DESMOPRESSIN ACETATE injection

Maa: Yhdysvallat

Kieli: englanti

Lähde: NLM (National Library of Medicine)

Aktiivinen ainesosa:

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

Saatavilla:

Dr.Reddys' Laboratories Inc

Antoreitti:

SUBCUTANEOUS

Prescription tyyppi:

PRESCRIPTION DRUG

Käyttöaiheet:

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 Willebrands Disease (Type I):  Desmopressin Acetate Injection 4 mcg/mL is indicated for patients with mild to moderate classic von Willebrands disease (Type I) with factor VIII levels greater than 5%. Desmopressin Acetate Injection will often maintain hemostas

Tuoteyhteenveto:

Desmopressin Acetate Injectio n USP 4 mcg/mL is available as a sterile solution in cartons of ten 1 mL single-dose ampules (NDC 43598-931-09) containing 4 mcg Desmopressin Acetate per mL. Store refrigerated 2 to 8°C (36 to 46°F). Keep out of the reach of children. Manufactured by: UBI Pharma Inc. No. 45, Guangfu N. Rd., Hukou, Hsinchu 30351, Taiwan Distributed by: Dr. Reddy’s Laboratories Inc. Princeton, NJ 08540

Valtuutuksen tilan:

Abbreviated New Drug Application

Valmisteyhteenveto

DESMOPRESSIN ACETATE- DESMOPRESSIN ACETATE INJECTION
DR.REDDYS' LABORATORIES INC
----------
DESMOPRESSIN ACETATE INJECTION
(desmopressin acetate)
4 MCG/ML
RX ONLY
DESCRIPTION
DESMOPRESSIN ACETATE INJECTION USP (desmopressin acetate) 4 mcg/mL is
a synthetic analogue of the
natural pituitary hormone8-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/mL is provided as a sterile,
aqueous solution for
injection.
Each mL provides:
Desmopressin acetate 4 mcg
Sodium chloride 9 mg
Hydrochloric acid to adjust pH to 4
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 Injection(desmopressin acetate) solution has an antidiuretic
activity of about 16 IU; 1 mcg of
Desmopressin Acetate Injection is equivalent to 4 IU.
Desmopressin Acetate Injection 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 Injection 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.
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