DESMOPRESSIN ACETATE injection, solution

País: Estados Unidos

Idioma: inglés

Fuente: NLM (National Library of Medicine)

Ingredientes activos:

desmopressin acetate (UNII: XB13HYU18U) (desmopressin - UNII:ENR1LLB0FP)

Disponible desde:

Sagent Pharmaceuticals

Vía de administración:

INTRAVENOUS

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

Desmopressin Acetate Injection is indicated for patients with hemophilia A with factor VIII coagulant activity levels greater than 5%. Desmopressin Acetate Injection will often maintain hemostasis in patients with hemophilia A during surgical procedures and postoperatively when administered 30 minutes prior to scheduled procedure. Desmopressin Acetate Injection will also stop bleeding in hemophilia A patients with episodes of spontaneous or trauma-induced injuries such as hemarthroses, intramuscular hematomas or mucosal bleeding. In certain clinical situations, it may be justified to try Desmopressin Acetate Injection in patients with factor VIII levels between 2% to 5%; however, these patients should be carefully monitored. Desmopressin Acetate Injection is indicated for patients with mild to moderate classic von Willebrand's disease (Type I) with factor VIII levels greater than 5%. Desmopressin Acetate Injection will often maintain hemostasis in patients with mild to moderate von Willebrand's disease during

Resumen del producto:

Desmopressin Acetate Injection, USP is supplied as follows: Desmopressin Acetate Injection, USP is a clear, colorless solution, free from particulate matter filled in a clear glass vial. Store refrigerated between 2° and 8°C (36° and 46°F). Keep out of the reach of children. Sterile, Nonpyrogenic. The container closure is not made with natural rubber latex. SAGENT® Mfd. for SAGENT Pharmaceuticals Schaumburg, IL 60195 (USA) Made in India ©2017 Sagent Pharmaceuticals, Inc. July 2017 SAGENT Pharmaceuticals®

Estado de Autorización:

Abbreviated New Drug Application

Ficha técnica

DESMOPRESSIN ACETATE- DESMOPRESSIN ACETATE INJECTION, SOLUTION
SAGENT PHARMACEUTICALS
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DESMOPRESSIN ACETATE INJECTION, USP
FOR INTRAVENOUS OR SUBCUTANEOUS USE ONLY
SAGENT
Rx only
DESCRIPTION
Desmopressin Acetate Injection, USP 4 mcg per mL is a synthetic
analogue of the natural pituitary
hormone 8-arginine vasopressin (ADH), an antidiuretic hormone
affecting renal water conservation. It is
chemically defined as follows:
Mol. Wt. 1183.34 Empirical Formula: C
H N O S •C H O •3H O
1-(3-mercaptopropionic acid)-8-D-arginine vasopressin monoacetate
(salt) trihydrate.
Desmopressin Acetate Injection, USP 4 mcg per mL is provided as a
sterile, aqueous solution for
intravenous or subcutaneous injection.
Each mL provides:
The 10 mL vial contains chlorobutanol as a preservative (5 mg per mL).
CLINICAL PHARMACOLOGY
Desmopressin acetate contains as active substance, desmopressin
acetate, a synthetic analogue of the
natural hormone arginine vasopressin. One mL (4 mcg) of desmopressin
acetate solution has an
antidiuretic activity of about 16 IU; 1 mcg of desmopressin acetate is
equivalent to 4 IU.
Desmopressin acetate has been shown to be more potent than arginine
vasopressin in increasing plasma
levels of factor VIII activity in patients with hemophilia and von
Willebrand's disease Type I.
Dose-response studies were performed in healthy persons, using doses
of 0.1 to 0.4 mcg/kg body
weight, infused over a 10-minute period. Maximal dose response
occurred at 0.3 to 0.4 mcg/kg. The
response to desmopressin acetate of factor VIII activity and
plasminogen activator is dose-related, with
maximal plasma levels of 300 to 400 percent of initial concentrations
obtained after infusion of 0.4
mcg/kg body weight. The increase is rapid and evident within 30
minutes, reaching a maximum at a point
ranging from 90 minutes to two hours. The factor VIII related antigen
and ristocetin cofactor activity
were also increased to a smaller degree, but still are dose-dependent.
1. The biphasic half-lives of desmopressin acetate were 7.8 an