Страна: Армения
Език: английски
Източник: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
gadobutrol
Bayer AG
V08CA09
gadobutrol
604.72mg/ml
solution for injection
(5) glass syringe 7.5ml
Prescription
Registered
2019-02-08
1 SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Gadovist 1.0 mmol/ml solution for injection in prefilled syringe/cartridge 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 1 ml of solution for injection contains 604.72 mg gadobutrol (equivalent to 1.0 mmol gadobutrol containing 157.25 mg gadolinium). 1 syringe with 5.0 ml contains 3023.6 mg gadobutrol, 1 syringe with 7.5 ml contains 4535.4 mg gadobutrol, 1 syringe with 10 ml contains 6047.2 mg gadobutrol, 1 syringe with 15 ml contains 9070.8 mg gadobutrol, 1 syringe with 20 ml contains 12094.4 mg gadobutrol. Excipient with known effect: 1 ml contains 0.00056 mmol (equivalent to 0.013 mg) of sodium (see section 4.4)._ _ For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Solution for injection in prefilled syringe/cartridge Clear, colourless to pale yellow liquid. Physico-chemical properties: Osmolality at 37 °C: 1603 mOsm/kg H 2 O Viscosity at 37 °C: 4.96 mPa·s 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS This medicinal product is for diagnostic use only. Gadovist is indicated in adults and children of all ages (including term neonates) for: Contrast enhancement in cranial and spinal magnetic resonance imaging (MRI). Contrast enhanced MRI of liver or kidneys in patients with high suspicion or evidence of having focal lesions to classify these lesions as benign or malignant. Contrast enhancement in magnetic resonance angiography (CE-MRA). Gadovist can also be used for MR Imaging of pathologies of the whole body. It facilitates visualisation of abnormal structures or lesions and helps in the differentiation between healthy and pathological tissue. Gadovist should only be used when essential diagnostic information cannot be obtained with non-contrast enhanced magnetic resonance imaging (MRI). 3 4.2 POSOLOGY AND METHOD OF ADMINISTRATION GADOVIST SHOULD ONLY BE ADMINISTERED BY HEALTHCARE PROFESSIONALS EXPERIENCED IN THE FIELD OF CLINICAL MRI PRACTICE. Method of administration This medicinal product is for i Прочетете целия документ