NIGHTTIME PAIN RELIEVER CAPSULE
Država: Kanada
Jezik: angleščina
Source: Health Canada
Lastnosti izdelka
(SPC)
06-10-2016
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Aktivna sestavina:
IBUPROFEN; DIPHENHYDRAMINE HYDROCHLORIDE
Dostopno od:
MARCAN PHARMACEUTICALS INC
Koda artikla:
M01AE51
INN (mednarodno ime):
IBUPROFEN, COMBINATIONS
Odmerek:
200MG; 25MG
Farmacevtska oblika:
CAPSULE
Sestava:
IBUPROFEN 200MG; DIPHENHYDRAMINE HYDROCHLORIDE 25MG
Pot uporabe:
ORAL
Enote v paketu:
10/40/100
Tip zastaranja:
OTC
Terapevtsko območje:
ETHANOLAMINE DERIVATIVES
Povzetek izdelek:
Active ingredient group (AIG) number: 0252788001; AHFS:
Status dovoljenje:
CANCELLED PRE MARKET
Datum dovoljenje:
2021-05-13
Lastnosti izdelka
Page 1 of 52
PRODUCT MONOGRAPH
NIGHTTIME PAIN RELIEVER
Ibuprofen and Diphenhydramine Hydrochloride Liquid Gel Capsules
Ibuprofen 200mg and Diphenhydramine Hydrochloride 25mg
Analgesic/Sleep Aid
Date of Revision:
September 13, 2016
Marcan Pharmaceuticals Inc.
77 Auriga Drive, Unit# 4,
Ottawa, Ontario
K2E 7Z7
CONTROL# 197397
Page 2 of 52
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.............................................................................
3
SUMMARY PRODUCT INFORMATION
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3
INDICATIONS AND CLINICAL USE
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3
CONTRAINDICATIONS
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3
WARNINGS AND PRECAUTIONS
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4
ADVERSE REACTIONS
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10
DRUG INTERACTIONS
........................................................................................................................
17
DOSAGE AND ADMINISTRATION
....................................................................................................
21
OVERDOSAGE
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21
ACTION AND CLINICAL PHARMACOLOGY
..................................................................................
23
STORAGE AND STABILITY
...............................................................................................................
26
SPECIAL HANDLING INSTRUCTIONS
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26
DOSAGE FORMS, COMPOSITION AND PACKAGING
.........................................................
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