APO-IBUPROFEN TABLET

Land: Kanada

Språk: engelska

Källa: Health Canada

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Ladda ner Produktens egenskaper (SPC)
19-10-2020

Aktiva substanser:

IBUPROFEN

Tillgänglig från:

APOTEX INC

ATC-kod:

M01AE01

INN (International namn):

IBUPROFEN

Dos:

200MG

Läkemedelsform:

TABLET

Sammansättning:

IBUPROFEN 200MG

Administreringssätt:

ORAL

Enheter i paketet:

50/100/1000

Receptbelagda typ:

OTC

Terapiområde:

OTHER NONSTEROIDAL ANTIIMFLAMMATORY AGENTS

Produktsammanfattning:

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

Bemyndigande status:

APPROVED

Tillstånd datum:

2020-11-05

Produktens egenskaper

                                Page 1 of 41
0
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
.....................................................
                                
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