DESMOPRESSIN TABLETS

Land: Canada

Sprog: engelsk

Kilde: Health Canada

Aktiv bestanddel:

DESMOPRESSIN ACETATE

Tilgængelig fra:

RAINBOW PHARMACEUTICALS INC

ATC-kode:

H01BA02

INN (International Name):

DESMOPRESSIN

Dosering:

0.2MG

Lægemiddelform:

TABLET

Sammensætning:

DESMOPRESSIN ACETATE 0.2MG

Indgivelsesvej:

ORAL

Enheder i pakken:

100

Recept type:

Prescription

Terapeutisk område:

PITUITARY

Produkt oversigt:

Active ingredient group (AIG) number: 0112050003; AHFS:

Autorisation status:

CANCELLED POST MARKET

Autorisation dato:

2012-08-03

Produktets egenskaber

_ _
_Desmopressin Tablets 0.1 mg and 0.2 mg _
_Page 1 of 33 _
PRODUCT MONOGRAPH
PR
DESMOPRESSIN TABLETS
(Desmopressin Acetate)
0.1 mg and 0.2 mg Tablets
Antidiuretic
Rainbow Pharmaceuticals
200 Yorkland Boulevard
Suite 804
North York, Ontario
M2J 5C1
Date of Preparation:
16 August 2004
Date of Revision:
13 April 2007
CONTROL NUMBER: 113504
_ _
_Desmopressin Tablets 0.1 mg and 0.2 mg _
_Page 2 of 33 _
TABLE OF CONTENTS
PART 1: 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
.................................................................................................................
8
ACTION AND CLINICAL PHARMACOLOGY
............................................................. 8
STORAGE AND STABILITY
.........................................................................................
18
DOSAGE FORMS: COMPOSITION AND PACKAGING
............................................ 18
PART II: SCIENTIFIC INFORMATION
...............................................................................
19
PHARMACEUTICAL INFORMATION
........................................................................
19
CLINICAL TRIALS
...................................................................................