CODEINE PHOSPHATE INJ 60MG/ML SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

CODEINE PHOSPHATE

Available from:

HOSPIRA HEALTHCARE ULC

ATC code:

R05DA04

INN (International Name):

CODEINE

Dosage:

60MG

Pharmaceutical form:

SOLUTION

Composition:

CODEINE PHOSPHATE 60MG

Administration route:

INTRAMUSCULAR

Units in package:

1ML

Prescription type:

Narcotic (CDSA I)

Therapeutic area:

OPIATE AGONISTS

Product summary:

Active ingredient group (AIG) number: 0104398005; AHFS:

Authorization status:

CANCELLED POST MARKET

Authorization date:

2018-09-21

Summary of Product characteristics

PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
N
CODEINE PHOSPHATE INJECTION USP
30 mg/mL and 60 mg/mL
Sterile Solution
OPIOID ANALGESIC
Hospira Healthcare Corporation
17300 Trans-Canada Highway
Kirkland, QC
H9J 2M5
Date of Revision:
April 17, 2018
Submission Control No: 213735
_N_
_CODEINE PHOSPHATE INJECTION USP _
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TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.........................................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
INDICATIONS AND CLINICAL USE
..............................................................................3
CONTRAINDICATIONS
...................................................................................................3
WARNINGS AND PRECAUTIONS
..................................................................................4
ADVERSE REACTIONS
..................................................................................................13
DRUG INTERACTIONS
..................................................................................................15
DOSAGE AND ADMINISTRATION
..............................................................................16
OVERDOSAGE
................................................................................................................20
ACTION AND CLINICAL PHARMACOLOGY
............................................................20
STORAGE AND STABILITY
..........................................................................................21
SPECIAL HANDLING INSTRUCTIONS
.......................................................................21
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................22
PART II: SCIENTIFIC INFORMATION
...............................................................................23
PHARMACEUTICAL INFORMATION
..........................................................................23
PATIENT MEDICATION INFORMATION
.......................