CO VALACYCLOVIR TABLET

Krajina: Kanada

Jazyk: angličtina

Zdroj: Health Canada

Aktívna zložka:

VALACYCLOVIR (VALACYCLOVIR HYDROCHLORIDE)

Dostupné z:

COBALT PHARMACEUTICALS COMPANY

ATC kód:

J05AB11

INN (Medzinárodný Name):

VALACICLOVIR

Dávkovanie:

500MG

Forma lieku:

TABLET

Zloženie:

VALACYCLOVIR (VALACYCLOVIR HYDROCHLORIDE) 500MG

Spôsob podávania:

ORAL

Počet v balení:

21/42/100/500

Typ predpisu:

Prescription

Terapeutické oblasti:

NUCLEOSIDES AND NUCLEOTIDES

Prehľad produktov:

Active ingredient group (AIG) number: 0128626001; AHFS:

Stav Autorizácia:

CANCELLED POST MARKET

Dátum Autorizácia:

2018-11-12

Súhrn charakteristických

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_Page 1 of 40_
PRODUCT MONOGRAPH
PR
_CO _VALACYCLOVIR
Valacyclovir Hydrochloride Tablets
500 mg and 1000 mg valacyclovir (as valacyclovir hydrochloride)
Antiviral Agent
Actavis Pharma Company
6733 Mississauga Road, Suite 400
Mississauga, Ontario
L5N 6J5
Date of Revision:
February 01, 2016
Control No.: 191484
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_Page 2 of 40_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
........................................................ 3
SUMMARY PRODUCT INFORMATION
.......................................................................
3
INDICATIONS AND CLINICAL USE
.............................................................................
3
CONTRAINDICATIONS
..................................................................................................
3
WARNINGS AND PRECAUTIONS
.................................................................................
4
ADVERSE REACTIONS
...................................................................................................
7
DRUG INTERACTIONS
.................................................................................................
13
DOSAGE AND ADMINISTRATION
.............................................................................
14
OVERDOSAGE
...............................................................................................................
16
ACTION AND CLINICAL PHARMACOLOGY
........................................................... 17
STORAGE AND STABILITY
.........................................................................................
18
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................ 19
PART II: SCIENTIFIC INFORMATION
..............................................................................
20
PHARMACEUTICAL INFORMATION
.........................................................................
20
CLINICAL TRIALS
.........................................................................................................
21
DETAILED PHARMACOLOGY
...............