GADOVIST^® 1.0 mmol/mL solution for injection.

Composition: GADOVIST 1.0 is a clear, sterile, aqueous solution. Each mL of GADOVIST 1.0 contains 604.72 mg (1.0 mmol) of gadobutrol, 1.211 mg trometamol, 0.013 mg sodium (0.00056 mmol), and 0.513 mg calcium sodium butrol in water for injection. The pH of GADOVIST 1.0 is adjusted to between 6.6 and 8.0 with hydrochloric acid.

Indications: 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 ofadditional 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.

Contraindications: GADOVIST 1.0 should not be administered to patients who have experienced a life-threatening reaction to GADOVIST 1.0 previously.

Serious warnings and precautions for use: 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.

Adverse reactions: Patients with a history of previous reaction to contrast media, allergic disorders or bronchial asthma suffer more frequently from hypersensitivity reactions than others. As with other contrast media, delayed allergoid reactions occurring hours or days after administration have been observed, though rarely. Anaphylactoid reactions may occur. Transient sensations of taste or smell perversion may occur during or immediately after injection of GADOVIST 1.0.