BIO-TRAMADOL/ACET TABLET

Država: Kanada

Jezik: angleščina

Source: Health Canada

Aktivna sestavina:

ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE

Dostopno od:

BIOMED PHARMA

Koda artikla:

N02AJ13

INN (mednarodno ime):

TRAMADOL AND PARACETAMOL

Odmerek:

325MG; 37.5MG

Farmacevtska oblika:

TABLET

Sestava:

ACETAMINOPHEN 325MG; TRAMADOL HYDROCHLORIDE 37.5MG

Pot uporabe:

ORAL

Enote v paketu:

30/60/100/500

Tip zastaranja:

Narcotic (CDSA I)

Terapevtsko območje:

OPIATE AGONISTS

Povzetek izdelek:

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

Status dovoljenje:

CANCELLED PRE MARKET

Datum dovoljenje:

2021-09-10

Lastnosti izdelka

_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
.............................................................