ADVIL MIGRAINE EXTRA STRENGTH TABLET

Negara: Kanada

Bahasa: Inggris

Sumber: Health Canada

Bahan aktif:

IBUPROFEN (IBUPROFEN SODIUM DIHYDRATE)

Tersedia dari:

PFIZER CONSUMER HEALTHCARE A DIVISION OF PFIZER CANADA ULC

Kode ATC:

M01AE01

INN (Nama Internasional):

IBUPROFEN

Dosis:

400MG

Bentuk farmasi:

TABLET

Komposisi:

IBUPROFEN (IBUPROFEN SODIUM DIHYDRATE) 400MG

Rute administrasi :

ORAL

Unit dalam paket:

12/20/30/60/67/77/180

Jenis Resep:

OTC

Area terapi:

OTHER NONSTEROIDAL ANTIIMFLAMMATORY AGENTS

Ringkasan produk:

Active ingredient group (AIG) number: 0108883002; AHFS:

Status otorisasi:

CANCELLED PRE MARKET

Tanggal Otorisasi:

2018-08-02

Karakteristik produk

_ _
_Pfizer Consumer Healthcare, a division of Pfizer Canada Inc. _
_Page 1 of 67 _
PRODUCT MONOGRAPH
ADVIL
®
MIGRAINE CAPLETS
200 mg Ibuprofen Caplets (provided as 256 mg Ibuprofen Sodium
Dihydrate)
ADVIL
®
MIGRAINE TABLETS
200 mg Ibuprofen Tablets (provided as 256 mg Ibuprofen Sodium
Dihydrate)
ADVIL
®
MIGRAINE EXTRA STRENGTH
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.: 206595
Date of Preparation:
May 12, 2015
Date of Revision :
August 11, 2017
_ _
_Pfizer Consumer Healthcare, a division of Pfizer Canada Inc. _
_Page 2 of 67 _
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 INSTRUCTIONS
.............................................