IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE CAPSULES
국가: 캐나다
언어: 영어
출처: Health Canada
제품 특성 요약
(SPC)
28-01-2020
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유효 성분:
IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE
제공처:
CATALENT ONTARIO LIMITED
ATC 코드:
M01AE51
INN (International Name):
IBUPROFEN, COMBINATIONS
복용량:
200MG; 30MG
약제 형태:
CAPSULE
구성:
IBUPROFEN 200MG; PSEUDOEPHEDRINE HYDROCHLORIDE 30MG
관리 경로:
ORAL
패키지 단위:
100
처방전 유형:
OTC
치료 영역:
OTHER NONSTEROIDAL ANTIIMFLAMMATORY AGENTS
제품 요약:
Active ingredient group (AIG) number: 0222394001; AHFS:
승인 상태:
APPROVED
승인 날짜:
2020-01-31
제품 특성 요약
Page 1 of 52
PRODUCT MONOGRAPH
IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE CAPSULES
Ibuprofen (free acid and potassium salt) and Pseudoephedrine
Hydrochloride Capsules
200 mg / 30 mg
Analgesic/Antipyretic/Nasal Decongestant
Catalent Ontario Limited,
2125 Ambassador Dr.
Windsor, ON N9C 3R5
Control No. 227874
Date of Preparation:
January 28, 2020
Page 2 of 52
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
.....................................................................................................
11
DRUG INTERACTIONS
.....................................................................................................
18
DOSAGE AND ADMINISTRATION
.................................................................................
21
OVERDOSAGE
....................................................................................................................
22
ACTION AND CLINICAL PHARMACOLOGY
................................................................ 24
STORAGE AND STABILITY
.............................................................................................
28
SPECIAL HANDLING INSTRUCTIONS
...........................................................................
28
DOSAGE FORMS, COMPOSITION AND PACKAGING
................................................. 29
PART II: SCIENTIFIC
INFORMATION...................................................................................
30
PHARMACEUTICAL INFORMATION
......................................................
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