Country: Kanada
Lingwa: Ingliż
Sors: Health Canada
ACYCLOVIR
MYLAN PHARMACEUTICALS ULC
J05AB01
ACYCLOVIR
400MG
TABLET
ACYCLOVIR 400MG
ORAL
100
Prescription
NUCLEOSIDES AND NUCLEOTIDES
Active ingredient group (AIG) number: 0115506004; AHFS:
APPROVED
2009-07-03
_ _ _Product Monograph –Mylan_-_Acyclovir _ _Page 1 _ PRODUCT MONOGRAPH PR MYLAN-ACYCLOVIR Acyclovir, USP 200, 400 and 800 mg Tablets Manufacturer Standard ANTIVIRAL AGENT Mylan Pharmaceuticals ULC 85 Advance Road Etobicoke, ON Canada M8Z 2S6 Control No.: 181160 DATE OF REVISION: January 15, 2015 _ _ _Product Monograph –Mylan_-_Acyclovir _ _Page 2_ 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 ............................................................................................................... 11 ACTION AND CLINICAL PHARMACOLOGY ........................................................... 12 STORAGE AND STABILITY ......................................................................................... 14 DOSAGE FORMS, COMPOSITION AND PACKAGING ............................................ 14 AVAILABILITY OF DOSAGE FORMS ........................................................................ 14 PART II: SCIENTIFIC INFORMATION ............................................................................... 16 PHARMACEUTICAL INFORMATION ......................................................................... 16 CLINICAL TRIALS ......................... Aqra d-dokument sħiħ