"The U.S. Food and Drug Administration today approved Dotarem (gadoterate meglumine) for use in magnetic resonance imaging (MRI) of the brain, spine and associated tissues of patients ages 2 years and older.
Dotarem is a gadolinium-based"...
WARNING: (heparin lock flush solution)
Each milliliter (mL) contains: Heparin sodium, 10 or 100 USP units (derived from porcine intestinal mucosa); sodium chloride 9 mg; edetate disodium, anhydrous 0.1 mg added as a stabilizer; and benzyl alcohol 9 mg added as preservative in water for injection. Headspace nitrogen gassed. May contain sodium hydroxide for pH adjustment. pH 6.5 (5.0 to 7.5). The osmolar concentrations of these solutions are 392 mOsmol/L (calc). Repeated withdrawals may be made from the multiple-dose vial.
Heparin Sodium, USP is a heterogenous group of straight-chain anionic mucopolysaccharides, called glycosaminoglycans having anticoagulant properties. Although others may be present, the main sugars occurring in heparin are:
(1) a-L-iduronic acid 2-sulfate, (2) 2-deoxy-2-sulfamino-a-0-glucose 6-sulfate, (3) b-0-glucuronic acid, (4) 2-acetamido-2-deoxy-a-D-glucose, and (5) a-L-iduronic acid. These sugars are present in decreasing amounts, usually in the order (2)>(1)>(4)>(3)>(5), and are joined by glycosidic linkages, forming polymers of varying sizes. Heparin is strongly acidic because of its content of covalently linked sulfate and carboxylic acid groups. In heparin sodium the acidic protons of the sulfate units are partially replaced by sodium ions. The potency is determined by a biological assay using a USP reference standard based on units of heparin activity per milligram.
Sodium Chloride, USP is chemically designated NaCl, a white crystalline compound freely soluble in water.
The semi-rigid vials are fabricated from a specially formulated polyolefin. It is a copolymer of ethylene and propylene. The safety of the plastic has been confirmed by tests in animals according to USP biological standards for plastic containers. The container requires no vapor barrier to maintain the proper drug concentration.
Last reviewed on RxList: 1/10/2004
This monograph has been modified to include the generic and brand name in many instances.
Additional Lok Pak Information
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