COLD + SINUS PLUS TABLET
국가: 캐나다
언어: 영어
출처: Health Canada
제품 특성 요약
(SPC)
16-09-2020
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유효 성분:
PSEUDOEPHEDRINE HYDROCHLORIDE; IBUPROFEN; CHLORPHENIRAMINE MALEATE
제공처:
VITA HEALTH PRODUCTS INC
ATC 코드:
M01AE51
INN (International Name):
IBUPROFEN, COMBINATIONS
복용량:
30.0MG; 200.0MG; 2.0MG
약제 형태:
TABLET
구성:
PSEUDOEPHEDRINE HYDROCHLORIDE 30.0MG; IBUPROFEN 200.0MG; CHLORPHENIRAMINE MALEATE 2.0MG
관리 경로:
ORAL
패키지 단위:
10/20/24/72/100
처방전 유형:
OTC
치료 영역:
OTHER NONSTEROIDAL ANTIIMFLAMMATORY AGENTS
제품 요약:
Active ingredient group (AIG) number: 0349765001; AHFS:
승인 상태:
APPROVED
승인 날짜:
2010-11-29
제품 특성 요약
Page 1 of 69
PRODUCT MONOGRAPH
COLD + SINUS PLUS
Ibuprofen 200 mg, Pseudoephedrine Hydrochloride 30 mg
and Chlorpheniramine Maleate 2 mg Tablets
Analgesic/Antipyretic/Nasal Decongestant/Antihistamine
Vita Health Products Inc.
Date of Revision:
150 Beghin Avenue
September 16, 2020
Winnipeg, Manitoba Canada, R2J 3W2
Control No.: 238538
Page 2 of 69
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
................................................................................................
12
DRUG INTERACTIONS
................................................................................................
21
DOSAGE AND ADMINISTRATION
............................................................................
25
OVERDOSAGE
...............................................................................................................
26
ACTION AND CLINICAL PHARMACOLOGY
........................................................... 29
STORAGE AND STABILITY
........................................................................................
35
SPECIAL HANDLING INSTRUCTIONS
......................................................................
35
DOSAGE FORMS, COMPOSITION AND
PACKAGING............................................ 35
PART II: SCIENTIFIC INFORMATION
................................................................................
36
PHARMACEUTICAL INFORMATION
........................................................................
36
CLINICAL TRIALS
........................................
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