NAPROXEN TABLET

ประเทศ: แคนาดา

ภาษา: อังกฤษ

แหล่งที่มา: Health Canada

สารออกฤทธิ์:

NAPROXEN SODIUM

มีจำหน่ายจาก:

DOMINION PHARMACAL

รหัส ATC:

M01AE02

INN (ชื่อสากล):

NAPROXEN

ปริมาณ:

220MG

แบบฟอร์มเภสัชกรรม:

TABLET

องค์ประกอบ:

NAPROXEN SODIUM 220MG

เส้นทางการบริหาร:

ORAL

หน่วยในแพ็คเกจ:

24/100/125

ประเภทใบสั่งยา:

OTC

พื้นที่บำบัด:

OTHER NONSTEROIDAL ANTIIMFLAMMATORY AGENTS

สรุปสินค้า:

Active ingredient group (AIG) number: 0113934003; AHFS:

สถานะการอนุญาต:

CANCELLED POST MARKET

วันที่อนุญาต:

2020-05-06

สรุปลักษณะสินค้า

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
..................