CODEINE PHOSPHATE INJECTION USP LIQUID

מדינה: קנדה

שפה: אנגלית

מקור: Health Canada

מרכיב פעיל:

CODEINE PHOSPHATE

זמין מ:

SANDOZ CANADA INCORPORATED

קוד ATC:

R05DA04

INN (שם בינלאומי):

CODEINE

כמות:

30MG

טופס פרצבטיות:

LIQUID

הרכב:

CODEINE PHOSPHATE 30MG

מסלול נתינה (של תרופות):

INTRAMUSCULAR

יחידות באריזה:

10X1ML/25X1ML

סוג מרשם:

Narcotic (CDSA I)

איזור תרפויטי:

OPIATE AGONISTS

leaflet_short:

Active ingredient group (AIG) number: 0104398004; AHFS:

מצב אישור:

APPROVED

תאריך אישור:

2005-08-11

מאפייני מוצר

_Codeine Phosphate Injection USP _
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_Page 1 of 34 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
N
CODEINE PHOSPHATE INJECTION USP
Codeine Phosphate
Solution for Injection 30mg/mL
USP
Opioid Analgesic–Antitussive
Sandoz Canada Inc.
Date of Revision:
110 Rue de Lauzon
December 16, 2019
Boucherville, QC, Canada
J4B 1E6
Submission Control No: 225996
_Codeine Phosphate Injection USP _
_ _
_Page 2 of 34 _
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.........................................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
INDICATIONS AND CLINICAL USE
..............................................................................3
WARNINGS AND PRECAUTIONS
..................................................................................4
ADVERSE REACTIONS
..................................................................................................13
DRUG INTERACTIONS
..................................................................................................15
DOSAGE AND ADMINISTRATION
..............................................................................18
OVERDOSAGE
................................................................................................................21
ACTION AND CLINICAL PHARMACOLOGY
............................................................22
STORAGE AND STABILITY
..........................................................................................23
SPECIAL HANDLING INSTRUCTIONS
.......................................................................23
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................24
PART II: SCIENTIFIC INFORMATION
...............................................................................25
PHARMACEUTICAL INFORMATION
..........................................................................25
PART III: CONSUMER MEDICATION INFORMATION
..................................................26
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