Rx Item-Gadavist 2 Mmol 2Ml Vial 15X2Ml By Bayer Healthcare

GADAVIST- gadobutrol injection
Bayer HealthCare Pharmaceuticals Inc.

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.

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The risk for NSF appears highest among patients with:
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Chronic, severe kidney disease (GFR < 30 mL/min/1.73m2), or
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Acute kidney injury.
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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.
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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 (5.1)].
1 INDICATIONS AND USAGE

1.1 Magnetic Resonance Imaging (MRI) of the Central Nervous System (CNS)


Gadavist is indicated for use with magnetic resonance imaging (MRI) in adult and pediatric patients (including term neonates) to detect and visualize areas with disrupted blood brain barrier and/or abnormal vascularity of the central nervous system.

1.2 MRI of the Breast
Gadavist is indicated for use with MRI to assess the presence and extent of malignant breast disease.

1.3 Magnetic Resonance Angiography (MRA)
​Gadavist is indicated for use in magnetic resonance angiography (MRA) in adult and pediatric patients (including term neonates) to evaluate known or suspected supra-aortic or renal artery disease.

2 DOSAGE AND ADMINISTRATION

2.1 Recommended Dose
The recommended dose of Gadavist for adult and pediatric patients (including term neonates) is 0.1 mL/kg body weight (0.1 mmol/kg). Refer to Table 1 to determine the volume to be administered.

RX ITEM-Gadavist 2 Mmol 2Ml Vial 15X2Ml
NDC 50419-0325-37 UPC/GTIN No.3-50419-32537-5 Mfg.Part No.42706

Gadavist 2 Mmol 2Ml Vial 15X2Ml By Bayer
BRAND: GADAVIST NDC: 50419-0325-37,50419032537 UPC: 3-50419-32537-5,350419325375

GADOBUTROL INTRAVEN VIAL
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