lower limbs 1.8 2.8 42-210 85-300 Angiocardiography 1.1 70-125 XENETIX 350 Indications Mean dose (mL/kg) Total volume (min.-max.) mL Intravenous urography 1 50-100 CT-scan • brain • whole-body 1 1. 8 40-100 90-180 Intravenous digital subtraction angiography 2.1 95-250 Arteriography • peripheral • lower limbs • abdominal 2.2 1.8 3.6 10 Læs hele dokumentet