MYLAN-AZITHROMYCIN TABLET

Quốc gia: Canada

Ngôn ngữ: Tiếng Anh

Nguồn: Health Canada

Thành phần hoạt chất:

AZITHROMYCIN (AZITHROMYCIN MONOHYDRATE HEMIETHANOLATE)

Sẵn có từ:

MYLAN PHARMACEUTICALS ULC

Mã ATC:

J01FA10

INN (Tên quốc tế):

AZITHROMYCIN

Liều dùng:

250MG

Dạng dược phẩm:

TABLET

Thành phần:

AZITHROMYCIN (AZITHROMYCIN MONOHYDRATE HEMIETHANOLATE) 250MG

Tuyến hành chính:

ORAL

Các đơn vị trong gói:

6/30

Loại thuốc theo toa:

Prescription

Khu trị liệu:

OTHER MACROLIDES

Tóm tắt sản phẩm:

Active ingredient group (AIG) number: 0126072001; AHFS:

Tình trạng ủy quyền:

CANCELLED POST MARKET

Ngày ủy quyền:

2018-03-09

Đặc tính sản phẩm

PRODUCT MONOGRAPH
PR
MYLAN-AZITHROMYCIN
Azithromycin Tablets
250 mg
USP
ANTIBACTERIAL AGENT
MYLAN PHARMACEUTICALS ULC
85 Advance Road
Etobicoke, Ontario
M8Z 2S6
Date of Revision:
February 8, 2018
Control number: 213343
_ _
_MYLAN-AZITHROMYCIN Product Monograph _
_Page 2 of 62_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.........................................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
INDICATIONS AND CLINICAL USE
..............................................................................3
CONTRAINDICATIONS
...................................................................................................5
WARNINGS AND PRECAUTIONS
..................................................................................5
ADVERSE REACTIONS
....................................................................................................9
DRUG INTERACTIONS
..................................................................................................15
DOSAGE AND ADMINISTRATION
..............................................................................21
OVERDOSAGE
................................................................................................................22
ACTION AND CLINICAL PHARMACOLOGY
............................................................22
STORAGE AND STABILITY
..........................................................................................25
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................25
PART II: SCIENTIFIC INFORMATION
...............................................................................26
PHARMACEUTICAL INFORMATION
..........................................................................26
CLINICAL TRIALS
..........................................................................................................27
DETAILED PHARMACOLOGY
..............................................................................