New Zealand - English - Medsafe (Medicines Safety Authority)

bayer new zealand limited - gadobutrol 604.72mg equivalent to 1 mmol/ml - solution for injection - 1 mmol/ml - active: gadobutrol 604.72mg equivalent to 1 mmol/ml excipient: calcobutrol hydrochloric acid trometamol water for injection - gadovist 1.0 is indicated in adults and children of all ages including full-term newborns for: · contrast enhancement in cranial and spinal magnetic resonance imaging (mri). for spinal mri this includes: differentiation of intra- and extramedullary tumours, demonstration of solid tumour areas in known syrinx, determination of intramedullary tumour spread. gadovist 1.0 is especially suited for high dose indications, such as cases where the exclusion or demonstration of additional foci may influence the therapy or patient management, for detection of very small lesions and for visualisation of lesions that do not readily take up contrast media. gadovist 1.0 is also indicated for perfusion studies such as the diagnosis of stroke, the detection of focal cerebral ischaemia and tumour perfusion. · contrast enhancement in whole body mri including head and neck region, thoracic space, breast, abdomen (pancreas, liver and spleen), pelvis (prostate, bladder and uterus), retroperitoneal space (kidney), extremities and musculoskeletal system. · contrast enhancement in magnetic resonance angiography (ce mra). · contrast enhancement in cardiac mri including assessment of rest and pharmacological stress perfusion and delayed enhancement.

Australia - English - Department of Health (Therapeutic Goods Administration)

bayer australia ltd - gadobutrol, quantity: 604.72 mg/ml - injection, solution - excipient ingredients: hydrochloric acid; water for injections; calcobutrol; trometamol - this medicinal product is for diagnostic use only. gadovist 1.0 is indicated in adults and children including full-term newborns for: contrast enhancement in cranial and spinal magnetic resonance imaging (mri) contrast enhancement in whole body mri including head and neck region, thoracic space, breast, abdomen (pancreas, liver and spleen), pelvis (prostate, bladder and uterus), retroperitoneal space (kidney), extremities and musculoskeletal system use in first-pass mri studies of cerebral perfusion (see precautions) contrast enhancement in magnetic resonance angiography (ce mra) (see clinical trials) contrast enhancement in cardiac mri including assessment of rest and pharmacological stress perfusion and delayed enhancement

Australia - English - Department of Health (Therapeutic Goods Administration)

bayer australia ltd - gadobutrol, quantity: 604.72 mg/ml - injection, solution - excipient ingredients: calcobutrol; trometamol; water for injections; hydrochloric acid - this medicinal product is for diagnostic use only. gadovist 1.0 is indicated in adults and children including full-term newborns for: contrast enhancement in cranial and spinal magnetic resonance imaging (mri) contrast enhancement in whole body mri including head and neck region, thoracic space, breast, abdomen (pancreas, liver and spleen), pelvis (prostate, bladder and uterus), retroperitoneal space (kidney), extremities and musculoskeletal system use in first-pass mri studies of cerebral perfusion (see precautions) contrast enhancement in magnetic resonance angiography (ce mra) (see clinical trials) contrast enhancement in cardiac mri including assessment of rest and pharmacological stress perfusion and delayed enhancement

Australia - English - Department of Health (Therapeutic Goods Administration)

bayer australia ltd - gadobutrol, quantity: 604.72 mg/ml - injection, solution - excipient ingredients: trometamol; hydrochloric acid; calcobutrol; water for injections - this medicinal product is for diagnostic use only. gadovist 1.0 is indicated in adults and children including full-term newborns for: contrast enhancement in cranial and spinal magnetic resonance imaging (mri) contrast enhancement in whole body mri including head and neck region, thoracic space, breast, abdomen (pancreas, liver and spleen), pelvis (prostate, bladder and uterus), retroperitoneal space (kidney), extremities and musculoskeletal system use in first-pass mri studies of cerebral perfusion (see precautions) contrast enhancement in magnetic resonance angiography (ce mra) (see clinical trials) contrast enhancement in cardiac mri including assessment of rest and pharmacological stress perfusion and delayed enhancement

Australia - English - Department of Health (Therapeutic Goods Administration)

bayer australia ltd - gadobutrol, quantity: 604.72 mg/ml - injection, solution - excipient ingredients: hydrochloric acid; trometamol; water for injections; calcobutrol - this medicinal product is for diagnostic use only. gadovist 1.0 is indicated in adults and children including full-term newborns for: contrast enhancement in cranial and spinal magnetic resonance imaging (mri) contrast enhancement in whole body mri including head and neck region, thoracic space, breast, abdomen (pancreas, liver and spleen), pelvis (prostate, bladder and uterus), retroperitoneal space (kidney), extremities and musculoskeletal system use in first-pass mri studies of cerebral perfusion (see precautions) contrast enhancement in magnetic resonance angiography (ce mra) (see clinical trials) contrast enhancement in cardiac mri including assessment of rest and pharmacological stress perfusion and delayed enhancement

Australia - English - Department of Health (Therapeutic Goods Administration)

bayer australia ltd - gadobutrol, quantity: 604.72 mg/ml - injection, solution - excipient ingredients: trometamol; water for injections; hydrochloric acid; calcobutrol sodium - this medicinal product is for diagnostic use only. gadovist 1.0 is indicated in adults and children including full-term newborns for: contrast enhancement in cranial and spinal magnetic resonance imaging (mri) contrast enhancement in whole body mri including head and neck region, thoracic space, breast, abdomen (pancreas, liver and spleen), pelvis (prostate, bladder and uterus), retroperitoneal space (kidney), extremities and musculoskeletal system use in first-pass mri studies of cerebral perfusion (see precautions) contrast enhancement in magnetic resonance angiography (ce mra) (see clinical trials) contrast enhancement in cardiac mri including assessment of rest and pharmacological stress perfusion and delayed enhancement

Australia - English - Department of Health (Therapeutic Goods Administration)

bayer australia ltd - gadobutrol, quantity: 604.72 mg/ml - injection, solution - excipient ingredients: trometamol; calcobutrol sodium; water for injections; hydrochloric acid - this medicinal product is for diagnostic use only. gadovist 1.0 is indicated in adults and children including full-term newborns for: contrast enhancement in cranial and spinal magnetic resonance imaging (mri) contrast enhancement in whole body mri including head and neck region, thoracic space, breast, abdomen (pancreas, liver and spleen), pelvis (prostate, bladder and uterus), retroperitoneal space (kidney), extremities and musculoskeletal system use in first-pass mri studies of cerebral perfusion (see precautions) contrast enhancement in magnetic resonance angiography (ce mra) (see clinical trials) contrast enhancement in cardiac mri including assessment of rest and pharmacological stress perfusion and delayed enhancement

Australia - English - Department of Health (Therapeutic Goods Administration)

bayer australia ltd - gadobutrol, quantity: 604.72 mg/ml - injection, solution - excipient ingredients: trometamol; calcobutrol sodium; water for injections; hydrochloric acid - this medicinal product is for diagnostic use only. gadovist 1.0 is indicated in adults and children including full-term newborns for: contrast enhancement in cranial and spinal magnetic resonance imaging (mri) contrast enhancement in whole body mri including head and neck region, thoracic space, breast, abdomen (pancreas, liver and spleen), pelvis (prostate, bladder and uterus), retroperitoneal space (kidney), extremities and musculoskeletal system use in first-pass mri studies of cerebral perfusion (see precautions) contrast enhancement in magnetic resonance angiography (ce mra) (see clinical trials) contrast enhancement in cardiac mri including assessment of rest and pharmacological stress perfusion and delayed enhancement

Australia - English - Department of Health (Therapeutic Goods Administration)

bayer australia ltd - gadobutrol, quantity: 604.72 mg/ml - injection, solution - excipient ingredients: trometamol; water for injections; hydrochloric acid; calcobutrol sodium - this medicinal product is for diagnostic use only. gadovist 1.0 is indicated in adults and children including full-term newborns for: contrast enhancement in cranial and spinal magnetic resonance imaging (mri) contrast enhancement in whole body mri including head and neck region, thoracic space, breast, abdomen (pancreas, liver and spleen), pelvis (prostate, bladder and uterus), retroperitoneal space (kidney), extremities and musculoskeletal system use in first-pass mri studies of cerebral perfusion (see precautions) contrast enhancement in magnetic resonance angiography (ce mra) (see clinical trials) contrast enhancement in cardiac mri including assessment of rest and pharmacological stress perfusion and delayed enhancement

Australia - English - Department of Health (Therapeutic Goods Administration)

bayer australia ltd - gadobutrol, quantity: 604.72 mg/ml - injection, solution - excipient ingredients: calcobutrol sodium; trometamol; hydrochloric acid; water for injections - this medicinal product is for diagnostic use only. gadovist 1.0 is indicated in adults and children including full-term newborns for: ? contrast enhancement in cranial and spinal magnetic resonance imaging (mri) ? contrast enhancement in whole body mri including head and neck region, thoracic space, breast, abdomen (pancreas, liver and spleen), pelvis (prostate, bladder and uterus), retroperitoneal space (kidney), extremities and musculoskeletal system ? use in first?pass mri studies of cerebral perfusion (see precautions) ? contrast enhancement in magnetic resonance angiography (ce mra) (see clinical trials) ? contrast enhancement in cardiac mri including assessment of rest and pharmacological stress perfusion and delayed enhancement