NAPROXEN TABLET

Kraj: Kanada

Język: angielski

Źródło: Health Canada

Składnik aktywny:

NAPROXEN SODIUM

Dostępny od:

PERRIGO INTERNATIONAL

Kod ATC:

M01AE02

INN (International Nazwa):

NAPROXEN

Dawkowanie:

220MG

Forma farmaceutyczna:

TABLET

Skład:

NAPROXEN SODIUM 220MG

Droga podania:

ORAL

Sztuk w opakowaniu:

200

Typ recepty:

OTC

Dziedzina terapeutyczna:

OTHER NONSTEROIDAL ANTIIMFLAMMATORY AGENTS

Podsumowanie produktu:

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

Status autoryzacji:

CANCELLED POST MARKET

Data autoryzacji:

2021-05-28

Charakterystyka produktu

_ _
_Naproxen Sodium Product Monograph _
_Page 1 of 31_
PRODUCT MONOGRAPH
NAPROXEN
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 10, 2012
Submission Control No: 133440
_ _
_Naproxen Sodium Product Monograph _
_Page 2 of 31_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
........................................................ 3
SUMMARY PRODUCT INFORMATION
.......................................................................
3
INDICATIONS AND CLINICAL USE
.............................................................................
3
CONTRAINDICATIONS
..................................................................................................
3
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
....................................................................................................