Țară: Canada
Limbă: engleză
Sursă: Health Canada
IBUPROFEN
GLAXOSMITHKLINE CONSUMER HEALTHCARE ULC
M01AE01
IBUPROFEN
400MG
TABLET
IBUPROFEN 400MG
ORAL
15G/50G
OTC
OTHER NONSTEROIDAL ANTIIMFLAMMATORY AGENTS
Active ingredient group (AIG) number: 0108883002; AHFS:
APPROVED
2010-09-02
_ _ _Pfizer Consumer Healthcare, a division of Pfizer Canada ULC _ _Page 1 of 53_ PRODUCT MONOGRAPH ADVIL ® TABLETS ADVIL ® CAPLETS ADVIL ® GEL CAPLETS Ibuprofen Tablets USP, 200 mg ADVIL ® EXTRA STRENGTH CAPLETS ADVIL ® MUSCLE AND JOINT Ibuprofen Tablets USP, 400 mg ADVIL ® 12 HOUR Ibuprofen Extended Release Tablets BP, 600 mg Analgesic/Antipyretic Pfizer Consumer Healthcare, a division of Pfizer Canada ULC 450-55 Standish Court Mississauga, Ontario L5R 4B2 Date of Preparation: September 26, 2011 Date of Revision : October 23, 2019 Submission Control No: 231383 _ _ _Pfizer Consumer Healthcare, a division of Pfizer Canada ULC _ _Page 2 of 53_ TABLE OF CONTENTS PART I: HEALTH PROFESSIONAL INFORMATION .........................................................3 SUMMARY PRODUCT INFORMATION ........................................................................3 INDICATIONS AND CLINICAL USE ..............................................................................3 CONTRAINDICATIONS ...................................................................................................4 WARNINGS AND PRECAUTIONS ..................................................................................6 ADVERSE REACTIONS ..................................................................................................11 DRUG INTERACTIONS ..................................................................................................16 DOSAGE AND ADMINISTRATION ..............................................................................19 OVERDOSAGE ................................................................................................................20 ACTION AND CLINICAL PHARMACOLOGY ............................................................21 STORAGE AND STABILITY ..........................................................................................23 SPECIAL HANDLING INSTRUCTIONS .......................................................................23 DOSAGE FORMS, COMPOSITION AND PACKAGING ......... Citiți documentul complet