国: ニュージーランド
言語: 英語
ソース: Medsafe (Medicines Safety Authority)
Meglumine gadopentetate 469 mg/mL (Formed from gadolinium oxide, diethylenetriamine pentetic acid & meglumine)
Bayer New Zealand Limited
Meglumine gadopentetate 469 mg/mL (Formed from gadolinium oxide, diethylenetriamine pentetic acid & meglumine)
469 mg/mL
Solution for injection
Active: Meglumine gadopentetate 469 mg/mL (Formed from gadolinium oxide, diethylenetriamine pentetic acid & meglumine) Excipient: Meglumine Pentetic acid Water for injection
Syringe, glass, 10 mL
General sale
General sale
Bayer AG
For diagnostic use by intravenous administration 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 breast, the pelvis and the active and passive locomotive apparatus and imaging of vessels throughout the body. In particular, Magnevist permits diagnostic information: · For the demonstration or exclusion of tumours, inflammation 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 the circulatory situation of normal and pathologically changed tissues; · For the differentiation of tumour and scar tissue after therapy; · For the recognition of recurrent prolapse of a disk after surgery. · For the semi-quantitative evaluation of the renal function combined with anatomical organ diagnosis.
Package - Contents - Shelf Life: Syringe, glass, 20mL - 5 dose units - 60 months from date of manufacture stored at or below 30°C - Syringe, glass, 15mL - 5 dose units - 60 months from date of manufacture stored at or below 30°C - Syringe, glass, 10mL - 5 dose units - 60 months from date of manufacture stored at or below 30°C - Syringe, plastic, Pre-filled 15mL fill in 20 mL - 5 dose units - 36 months from date of manufacture stored at or below 30°C. Do not freeze - Syringe, plastic, Pre-filled 10mL fill in 10 mL - 5 dose units - 36 months from date of manufacture stored at or below 30°C. Do not freeze
1995-09-12
MAGNEVIST ® (MAG·NE ⋅ VIST) _DIMEGLUMINE GADOPENTETATE _ _ _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Magnevist. It does not contain all the available information. It does not take the place of talking to your doctor. All diagnostic agents have risks and benefits. Your doctor has weighed the risks of you using Magnevist against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT USING THIS DIAGNOSTIC AGENT, ASK YOUR DOCTOR OR RADIOLOGIST. KEEP THIS LEAFLET. You may need to read it again. WHAT MAGNEVIST IS USED FOR Magnevist is used at the same time as magnetic resonance imaging (MRI) to aid in the detection of abnormalities in the brain, spinal cord, neck, chest, abdomen, pelvis, bones and muscles in adults; and in the brain and spinal cord in children and babies. MRI is a form of medical diagnostic imaging that forms pictures after detecting water molecules in normal and abnormal tissues. This is done using a complex system of magnets and radiowaves. Magnevist is a liquid that alters the way in which the MRI machine detects certain tissues within the body. Magnevist often makes the pictures clearer and often shows things that may not have been visible using MRI alone. Magnevist is only available at MRI units for use in conjunction with MRI . ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY MAGNEVIST IS BEING USED IN YOU. Your doctor may be using it for another reason. BEFORE YOU ARE GIVEN MAGNEVIST _WHEN YOU MUST NOT BE _ _GIVEN IT _ YOU MUST NOT BE GIVEN MAGNEVIST IF YOU HAVE AN ALLERGY TO: • dimeglumine gadopentetate, the active ingredient in Magnevist • any of the ingredients listed at the end of this leaflet. Some of the symptoms of an allergic reaction may include: • shortness of breath • wheezing or difficulty breathing • swelling of the face, lips, tongue or other parts of the body • rash, itching or hives on the skin. YOU MUST NOT BE GIVEN MAGNEVIST IF YOU HAVE SEVERE DISTURBANCES OF KIDNEY FUNCTION 完全なドキュメントを読む
180916 MAGNEVIST DS 1 DATA SHEET MAGNEVIST DIMEGLUMINE GADOPENTETATE 469 MG/ML 1 PRODUCT NAME MAGNEVIST (469 mg/mL solution for injection) 2 QUALITATIVE AND QUANTITATIVE COMPOSITION MAGNEVIST contains dimeglumine gadopentetate 469 mg/mL as the active ingredient. MAGNEVIST (dimeglumine gadopentetate) solution for intravenous injection is the N-methylglucamine salt of the gadolinium complex of diethylenetriamine pentaacetic acid, and is an injectable contrast medium for magnetic resonance imaging (MRI). For the full list of excipients, see Section 6.1 . 3 PHARMACEUTICAL FORM MAGNEVIST injection is a sterile, clear, colourless to slightly yellow solution for intravenous injection. The physico-chemical properties of Magnevist are listed below: Osmolality (Osm/kg H 2 O) At 37 o C 1.96 Viscosity (mPa·s) At 20 o C At 37 o C 4.9 2.9 pH - value 7.0 - 7.9 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For diagnostic use by intravenous administration 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 180916 MAGNEVIST DS 2 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 breast, the pelvis and the active and passive locomotive apparatus and imaging of vessels throughout the body. _ _ In particular, MAGNEVIST permits diagnostic information: • For the demonstration or exclusion of 完全なドキュメントを読む