DDAVP TABLETS 0.1MG
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
31-12-2015
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Active ingredient:
DESMOPRESSIN ACETATE
Available from:
FERRING INC
ATC code:
H01BA02
INN (International Name):
DESMOPRESSIN
Dosage:
0.1MG
Pharmaceutical form:
TABLET
Composition:
DESMOPRESSIN ACETATE 0.1MG
Administration route:
ORAL
Units in package:
30
Prescription type:
Prescription
Therapeutic area:
PITUITARY
Product summary:
Active ingredient group (AIG) number: 0112050005; AHFS:
Authorization status:
CANCELLED POST MARKET
Authorization date:
2022-05-31
Summary of Product characteristics
_DDAVP Tablets 0.1 mg and 0.2 mg _
_Template Date: January 2010 _
_Page 1 of 29 _
PRODUCT MONOGRAPH
PR
DDAVP
® TABLETS
Desmopressin Acetate
0.1 mg and 0.2 mg Tablets
Antidiuretic
Ferring Inc.
200 Yorkland Boulevard
Suite 500
North York, Ontario
M2J 5C1
Date of Revision:
DECEMBER 17, 2015.
CONTROL NUMBER: 187744
_DDAVP Tablets 0.1 mg and 0.2 mg _
_Template Date: January 2010 _
_Page 2 of 29 _
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.........................................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
INDICATIONS AND CLINICAL USE
...........................................................................3
CONTRAINDICATIONS
...................................................................................................4
WARNINGS AND PRECAUTIONS
..................................................................................4
ADVERSE REACTIONS
....................................................................................................6
DRUG INTERACTIONS
....................................................................................................7
DOSAGE AND ADMINISTRATION
................................................................................8
OVERDOSAGE
................................................................................................................10
ACTION AND CLINICAL PHARMACOLOGY
............................................................10
STORAGE AND STABILITY
..........................................................................................13
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................13
PART II: SCIENTIFIC INFORMATION
...............................................................................14
PHARMACEUTICAL INFORMATION
..........................................................................14
CLINICAL TRIALS
............................................................................................
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