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Diagnostic Imaging

Our Diagnostic Imaging Products

 

INDICATIONS and IMPORTANT SAFETY INFORMATION

MAGNEVIST(gadopentetate dimeglumine) Injection

INDICATIONS AND USAGE

Central Nervous System: MAGNEVIST (gadopentetate dimeglumine) 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.

Extracranial/Extraspinal Tissues: MAGNEVIST 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.

Body: 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 (excluding the heart).

IMPORTANT SAFETY INFORMATION

WARNING: : NEPHROGENIC SYSTEMIC FIBROSIS (NSF)
Gadolinium-based contrast agents (GBCAs) increase the risk for NSF among patients with impaired elimination of the drugs. Avoid use of GBCAs in these patients unless the diagnostic information is essential and not available with non-contrasted MRI or other modalities. NSF may result in fatal or debilitating fibrosis affecting the skin, muscle and internal organs.
  • Do not administer MAGNEVIST to patients with:
    • chronic, severe kidney disease (GFR < 30 mL/min/1.73m2), or
    • acute kidney injury (see CONTRAINDICATIONS)
  • Screen patients for acute kidney injury and other conditions that may reduce renal function. For patients at risk for chronically reduced renal function (for example, age >60 years, hypertension or diabetes), estimate the glomerular filtration rate (GFR) through laboratory testing.
Do not exceed the recommended MAGNEVIST dose and allow a sufficient period of time for elimination of the drug from the body prior to any re-administration (see WARNINGS AND PRECAUTIONS).

  • Magnevist is contraindicated in patients with chronic, severe kidney disease (glomerular filtration rate, (GFR < 30 mL/min/1.73m2), or acute kidney injury.

     

  • The possibility of serious or life-threatening anaphylactic or anaphylactoid reactions should always be considered. Acute reactions including cardiac or respiratory arrest, anaphylactic shock and shock have been reported. Caution should be exercised in patients with renal insufficiency due to the possibility of further deterioration in renal function. Cases of phlebitis and thrombophlebitis have been reported; assessment of the dosed limb for the development of injection site reactions is recommended.

     

  • In clinical trials, the most frequently reported adverse reactions included headache, nausea, injection site coldness/localized coldness/localized coldness and dizziness. 

Please see full prescribing information.

 

Eovist® (gadoxetate disodium) Injection

INDICATIONS AND USAGE

EOVIST® (gadoxetate disodium) Injection is a gadolinium-based contrast agent indicated for intravenous use in T1-weighted magnetic resonance imaging (MRI) of the liver to detect and characterize lesions in adults with known or suspected focal liver disease.

IMPORTANT SAFETY INFORMATION

WARNING: NEPHROGENIC SYSTEMIC FIBROSIS (NSF)
Gadolinium-based contrast agents (GBCAs) increase the risk for NSF among patients with impaired elimination of the drugs. Avoid use of GBCAs in these patients unless the diagnostic information is essential and not available with non-contrasted MRI or other modalities. NSF may result in fatal or debilitating fibrosis affecting the skin, muscle and internal organs.
  • The risk for NSF appears highest among patients with:
    • chronic, severe kidney disease(GFR < 30 mL/min/1.73m2), or
    • acute kidney injury
  • Screen patients for acute kidney injury and other conditions that may reduce renal function. For patients at risk for chronically reduced renal function (for example, age >60 years, hypertension or diabetes), estimate the glomerular filtration rate (GFR) through laboratory testing.
  • For patients at highest risk for NSF, do not exceed the recommended EOVIST dose and allow a sufficient period of time for elimination of the drug from the body prior to re-administration (see WARNINGS AND PRECAUTIONS).

  • The possibility of serious or life-threatening anaphylactoid/hypersensitivity reactions with cardiovascular, respiratory and/or cutaneous manifestations should always be considered.

  • The most common adverse reactions observed in clinical trials at the recommended dose included feeling hot, nausea and headache.

 

Please see full prescribing information.

 

ULTRAVIST® (iopromide) Injection

INDICATIONS AND USAGE

ULTRAVIST® Injection is an iodinated contrast agent indicated for:

Intra-arterial Procedures*: 300 mgI/mL for cerebral arteriography and peripheral arteriography; 370 mgI/mL for coronary arteriography and left ventriculography, visceral angiography, and aortography.

Intravenous Procedures*: 240 mgI/mL for peripheral venography; 300 mgI/mL for excretory urography; 300 mgI/mL and 370 mgI/mL for contrast Computed Tomography (CT) of the head and body (intrathoracic, intra-abdominal and retroperitoneal regions) for the evaluation of neoplastic and non-neoplastic lesions. The usefulness of contrast enhancement for the investigation of the retrobulbar space and of low grade or infiltrative glioma has not been demonstrated.

* For information on the concentrations and doses for the Pediatric Population [see Dosage and Administration (2.3) and Use in Specific Populations (8.4) in the full prescribing information].

IMPORTANT SAFETY INFORMATION

WARNING: NOT FOR INTRATHECAL USE
Inadvertent intrathecal administration may cause death, convulsions, cerebral hemorrhage, coma, paralysis, arachnoiditis, acute renal failure, cardiac arrest, seizures, rhabdomyolysis, hyperthermia, and brain edema.

CONTRAINDICATIONS
ULTRAVIST Injection is contraindicated for intrathecal use.

Preparatory dehydration (e.g. prolonged fasting and the administration of a laxative before ULTRAVIST Injection) is contraindicated in pediatric patients because of risk of renal failure.

WARNINGS AND PRECAUTIONS
Life-threatening or fatal anaphylactoid reactions may occur during or after Ultravist administration. Acute renal failure may occur following ULTRAVIST administration, particularly in patients with renal insufficiency, diabetes, multiple myeloma. Hemodynamic disturbances including shock and cardiac arrest may occur during or shortly after administration of ULTRAVIST. Angiography may be associated with local and distal organ damage, ischemia, thromboembolism and organ failure.

MOST COMMON ADVERSE REACTIONS
Most common adverse reactions (>1%) are headache, dysguesia, abnormal vision, chest pain, vasodilatation, nausea, vomiting, back pain, urinary urgency, injection site and infusion site reactions, and pain.

Please see full prescribing information, with additional Warnings and Precautions.

GadavistTM(gadobutrol) injection

INDICATIONS AND USAGE

GadavistTM is a gadolinium-based contrast agent indicated for intravenous use in diagnostic magnetic resonance imaging (MRI) in adults and children (2 years of age and older) to detect and visualize areas with disrupted blood brain barrier (BBB) and/or abnormal vascularity of the central nervous system.

IMPORTANT SAFETY INFORMATION

WARNING: NEPHROGENIC SYSTEMIC FIBROSIS (NSF)
Gadolinium-based contrast agents (GBCAs) increase the risk for NSF among patients with impaired elimination of the drugs. Avoid use of GBCAs in these patients unless the diagnostic information is essential and not available with non-contrasted MRI or other modalities. NSF may result in fatal or debilitating fibrosis affecting the skin, muscle and internal organs.
  • The risk for NSF appears highest among patients with:
    • Chronic, severe kidney disease(GFR < 30 mL/min/1.73m2), or
    • Acute kidney injury
  • Screen patients for acute kidney injury and other conditions that may reduce renal function. For patients at risk for chronically reduced renal function (for example, age >60 years, hypertension or diabetes), estimate the glomerular filtration rate (GFR) through laboratory testing
  • For patients at highest risk for NSF, do not exceed the recommended Gadavist dose and allow a sufficient period of time for elimination of the drug from the body prior to any re-administration [see Warnings and Precautions].

  • The possibility of serious or life-threatening hypersensitivity, anaphylactic or anaphylactoid reactions associated with cardiovascular, respiratory, or cutaneous manifestations, including death, should always be considered.

  • The most frequent adverse reactions associated with Gadavist in clinical studies were headache, nausea, injection site reaction, dysgeusia and feeling hot.

 

Please see full prescribing information.

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