SPL Set ID: 57db5686-7f7f-4999-87e3-e1cbbda4a98d

Tromethamine Injection is a sterile, non-pyrogenic 0.3 M solution of tromethamine, adjusted to a pH of approximately 8.6 with glacial acetic acid. It is administered by intravenous injection, by addition to ACD blood for priming cardiac bypass equipment and by injection into the ventricular cavity during cardiac arrest. Each 100 mL contains tromethamine 3.6 g (30 mEq) in water for injection. The solution is hypertonic 385 mOsmol/L (calc.). pH 8.6 (8.4-8.7). The solution contains no bacteriostat, antimicrobial agent or added buffer (except acetic acid for pH adjustment) and is intended only for use as a single-dose injection. When smaller doses are required the unused portion should be discarded. Tromethamine Injection is a parenteral systemic alkalizer and fluid replenisher. Tromethamine, USP (sometimes called “tris” or “tris buffer”) is chemically designated 2-amino-2-(hydroxymethyl)-1, 3-propanediol, a solid readily soluble in water, also classified as an organic amine buffer. It has the following structural formula: structural formula tromethamine Water for Injection, USP is chemically designated H 2 O. The EXCEL ® plastic container is made from a multilayered film. The solution contact layer is a rubberized copolymer of ethylene and propylene. The container is nontoxic and biologically inert. The container-solution unit is a closed system and is not dependent upon entry of external air during administration. The container is overwrapped to provide protection from the physical environment and to provide an additional moisture barrier when necessary. Addition of medication should be accomplished using complete aseptic technique. The closure system has two ports; the one for the administration set has a tamper evident plastic protector and the other is a medication addition site. Refer to the Directions for Use of the container. structural formula tromethamine