Država: Sjedinjene Američke Države
Jezik: engleski
Izvor: NLM (National Library of Medicine)
desmopressin acetate (UNII: XB13HYU18U) (desmopressin - UNII:ENR1LLB0FP)
Ferring Pharmaceuticals Inc.
desmopressin acetate
desmopressin 4 ug in 1 mL
PRESCRIPTION DRUG
New Drug Application
DESMOPRESSIN ACETATE- DESMOPRESSIN ACETATE SOLUTION FERRING PHARMACEUTICALS INC. ---------- DESMOPRESSIN ACETATE INJECTION 4 MCG/ML RX ONLY DESCRIPTION DESMOPRESSIN ACETATE INJECTION (desmopressin acetate) 4 mcg/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 ACEATE INJECTION 4 mcg/mL is provided as a sterile, aqueous solution for injection. Each mL provides: Desmopressin acetate 4.0 mcg Sodium chloride 9.0 mg Hydrochloric acid to adjust pH to 4 The 10 mL vial contains chlorobutanol as a preservative (5.0 mg/mL). CLINICAL PHARMACOLOGY DESMOPRESSIN ACETATE INJECTION 4 mcg/mL contains as active substance, desmopressin acetate, a synthetic analogue of the natural hormone arginine vasopressin. One mL (4 mcg) of DESMOPRESSIN ACETATE (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 Pročitajte cijeli dokument