IBUPROFEN ORAL SUSPENSION USP
Země: Kanada
Jazyk: angličtina
Zdroj: Health Canada
Charakteristika produktu
(SPC)
06-01-2021
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Aktivní složka:
IBUPROFEN
Dostupné s:
APOTEX INC
ATC kód:
M01AE01
INN (Mezinárodní Name):
IBUPROFEN
Dávkování:
100MG
Léková forma:
SUSPENSION
Složení:
IBUPROFEN 100MG
Podání:
ORAL
Jednotky v balení:
100
Druh předpisu:
OTC
Terapeutické oblasti:
OTHER NONSTEROIDAL ANTIIMFLAMMATORY AGENTS
Přehled produktů:
Active ingredient group (AIG) number: 0108883005; AHFS:
Stav Autorizace:
APPROVED
Datum autorizace:
2007-08-22
Charakteristika produktu
Page 1 of 30
PRODUCT MONOGRAPH
IBUPROFEN ORAL SUSPENSION
USP
100 MG/5 ML
ANALGESIC, ANTIPYRETIC AGENT – FOR CHILDREN
APOTEX INC.
150 SIGNET DRIVE
TORONTO, ONTARIO
M9L 1T9
DATE OF REVISION:
JANUARY 6, 2021
SUBMISSION CONTROL NO. 246862
Page 2 of 30
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
............................................................. 3
SUMMARY PRODUCT INFORMATION
...............................................................................
3
INDICATIONS AND CLINICAL
USE......................................................................................
3
CONTRAINDICATIONS
.........................................................................................................
3
WARNINGS AND
PRECAUTIONS........................................................................................
3
ADVERSE
REACTIONS.........................................................................................................
7
DRUG INTERACTIONS
.........................................................................................................
9
DOSAGE AND ADMINISTRATION
.....................................................................................
10
OVERDOSAGE.....................................................................................................................
11
ACTION AND CLINICAL PHARMACOLOGY
.....................................................................
12
STORAGE AND STABILITY
................................................................................................
14
SPECIAL HANDLING INSTRUCTIONS
..............................................................................
14
DOSAGE FORMS, COMPOSITION AND
PACKAGING.................................................... 14
PART II: SCIENTIFIC INFORMATION
...................................................................................
15
PHARMACEUTICAL INFORMATION
.................................................................................
15
CLINICAL TRIALS
.............................
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