PEDIATRIC DIGOXIN INJECTION C.S.D. LIQUID
Land: Kanada
Språk: engelska
Källa: Health Canada
Produktens egenskaper
(SPC)
29-06-2006
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Aktiva substanser:
DIGOXIN
Tillgänglig från:
SANDOZ CANADA INCORPORATED
ATC-kod:
C01AA05
INN (International namn):
DIGOXIN
Dos:
0.05MG
Läkemedelsform:
LIQUID
Sammansättning:
DIGOXIN 0.05MG
Administreringssätt:
INTRAMUSCULAR
Enheter i paketet:
3X1ML
Receptbelagda typ:
Prescription
Terapiområde:
CARDIOTONIC AGENTS
Produktsammanfattning:
Active ingredient group (AIG) number: 0107281001; AHFS:
Bemyndigande status:
CANCELLED POST MARKET
Tillstånd datum:
2019-08-01
Produktens egenskaper
_ _
_Digoxin Injection C.S.D. & Pediatric Digoxin Injection C.S.D. _
_Page 1 of 39 _
PRODUCT MONOGRAPH
Pr
DIGOXIN INJECTION, C.S.D.
Digoxin
0.25 mg/mL Injection
&
Pr
PEDIATRIC DIGOXIN INJECTION, C.S.D.
Digoxin
0.05 mg/mL Injection
C.S.D.
Cardiotonic Glycoside
Sandoz Canada Inc.
145 rue Jules Léger
Boucherville, (QC), Canada
J4B 7K8
Date of Revision:
June 28, 2006
Submission Control No: 104646
_ _
_Digoxin Injection C.S.D. & Pediatric Digoxin Injection C.S.D. _
_Page 2 of 39_
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....................................................................................................9
DRUG INTERACTIONS
..................................................................................................12
OVERDOSAGE
................................................................................................................25
ACTION AND CLINICAL PHARMACOLOGY
............................................................27
STORAGE AND
STABILITY..........................................................................................31
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................31
PART II: SCIENTIFIC INFORMATION
...............................................................................32
PHARMACEUTICAL
INFORMATION..........................................................................32
CLINICAL
TRIALS..........................................................................................................33
DETAILED
PH
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