Država: Sjedinjene Američke Države
Jezik: engleski
Izvor: NLM (National Library of Medicine)
gadofosveset trisodium (UNII: XM33Q67UVH) (gadofosveset - UNII:E65RW73PHS)
Bayer Healthcare, Inc.
gadofosveset trisodium
INJECTION
244 mg in 1 mL
INTRAVENOUS
PRESCRIPTION DRUG
VASOVIST is indicated for use as a contrast agent in magnetic resonance angiography (MRA) to evaluate aortoiliac occlusive disease (AIOD) in adults with known or suspected peripheral vascular disease [see Clinical Studies (14) ]. History of a prior allergic reaction to a gadolinium-based contrast agent. Pregnancy Category C There are no adequate and well-controlled studies of VASOVIST in pregnant women. In animal studies, pregnant rabbits treated with gadofosveset trisodium at doses 3 times the human dose (based on body surface area) experienced higher rates of fetal loss and resorptions. Because animal reproduction studies are not always predictive of human response, only use VASOVIST during pregnancy if the diagnostic benefit justifies the potential risks to the fetus. In reproductive studies, pregnant rats and rabbits received gadofosveset trisodium at various doses up to approximately 11 (rats) and 21.5 (rabbits) times the human dose (based on body surface area). The highest dose resulted in maternal t
VASOVIST Injection is a sterile, clear, colorless to pale yellow solution containing 244 mg/mL (0.25 mmol/mL) of gadofosveset trisodium in rubber-stoppered vials with an aluminum seal. VASOVIST Injection is supplied as follows: Store VASOVIST Injection at 25°C (77°F: excursions permitted to 15 to 30°C [59 to 86°F]). Protect from light and freezing.
VASOVIST- GADOFOSVESET TRISODIUM INJECTION BAYER HEALTHCARE, INC. ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION WARNING: NEPHROGENIC SYSTEMIC FIBROSIS (NSF) _SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING_ GADOLINIUM-BASED CONTRAST AGENTS INCREASE THE RISK OF NEPHROGENIC SYSTEMIC FIBROSIS (NSF) IN PATIENTS WITH: ACUTE OR CHRONIC SEVERE RENAL INSUFFICIENCY (GLOMERULAR FILTRATION RATE <30 ML/MIN/1.73M ), OR ACUTE RENAL INSUFFICIENCY OF ANY SEVERITY DUE TO THE HEPATO-RENAL SYNDROME OR IN THE PERIOPERATIVE LIVER TRANSPLANTATION PERIOD. IN THESE PATIENTS, AVOID USE OF GADOLINIUM-BASED CONTRAST AGENTS UNLESS THE DIAGNOSTIC INFORMATION IS ESSENTIAL AND NOT AVAILABLE WITH NON-CONTRAST 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 GADOLINIUM-BASED CONTRAST AGENT, DO NOT EXCEED THE RECOMMENDED DOSE AND ALLOW A SUFFICIENT PERIOD OF TIME FOR ELIMINATION OF THE AGENT FROM THE BODY PRIOR TO ANY RE-ADMINISTRATION [_SEE WARNINGS AND_ _PRECAUTIONS (5.1)_] INDICATIONS AND USAGE VASOVIST Injection is a gadolinium-based contrast agent indicated for use as a contrast agent in magnetic resonance angiography (MRA) to evaluate aortoiliac occlusive disease (AIOD) in adults with known or suspected peripheral vascular disease . (1) DOSAGE AND ADMINISTRATION Administer VASOVIST Injection by an intravenous bolus, manually or by power injection, at a dose of 0.12 mL/kg body weight (0.03 mmol/kg) over a period of time up to 30 seconds followed by a 25-30 mL normal saline flush. (2) Imaging is performed in two stages, the dynamic stage which begins immediately following VASOVIST Injection and the steady-state stage, which begins following dynamic imaging; generally 5 to 7 minutes after VASOVIST Injection. (2) DOSAGE FORMS AND STRENGTHS Each mL of VASOVIST Injection contains 244 mg gadofosveset trisodium (equivalent to Pročitajte cijeli dokument