Šalis: Singapūras
kalba: anglų
Šaltinis: HSA (Health Sciences Authority)
GADOPENTETIC ACID, DIMEGLUMINE SALT
BAYER (SOUTH EAST ASIA) PTE LTD
V08CA01
469 mg/ml
INJECTION
GADOPENTETIC ACID, DIMEGLUMINE SALT 469 mg/ml
INTRAVENOUS
Prescription Only
BAYER AG
ACTIVE
1990-04-27
Magnevist PI_SG_CCDS 9 _7June 2013 1.NAME OF THE MEDICINAL PRODUCT Magnevist 0.5 mmol per ml solution for injection. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains 0.5 mmol gadopentetate dimeglumine (equivalent to 469.01 mg gadopentetate dimeglumine) as active ingredient. For full list of excipients, see section ‘List of excipients’. 3. PHARMACEUTICAL FORM Solution for injection. Clear, colourless to pale yellow solution. The physio-chemical properties of Magnevist listed below are: Osmolarity at 37 ºC (osm/l solution) 1.44 Osmolality at 37 ºC (osm/kg H 2 O) 1.96 Osmot. pressure at 37 ºC (atm) 49.8 (mPa) 5.06 Viscosity (mPa · s or cP) at 20 ºC 4.9 at 37 ºC 2.9 pH 7.0-7.9 4. CLINICAL PARTICULARS 4.1 INDICATION(S) This medicinal product is for diagnostic use only. • Cranial and spinal magnetic resonance imaging (MRI) In particular for the demonstration of tumours and for further differential-diagnostic clarification in suspected meningioma, (acoustic) neurinoma, invasive tumours (e. g. glioma) and metastases; for the demonstration of small and/or isointense tumours; in suspected recurrence after surgery or radiotherapy; for the differentiated demonstration of rare neoplasms such as haemangioblastomas, ependymomas and small pituitary adenomas; for improved determination of the spread of tumours not of cerebral origin. Additionally in spinal MRI: Differentiation of intra and extramedullary tumours; demonstration of solid tumour areas in known syrinx; determination of intramedullary tumour spread. • Whole body MRI Including the facial skull, the neck region, the thoracic and abdominal space, the female Magnevist PI_SG_CCDS 9 _7June 2013 breast, the Perskaitykite visą dokumentą
Magnevist PI_CCDS 9 _13 Apr 2018 1.NAME OF THE MEDICINAL PRODUCT Magnevist 0.5 mmol per ml solution for injection. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each ml contains 0.5 mmol gadopentetate dimeglumine (equivalent to 469.01 mg gadopentetate dimeglumine) as active ingredient. For full list of excipients, see section ‘List of excipients’. 3. PHARMACEUTICAL FORM Solution for injection. Clear, colourless to pale yellow solution. The physio-chemical properties of Magnevist listed below are: Osmolarity at 37 ºC (osm/l solution) 1.44 Osmolality at 37 ºC (osm/kg H 2 O) 1.96 Osmot. pressure at 37 ºC (atm) 49.8 (mPa) 5.06 Viscosity (mPa · s or cP) at 20 ºC 4.9 at 37 ºC 2.9 pH 7.0-7.9 4. CLINICAL PARTICULARS 4.1 INDICATION(S) This medicinal product is for diagnostic use only. • Cranial and spinal magnetic resonance imaging (MRI) In particular for the demonstration of tumours and for further differential-diagnostic clarification in suspected meningioma, (acoustic) neurinoma, invasive tumours (e. g. glioma) and metastases; for the demonstration of small and/or isointense tumours; in suspected recurrence after surgery or radiotherapy; for the differentiated demonstration of rare neoplasms such as haemangioblastomas, ependymomas and small pituitary adenomas; for improved determination of the spread of tumours not of cerebral origin. Additionally in spinal MRI: Differentiation of intra and extramedullary tumours; demonstration of solid tumour areas in known syrinx; determination of intramedullary tumour spread. • Whole body MRI Including the facial skull, the neck region, the thoracic and abdominal space, the female Magnevist PI_CCDS 9 _13 Apr 2018 breast, the pelvis and the active and passive locomotive apparatus. In particular, Magnevist permits diagnostic information: - For the demonstration or exclusion of tumours, inflammations and vascular lesions; - For determination of the spread and demarcation of these lesions; - For the differentiation of the internal structure of lesions; - For assessment of th Perskaitykite visą dokumentą