ADVIL MINI-GELS CAPSULE
Země: Kanada
Jazyk: angličtina
Zdroj: Health Canada
Charakteristika produktu
(SPC)
02-04-2020
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Aktivní složka:
IBUPROFEN
Dostupné s:
GLAXOSMITHKLINE CONSUMER HEALTHCARE ULC
ATC kód:
M01AE01
INN (Mezinárodní Name):
IBUPROFEN
Dávkování:
200MG
Léková forma:
CAPSULE
Složení:
IBUPROFEN 200MG
Podání:
ORAL
Jednotky v balení:
15G/50G
Druh předpisu:
OTC
Terapeutické oblasti:
OTHER NONSTEROIDAL ANTIIMFLAMMATORY AGENTS
Přehled produktů:
Active ingredient group (AIG) number: 0108883004; AHFS:
Stav Autorizace:
APPROVED
Datum autorizace:
2019-02-04
Charakteristika produktu
_ _
_GlaxoSmithKline Consumer Healthcare Inc.. Page 1 of 39_
PRODUCT MONOGRAPH
ADVIL
®
MINI-GELS
Ibuprofen Capsules 200 mg (free acid and potassium salt)
Analgesic/Antipyretic
GlaxoSmithKine Consumer Healthcare Inc.
7333 Mississauga Road
Mississauga, Ontario
L5N 6L4
Date of Preparation:
February 26, 2004
Date of Revision :
April 2, 2020
Submission Control No: 236621
_ _
_GlaxoSmithKline Consumer Healthcare Inc. Page 2 of 39_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
..........................................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
INDICATIONS AND CLINICAL USE
..............................................................................3
CONTRAINDICATIONS
...................................................................................................4
WARNINGS AND PRECAUTIONS
..................................................................................5
ADVERSE REACTIONS
..................................................................................................10
DRUG INTERACTIONS
..................................................................................................14
DOSAGE AND ADMINISTRATION
..............................................................................17
OVERDOSAGE
................................................................................................................18
ACTION AND CLINICAL PHARMACOLOGY
............................................................19
STORAGE AND STABILITY
..........................................................................................21
SPECIAL HANDLING INSTRUCTIONS
.......................................................................21
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................21
PART II: SCIENTIFIC INFORMATION
................................................................................22
PHARMACEUTICAL INFORMATION
.............................................
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