![]() These patients may have an increased risk for a hypersensitivity reaction to DOTAREM. Before DOTAREM administration, assess all patients for any history of a reaction to contrast media, bronchial asthma and/or allergic disorders.In most cases, initial symptoms occurred within minutes of DOTAREM administration and resolved with prompt emergency treatment Some patients experienced circulatory collapse and died. Hypersensitivity Reactions: Anaphylactic and anaphylactoid reactions have been reported with DOTAREM, involving cardiovascular, respiratory, and/or cutaneous manifestations.History of clinically important hypersensitivity reactions to DOTAREM. Frozen syringes should be discarded.ĭOTAREM ® (gadoterate meglumine) injection is a prescription gadolinium-based contrast agent indicated for intravenous use with magnetic resonance imaging (MRI) in brain (intracranial), spine and associated tissues in adult and pediatric patients (including term neonates) to detect and visualize areas with disruption of the blood brain barrier (BBB) and/or abnormal vascularity. Pharmacy Bulk Package is individually packaged in a box of 6. Syringes, including plunger rod, are packaged in a box of 10. Pharmacy Bulk Package is supplied in 100 mL For patients at highest risk for NSF, do not exceed the recommended DOTAREM dose and allow a sufficient period of time for elimination of the drug from the body prior to any re-administration.ĥ mL, 10 mL, 15 mL or 20 mL available in glass vialsġ0mL, 15 mL, or 20 mL solution available in prefilled syringes.Chronic, severe kidney disease (GFR 60 years, hypertension, diabetes), estimate the glomerular filtration rate (GFR) through laboratory testing.The risk for NSF appears highest among patients with:.NSF may result in fatal or debilitating fibrosis affecting the skin, muscle and internal organs. Avoid use of GBCAs in these patients unless the diagnostic information is essential and not available with non-contrasted MRI or other modalities. Gadolinium-based contrast agents (GBCAs) increase the risk for NSF among patients with impaired elimination of the drugs. WARNING: NEPHROGENIC SYSTEMIC FIBROSIS (NSF) OptiVantage ® Dual-Head CT Contrast Delivery System.Illumena ® Néo Contrast Delivery System.OptiOne ® Single-Head CT Contrast Delivery System.MD-Gastroview ® (diatrizoate meglumine and diatrizoate sodium solution USP).Cysto-Conray ® II (Iothalamate meglumine Injection USP 17.2%).Conray ® (iothalamate meglumine injection USP 60%).Contrast&Care ® Injection Data Management Solution.OptiProtect™ 3S Technical Services & Support.OptiStar ® Elite MR Contrast Delivery System. ![]() Sodium Chloride Injection USP 0.9% in Ultraject ® Prefilled Syringes.Dotarem ® (gadoterate meglumine) Injection.
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