Страна: Канада
мова: англійська
Джерело: Health Canada
IBUPROFEN (IBUPROFEN SODIUM DIHYDRATE)
PFIZER CONSUMER HEALTHCARE A DIVISION OF PFIZER CANADA ULC
M01AE01
IBUPROFEN
400MG
TABLET
IBUPROFEN (IBUPROFEN SODIUM DIHYDRATE) 400MG
ORAL
1/10/12/20/30/60/67/77/180
OTC
OTHER NONSTEROIDAL ANTIIMFLAMMATORY AGENTS
Active ingredient group (AIG) number: 0108883002; AHFS:
CANCELLED PRE MARKET
2018-08-02
_ _ _Pfizer Consumer Healthcare, a division of Pfizer Canada Inc. _ _Page 1 of 64 _ PRODUCT MONOGRAPH ADVIL ® HEADACHE & MIGRAINE PAIN CAPLETS 200 mg Ibuprofen Caplets (provided as 256 mg Ibuprofen Sodium Dihydrate) ADVIL ® HEADACHE & MIGRAINE PAIN TABLETS 200 mg Ibuprofen Tablets (provided as 256 mg Ibuprofen Sodium Dihydrate) ADVIL ® HEADACHE & MIGRAINE PAIN EXTRA STRENGTH CAPLETS 400 mg Ibuprofen Caplets (provided as 512 mg Ibuprofen Sodium Dihydrate) Analgesic/Antipyretic Pfizer Consumer Healthcare, a division of Pfizer Canada Inc. 450 – 55 Standish Court Mississauga, Ontario Canada L5R 4B2 Submission Control No.: 179222 Date of Preparation: May 12, 2015 Date of Revision : July 29, 2016 _ _ _Pfizer Consumer Healthcare, a division of Pfizer Canada Inc. _ _Page 2 of 64 _ 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 ..................................................................................................13 DRUG INTERACTIONS ..................................................................................................20 DOSAGE AND ADMINISTRATION ..............................................................................24 OVERDOSAGE ................................................................................................................25 ACTION AND CLINICAL PHARMACOLOGY ............................................................27 STORAGE AND STABILITY ..........................................................................................31 SPECIAL HANDLING INST Прочитайте повний документ