Χώρα: Ηνωμένες Πολιτείες
Γλώσσα: Αγγλικά
Πηγή: NLM (National Library of Medicine)
DEXTRAN 40 (UNII: K3R6ZDH4DU) (DEXTRAN 40 - UNII:K3R6ZDH4DU)
Hospira, Inc.
DEXTRAN 40
DEXTRAN 40 10 g in 100 mL
INTRAVENOUS
PRESCRIPTION DRUG
LMD (dextran 40) is indicated for use in the adjunctive treatment of shock or impending shock due to hemorrhage, burns, surgery or other trauma. It is not indicated as a replacement for whole blood or blood components if they are available. It should not replace other forms of therapy known to be of value in the treatment of shock. LMD is also indicated for use as a priming fluid, either as a sole prime or as an additive, in pump oxygenators during extracorporeal circulation. LMD is also indicated for use in prophylaxis of venous thrombosis and pulmonary embolism in patients undergoing procedures known to be associated with a high incidence of thromboembolic complications, such as hip surgery. LMD (dextran 40) is contraindicated in patients with known hypersensitivity to dextran, in those with marked hemostatic defects of all types (thrombocytopenia, hypofibrinogenemia, etc.) including those caused by drugs (heparin, warfarin, etc.), marked cardiac decompensation and in renal disease with severe oliguria or a
10% LMD in 5% Dextrose Injection (Dextran 40 in Dextrose Injection, USP) is supplied as follows: NDC 0409-7418-03 Case containing 12 500 mL Single-dose flexible containers 50 g/500 mL (10 g/100 mL) 10% LMD in 0.9% Sodium Chloride Injection (Dextran 40 in Sodium Chloride Injection, USP) is supplied as follows: NDC 0409-7419-03 Case containing 12 500 mL Single-dose flexible containers 50 g/500 mL (10 g/100 mL)
Abbreviated New Drug Application
LMD IN DEXTROSE- DEXTRAN 40 INJECTION, SOLUTION LMD IN SODIUM CHLORIDE- DEXTRAN 40 INJECTION, SOLUTION HOSPIRA, INC. ---------- 10% LMD IN 5% DEXTROSE INJECTION RX ONLY (DEXTRAN 40 IN DEXTROSE INJECTION, USP) 10% LMD IN 0.9% SODIUM CHLORIDE INJECTION (DEXTRAN 40 IN SODIUM CHLORIDE INJECTION, USP) Low Molecular Weight Dextran for Intravenous Administration FLEXIBLE PLASTIC CONTAINER DESCRIPTION LMD (dextran 40) is a sterile, nonpyrogenic preparation of low molecular weight dextran (average mol. wt. 40,000) in 5% Dextrose Injection or 0.9% Sodium Chloride Injection. It is administered by intravenous infusion. Also described as low viscous or low viscosity dextran, dextran 40 is prepared by acid hydrolysis and differential fractionation of a crude macromolecular polysaccharide produced from the fermentation of sucrose by the bacterium, Leuconostoc mesenteroides (strain B-512). The crude material is composed of linked glucose units. In the fraction represented by dextran 40, 80% of the molecules have a molecular weight ranging from 10,000 to 90,000 (average approximately 40,000) when measured by a light scattering method. More than 90% of the linkages are of the 1,6 alpha glucosidic, straight chain type. Each 100 mL of 10% LMD (dextran 40) in 5% Dextrose Injection contains 10 g dextran 40 and 5 g dextrose hydrous in water for injection. Total osmolar concentration is 255 mOsmol/liter (calc.); pH is 4.4 (3.0 to 7.0). Each 100 mL of 10% LMD (dextran 40) in 0.9% Sodium Chloride Injection contains 10 g dextran 40 and 0.9 g sodium chloride in water for injection. Total osmolar concentration is 310 mOsmol/liter (calc.); pH is 4.9 (3.5 to 7.0) (may contain sodium hydroxide and/or hydrochloric acid for pH adjustment). Electrolyte concentration per liter: Na 154 mEq; Cl 154 mEq (not including ions for pH adjustment). The solutions contain no bacteriostat, antimicrobial agent or added buffers (except for pH adjustment) and are intended only for single-dose injection. When smaller doses are required the unused portion should be Διαβάστε το πλήρες έγγραφο