ארצות הברית - אנגלית - NLM (National Library of Medicine)

bayer healthcare pharmaceuticals inc. - gadopentetate dimeglumine (unii: rh248g8v27) (gadopentetate - unii:v7ok6j19hq) - gadopentetate dimeglumine 469.01 mg in 1 ml - magnevist injection is indicated for use with magnetic resonance imaging (mri) in adults, and pediatric patients (2 years of age and older) to visualize lesions with abnormal vascularity in the brain (intracranial lesions), spine and associated tissues. magnevist injection has been shown to facilitate visualization of intracranial lesions including but not limited to tumors. magnevist injection is indicated for use with mri in adults and pediatric patients (2 years of age and older) to facilitate the visualization of lesions with abnormal vascularity in the head and neck. magnevist injection is indicated for use in mri in adults and pediatric patients (2 years of age and older) to facilitate the visualization of lesions with abnormal vascularity in the body. magnevist is contraindicated in patients with: risk summary gbcas cross the placenta and result in fetal exposure and gadolinium retention. the human data on the association between gbcas and adverse fetal outcomes are limited and inconclusive (see data

ארצות הברית - אנגלית - NLM (National Library of Medicine)

bayer healthcare pharmaceuticals inc. - gadopentetate dimeglumine (unii: rh248g8v27) (gadopentetate - unii:v7ok6j19hq) - magnevist injection is indicated for use with magnetic resonance imaging (mri) in adults, and pediatric patients (2 years of age and older) to visualize lesions with abnormal vascularity in the brain (intracranial lesions), spine and associated tissues. magnevist injection has been shown to facilitate visualization of intracranial lesions including but not limited to tumors. magnevist injection is indicated for use with mri in adults and pediatric patients (2 years of age and older) to facilitate the visualization of lesions with abnormal vascularity in the head and neck. magnevist injection is indicated for use in mri in adults and pediatric patients (2 years of age and older) to facilitate the visualization of lesions with abnormal vascularity in the body. magnevist is contraindicated in patients with: gbcas cross the placenta and result in fetal exposure and gadolinium retention. the human data on the association between gbcas and adverse fetal outcomes are limited and inconclusive (see data). in animal

ניו זילנד - אנגלית - Medsafe (Medicines Safety Authority)

bayer new zealand limited - meglumine gadopentetate 469 mg/ml (formed from gadolinium oxide, diethylenetriamine pentetic acid & meglumine) - solution for injection - 469 mg/ml - active: meglumine gadopentetate 469 mg/ml (formed from gadolinium oxide, diethylenetriamine pentetic acid & meglumine) excipient: meglumine pentetic acid water for injection - 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.

אוסטרליה - אנגלית - Department of Health (Therapeutic Goods Administration)

bayer australia ltd - gadopentetate dimeglumine, quantity: 469.01 mg/ml - injection, solution - excipient ingredients: pentetate meglumine; water for injections; meglumine - using magnetic resonance imaging (mri) dimeglumine gadopentetate provides contrast enhancement: . in intracranial and spinal lesions in adults and children with abnormal blood-brain barrier, or abnormal vascularity; . in whole body imaging in adult patients, including the neck region, the thoracic and abdominal space, the female breast, the pelvis and the musculoskeletal system. note: reliable enhancement is not provided in imaging the pancreas and the male reproductive organs (prostate, testis and penis). indications as at 30 august 1996: using magnetic resonance imaging (mri) dimeglumine gadopentetate provides contrast enhancement; in intracranial and spinal lesions in adults and children, including neonates and infants, with an abnormal blood-brain barrier, or abnormal vascularity; in whole body imaging in adult patients, including the neck region, the thoracic and abdominal space, the female breast, the pelvis and the musculoskeletal system. note: reliable enhancement is not provided in imaging the pan

אוסטרליה - אנגלית - Department of Health (Therapeutic Goods Administration)

bayer australia ltd - gadopentetate dimeglumine, quantity: 469.01 mg/ml - injection, solution - excipient ingredients: water for injections; meglumine; pentetate meglumine - indications as at 30 aug 1996: using magnetic resonance imaging (mri) dimeglumine gadopentetate provides contrast enhancement; in intracranial and spinal lesions in adults and children, including neonates and infants, with an abnormal blood-brain barrier, or abnormal vascularity; in whole body imaging in adult patients , including the neck region, the thoracic and abdominal space, the female breast, the pelvis and the musculoskeletal system. note: reliable enhancement is not provided in imaging the pancreas and the male reproductive organs (prostate, testis and penis).

אוסטרליה - אנגלית - Department of Health (Therapeutic Goods Administration)

bayer australia ltd - gadopentetate dimeglumine, quantity: 469.01 mg/ml - injection, solution - excipient ingredients: pentetate meglumine; meglumine; water for injections - indications as at 30 aug 1996: using magnetic resonance imaging (mri) dimeglumine gadopentetate provides contrast enhancement; in intracranial and spinal lesions in adults and children, including neonates and infants, with an abnormal blood-brain barrier, or abnormal vascularity; in whole body imaging in adult patients , including the neck region, the thoracic and abdominal space, the female breast, the pelvis and the musculoskeletal system. note: reliable enhancement is not provided in imaging the pancreas and the male reproductive organs (prostate, testis and penis).

אוסטרליה - אנגלית - Department of Health (Therapeutic Goods Administration)

bayer australia ltd - gadopentetate dimeglumine, quantity: 469.01 mg/ml - injection, solution - excipient ingredients: meglumine; water for injections; pentetate meglumine - indications as at 30 august 1996: using magnetic resonance imaging (mri) dimeglumine gadopentetate provides contrast enhancement; in intracranial and spinal lesions in adults and children, including neonates and infants, with an abnormal blood-brain barrier, or abnormal vascularity; in whole body imaging in adult patients, including the neck region, the thoracic and abdominal space, the female breast, the pelvis and the musculoskeletal system. note: reliable enhancement is not provided in imaging the pancreas and the male reproductive organs (prostate, testis and penis).

אוסטרליה - אנגלית - Department of Health (Therapeutic Goods Administration)

bayer australia ltd - gadopentetate dimeglumine, quantity: 469.01 mg/ml - injection, solution - excipient ingredients: water for injections; meglumine; pentetate meglumine - indications as at 30 august 1996: using magnetic resonance imaging (mri) dimeglumine gadopentetate provides contrast enhancement; in intracranial and spinal lesions in adults and children, including neonates and infants, with an abnormal blood-brain barrier, or abnormal vascularity; in whole body imaging in adult patients, including the neck region, the thoracic and abdominal space, the female breast, the pelvis and the musculoskeletal system. note: reliable enhancement is not provided in imaging the pancreas and the male reproductive organs (prostate, testis and penis).

אוסטרליה - אנגלית - Department of Health (Therapeutic Goods Administration)

bayer australia ltd - gadopentetate dimeglumine, quantity: 469.01 mg/ml - injection, solution - excipient ingredients: meglumine; pentetate meglumine; water for injections - indications as 30 august 1996: using magnetic resonance imaging (mri) dimeglumine gadopentetate provides contrast enhancement; in intracranial and spinal lesions in adults and children, including neonates and infants, with an abnormal blood-brain barrier, or abnormal vascularity; in whole body imaging in adult patients, including the neck region, the thoracic and abdominal space, the female breast, the pelvis and the musculoskeletal system. note: reliable enhancement is not provided in imaging the pancreas and the male reproductive organs (prostate, testis and penis).

אוסטרליה - אנגלית - Department of Health (Therapeutic Goods Administration)

bayer australia ltd - gadopentetate dimeglumine, quantity: 469.01 mg/ml - injection, solution - excipient ingredients: water for injections; meglumine; pentetate meglumine - indications as at 30 august 1996: using magnetic resonance imaging (mri) dimeglumine gadopentetate provides contrast enhancement; in intracranial and spinal lesions in adults and children, including neonates and infants, with an abnormal blood-brain barrier, or abnormal vascularity; in whole body imaging in adult patients , including the neck region, the thoracic and abdominal space, the female breast, the pelvis and the musculoskeletal system. note: reliable enhancement is not provided in imaging the pancreas and the male reproductive organs (prostate, testis and penis).