GADOPENTETATE DIMEGLUMINE 商标名：MAGNEVIST SYG 参比制剂 美国上市，一次性进口，平价供应
英文名：GADOPENTETATE DIMEGLUMINE
商标名：MAGNEVIST SYG
中文名：马根维显
剂 型：注射
上市国家：美国
包装与价格
MAGNEVIST SYG 5X10ML GADOPENTETATE DIMEGLUMINE MCKESSON SPECIALTY LLC 50419018836 $502.75
MAGNEVIST SOL 20X5ML GADOPENTETATE DIMEGLUMINE MCKESSON SPECIALTY LLC 50419018881 $781.67
MAGNEVIST SOL 20X10ML GADOPENTETATE DIMEGLUMINE MCKESSON SPECIALTY LLC 50419018882 $1,382.76
MAGNEVIST SOL 20X15ML GADOPENTETATE DIMEGLUMINE MCKESSON SPECIALTY LLC 50419018883 $1,886.37
MAGNEVIST SOL 2X10X20ML GADOPENTETATE DIMEGLUMINE MCKESSON SPECIALTY LLC 50419018884 $2,589.98
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MAGNEVIST（gadopentetate dimeglumine liquid）
Bayer HealthCare Pharmaceuticals Inc.
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MAGNEVIST
(brand of gadopentetate dimeglumine)
Injection
FOR INTRAVENOUS ADMINISTRATION
Pharmacy Bulk Package—Not For Direct Infusion
Rx only
WARNING: NEPHROGENIC SYSTEMIC FIBROSIS
Gadolinium-based contrast agents increase the risk for nephrogenic systemic fibrosis (NSF) in patients with:
Acute or chronic severe renal insufficiency (glomerular filtration rate < 30 mL/min/1.73m2), 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 readminstration (See WARNINGS).
DESCRIPTION
MAGNEVIST® (brand of gadopentetate dimeglumine) Injection is the N-methylglucamine salt of the gadolinium complex of diethylenetriamine pentaacetic acid, and is an injectable contrast medium for magnetic resonance imaging (MRI). MAGNEVIST Injection is provided as a sterile, clear, colorless to slightly yellow aqueous solution for intravenous injection.
MAGNEVIST 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 C28H54GdN5O20, and has the following structural formula:
Magnevist Structural Formula
Each mL of MAGNEVIST Injection contains 469.01 mg gadopentetate dimeglumine, 0.99 mg meglumine, 0.40 mg diethylenetriamine pentaacetic acid and water for injection. MAGNEVIST Injection contains no antimicrobial preservative.
MAGNEVIST Injection has an osmolality 6.9 times that of plasma which has an osmolality of 285 mOsmol/kg water. MAGNEVIST Injection is hypertonic under conditions of use.
CLINICAL PHARMACOLOGY
Pharmacokinetics
The pharmacokinetics of intravenously administered gadopentetate dimeglumine in normal subjects conforms to a two compartment open-model with mean distribution and eliminatio |
