Quốc gia: Hoa Kỳ
Ngôn ngữ: Tiếng Anh
Nguồn: NLM (National Library of Medicine)
GADOVERSETAMIDE (UNII: RLM74T3Z9D) (GADOLINIUM CATION (3+) - UNII:AZV954TZ9N)
Liebel-Flarsheim Company LLC
GADOVERSETAMIDE - UNII:AZV954TZ9N)
GADOVERSETAMIDE 0.5 mmol in 1 mL
PRESCRIPTION DRUG
New Drug Application
OPTIMARK- GADOVERSETAMIDE INJECTION, SOLUTION LIEBEL-FLARSHEIM COMPANY LLC ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE OPTIMARK™ SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR OPTIMARK. OPTIMARK (GADOVERSETAMIDE) INJECTION, FOR INTRAVENOUS USE INITIAL U.S. APPROVAL: 1999 WARNING: NEPHROGENIC SYSTEMIC FIBROSIS (NSF) _SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._ 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 (5.1). DO NOT ADMINISTER OPTIMARK TO PATIENTS WITH: CHRONIC, SEVERE KIDNEY DISEASE (GFR <30 ML/MIN/1.73M ), OR ACUTE KIDNEY INJURY (4). SCREEN PATIENTS FOR ACUTE KIDNEY INJURY AND OTHER CONDITIONS THAT MAY REDUCE RENAL FUNCTION. FOR PATIENTS AT RISK FOR CHRONICALLY REDUCED RENAL FUNCTION (E.G. AGE >60 YEARS, HYPERTENSION OR DIABETES), ESTIMATE THE GLOMERULAR FILTRATION RATE (GFR) THROUGH LABORATORY TESTING (5.1). INDICATIONS AND USAGE Optimark is a gadolinium-based paramagnetic contrast agent for diagnostic magnetic resonance imaging (MRI) indicated for intravenous use: In patients with abnormal blood-brain barrier or abnormal vascularity of the brain, spine and associated tissues (1) To provide contrast enhancement and facilitate visualization of lesions with abnormal vascularity in the liver in patients who are highly suspect for liver structural abnormalities on computed tomography (1) DOSAGE AND ADMINISTRATION Bolus peripheral intravenous injection at a dose of 0.2 mL/kg (0.1 mmol/kg) (2) Follow injection with a 5 mL normal saline flush. (2) Complete imaging procedure within 1 hour of injection. (2) DOSAGE FORMS AND STRENGTHS Injection: Each ml of Optimark contains 330.9 mg gadoversetamide (3) Đọc toàn bộ tài liệu