国: カナダ
言語: 英語
ソース: Health Canada
IBUPROFEN (IBUPROFEN SODIUM DIHYDRATE)
GLAXOSMITHKLINE CONSUMER HEALTHCARE ULC
M01AE01
IBUPROFEN
200MG
TABLET
IBUPROFEN (IBUPROFEN SODIUM DIHYDRATE) 200MG
ORAL
10/16//20/40/55/120/150/325/350
OTC
OTHER NONSTEROIDAL ANTIIMFLAMMATORY AGENTS
Active ingredient group (AIG) number: 0108883004; AHFS:
APPROVED
2020-07-16
_ _ _GlaxoSmithKline Consumer Healthcare Inc. _ _Page 1 of 66 _ PRODUCT MONOGRAPH ADVIL ® HEADACHE & MIGRAINE CAPLETS 200 mg Ibuprofen Caplets (provided as 256 mg Ibuprofen Sodium Dihydrate) ADVIL ® HEADACHE & MIGRAINE TABLETS 200 mg Ibuprofen Tablets (provided as 256 mg Ibuprofen Sodium Dihydrate) ADVIL ® HEADACHE & MIGRAINE EXTRA STRENGTH 400 mg Ibuprofen Caplets (provided as 512 mg Ibuprofen Sodium Dihydrate) Analgesic/Antipyretic GlaxoSmithKline Consumer Healthcare Inc. 7333 Mississauga Road Mississauga, Ontario Canada L5N 6L4 Submission Control No.: 240099 Date of Preparation: May 12, 2015 Date of Revision : July 10, 2020 _ _ _GlaxoSmithKline Consumer Healthcare Inc. _ _Page 2 of 66 _ TABLE OF CONTENTS PART I: HEALTH PROFESSIONAL INFORMATION .........................................................3 SUMMARY PRODUCT INFORMATION ........................................................................3 INDICATIONS AND CLINICAL USE ..............................................................................4 CONTRAINDICATIONS ...................................................................................................5 WARNINGS AND PRECAUTIONS ..................................................................................6 ADVERSE REACTIONS ..................................................................................................12 DRUG INTERACTIONS ..................................................................................................19 DOSAGE AND ADMINISTRATION ..............................................................................23 OVERDOSAGE ................................................................................................................24 ACTION AND CLINICAL PHARMACOLOGY ............................................................26 STORAGE AND STABILITY ..........................................................................................30 SPECIAL HANDLING INSTRUCTIONS .......................................................................30 DOSA 完全なドキュメントを読む