NAPROXEN TABLET
국가: 캐나다
언어: 영어
출처: Health Canada
제품 특성 요약
(SPC)
10-05-2019
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유효 성분:
NAPROXEN SODIUM
제공처:
DOMINION PHARMACAL
ATC 코드:
M01AE02
INN (International Name):
NAPROXEN
복용량:
220MG
약제 형태:
TABLET
구성:
NAPROXEN SODIUM 220MG
관리 경로:
ORAL
패키지 단위:
24/100/125
처방전 유형:
OTC
치료 영역:
OTHER NONSTEROIDAL ANTIIMFLAMMATORY AGENTS
제품 요약:
Active ingredient group (AIG) number: 0113934003; AHFS:
승인 상태:
CANCELLED POST MARKET
승인 날짜:
2020-05-06
제품 특성 요약
PRODUCT MONOGRAPH
NAPROXEN
Naproxen Sodium Tablets USP
220 mg
Non-steroidal anti-inflammatory drug
Analgesic, Antipyretic
DOMINION PHARMACAL
6111 Royalmount Ave., Suite 100,
Montréal, Québec
H4P 2T4
www.pharmascience.com DATE OF REVISION:
May 10, 2019
Submission Control no.: 227094
_ _
_NAPROXEN Product Monograph _
_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
....................................................................................
4
ADVERSE REACTIONS
......................................................................................................
6
DRUG INTERACTIONS
......................................................................................................
9
DOSAGE AND ADMINISTRATION
................................................................................
11
OVERDOSAGE
...................................................................................................................
12
ACTION AND CLINICAL PHARMACOLOGY
.............................................................. 12
STORAGE AND STABILITY
............................................................................................
14
SPECIAL HANDLING INSTRUCTIONS
.........................................................................
14
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................... 14
PART II: SCIENTIFIC INFORMATION
.........................................................................
15
PHARMACEUTICAL INFORMATION
............................................................................
15
CLINICAL TRIALS
..................
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