PMS-DESMOPRESSIN TABLET

Pays: Canada

Langue: anglais

Source: Health Canada

Ingrédients actifs:

DESMOPRESSIN ACETATE (DESMOPRESSIN ACETATE TRIHYDRATE)

Disponible depuis:

PHARMASCIENCE INC

Code ATC:

H01BA02

DCI (Dénomination commune internationale):

DESMOPRESSIN

Dosage:

0.2MG

forme pharmaceutique:

TABLET

Composition:

DESMOPRESSIN ACETATE (DESMOPRESSIN ACETATE TRIHYDRATE) 0.2MG

Mode d'administration:

ORAL

Unités en paquet:

100

Type d'ordonnance:

Prescription

Domaine thérapeutique:

PITUITARY

Descriptif du produit:

Active ingredient group (AIG) number: 0112050003; AHFS:

Statut de autorisation:

APPROVED

Date de l'autorisation:

2008-01-15

Résumé des caractéristiques du produit

PRODUCT MONOGRAPH
PR
PMS-DESMOPRESSIN
Desmopressin Tablets
0.1 mg and 0.2 mg desmopressin acetate (as desmopressin acetate
trihydrate)
Antidiuretic
PHARMASCIENCE INC.
6111 Royalmount Ave., Suite 100
Montréal, Québec
H4P 2T4
www.pharmascience.com
Date of Revision:
FEBRUARY 8, 2016
Submission Control No.: 188760
pms-DESMOPRESSIN Product Monograph
Page 2 of 28
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.......................................................... 3
SUMMARY
PRODUCT
INFORMATION
.................................................................................
3
INDICATIONS
AND
CLINICAL
USE
.......................................................................................
3
CONTRAINDICATIONS
............................................................................................................
3
WARNINGS
AND
PRECAUTIONS
...........................................................................................
4
ADVERSE
REACTIONS
............................................................................................................
6
DRUG
INTERACTIONS
.............................................................................................................
6
DOSAGE
AND
ADMINISTRATION
.........................................................................................
7
OVERDOSAGE
...........................................................................................................................
9
ACTION
AND
CLINICAL
PHARMACOLOGY
.......................................................................
9
STORAGE
AND
STABILITY
...................................................................................................
11
DOSAGE
FORMS,
COMPOSITION
AND
PACKAGING....................................................... 11
PART II: SCIENTIFIC INFORMATION
................................................................................
13
PHARMACEUTICAL
INFORMATION
..................................................................................
13
CLINICAL
TRIALS