APO-DESMOPRESSIN TABLET
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
22-11-2021
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Active ingredient:
DESMOPRESSIN ACETATE
Available from:
APOTEX INC
ATC code:
H01BA02
INN (International Name):
DESMOPRESSIN
Dosage:
0.2MG
Pharmaceutical form:
TABLET
Composition:
DESMOPRESSIN ACETATE 0.2MG
Administration route:
ORAL
Units in package:
100
Prescription type:
Prescription
Therapeutic area:
PITUITARY
Product summary:
Active ingredient group (AIG) number: 0112050003; AHFS:
Authorization status:
APPROVED
Authorization date:
2017-12-19
Summary of Product characteristics
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
.........................
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