Страна: Канада
Язык: английский
Источник: Health Canada
ACYCLOVIR
TEVA CANADA LIMITED
J05AB01
ACYCLOVIR
200MG
TABLET
ACYCLOVIR 200MG
ORAL
100
Prescription
NUCLEOSIDES AND NUCLEOTIDES
Active ingredient group (AIG) number: 0115506002; AHFS:
CANCELLED PRE MARKET
2015-08-06
_ _ _ _ PRODUCT MONOGRAPH PR NTP-ACYCLOVIR Acyclovir Tablets, USP 200 mg, 400 mg and 800 mg (Acyclovir, as Acyclovir Hydrate) ANTIVIRAL AGENT Teva Canada Limited 30 Novopharm Court Toronto, Ontario Canada, M1B 2K9 Date of Preparation: June 20, 2013 Submission Control No: 165696 _ _ _ _ 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 ................................................................................................... 8 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 ................................................................... Прочитать полный документ