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

País: Canadà

Idioma: anglès

Font: Health Canada

ingredients actius:

MEPERIDINE HYDROCHLORIDE

Disponible des:

HOSPIRA HEALTHCARE ULC

Codi ATC:

N02AB02

Designació comuna internacional (DCI):

PETHIDINE

Dosis:

50MG

formulario farmacéutico:

SOLUTION

Composición:

MEPERIDINE HYDROCHLORIDE 50MG

Vía de administración:

INTRAMUSCULAR

Unidades en paquete:

1ML

tipo de receta:

Narcotic (CDSA I)

Área terapéutica:

OPIATE AGONISTS

Resumen del producto:

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

Estat d'Autorització:

CANCELLED POST MARKET

Data d'autorització:

2018-10-25

Fitxa tècnica

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_DEMEROL _
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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 _
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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