RATIO-ACYCLOVIR TABLET

Negara: Kanada

Bahasa: Inggris

Sumber: Health Canada

Bahan aktif:

ACYCLOVIR

Tersedia dari:

TEVA CANADA LIMITED

Kode ATC:

J05AB01

INN (Nama Internasional):

ACYCLOVIR

Dosis:

200MG

Bentuk farmasi:

TABLET

Komposisi:

ACYCLOVIR 200MG

Rute administrasi :

ORAL

Unit dalam paket:

100/500

Jenis Resep:

Prescription

Area terapi:

NUCLEOSIDES AND NUCLEOTIDES

Ringkasan produk:

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

Status otorisasi:

CANCELLED POST MARKET

Tanggal Otorisasi:

2018-05-18

Karakteristik produk

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_Product Monograph _RATIO-ACYCLOVIR_ _
_Page 1 of 39_
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PRODUCT MONOGRAPH
PR
RATIO-ACYCLOVIR
acyclovir
Tablets USP, 200 mg, 400 mg and 800 mg
Antiviral Agent
Teva Canada Limited
30 Novopharm Court
Toronto, Ontario
Canada M1B 2K9
www.tevacanada.com
Date of Preparation :
July 24, 2013
Submission Control No: 166251
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_Product Monograph _RATIO-ACYCLOVIR_ _
_Page 2 of 39_
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
.............................................................................
10
OVERDOSAGE
................................................................................................................
12
ACTION AND CLINICAL PHARMACOLOGY
............................................................ 12
STORAGE AND STABILITY
.........................................................................................
14
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................. 14
PART II: SCIENTIFIC
INFORMATION...............................................................................
16
PHARMACEUTICAL INFORMATION
.........................................................................
16
CLINICAL TRIALS
..........................................................................................