SUPEUDOL 20 SUPPOSITORY

País: Canadà

Idioma: anglès

Font: Health Canada

ingredients actius:

OXYCODONE HYDROCHLORIDE

Disponible des:

SANDOZ CANADA INCORPORATED

Codi ATC:

N02AA05

Designació comuna internacional (DCI):

OXYCODONE

Dosis:

20MG

formulario farmacéutico:

SUPPOSITORY

Composición:

OXYCODONE HYDROCHLORIDE 20MG

Vía de administración:

RECTAL

Unidades en paquete:

12

tipo de receta:

Narcotic (CDSA I)

Área terapéutica:

OPIATE AGONISTS

Resumen del producto:

Active ingredient group (AIG) number: 0107552001; AHFS:

Estat d'Autorització:

APPROVED

Data d'autorització:

2007-05-23

Fitxa tècnica

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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
........................................