DDAVP MELT TABLET (ORALLY DISINTEGRATING)

Country: Կանադա

language: անգլերեն

source: Health Canada

active_ingredient:

DESMOPRESSIN (DESMOPRESSIN ACETATE)

MAH:

FERRING INC

ATC_code:

H01BA02

INN:

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

leaflet_short:

Active ingredient group (AIG) number: 0151664003; AHFS:

authorization_status:

CANCELLED POST MARKET

authorization_date:

2022-05-31

SPC

_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
...................................