BIO-TRAMADOL/ACET TABLET

Ország: Kanada

Nyelv: angol

Forrás: Health Canada

Aktív összetevők:

ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE

Beszerezhető a:

BIOMED PHARMA

ATC-kód:

N02AJ13

INN (nemzetközi neve):

TRAMADOL AND PARACETAMOL

Adagolás:

325MG; 37.5MG

Gyógyszerészeti forma:

TABLET

Összetétel:

ACETAMINOPHEN 325MG; TRAMADOL HYDROCHLORIDE 37.5MG

Az alkalmazás módja:

ORAL

db csomag:

30/60/100/500

Recept típusa:

Narcotic (CDSA I)

Terápiás terület:

OPIATE AGONISTS

Termék összefoglaló:

Active ingredient group (AIG) number: 0250601001; AHFS:

Engedélyezési státusz:

CANCELLED PRE MARKET

Engedély dátuma:

2021-09-10

Termékjellemzők

_Page 1 of 56 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
BIO-TRAMADOL/ACET
Acetaminophen and Tramadol Hydrochloride Tablets, House Std.
37.5 mg Tramadol Hydrochloride/325 mg Acetaminophen
Centrally Acting Analgesic
Date of preparation
June 7, 2018
Biomed Pharma
1565 boul. Lionel-Boulet
Varennes, Quebec
J3X 1P7
Control# 215703
_Page 2 of 56 _
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
.......................................................................................................................
15
DRUG INTERACTIONS
.......................................................................................................................
20
DOSAGE AND ADMINISTRATION
...................................................................................................
23
OVERDOSAGE
......................................................................................................................................27
ACTION AND CLINICAL PHARMACOLOGY
..................................................................................
27
STORAGE AND STABILITY
...............................................................................................................
33
DOSAGE FORMS, COMPOSITION AND PACKAGING
.................................................................. 33
PART II: SCIENTIFIC INFORMATION
.............................................................