দেশ: মার্কিন যুক্তরাষ্ট্র
ভাষা: ইংরেজি
সূত্র: NLM (National Library of Medicine)
DESMOPRESSIN ACETATE (UNII: XB13HYU18U) (DESMOPRESSIN - UNII:ENR1LLB0FP)
NorthStar RxLLC
INTRAVENOUS
PRESCRIPTION DRUG
Hemophilia A: Desmopressin Acetate Injection 4 mcg/mL 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. von Willebrand’s Disease (Type I): Desmopressin acetate injection 4 mcg/mL 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 ma
Desmopressin acetate injection, USP 4 mcg/mL is available as a sterile solution in 10 mL multiple-dose vials (NDC 16714-015-01), each containing 4 mcg desmopressin acetate, USP per mL. Store refrigerated 2° to 8°C (36° to 46°F). Preserve in tight containers, protected from light. Keep out of the reach of children. Manufactured for: Northstar Rx LLC Memphis, TN 38141. Toll No: 1-800-206-7821 Manufactured by: Sun Pharmaceutical Industries Ltd. Halol-Baroda Highway, Halol-389 350, Gujarat, India Rev. 05/2020 PJPI0660
Abbreviated New Drug Application
DESMOPRESSIN ACETATE - DESMOPRESSIN ACETATE INJECTION, SOLUTION NORTHSTAR RXLLC ---------- DESMOPRESSIN ACETATE INJECTION, USP, 4 MCG/ML DESCRIPTION Desmopressin acetate injection, USP 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. 1069.23 Molecular Formula: C H N O S 1-(3-mercaptopropionic acid)-8-D-arginine vasopressin acetate. Desmopressin acetate Injection, USP 4 mcg/mL is provided as a sterile, aqueous solution for injection. Each mL provides: Desmopressin acetate, USP, 4 mcg Sodium chloride, 9 mg Hydrochloric acid to adjust pH to 4 Water for injection, q.s. to 1 mL The 10 mL vial contains chlorobutanol as a preservative (5 mg/mL). CLINICAL PHARMACOLOGY Desmopressin acetate injection 4 mcg/mL contains as active substance, desmopressin acetate,USP, 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 46 64 14 12 2 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 সম্পূর্ণ নথি পড়ুন