IBUPROFEN + PSEUDOEPHEDRINE CAPLETS TABLET

국가: 캐나다

언어: 영어

출처: Health Canada

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Download 제품 특성 요약 (SPC)
25-08-2016

유효 성분:

IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE

제공처:

MARCAN PHARMACEUTICALS INC

ATC 코드:

M01AE51

INN (International Name):

IBUPROFEN, COMBINATIONS

복용량:

200MG; 30MG

약제 형태:

TABLET

구성:

IBUPROFEN 200MG; PSEUDOEPHEDRINE HYDROCHLORIDE 30MG

관리 경로:

ORAL

패키지 단위:

10/24/100

처방전 유형:

OTC

치료 영역:

OTHER NONSTEROIDAL ANTIIMFLAMMATORY AGENTS

제품 요약:

Active ingredient group (AIG) number: 0222394001; AHFS:

승인 상태:

APPROVED

승인 날짜:

2016-08-23

제품 특성 요약

                                Page 1 of 47
PRODUCT MONOGRAPH
IBUPROFEN + PSEUDOEPHEDRINE CAPLETS
Ibuprofen and Pseudoephedrine Hydrochloride Tablets USP
Ibuprofen 200 mg, Pseudoephedrine Hydrochloride 30 mg
Caplets
Analgesic/Antipyretic/Nasal Decongestant
Marcan Pharmaceuticals Inc.
Date of Preparation:
77 Auriga Drive, Unit #4
August 23, 2016
Ottawa, Ontario
K2E 7Z7
Control# 197421
Page 2 of 47
_ _
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.................................................................... 3
SUMMARY PRODUCT INFORMATION
...........................................................................................
3
INDICATIONS AND CLINICAL USE
.................................................................................................
3
CONTRAINDICATIONS
......................................................................................................................
3
WARNINGS AND PRECAUTIONS
....................................................................................................
5
ADVERSE REACTIONS
....................................................................................................................
10
DRUG INTERACTIONS
.....................................................................................................................
17
DOSAGE AND ADMINISTRATION
.................................................................................................
20
OVERDOSAGE
...................................................................................................................................
20
ACTION AND CLINICAL PHARMACOLOGY
...............................................................................
22
STORAGE AND STABILITY
............................................................................................................
26
SPECIAL HANDLING INSTRUCTION
............................................................................................
26
DOSAGE FORMS, COMPOSITION AND PACKAGING
...............................................................
                                
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