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MR Contrast

Contrast

MR Image Enhancement

Please see Important Safety Information for Gadovist® and Primovist®.

Our portfolio of magnetic resonance (MR) contrast products includes the first gadolinium-based MR contrast agent, the only gadolinium-based liver-specific MR contrast agent with hepatocyte phase imaging approved for use in the Canada, and a macrocyclic gadolinium-based contrast agent. Bayer has a long tradition of clinical research. We invite you to take a closer look at our MR contrast products.

Gadovist Primovist

INDICATIONS and IMPORTANT SAFETY INFORMATION

Gadovist® (gadobutrol) Injection

INDICATIONS AND CLINICAL USE

GADOVIST 1.0 (gadobutrol) is a medicinal product for diagnostic use only.
GADOVIST 1.0 (gadobutrol) is indicated in adults and children of all ages including term newborns for:

  • Contrast enhancement during cranial and spinal MRI investigations and for contrast-enhanced magnetic resonance angiography (CE-MRA).
  • Contrast enhanced MRI of the breast to assess the presence and extent of malignant breast disease, and MRI of the kidney.
  • GADOVIST 1.0 is particularly suited for cases where the exclusion or demonstration of additional pathology may influence the choice of therapy or patient management, for detection of very small lesions and for visualization of tumors that do not readily take up contrast media.
  • GADOVIST 1.0 is also suited for perfusion studies for the diagnosis of stroke, detection of focal cerebral ischemia and tumor perfusion.

IMPORTANT SAFETY INFORMATION

Serious Warnings and Precautions

NEPHROGENIC SYSTEMIC FIBROSIS

Gadolinium-based contrast agents (GBCAs) increase the risk for Nephrogenic Systemic Fibrosis (NSF) in patients with:

  • - chronic severe renal insufficiency (glomerular filtration rate <30 mL/min/1.73m2), or
  • - acute renal failure / acute kidney injury

In these patients, avoid use of GBCAs unless the diagnostic information is essential and not available with noncontrast-enhanced magnetic resonance imaging (MRI). NSF may result in fatal or debilitating systemic fibrosis affecting the skin, muscle, and internal organs. Screen all patients for renal dysfunction by obtaining a history and/or laboratory tests. When administering a GBCA, do not exceed the recommended dose and allow a sufficient period of time for elimination of the agent from the body prior to any readministration.

CONTRAINDICATIONS: Gadovist® should not be administered to patients who have experienced a life-threatening reaction to Gadovist® 1.0 previously.

Adverse Reactions:The most common adverse events reported following administration of Gadovist® for Central Nervous System (CNS) Indications were: headache (0.9%), vasodilatation (0.6%), nausea (0.5%), injection site pain (0.4%), dizziness (0.3%), rash (0.3%), and dyspnea (0.3%). These reactions were mild to moderate in severity. The most common adverse events reported following administration of Gadovist® for MRA indications were thermal sensations (2.5%) and headache (1.1%). Pediatric Population - Most common adverse events were dysgeusia (1.4%) and feeling hot (1.4%).

OTHER CLINICAL TRIALS: Subsequent to market introduction, additional data from clinical trials with Gadovist® has become available. The overall safety profile of Gadovist® is based on data from more than 5,700 patients in clinical trials. The most frequently observed adverse drug reactions (≥0.5 %) in patients receiving Gadovist® are headache, nausea, and dizziness. Serious adverse drug reactions in patients receiving Gadovist® 1.0 are cardiac arrest, and severe anaphylactoid reactions.

Please see Product Monograph.

Primovist® (gadoxetate disodium) Injection

INDICATION AND USAGE

Primovist® (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

Serious Warnings and Precautions

NEPHROGENIC SYSTEMIC FIBROSIS

Gadolinium-based contrast agents (GBCAs) increase the risk for Nephrogenic Systemic Fibrosis (NSF) in patients with:

  • - Chronic severe renal insufficiency (glomerular filtration rate <30 mL/min/1.73m2), or
  • - Acute renal failure / acute kidney injury

In these patients, avoid use of GBCAs unless the diagnostic information is essential and not available with noncontrast-enhanced magnetic resonance imaging (MRI). NSF may result in fatal or debilitating systemic fibrosis affecting the skin, muscle, and internal organs. Screen all patients for renal dysfunction by obtaining a history and/or laboratory tests. When administering a GBCA, do not exceed the recommended dose and allow a sufficient period of time for elimination of the agent from the body prior to any readministration.

CONTRAINDICATIONS: Patients who are hypersensitive to this drug or to any ingredient in the formulation or component of the container.

Interference with Laboratory Tests: Serum iron determination using complexometric method (for example, Ferrocine complexation method) may result in falsely high or low values for up to 24 hours after Primovist® administration.

Elevated levels of bilirubin (>3 mg/dL) or ferritin can reduce the hepatic contrast effect of Primovist®. If Primovist® is used in these patients, complete the magnetic resonance imaging no later than 60 minutes after Primovist® administration.

Adverse Reactions: Most adverse drug reactions reported with Primovist® were of mild to moderate severity, and did not require a discontinuation of the procedure. The most frequently reported adverse reactions in clinical trials were headache (0.6%; mild), nausea (0.7%; usually occurring just after injection and resolving quickly), and feeling hot (0.7%: usually occurring during injection). Life threatening and/or fatal cases of the following adverse drug reactions have been reported during postmarketing use of Primovist®: dyspnea, and anaphylactoid shock.

Please see Product Monograph.

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