MORPHINE SULFATE INJECTION USP SOLUTION

Country: Կանադա

language: անգլերեն

source: Health Canada

active_ingredient:

MORPHINE SULFATE

MAH:

PFIZER CANADA ULC

ATC_code:

N02AA01

INN:

MORPHINE

dosage:

2MG

pharmaceutical_form:

SOLUTION

composition:

MORPHINE SULFATE 2MG

administration_route:

INTRAMUSCULAR

units_in_package:

10X1 ML

prescription_type:

Narcotic (CDSA I)

therapeutic_area:

OPIATE AGONISTS

leaflet_short:

Active ingredient group (AIG) number: 0104545008; AHFS:

authorization_status:

CANCELLED PRE MARKET

authorization_date:

2019-03-04

SPC

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_Product Monograph - _
_N_
_MORPHINE SULFATE INJECTION USP _
_Page 1 of 33 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
N
MORPHINE SULFATE INJECTION USP
Sterile Solution
2 mg/mL, 10 mg/mL and 15 mg/mL
Narcotic Analgesic
Pfizer Canada Inc
17300 Trans-Canada Highway
Kirkland, Québec
H9J 2M5
Date of Revision:
October 3, 2018
Submission Control No: 219782
_ _
_Product Monograph - _
_N_
_MORPHINE SULFATE INJECTION USP _
_Page 2 of 33 _
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
..................................................................................................14
DOSAGE AND ADMINISTRATION
..............................................................................15
OVERDOSAGE
................................................................................................................20
ACTION AND CLINICAL PHARMACOLOGY
............................................................21
STORAGE AND STABILITY
..........................................................................................22
SPECIAL HANDLING INSTRUCTIONS
.......................................................................22
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................22
PART II: SCIENTIFIC INFORMATION
................................................................................24
PHARMACEUTICAL INFORMATION
...................