Land: Israël
Taal: Engels
Bron: Ministry of Health
SODIUM IOXITALAMATE
PROMEDICO LTD
V08AA05
SOLUTION FOR INJECTION
SODIUM IOXITALAMATE 21 G / 100 ML
INTRAVESICAL
Required
GUERBET, FRANCE
IOXITALAMIC ACID
IOXITALAMIC ACID
contrast medium for retrograd cystography.
2011-08-31
אפורל ןולעב )תוחיטב עדימ ( הרמחה לע העדוה אפורל ןולעב )תוחיטב עדימ ( הרמחה לע העדוה :ךיראת 28/07/2011 :תילגנאב רישכת םש TELEBRIX 12 SODIUM : םושיר רפסמ 26111 : םושירה לעב םש PROMEDICO LTD . םי/שקובמה םי/יונישה לע םיטרפ ןולעב קרפ יחכונ טסקט שדח טסקט 4.3 CONTRAINDICATIONS Hypersensitivity to ioxitalamic acid or to any of the excipients; History of major immediate or delayed skin reaction (see section 4.8) to Telebrix 12 Sodium (120 mg iodine/mL), solution for injection; Decompensated heart failure, when used by systemic injection; Endoscopic retrograde pancreatography (ERP) for acute pancreatitis; 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 12 Sodium Intra-vascular administration. Intra-vascular administration Manifest thyrotoxicosis . Intrathecal or subarachnoid (or epidural) administration of TELEBRIX 12 Sodium 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 _4.4.1.2.1. Intolerance to iodinated contrast media:_ Prior to the examination: Identify subjects at risk via specific questioning concerning history. Corticosteroids and H1-antihistamines were suggested as 4.4.1. SPECIAL WARNINGS 4.4.1.1 Hypersensitivity Any All iodinated contrast medium can cause minor or major reactions that may be life-threatening. They may be immediate (less than 60 minutes) or delayed (up to 7 days). They are often unpredictable. premedication in patients at the highest risk of intolerance reaction (known to be intolerant to an iodinated contrast medium). However, they do not prevent serious or fatal anaphylactic Lees het volledige document
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT TELEBRIX 12 SODIUM , SOLUTION FOR INJECTION FOR INTRAVESICAL ADMINISTRATION 2. QUALITATIVE AND QUANTITATIVE COMPOSITION For 100 mL of solution: Sodium ioxitalamate ................................................................................................ 21.00 g Equivalent to iodine ...................................................................................................... 12 g • Iodine content per mL: 120 mg • Iodine mass per 250 mL bottle: 30g For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for intravesical administration • Viscosity at 20°C: 1.7 mPa.s • Viscosity at 37 °C: 1.1 mPa.s • Osmolality: 640 mOsm / kg 4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS For diagnostic use only. Contrast medium for: • Retrograde cystography; 4.2 POSOLOGY INDICATIONS AVERAGE DOSE TOTAL VOLUME ML/KG (MIN.-MAX.) ML Retrograde cystography Dose to be adapted to the volume of the organ to be injected 20 - 100 _U_ METHOD OF ADMINISTRATION The product must be administered by intravesical administration only 4.3 CONTRAINDICATIONS • 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 12 Sodium Intra-vascular administration. • Intra-vascular administration • Manifest thyrotoxicosis • Intrathecal or subarachnoid (or epidural) administration of TELEBRIX 12 Sodium 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 • There is a risk of allergy, whatever the administration route or dosage. • The risk of intolerance cannot be ruled out when medicinal products are administered locally to opacify body cavities: a) administration via certain routes (e.g. articular, biliary, intrathecal, intra-uterine) res Lees het volledige document