País: Canadá
Língua: inglês
Origem: Health Canada
IBUPROFEN
APOTEX INC
M01AE01
IBUPROFEN
100MG
SUSPENSION
IBUPROFEN 100MG
ORAL
100
OTC
OTHER NONSTEROIDAL ANTIIMFLAMMATORY AGENTS
Active ingredient group (AIG) number: 0108883005; AHFS:
APPROVED
2007-08-22
Page 1 of 30 PRODUCT MONOGRAPH IBUPROFEN ORAL SUSPENSION USP 100 MG/5 ML ANALGESIC, ANTIPYRETIC AGENT – FOR CHILDREN APOTEX INC. 150 SIGNET DRIVE TORONTO, ONTARIO M9L 1T9 DATE OF REVISION: JANUARY 6, 2021 SUBMISSION CONTROL NO. 246862 Page 2 of 30 TABLE OF CONTENTS PART I: HEALTH PROFESSIONAL INFORMATION ............................................................. 3 SUMMARY PRODUCT INFORMATION ............................................................................... 3 INDICATIONS AND CLINICAL USE...................................................................................... 3 CONTRAINDICATIONS ......................................................................................................... 3 WARNINGS AND PRECAUTIONS........................................................................................ 3 ADVERSE REACTIONS......................................................................................................... 7 DRUG INTERACTIONS ......................................................................................................... 9 DOSAGE AND ADMINISTRATION ..................................................................................... 10 OVERDOSAGE..................................................................................................................... 11 ACTION AND CLINICAL PHARMACOLOGY ..................................................................... 12 STORAGE AND STABILITY ................................................................................................ 14 SPECIAL HANDLING INSTRUCTIONS .............................................................................. 14 DOSAGE FORMS, COMPOSITION AND PACKAGING.................................................... 14 PART II: SCIENTIFIC INFORMATION ................................................................................... 15 PHARMACEUTICAL INFORMATION ................................................................................. 15 CLINICAL TRIALS ............................. Leia o documento completo