CODEINE PHOSPHATE SYRUP

País: Canadà

Idioma: anglès

Font: Health Canada

ingredients actius:

CODEINE PHOSPHATE

Disponible des:

LABORATOIRE ATLAS INC

Codi ATC:

R05DA04

Designació comuna internacional (DCI):

CODEINE

Dosis:

25MG

formulario farmacéutico:

SYRUP

Composición:

CODEINE PHOSPHATE 25MG

Vía de administración:

ORAL

Unidades en paquete:

500ML/2L

tipo de receta:

Narcotic (CDSA I)

Área terapéutica:

OPIATE AGONISTS

Resumen del producto:

Active ingredient group (AIG) number: 0104398001; AHFS:

Estat d'Autorització:

MARKETED

Data d'autorització:

1986-12-18

Fitxa tècnica

CODEINE PHOSPHATE SYRUP 5 mg/mL
Page 1 of 31
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
N
CODEINE PHOSPHATE SYRUP
CODEINE PHOSPHATE 5 MG/ML (ORAL SYRUP)
OPIOID ANALGESIC
Laboratoire Atlas Inc,
9600, boul. des Sciences,
Montréal, Québec, Canada,
H1J 3B6
Date of Initial Approval:
January 16, 2013
Date of Revision:
August 30, 2018
Submission Control No: 213737
CODEINE PHOSPHATE SYRUP 5 mg/mL
Page 2 of 31
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.................................................................. 4
1
INDICATIONS
...................................................................................................................
4
1.1
Pediatrics
.................................................................................................................
4
1.2
Geriatrics
.................................................................................................................
4
2
CONTRAINDICATIONS
...................................................................................................
4
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
........................................................ 5
4
DOSAGE AND ADMINISTRATION
..................................................................................
6
4.1
Dosing Considerations
............................................................................................
6
4.2
Recommended Dose and Dosage Adjustment
....................................................... 7
4.3
Administration
..........................................................................................................
8
4.4
Missed Dose
............................................................................................................
8
4.5
Disposal
...................................................................................................................
9
5
OVERDOSAGE
................................................................................................................
9
5.1
Symptoms:
.....................