Pajjiż: Kanada
Lingwa: Ingliż
Sors: Health Canada
DESMOPRESSIN ACETATE
RAINBOW PHARMACEUTICALS INC
H01BA02
DESMOPRESSIN
0.2MG
TABLET
DESMOPRESSIN ACETATE 0.2MG
ORAL
100
Prescription
PITUITARY
Active ingredient group (AIG) number: 0112050003; AHFS:
CANCELLED POST MARKET
2012-08-03
_ _ _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 ................................................................................... Aqra d-dokument sħiħ