PEDIATRIC DIGOXIN INJECTION C.S.D. LIQUID

Valsts: Kanāda

Valoda: angļu

Klimata pārmaiņas: Health Canada

Aktīvā sastāvdaļa:

DIGOXIN

Pieejams no:

SANDOZ CANADA INCORPORATED

ATĶ kods:

C01AA05

SNN (starptautisko nepatentēto nosaukumu):

DIGOXIN

Deva:

0.05MG

Zāļu forma:

LIQUID

Kompozīcija:

DIGOXIN 0.05MG

Ievadīšanas:

INTRAMUSCULAR

Vienības iepakojumā:

3X1ML

Receptes veids:

Prescription

Ārstniecības joma:

CARDIOTONIC AGENTS

Produktu pārskats:

Active ingredient group (AIG) number: 0107281001; AHFS:

Autorizācija statuss:

CANCELLED POST MARKET

Autorizācija datums:

2019-08-01

Produkta apraksts

_ _
_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