DDAVP MELT TABLET (ORALLY DISINTEGRATING)
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
31-12-2015
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Active ingredient:
DESMOPRESSIN (DESMOPRESSIN ACETATE)
Available from:
FERRING INC
ATC code:
H01BA02
INN (International Name):
DESMOPRESSIN
Dosage:
240MCG
Pharmaceutical form:
TABLET (ORALLY DISINTEGRATING)
Composition:
DESMOPRESSIN (DESMOPRESSIN ACETATE) 240MCG
Administration route:
SUBLINGUAL
Units in package:
30
Prescription type:
Prescription
Therapeutic area:
PITUITARY
Product summary:
Active ingredient group (AIG) number: 0151664003; AHFS:
Authorization status:
CANCELLED POST MARKET
Authorization date:
2022-05-31
Summary of Product characteristics
_DDAVP® MELT (60μg, 120μg, 240μg) _
_Template Date: January 2010 _
_Page 1 of 34 _
_ _
PRODUCT MONOGRAPH
PR
DDAVP
®
MELT
Desmopressin acetate
60 μg, 120 μg and 240 μg
Oral Disintegrating Tablets
Antidiuretic
Ferring Inc.
200 Yorkland Boulevard
Suite 500
North York, Ontario
M2J 5C1
Date of Revision: DECEMBER 17, 2015.
SUBMISSION CONTROL NO: 187742
_DDAVP® MELT (60μg, 120μg, 240μg) _
_Template Date: January 2010 _
_Page 2 of 34 _
_ _
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
....................................................................................................8
DOSAGE AND ADMINISTRATION
................................................................................9
OVERDOSAGE
................................................................................................................10
ACTION AND CLINICAL PHARMACOLOGY
............................................................11
STORAGE AND STABILITY
..........................................................................................13
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................13
PART II: SCIENTIFIC INFORMATION
................................................................................14
PHARMACEUTICAL INFORMATION
..........................................................................14
CLINICAL TRIALS
...................................
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