PMS-DESMOPRESSIN TABLET
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
12-02-2016
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Active ingredient:
DESMOPRESSIN ACETATE (DESMOPRESSIN ACETATE TRIHYDRATE)
Available from:
PHARMASCIENCE INC
ATC code:
H01BA02
INN (International Name):
DESMOPRESSIN
Dosage:
0.1MG
Pharmaceutical form:
TABLET
Composition:
DESMOPRESSIN ACETATE (DESMOPRESSIN ACETATE TRIHYDRATE) 0.1MG
Administration route:
ORAL
Units in package:
100
Prescription type:
Prescription
Therapeutic area:
PITUITARY
Product summary:
Active ingredient group (AIG) number: 0112050005; AHFS:
Authorization status:
APPROVED
Authorization date:
2008-01-15
Summary of Product characteristics
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
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