DEMEROL 50 MG/ML (SINGLE USE, PRESERVATIVE FREE) SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

MEPERIDINE HYDROCHLORIDE

Available from:

HOSPIRA HEALTHCARE ULC

ATC code:

N02AB02

INN (International Name):

PETHIDINE

Dosage:

50MG

Pharmaceutical form:

SOLUTION

Composition:

MEPERIDINE HYDROCHLORIDE 50MG

Administration route:

INTRAMUSCULAR

Units in package:

1ML

Prescription type:

Narcotic (CDSA I)

Therapeutic area:

OPIATE AGONISTS

Product summary:

Active ingredient group (AIG) number: 0104542001; AHFS:

Authorization status:

CANCELLED POST MARKET

Authorization date:

2018-10-25

Summary of Product characteristics

_N_
_DEMEROL _
_Page 1 of 33 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
N
DEMEROL
(MEPERIDINE HYDROCHLORIDE INJECTION USP)
50 mg/mL, 75 mg/mL and 100 mg/mL
Sterile Solution
NARCOTIC ANALGESIC
Hospira Healthcare Corporation
17300 Trans-Canada Highway
Kirkland, Québec
H9J 2M5
Date of Revision:
April 26, 2018
Submission Control No: 212492
_N_
_DEMEROL _
_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
..................................................................................................12
DRUG INTERACTIONS
..................................................................................................14
DOSAGE AND ADMINISTRATION
..............................................................................15
OVERDOSAGE
................................................................................................................19
ACTION AND CLINICAL PHARMACOLOGY
............................................................20
STORAGE AND STABILITY
..........................................................................................22
SPECIAL HANDLING INSTRUCTIONS
.......................................................................23
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................23
PART II: SCIENTIFIC INFORMATION
...............................................................................24
PHARMACEUTICAL INFORMATION
..........................................................................24
PATIENT MEDI