CODEINE PHOSPHATE INJECTION USP LIQUID
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
16-12-2019
Some documents for this product are not currently available, you can send a request to our customer service and we will notify you as soon as we are able to obtain them.
Send request.
Send request.
Active ingredient:
CODEINE PHOSPHATE
Available from:
SANDOZ CANADA INCORPORATED
ATC code:
R05DA04
INN (International Name):
CODEINE
Dosage:
30MG
Pharmaceutical form:
LIQUID
Composition:
CODEINE PHOSPHATE 30MG
Administration route:
INTRAMUSCULAR
Units in package:
10X1ML/25X1ML
Prescription type:
Narcotic (CDSA I)
Therapeutic area:
OPIATE AGONISTS
Product summary:
Active ingredient group (AIG) number: 0104398004; AHFS:
Authorization status:
APPROVED
Authorization date:
2005-08-11
Summary of Product characteristics
_Codeine Phosphate Injection USP _
_ _
_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
_
Read the complete document
