BIPAZEN SOLUTION

Țară: Canada

Limbă: engleză

Sursă: Health Canada

Ingredient activ:

DESMOPRESSIN ACETATE

Disponibil de la:

KVR PHARMACEUTICALS INC.

Codul ATC:

H01BA02

INN (nume internaţional):

DESMOPRESSIN

Dozare:

4MCG

Forma farmaceutică:

SOLUTION

Compoziție:

DESMOPRESSIN ACETATE 4MCG

Calea de administrare:

INTRAMUSCULAR

Unități în pachet:

15G/50G

Tip de prescriptie medicala:

Prescription

Zonă Terapeutică:

PITUITARY

Rezumat produs:

Active ingredient group (AIG) number: 0112050006; AHFS:

Statutul autorizaţiei:

APPROVED

Data de autorizare:

2021-03-12

Caracteristicilor produsului

Bipazen (Desmopressin Acetate Injection)
Page 1 of 15
PRODUCT MONOGRAPH
PR BIPAZEN
TM
Desmopressin Acetate Injection, USP
Solution; 4 mcg / mL of Desmopressin Acetate
For Intravenous, Intramuscular and Subcutaneous Use
Antihemorrhagic
/
Antidiuretic
KVR Pharmaceuticals Inc.
Date of Preparation:
21 Parr Boulevard, Unit 12
March 11, 2021
Caledon, Ontario L7E 4G3
CONTROL NO: 232051
Bipazen (Desmopressin Acetate Injection)
Page 2 of 15
PRODUCT MONOGRAPH
NAME OF DRUG
PR BIPAZEN
TM
Desmopressin Acetate Injection, USP
4 MCG / ML
THERAPEUTIC CLASSIFICATION
Antihemorrhagic
Antidiuretic
CLINICAL PHARMACOLOGY
Desmopressin acetate is a synthetic structural analogue of the natural
human hormone, arginine
vasopressin.
Desmopressin acetate administration causes a transient increase in all
components of the Factor
VIII complex (Factor VIII coagulant activity, Factor VIII related
antigen, and ristocetin
cofactor) and in plasminogen activator. Either directly or indirectly,
desmopressin acetate causes
these factors to be released very rapidly from their endothelial cell
storage sites. In addition,
desmopressin acetate may have a direct effect on the vessel wall, with
increased platelet
spreading and adhesion at injury sites.
A second dose given before endothelial cell stores are replenished
will not have as great an effect
as the initial dose. Responses as great as the initial one usually are
seen if 48 hours or more have
elapsed between doses.
Bipazen (Desmopressin Acetate Injection)
Page 3 of 15
Desmopressin acetate alters the permeability of the renal tubule to
increase resorption of water.
The increase in the permeability of both the distal tubules and
collecting ducts appears to be
mediated by a stimulation of the adenylcyclase activity in the renal
tubules.
The pharmacokinetic and pharmacodynamic profiles after subcutaneous or
intravenous
administration to healthy volunteers are equivalent. The plasma
half-life ranges from 3.2 to 3.6
hours.
INDICATIONS AND CLINICAL USE
Bipazen (desmopressin acetate injection) is indicated fo