APO-DESMOPRESSIN TABLET

Country: Kanada

Bahasa: Inggeris

Sumber: Health Canada

Bahan aktif:

DESMOPRESSIN ACETATE

Boleh didapati daripada:

APOTEX INC

Kod ATC:

H01BA02

INN (Nama Antarabangsa):

DESMOPRESSIN

Dos:

0.2MG

Borang farmaseutikal:

TABLET

Komposisi:

DESMOPRESSIN ACETATE 0.2MG

Laluan pentadbiran:

ORAL

Unit dalam pakej:

100

Jenis preskripsi:

Prescription

Kawasan terapeutik:

PITUITARY

Ringkasan produk:

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

Status kebenaran:

APPROVED

Tarikh kebenaran:

2017-12-19

Ciri produk

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