SUPEUDOL 20 SUPPOSITORY
Land: Canada
Taal: Engels
Bron: Health Canada
Productkenmerken
(SPC)
23-03-2018
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Werkstoffen:
OXYCODONE HYDROCHLORIDE
Beschikbaar vanaf:
SANDOZ CANADA INCORPORATED
ATC-code:
N02AA05
INN (Algemene Internationale Benaming):
OXYCODONE
Dosering:
20MG
farmaceutische vorm:
SUPPOSITORY
Samenstelling:
OXYCODONE HYDROCHLORIDE 20MG
Toedieningsweg:
RECTAL
Eenheden in pakket:
12
Prescription-type:
Narcotic (CDSA I)
Therapeutisch gebied:
OPIATE AGONISTS
Product samenvatting:
Active ingredient group (AIG) number: 0107552001; AHFS:
Autorisatie-status:
APPROVED
Autorisatie datum:
2007-05-23
Productkenmerken
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_Supeudol _
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PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
N SUPEUDOL
®
OXYCODONE HYDROCHLORIDE USP
Tablets 5 mg and 10 mg
N SUPEUDOL
®
OXYCODONE HYDROCHLORIDE
Suppositories 10 mg and 20 mg
THERAPEUTIC CLASSIFICATION
Opioid Analgesic
Sandoz Canada Inc.
145 Jules-Léger Street
Boucherville, QC, Canada
Date of revision:
J4B 7K8
March 23, 2018
Submission Control No: 210704
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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
..................................................................................................13
DRUG INTERACTIONS
..................................................................................................15
DOSAGE AND ADMINISTRATION
..............................................................................17
OVERDOSAGE
................................................................................................................20
ACTION AND CLINICAL PHARMACOLOGY
............................................................21
STORAGE AND STABILITY
..........................................................................................24
SPECIAL HANDLING INSTRUCTIONS
.......................................................................24
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................24
PART II: SCIENTIFIC INFORMATION
...............................................................................25
PHARMACEUTICAL INFORMATION
........................................
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