APO-DESMOPRESSIN TABLET
Krajina: Kanada
Jazyk: angličtina
Zdroj: Health Canada
Súhrn charakteristických
(SPC)
22-11-2021
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Aktívna zložka:
DESMOPRESSIN ACETATE
Dostupné z:
APOTEX INC
ATC kód:
H01BA02
INN (Medzinárodný Name):
DESMOPRESSIN
Dávkovanie:
0.2MG
Forma lieku:
TABLET
Zloženie:
DESMOPRESSIN ACETATE 0.2MG
Spôsob podávania:
ORAL
Počet v balení:
100
Typ predpisu:
Prescription
Terapeutické oblasti:
PITUITARY
Prehľad produktov:
Active ingredient group (AIG) number: 0112050003; AHFS:
Stav Autorizácia:
APPROVED
Dátum Autorizácia:
2017-12-19
Súhrn charakteristických
Page 1 of 28
PRODUCT MONOGRAPH
PR
APO-DESMOPRESSIN
Desmopressin Acetate Tablets
0.1
mg and 0.2 mg tablets
Apotex Standard
Antidiuretic
Apotex Inc.
Date of Revision:
150 Signet Drive
November 22, 2021
Toronto, Ontario
M9L 1T9
Control Number: 257601
Page 2 of 28
TABLE OF CONTENTS
PART I: 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
........................................................................................................................
9
ACTION AND CLINICAL PHARMACOLOGY
................................................................... 9
STORAGE AND STABILITY
...............................................................................................
11
DOSAGE FORMS, COMPOSITION AND PACKAGING
.................................................. 12
PART II: SCIENTIFIC INFORMATION
.............................................................................
13
PHARMACEUTICAL INFORMATION
...............................................................................
13
CLINICAL TRIALS
...............................................................................................................
15
TOXICOLOGY
.........................
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