TEVA-ACYCLOVIR TABLET

Quốc gia: Canada

Ngôn ngữ: Tiếng Anh

Nguồn: Health Canada

Thành phần hoạt chất:

ACYCLOVIR

Sẵn có từ:

TEVA CANADA LIMITED

Mã ATC:

J05AB01

INN (Tên quốc tế):

ACYCLOVIR

Liều dùng:

200MG

Dạng dược phẩm:

TABLET

Thành phần:

ACYCLOVIR 200MG

Tuyến hành chính:

ORAL

Các đơn vị trong gói:

100

Loại thuốc theo toa:

Prescription

Khu trị liệu:

NUCLEOSIDES AND NUCLEOTIDES

Tóm tắt sản phẩm:

Active ingredient group (AIG) number: 0115506002; AHFS:

Tình trạng ủy quyền:

APPROVED

Ngày ủy quyền:

2011-01-06

Đặc tính sản phẩm

Teva-Acyclovir
Page 1 of 40
_ _
_ _
PRODUCT MONOGRAPH
PR
TEVA-ACYCLOVIR
Acyclovir Tablets, USP
200 mg, 400 mg and 800 mg
(Acyclovir, as Acyclovir Hydrate)
ANTIVIRAL AGENT
Teva Canada Limited
30 Novopharm Court
Toronto, Canada
Ontario M1B 2K9
Date of Revision:
April 28, 2015
Submission Control No: 183526
Teva-Acyclovir
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
.................................................................................
4
ADVERSE REACTIONS
...................................................................................................
6
DRUG INTERACTIONS
...................................................................................................
9
DOSAGE AND ADMINISTRATION
...............................................................................
9
OVERDOSAGE
...............................................................................................................
10
ACTION AND CLINICAL PHARMACOLOGY
........................................................... 11
STORAGE AND STABILITY
.........................................................................................
13
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................ 13
PART II: SCIENTIFIC INFORMATION
..............................................................................
14
PHARMACEUTICAL INFORMATION
.........................................................................
14
CLINICAL TRIALS
.........................................................................................................
15
DETAILED PHARMACOLOGY
.................