BIO-TRAMADOL/ACET TABLET

Quốc gia: Canada

Ngôn ngữ: Tiếng Anh

Nguồn: Health Canada

Thành phần hoạt chất:

ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE

Sẵn có từ:

BIOMED PHARMA

Mã ATC:

N02AJ13

INN (Tên quốc tế):

TRAMADOL AND PARACETAMOL

Liều dùng:

325MG; 37.5MG

Dạng dược phẩm:

TABLET

Thành phần:

ACETAMINOPHEN 325MG; TRAMADOL HYDROCHLORIDE 37.5MG

Tuyến hành chính:

ORAL

Các đơn vị trong gói:

30/60/100/500

Loại thuốc theo toa:

Narcotic (CDSA I)

Khu trị liệu:

OPIATE AGONISTS

Tóm tắt sản phẩm:

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

Tình trạng ủy quyền:

CANCELLED PRE MARKET

Ngày ủy quyền:

2021-09-10

Đặc tính sản phẩm

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