DESMOPRESSIN TABLET
Land: Canada
Sprog: engelsk
Kilde: Health Canada
Produktets egenskaber
(SPC)
17-03-2010
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Aktiv bestanddel:
DESMOPRESSIN ACETATE TRIHYDRATE
Tilgængelig fra:
MELIAPHARM INC
ATC-kode:
H01BA02
INN (International Name):
DESMOPRESSIN
Dosering:
0.1MG
Lægemiddelform:
TABLET
Sammensætning:
DESMOPRESSIN ACETATE TRIHYDRATE 0.1MG
Indgivelsesvej:
ORAL
Enheder i pakken:
100
Recept type:
Prescription
Terapeutisk område:
PITUITARY
Produkt oversigt:
Active ingredient group (AIG) number: 0152416001; AHFS:
Autorisation status:
CANCELLED POST MARKET
Autorisation dato:
2014-06-25
Produktets egenskaber
PRODUCT MONOGRAPH
PR
DESMOPRESSIN
(Desmopressin Acetate Trihydrate)
0.1 mg and 0.2 mg Tablets
ANTIDIURETIC
MELIAPHARM INC.
DATE OF PREPARATION:
6111 Royalmount Ave., Suite 100
March 16, 2010
Montreal, Quebec
H4P 2T4
CONTROL NO.: 137032
Page 2 of 33
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
..........................................................3
SUMMARY
PRODUCT
INFORMATION
.............................................................................3
INDICATIONS
AND
CLINICAL
USE
....................................................................................3
CONTRAINDICATIONS
.........................................................................................................4
DRUG
INTERACTIONS
..........................................................................................................6
DOSAGE
AND
ADMINISTRATION
......................................................................................7
OVERDOSAGE
.........................................................................................................................8
ACTION
AND
CLINICAL
PHARMACOLOGY
...................................................................8
STORAGE
AND
STABILITY
................................................................................................16
DOSAGE
FORMS,
COMPOSITION
AND
PACKAGING
..................................................16
PART II: SCIENTIFIC INFORMATION
................................................................................18
PHARMACEUTICAL
INFORMATION
..............................................................................18
CLINICAL
TRIALS
................................................................................................................18
TOXICOLOGY
........................................................................................................................21
REFERENCES
.........................................................................................................................23
PART III: CONSUMER
IN
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