DEMEROL 50 MG/ML (MULTIPLE DOSE WITH METACRESOL AS PRESERVATIVE) SOLUTION

Land: Canada

Taal: Engels

Bron: Health Canada

Werkstoffen:

MEPERIDINE HYDROCHLORIDE

Beschikbaar vanaf:

HOSPIRA HEALTHCARE ULC

ATC-code:

N02AB02

INN (Algemene Internationale Benaming):

PETHIDINE

Dosering:

50MG

farmaceutische vorm:

SOLUTION

Samenstelling:

MEPERIDINE HYDROCHLORIDE 50MG

Toedieningsweg:

INTRAMUSCULAR

Eenheden in pakket:

30ML

Prescription-type:

Narcotic (CDSA I)

Therapeutisch gebied:

OPIATE AGONISTS

Product samenvatting:

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

Autorisatie-status:

CANCELLED POST MARKET

Autorisatie datum:

2012-08-03

Productkenmerken

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_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