NX 12 HOUR TABLET

ประเทศ: แคนาดา

ภาษา: อังกฤษ

แหล่งที่มา: Health Canada

สารออกฤทธิ์:

NAPROXEN SODIUM

มีจำหน่ายจาก:

PERRIGO INTERNATIONAL

รหัส ATC:

M01AE02

INN (ชื่อสากล):

NAPROXEN

ปริมาณ:

220MG

แบบฟอร์มเภสัชกรรม:

TABLET

องค์ประกอบ:

NAPROXEN SODIUM 220MG

เส้นทางการบริหาร:

ORAL

หน่วยในแพ็คเกจ:

24/50/100/120/200/300 FOR BOTH TABS & CAPL./400(CAPLETS ONLY)

ประเภทใบสั่งยา:

OTC

พื้นที่บำบัด:

OTHER NONSTEROIDAL ANTIIMFLAMMATORY AGENTS

สรุปสินค้า:

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

สถานะการอนุญาต:

CANCELLED PRE MARKET

วันที่อนุญาต:

2021-07-22

สรุปลักษณะสินค้า

_ _
_NX 12 Hour (naproxen sodium) Product Monograph _
_Page 1 of 32_
PRODUCT MONOGRAPH
NX 12 HOUR
Naproxen Sodium Tablets USP
220 mg Tablets and Caplets
Non-steroidal anti-inflammatory drug
Analgesic, Antipyretic
Perrigo
®
International
515 Eastern Ave.
Allegan, MI 49010
USA
Date of Preparation:
January 17, 2012
Submission Control No: 133444
_ _
_NX 12 Hour (naproxen sodium) Product Monograph _
_Page 2 of 32_
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
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................ 14
PART II: SCIENTIFIC INFORMATION
..............................................................................
15
PHARMACEUTICAL INFORMATION
.........................................................................
15
CLINICAL TRIALS
........................................................................