DDAVP TABLETS 0.1MG
País: Canadà
Idioma: anglès
Font: Health Canada
Fitxa tècnica
(SPC)
31-12-2015
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ingredients actius:
DESMOPRESSIN ACETATE
Disponible des:
FERRING INC
Codi ATC:
H01BA02
Designació comuna internacional (DCI):
DESMOPRESSIN
Dosis:
0.1MG
formulario farmacéutico:
TABLET
Composición:
DESMOPRESSIN ACETATE 0.1MG
Vía de administración:
ORAL
Unidades en paquete:
30
tipo de receta:
Prescription
Área terapéutica:
PITUITARY
Resumen del producto:
Active ingredient group (AIG) number: 0112050005; AHFS:
Estat d'Autorització:
CANCELLED POST MARKET
Data d'autorització:
2022-05-31
Fitxa tècnica
_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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