PMS-DIGOXIN TABLET
Land: Canada
Sprog: engelsk
Kilde: Health Canada
Produktets egenskaber
(SPC)
18-07-2006
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Aktiv bestanddel:
DIGOXIN
Tilgængelig fra:
PHARMASCIENCE INC
ATC-kode:
C01AA05
INN (International Name):
DIGOXIN
Dosering:
0.0625MG
Lægemiddelform:
TABLET
Sammensætning:
DIGOXIN 0.0625MG
Indgivelsesvej:
ORAL
Enheder i pakken:
250
Recept type:
Prescription
Terapeutisk område:
CARDIOTONIC AGENTS
Produkt oversigt:
Active ingredient group (AIG) number: 0107281004; AHFS:
Autorisation status:
CANCELLED POST MARKET
Autorisation dato:
2016-10-28
Produktets egenskaber
PRODUCT MONOGRAPH
Pr
pms-DIGOXIN
®
Digoxin Tablets, C.S.D. 0.0625 mg, 0.125 mg and 0.25 mg
Cardiotonic Glycoside
PHARMASCIENCE INC.
Date of Preparation:
6111 Royalmount Ave., Suite 100
July 14, 2006
Montreal, Quebec
H4P 2T4
www.pharmascience.com
Control No. 107065
Page 2 of 36
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
............................................................................................................8
DRUG
INTERACTIONS...........................................................................................................11
DOSAGE
AND
ADMINISTRATION.......................................................................................17
OVERDOSAGE.........................................................................................................................22
ACTION
AND
CLINICAL
PHARMACOLOGY
.....................................................................23
STORAGE
AND
STABILITY...................................................................................................28
DOSAGE
FORMS,
COMPOSITION
AND
PACKAGING ......................................................28
PART II: SCIENTIFIC INFORMATION
................................................................................29
PHARMACEUTICAL
INFORMATION
..................................................................................29
CLINICAL
TRIALS
............................................................................................................
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