APO-DESMOPRESSIN TABLET

Šalis: Kanada

kalba: anglų

Šaltinis: Health Canada

Veiklioji medžiaga:

DESMOPRESSIN ACETATE

Prieinama:

APOTEX INC

ATC kodas:

H01BA02

INN (Tarptautinis Pavadinimas):

DESMOPRESSIN

Dozė:

0.2MG

Vaisto forma:

TABLET

Sudėtis:

DESMOPRESSIN ACETATE 0.2MG

Vartojimo būdas:

ORAL

Vienetai pakuotėje:

100

Recepto tipas:

Prescription

Gydymo sritis:

PITUITARY

Produkto santrauka:

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

Autorizacija statusas:

APPROVED

Leidimo data:

2017-12-19

Prekės savybės

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
.........................