BIO-TRAMADOL/ACET TABLET

Nchi: Kanada

Lugha: Kiingereza

Chanzo: Health Canada

Nunua Sasa

Tabia za bidhaa Tabia za bidhaa (SPC)
07-06-2018

Viambatanisho vya kazi:

ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE

Inapatikana kutoka:

BIOMED PHARMA

ATC kanuni:

N02AJ13

INN (Jina la Kimataifa):

TRAMADOL AND PARACETAMOL

Kipimo:

325MG; 37.5MG

Dawa fomu:

TABLET

Tungo:

ACETAMINOPHEN 325MG; TRAMADOL HYDROCHLORIDE 37.5MG

Njia ya uendeshaji:

ORAL

Vitengo katika mfuko:

30/60/100/500

Dawa ya aina:

Narcotic (CDSA I)

Eneo la matibabu:

OPIATE AGONISTS

Bidhaa muhtasari:

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

Idhini hali ya:

CANCELLED PRE MARKET

Idhini ya tarehe:

2021-09-10

Tabia za bidhaa

                                _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
.............................................................
                                
                                Soma hati kamili
                                
                            

Nyaraka katika lugha zingine

Tabia za bidhaa Tabia za bidhaa Kifaransa 07-06-2018