APO-IBUPROFEN CAPLET TABLET

Država: Kanada

Jezik: engleski

Izvor: Health Canada

Aktivni sastojci:

IBUPROFEN

Dostupno od:

APOTEX INC

ATC koda:

M01AE01

INN (International ime):

IBUPROFEN

Doziranje:

400MG

Farmaceutski oblik:

TABLET

Sastav:

IBUPROFEN 400MG

Administracija rute:

ORAL

Jedinice u paketu:

100

Tip recepta:

OTC

Područje terapije:

OTHER NONSTEROIDAL ANTIIMFLAMMATORY AGENTS

Proizvod sažetak:

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

Status autorizacije:

APPROVED

Datum autorizacije:

2019-07-05

Svojstava lijeka

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
.....................................................