M-AZITHROMYCIN TABLET

Quốc gia: Canada

Ngôn ngữ: Tiếng Anh

Nguồn: Health Canada

Thành phần hoạt chất:

AZITHROMYCIN (AZITHROMYCIN DIHYDRATE)

Sẵn có từ:

MANTRA PHARMA INC

Mã ATC:

J01FA10

INN (Tên quốc tế):

AZITHROMYCIN

Liều dùng:

250MG

Dạng dược phẩm:

TABLET

Thành phần:

AZITHROMYCIN (AZITHROMYCIN DIHYDRATE) 250MG

Tuyến hành chính:

ORAL

Các đơn vị trong gói:

15G/50G

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:

APPROVED

Ngày ủy quyền:

2020-07-28

Đặc tính sản phẩm

PRODUCT MONOGRAPH
Pr
M-AZITHROMYCIN
Azithromycin Dihydrate Tablets
250 mg and 600 mg Azithromycin (supplied as azithromycin dihydrate),
manufacturer’s standard
Antibacterial Agent
Mantra Pharma Inc. Date of Revision:
9150 Leduc BLVD, Suite 201, Brossard July 24, 2020
Quebec, Canada
J4Y 0E3
Control Submission #: 240728
Pr
M-Azithromycin (as azithromycin dihydrate) 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
.........................................................................................................................
4
WARNINGS AND PRECAUTIONS
.......................................................................................................
4
ADVERSE REACTIONS
.........................................................................................................................
8
DRUG INTERACTIONS
.......................................................................................................................
14
DOSAGE AND ADMINISTRATION
...................................................................................................
19
OVERDOSAGE
......................................................................................................................................
20
ACTION AND CLINICAL PHARMACOLOGY
..................................................................................
20
STORAGE AND STABILITY
...............................................................................................................
23
DOSAGE FORMS, COMPOSITION AND PACKAGING
................................................................... 23
PART II: SCIENTIFIC INFORMATION
......................