AURO-TERBINAFINE TABLET

Quốc gia: Canada

Ngôn ngữ: Tiếng Anh

Nguồn: Health Canada

Thành phần hoạt chất:

TERBINAFINE (TERBINAFINE HYDROCHLORIDE)

Sẵn có từ:

AURO PHARMA INC

Mã ATC:

D01BA02

INN (Tên quốc tế):

TERBINAFINE

Liều dùng:

250MG

Dạng dược phẩm:

TABLET

Thành phần:

TERBINAFINE (TERBINAFINE HYDROCHLORIDE) 250MG

Tuyến hành chính:

ORAL

Các đơn vị trong gói:

28/100

Loại thuốc theo toa:

Prescription

Khu trị liệu:

ALLYLAMINES

Tóm tắt sản phẩm:

Active ingredient group (AIG) number: 0132855002; AHFS:

Tình trạng ủy quyền:

APPROVED

Ngày ủy quyền:

2008-12-03

Đặc tính sản phẩm

PRODUCT MONOGRAPH
PR
AURO-TERBINAFINE
(Terbinafine Tablets)
250 mg terbinafine (as terbinafine hydrochloride)
ANTIFUNGAL AGENT
AURO PHARMA INC.
Date of Revision:
3700 Steeles Avenue West, Suite # 402, July 27, 2016
Woodbridge, Ontario, L4L8K8
CANADA
Submission Control No.: 196718
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
…………………………………………….……………
11
DOSAGE AND ADMINISTRATION……………………….…………
14
OVERDOSAGE
………………………………………………………………….…
14
ACTION AND CLINICAL PHARMACOLOGY
……………………….…………
15
STORAGE AND STABILITY
…………………………………………………….
16
DOSAGE FORMS, COMPOSITION AND PACKAGING ………………………
16
PART II: SCIENTIFIC INFORMATION
………………………………………….
17
PHARMACEUTICAL INFORMATION
…………………………………………
17
DETAILED PHARMACOLOGY
…………………………………………………
24
TOXICOLOGY
…………………………………………….………………….……
27
REFERENCES
…………………………………………….…………………..……
35
PART III: CONSUMER INFORMATION
……………………………………..…
40
PR
AURO-TERBINAFINE
(Terbinafine Tablets)
250 mg terbinafine (as terbinafine hydrochloride)
PART I: HEALTH PROFESSIONAL INFORMATION
SUMMARY PRODUCT INFORMATION
ROUTE OF
ADMINISTRATION
DOSAGE FORM / STRENGTH
ALL NON-MEDICINAL INGREDIENTS
Oral
Tablets 250