Country: Canada
Language: English
Source: Health Canada
VALACYCLOVIR (VALACYCLOVIR HYDROCHLORIDE)
COBALT PHARMACEUTICALS COMPANY
J05AB11
VALACICLOVIR
1000MG
TABLET
VALACYCLOVIR (VALACYCLOVIR HYDROCHLORIDE) 1000MG
ORAL
21/30/100
Prescription
NUCLEOSIDES AND NUCLEOTIDES
Active ingredient group (AIG) number: 0128626003; AHFS:
CANCELLED PRE MARKET
2017-09-01
_ _ _ _ _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 _ _ _ _ _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 ............... Read the complete document