APO-DESMOPRESSIN TABLET

Pays: Canada

Langue: anglais

Source: Health Canada

Ingrédients actifs:

DESMOPRESSIN ACETATE

Disponible depuis:

APOTEX INC

Code ATC:

H01BA02

DCI (Dénomination commune internationale):

DESMOPRESSIN

Dosage:

0.1MG

forme pharmaceutique:

TABLET

Composition:

DESMOPRESSIN ACETATE 0.1MG

Mode d'administration:

ORAL

Unités en paquet:

100

Type d'ordonnance:

Prescription

Domaine thérapeutique:

PITUITARY

Descriptif du produit:

Active ingredient group (AIG) number: 0112050005; AHFS:

Statut de autorisation:

APPROVED

Date de l'autorisation:

2017-12-19

Résumé des caractéristiques du produit

Page 1 of 28
PRODUCT MONOGRAPH
PR
APO-DESMOPRESSIN
Desmopressin Acetate Tablets
0.1
mg and 0.2 mg tablets
Apotex Standard
Antidiuretic
Apotex Inc.
Date of Revision:
150 Signet Drive
November 22, 2021
Toronto, Ontario
M9L 1T9
Control Number: 257601
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
.................................................. 12
PART II: SCIENTIFIC INFORMATION
.............................................................................
13
PHARMACEUTICAL INFORMATION
...............................................................................
13
CLINICAL TRIALS
...............................................................................................................
15
TOXICOLOGY
.........................