国: イスラエル
言語: 英語
ソース: Ministry of Health
MEGLUMINE IOXITALAMATE; SODIUM IOXITALAMATE
PROMEDICO LTD
V08AA05
SOLUTION FOR INJECTION
SODIUM IOXITALAMATE 9.66 %; MEGLUMINE IOXITALAMATE 65.09 %
INTRAVASCULAR
Required
GUERBET, FRANCE
IOXITALAMIC ACID
IOXITALAMIC ACID
Angiocardiography (ventriculography - coronary angiography) - digital substraction angiography - computerized tomography- intravenous urography.
2011-08-31
העדוה לע הרמחה ( עדימ ןולעב )תוחיטב ל אפור :ךיראת 6.2013 םש רישכת תילגנאב רפסמו ( :םושירה 054-38-26112-00 ) TELEBRIX 35 MEGLUMINE םש לעב םושירה : PROMEDICO LTD םייונישה ןולעב םינמוסמ לע עקר בוהצ ספוט הז דעוימ טורפל תורמחהה דבלב ! םיטרפ לע םי/יונישה םי/שקובמה קרפ ןולעב טסקט יחכונ טסקט שדח 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Excipient with known effect: Sodium (341.8 mg sodium per 100 mL). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _Special populations_ _Elderly patients_ TELEBRIX 35 should be administered with caution (see section 4.4), in well-hydrated patients at the minimum effective dose. _Patients with renal impairment_ In patients with renal failure, the dose is reduced and sufficient hydration must be ensured (see also section 4.4.2.2. Precautions for use – Renal failure). METHOD OF ADMINISTRATION The product must be administered via intra-arterial or intravenous route. 4.3 CONTRA- INDICATIONS Hypersensitivity to ioxitalamic acid or to any of the excipients; History of major immediate or delayed skin reaction (see section 4.8) to TELEBRIX 35 ; Decompensated heart failure by systemic injection; Overt thyrotoxicosis; Myelography. Hypersensitivity to ioxitalamic acid or to any of the excipients listed in section 6.1. History of major immediate or delayed skin reaction (see section 4.8) to TELEBRIX 35 injection Decompensated heart failure Manifest thyrotoxicosis Intrathecal or subarachnoid (or epidural) administration of TELEBRIX 35 for myelography, cerebral ventriculography or cisternography is contraindicated as severe and potentially life- threatening neurotoxic reactions (e.g. myoclonus or epilepsy) can occur. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE _4.4.1._ _ _ _ 3. _ _ _ _ Extravasation_ _ _ _ _ Extravasation is not an uncommon complication (0.04% to 0.9%) of intravenous injectio 完全なドキュメントを読む
_ _ _ _ 1 SUMMARY OF PRODUCT CHARACTERISITCS 1. NAME OF THE MEDICINAL PRODUCT TELEBRIX 35 (350 MG I/ML), SOLUTION FOR INJECTION 2. QUALITATIVE AND QUANTITATIVE COMPOSITION For 100 mL of solution: Meglumine ioxitalamate ............................................................................................................ 65.09g Sodium ioxitalamate ................................................................................................................... 9.66 g Equivalent to iodine ........................................................................................................................ 35 g Iodine content per mL: 350 mg Iodine mass per 50 mL vial: 17.5 g Iodine mass per 100 mL bottle: 35 g Iodine mass per 200 mL bottle: 70 g Excipient with known effect: Sodium (341.8 mg sodium per 100 mL). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection Viscosity at 20° C: 15.1 mPa.s Viscosity at 37° C: 7.5 mPa.s Osmolality: 2130 mOsm / kg 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS This medicinal product is for diagnostic use only. Contrast medium for use via intra-arterial and intravenous administration for: - Angiocardiography (ventriculography- coronary angiography) - digital substraction angiography - computerized tomography - intravenous urography. 4.2. POSOLOGY AND METHOD OF ADMINISTRATION POSOLOGY The dose must be adapted according to the patient’s age, weight, renal function, the type of examination and the volume of the organ to be examined. INDICATIONS AVERAGE DOSE ML/KG TOTAL VOLUME (MIN. - MAX.) ML Intravenous urography: 1.0 50 - 100 Computed tomography: head full body 1.0 1.8 40 - 100 90 - 180 Digital angiography 2.1 95 - 250 Angiocardiography: ventriculography coronarography 40 mL per injection 4 to 8 mL per injection 30 - 60 270 _ _ _ _ 2 _Special populations _ _Elderly patients _ TELEBRIX 35 should be administered with caution (see section 4.4), in well-hydrated patients at the minimu 完全なドキュメントを読む