PMS-TRAMADOL-ACET TABLET
País: Canadà
Idioma: anglès
Font: Health Canada
Fitxa tècnica
(SPC)
27-09-2022
Alguns documents d’aquest producte actualment no estan disponibles, podeu enviar una sol·licitud al nostre servei d’atenció al client i us ho notificarem tan bon punt puguem obtenir-los.
Enviar sol.licitud.
Enviar sol.licitud.
ingredients actius:
ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE
Disponible des:
PHARMASCIENCE INC
Codi ATC:
N02AJ13
Designació comuna internacional (DCI):
TRAMADOL AND PARACETAMOL
Dosis:
325MG; 37.5MG
formulario farmacéutico:
TABLET
Composición:
ACETAMINOPHEN 325MG; TRAMADOL HYDROCHLORIDE 37.5MG
Vía de administración:
ORAL
Unidades en paquete:
30/100
tipo de receta:
Narcotic (CDSA I)
Área terapéutica:
OPIATE AGONISTS
Resumen del producto:
Active ingredient group (AIG) number: 0250601001; AHFS:
Estat d'Autorització:
APPROVED
Data d'autorització:
2013-02-08
Fitxa tècnica
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
N
PMS-TRAMADOL-ACET
Tramadol Hydrochloride and Acetaminophen Tablets, House Standard
37.5 mg tramadol hydrochloride
/ 325 mg acetaminophen
OPIOD ANALGESIC AND CENTRALLY ACTING ANALGESIC
PHARMASCIENCE INC.
6111 Royalmount, Suite 100
Montréal, Canada
H4P 2T4
www.pharmascience.com
DATE OF REVISION:
September 27, 2022
SUBMISSION CONTROL NO: 264215
_pms-TRAMADOL-ACET Product Monograph _
_Page 2 of 70_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
..................................................... 3
SUMMARY PRODUCT
INFORMATION.......................................................................
3
INDICATIONS AND CLINICAL USE
............................................................................
3
CONTRAINDICATIONS
.................................................................................................
4
WARNINGS AND
PRECAUTIONS.................................................................................
5
ADVERSE
REACTIONS................................................................................................
19
DRUG INTERACTIONS
................................................................................................
24
DOSAGE AND ADMINISTRATION
.............................................................................
28
OVERDOSAGE
..............................................................................................................
31
ACTION AND CLINICAL
PHARMACOLOGY...........................................................
33
STORAGE AND STABILITY
........................................................................................
41
SPECIAL HANDLING
INSTRUCTIONS......................................................................
41
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................ 41
PART II: SCIENTIFIC INFORMATION
..........................................................................
42
PHARMACEUTICAL INFORMATION
...................................
Llegiu el document complet
