APO-IBUPROFEN TABLET

Negara: Kanada

Bahasa: Inggris

Sumber: Health Canada

Bahan aktif:

IBUPROFEN

Tersedia dari:

APOTEX INC

Kode ATC:

M01AE01

INN (Nama Internasional):

IBUPROFEN

Dosis:

200MG

Bentuk farmasi:

TABLET

Komposisi:

IBUPROFEN 200MG

Rute administrasi :

ORAL

Unit dalam paket:

50/100/1000

Jenis Resep:

OTC

Area terapi:

OTHER NONSTEROIDAL ANTIIMFLAMMATORY AGENTS

Ringkasan produk:

Active ingredient group (AIG) number: 0108883004; AHFS:

Status otorisasi:

APPROVED

Tanggal Otorisasi:

2020-11-05

Karakteristik produk

Page 1 of 41
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PRODUCT MONOGRAPH
APO
-IBUPROFEN
IBUPROFEN TABLETS USP, 200 MG
APO
-IBUPROFEN CAPLET
IBUPROFEN TABLETS USP, 200 MG
APO
-IBUPROFEN
IBUPROFEN TABLETS USP, 300 MG
APO
-IBUPROFEN
IBUPROFEN TABLETS USP, 400 MG
APO
-IBUPROFEN CAPLET
IBUPROFEN TABLETS USP, 400 MG
NON-STEROIDAL ANTI-INFLAMMATORY DRUG
ANALGESIC, ANTIPYRETIC AGENT
APOTEX INC.
150 SIGNET DRIVE
TORONTO, ONTARIO
DATE OF REVISION:
M9L 1T9 OCTOBER 19, 2020
Submission Control No:
240021
Page 2 of 41
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
........................................................... 3
SUMMARY PRODUCT INFORMATION
......................................................................................
3
INDICATIONS AND CLINICAL
USE............................................................................................
4
CONTRAINDICATIONS
.................................................................................................................
4
WARNINGS AND PRECAUTIONS
...............................................................................................
5
ADVERSE REACTIONS
...............................................................................................................
11
DRUG INTERACTIONS
................................................................................................................
14
DOSAGE AND ADMINISTRATION
............................................................................................
16
OVERDOSAGE
..............................................................................................................................
17
ACTION AND CLINICAL PHARMACOLOGY
..........................................................................
18
STORAGE AND STABILITY
.......................................................................................................
19
SPECIAL HANDLING
INSTRUCTIONS……………………………………………………......19
DOSAGE FORMS, COMPOSITION AND PACKAGING
.....................................................