Valsts: Kanāda
Valoda: angļu
Klimata pārmaiņas: Health Canada
IBUPROFEN
PHARMASCIENCE INC
M01AE01
IBUPROFEN
400MG
TABLET
IBUPROFEN 400MG
ORAL
32/40/72/84
OTC
OTHER NONSTEROIDAL ANTIIMFLAMMATORY AGENTS
Active ingredient group (AIG) number: 0108883002; AHFS:
APPROVED
2011-12-14
PRODUCT MONOGRAPH IBUPROFEN MUSCLE AND JOINT Ibuprofen Tablets, USP Caplets 400 mg NON-STEROIDAL ANTI-INFLAMMATORY DRUG ANALGESIC, ANTIPYRETIC AGENT. PHARMASCIENCE INC. DATE OF REVISION: 6111 Royalmount Ave, Suite #100 December 8, 2020 Montreal, Quebec, H4P 2T4 www.pharmascience.com SUBMISSION CONTROL NO.: 246393 _IBUPROFEN _ _MUSCLE AND JOINT-_ _ Product Monograph_ _ _ _Page 2 of 38_ 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 ..................................................................................................10 DRUG INTERACTIONS ................................................................................................13 DOSAGE AND ADMINISTRATION ...........................................................................16 OVERDOSAGE ...............................................................................................................16 ACTION AND CLINICAL PHARMACOLOGY ............................................................17 STORAGE AND STABILITY........................................................................................19 SPECIAL HANDLING INSTRUCTIONS .......................................................................19 DOSAGE FORMS, COMPOSITION AND PACKAGING .............................................19 PART II: SCIENTIFIC INFORMATION ................................................................................20 PHARMACEUTICAL INFORMATION ..........................................................................20 CLINICAL TRIALS ... Izlasiet visu dokumentu