SANDOZ-DICLOFENAC SUPPOSITORY

Quốc gia: Canada

Ngôn ngữ: Tiếng Anh

Nguồn: Health Canada

Thành phần hoạt chất:

DICLOFENAC SODIUM

Sẵn có từ:

SANDOZ CANADA INCORPORATED

Mã ATC:

M01AB05

INN (Tên quốc tế):

DICLOFENAC

Liều dùng:

100MG

Dạng dược phẩm:

SUPPOSITORY

Thành phần:

DICLOFENAC SODIUM 100MG

Tuyến hành chính:

RECTAL

Các đơn vị trong gói:

30

Loại thuốc theo toa:

Prescription

Khu trị liệu:

OTHER NONSTEROIDAL ANTIIMFLAMMATORY AGENTS

Tóm tắt sản phẩm:

Active ingredient group (AIG) number: 0114417001; AHFS:

Tình trạng ủy quyền:

CANCELLED POST MARKET

Ngày ủy quyền:

2021-01-25

Đặc tính sản phẩm

_Sandoz-Diclofenac and Sandoz-Diclofenac SR _
_ _
_Page 1 of 40 _
PRODUCT MONOGRAPH
PR
SANDOZ-DICLOFENAC
PR
SANDOZ-DICLOFENAC SR
(diclofenac sodium)
50 mg Enteric-Coated Tablets
75 and 100 mg Slow-Release Tablets
50 and 100 mg Suppositories
Acetic Acid Derivatives and Related Substances
Sandoz Canada Inc.
Date of revision:
110 Rue de Lauzon,
January 6, 2020
Boucherville, Quebec
J4B 1E6
Control no. 233855
_Sandoz-Diclofenac and Sandoz-Diclofenac SR _
_ _
_Page 2 of 40 _
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
.........................................................................................................
17
DOSAGE AND ADMINISTRATION
.....................................................................................
21
OVERDOSAGE
.......................................................................................................................
23
ACTION AND CLINICAL PHARMACOLOGY
................................................................... 23
STORAGE AND STABILITY
.................................................................................................
25
DOSAGE FORMS, COMPOSITION AND PACKAGING
.................................................... 25
PART II: SCIENTIFIC INFORMATION
...............................................................................
27
PHARMACEUTICAL INFORMATION
.................