Страна: США
мова: англійська
Джерело: NLM (National Library of Medicine)
GADOPENTETATE DIMEGLUMINE (UNII: RH248G8V27) (GADOPENTETATE - UNII:V7OK6J19HQ)
Alvogen, Inc
INTRAVENOUS
PRESCRIPTION DRUG
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. Gadopentetate dimeglumine Injection has been shown to facilitate visualization of intracranial lesions including but not limited to tumors. Gadopentetate dimeglumine 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. Gadopentetate dimeglumine 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). Gadopentetate dimeglumine Injection is contraindicated in patients with:
Gadopentetate dimeglumine Injection is a clear, colorless to slightly yellow solution containing 469.01 mg/mL of gadopentetate dimeglumine. Gadopentetate dimeglumine Injection is supplied in the following sizes: 50 mL Pharmacy Bulk Package, rubber stoppered, 10 per box NDC 47781-147-25 100 mL Pharmacy Bulk Package, rubber stoppered, 10 per box NDC 47781-147-23
New Drug Application Authorized Generic
GADOPENTETATE DIMEGLUMINE- GADOPENTETATE DIMEGLUMINE INJECTION ALVOGEN, INC ---------- GADOPENTETATE DIMEGLUMINE INJECTION FOR INTRAVENOUS ADMINISTRATION PHARMACY BULK PACKAGE—NOT FOR DIRECT INFUSION RX ONLY 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 exceed the recommended gadopentetate dimeglumine 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). DESCRIPTION Gadopentetate dimeglumineInjection is the N-methylglucamine salt of the gadolinium complex of diethylenetriamine pentaacetic acid, and is an injectable contrast medium for magnetic resonance imaging (MRI). Gadopentetate dimeglumine Injection is provided as a sterile, clear, colorless to slightly yellow aqueous solution for intravenous injection. Gadopentetate dimeglumine Injection is a 0.5- mol/L solution of 1-deoxy-1-(methylamino)-D-glucitol dihydrogen [N,N-bis[2-[bis(carboxymethyl)amino]ethyl]- glycinato (5-)]gadolinate(2- ) (2:1) with a molecular weight of 938, an empirical formula of C H GdN O , and has the following structural formula: Each mL contains 469.01 mg gadopentetate dimeglumine, 0.99 mg meglumine, 0.40 mg diethylenetriamine pentaacetic acid and water for injection. Gadopentetate dimeglumine Injection Do not administer gadopentetate dimeglumine to patients with: • • chronic, severe kidney disease (GFR < 30 mL/min/1.73m ), or 2 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 d Прочитайте повний документ