Страна: Ізраїль
мова: англійська
Джерело: Ministry of Health
MEGLUMINE IOXITALAMATE
PROMEDICO LTD
P01CB01
SOLUTION FOR INJECTION
MEGLUMINE IOXITALAMATE 66.03 G / 100 ML
I.V, INTRAVASCULAR
Required
GUERBET, FRANCE
MEGLUMINE ANTIMONATE
MEGLUMINE ANTIMONATE
For urograph, selective angiography, peripheral angiography, arthrography, hysterosalpingography and digestive exploration.
2012-11-30
העדוה לע הרמחה ( עדימ ןולעב )תוחיטב ל אפור :ךיראת 5.2013 םש רישכת תילגנאב רפסמו ( :םושירה 027-67-21780-00 ) TELEBRIX 30 MEGLUMINE םש לעב םושירה : PROMEDICO LTD ספוט הז דעוימ טורפל תורמחהה דבלב ! םיטרפ לע םי/יונישה םי/שקובמה קרפ ןולעב טסקט יחכונ טסקט שדח 4.8. UNDE SIRABL E EFFECT S TABULATED LIST OF ADVERSE REACTIONS WITH TELEBRIX 30 MEGLUMINE OR ANOTHER FORM OF TELEBRIX FOLLOWING NON-ENTERAL ADMINISTRATION: SYSTEM ORGAN CLASS FREQUENCY: ADVERSE REACTION Immune system disorder Frequency not known: Anaphylactic shock, anaphylactic reaction, anaphylactoid reaction, hypersensetivity Endocrine disorders Frequency not known: Thyrotoxic crisis*, hyperthyroidism*, thyroid disorder** Psychiatric disorders Frequency not known: Conusional state, List summarising the undesirable effects reported with TELEBRIX 30 Meglumine or another form of TELEBRIX after intravascular administration or instillation: SYSTEM ORGAN CLASS FREQUENCY: UNDESIRABLE EFFECT Immune system disorders Unknown frequency: anaphylactic shock, anaphylactic reaction, anaphylactoid reaction, hypersensitivity Endocrine disorders agitation Nervous system disorders Frequency not known: Coma, loss of consciousness, syncope, convulsion, paresis/paralysis, paresthesia, tremor, dizziness, headache Eye disorders Frequency not known: Eyelid oedema Ear and labyrinth disorders Frequency not known: Vertigo Cardiac disorders Frequency not known: Cardiac arrest, myocardial infarction, angina pectoris, arrhythmia, tachycardia, cyanosis Vascular disorders Frequency not known: Shock, hypertension, hypotension, thrombophlebitis 1 , flushing, pallor Respiratory, thoracic and mediastinal disorders Frequency not known: Respiratory arrest, respiratory failure, laryngeal oedema, laryngospasm, pulmonary oedema, dyspnoea, bronchospasm, throat tightness, cough, sneezing Gastrointestinal disorders Frequency not known: Diarrhoea, nausea, vomit Прочитайте повний документ
_ _ _ _ 1 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT TELEBRIX 30 MEGLUMINE (300 MG IODINE/ML), SOLUTION FOR INJECTION 2. QUALITATIVE AND QUANTITATIVE COMPOSITION For 100 mL of solution: Meglumine ioxitalamate………………………………………………………. ....................... 66.03 g Equivalent to iodine………………………………………………………………. ...................... 30 g Iodine content per mL: 300 mg Iodine mass per 30 mL vial: 9 g Iodine mass per 50 mL vial: 15 g Iodine mass per 100 mL bottle: 30 g Excipient with known effect: Sodium (8.4 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: 10.2 mPa.s Viscosity at 37° C: 5.3 mPa.s Osmolality: 1710 mOsm/kg 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS This medicinal product is for diagnostic use only. Contrast medium for use in adults and children via intra -arterial and intravenous administration and by instillation for: Urograph, selective angiography, peripheral angiography, arthrography, hysterosalpingography and digestive exploration. 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. _ _ _ _ 2 INDICATIONS AVERAGE DOSE ML/KG TOTAL VOLUME (MIN.-MAX.) ML Intravenous urography The standard dose is 1 to 2 ml/kg. In children under 20 kg, the dose is 2 to 3 ml/kg. 50 – 100 mL Retrograde urethrocystography Dosage to be adapted to the volume of the organ to be injected. 20 – 100 mL Suprapubic cystography Dosage to be adapted to the volume of the organ to be injected. 100 – 250 mL SPECIAL POPULATIONS _Elderly patients _ TELEBRIX 30 Meglumine should be administered with caution (see section 4.4), in well-hydrated patients at the minimum effective dose. _Paediatric population _ As with all other hyperosmolar contr Прочитайте повний документ