DESMOPRESSIN ACETATE injection, solution

البلد: الولايات المتحدة

اللغة: الإنجليزية

المصدر: NLM (National Library of Medicine)

العنصر النشط:

DESMOPRESSIN ACETATE (UNII: XB13HYU18U) (DESMOPRESSIN - UNII:ENR1LLB0FP)

متاح من:

Sun Pharmaceutical Industries, Inc.

INN (الاسم الدولي):

DESMOPRESSIN ACETATE

تركيب:

DESMOPRESSIN ACETATE 4 ug in 1 mL

طريقة التعاطي:

INTRAVENOUS

نوع الوصفة الطبية :

PRESCRIPTION DRUG

الخصائص العلاجية:

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

ملخص المنتج:

Desmopressin acetate injection, USP 4 mcg/mL is available as a sterile solution in 10 mL multiple-dose vials (NDC 62756-529-26), 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. Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512 Manufactured by: Sun Pharmaceutical Ind. Ltd. Halol-Baroda Highway, Halol-389 350, Gujarat, India. ISS. 12/2014 PJPI0435A

الوضع إذن:

Abbreviated New Drug Application

خصائص المنتج

DESMOPRESSIN ACETATE - DESMOPRESSIN ACETATE INJECTION, SOLUTION
SUN PHARMACEUTICAL INDUSTRIES, INC.
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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 bi