LMD IN DEXTROSE- dextran 40 injection, solution LMD IN SODIUM CHLORIDE- dextran 40 injection, solution

Quốc gia: Hoa Kỳ

Ngôn ngữ: Tiếng Anh

Nguồn: NLM (National Library of Medicine)

Thành phần hoạt chất:

DEXTRAN 40 (UNII: K3R6ZDH4DU) (DEXTRAN 40 - UNII:K3R6ZDH4DU)

Sẵn có từ:

Hospira, Inc.

INN (Tên quốc tế):

DEXTRAN 40

Thành phần:

DEXTRAN 40 10 g in 100 mL

Tuyến hành chính:

INTRAVENOUS

Loại thuốc theo toa:

PRESCRIPTION DRUG

Chỉ dẫn điều trị:

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

Tóm tắt sản phẩm:

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)

Tình trạng ủy quyền:

Abbreviated New Drug Application

Đặc tính sản phẩm

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