MORPHINE HP 25 - 25MG/ML SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

MORPHINE SULFATE

Available from:

SANDOZ CANADA INCORPORATED

ATC code:

N02AA01

INN (International Name):

MORPHINE

Dosage:

25MG

Pharmaceutical form:

SOLUTION

Composition:

MORPHINE SULFATE 25MG

Administration route:

INTRAMUSCULAR

Units in package:

1/4ML

Prescription type:

Narcotic (CDSA I)

Therapeutic area:

OPIATE AGONISTS

Product summary:

Active ingredient group (AIG) number: 0104545005; AHFS:

Authorization status:

CANCELLED POST MARKET

Authorization date:

2023-07-28

Summary of Product characteristics

PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
MORPHINE HP 25
Morphine sulfate injection USP
25 mg/mL
MORPHINE HP 50
Morphine sulfate injection USP
50 mg/mL
Narcotic Analgesic
Sandoz Canada Inc.
110 rue de Lauzon
Date of Revision: May 17, 2019
Boucherville, QC, Canada
J4B 1E6
Submission Control No: 221205
_Morphine HP 25 / Morphine HP 50_
_Page 2 of 31 _
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
.................................................................................................
12
DRUG INTERACTIONS
.................................................................................................
14
DOSAGE AND ADMINISTRATION
.............................................................................
15
OVERDOSAGE
...............................................................................................................
19
ACTION AND CLINICAL PHARMACOLOGY
........................................................... 20
STORAGE AND STABILITY
.........................................................................................
21
SPECIAL HANDLING INSTRUCTIONS
......................................................................
21
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................ 21
PART II: SCIENTIFIC INFORMATION
...............................................................................
23
REFERENCES
.................................................................................................................
23
PART