NAPROXEN - 250 TABLET

מדינה: קנדה

שפה: אנגלית

מקור: Health Canada

מרכיב פעיל:

NAPROXEN

זמין מ:

PRO DOC LIMITEE

קוד ATC:

M01AE02

INN (שם בינלאומי):

NAPROXEN

כמות:

250MG

טופס פרצבטיות:

TABLET

הרכב:

NAPROXEN 250MG

מסלול נתינה (של תרופות):

ORAL

יחידות באריזה:

15G/50G

סוג מרשם:

Prescription

איזור תרפויטי:

OTHER NONSTEROIDAL ANTIIMFLAMMATORY AGENTS

leaflet_short:

Active ingredient group (AIG) number: 0109634001; AHFS:

מצב אישור:

APPROVED

תאריך אישור:

2022-04-13

מאפייני מוצר

_NAPROXEN (Naproxen Tablets) _
_Page 1 of 47_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
NAPROXEN – 250
PR
NAPROXEN – 375
PR
NAPROXEN – 500
Naproxen Tablets
Tablets, 250 mg, 375 mg and 500 mg, Oral
USP
ATC Code: M01AE02
Non-Steroidal Anti-Inflammatory Drug (NSAID)
PRO DOC LTÉE
2925, Boul. Industriel
Laval, Québec
H7L 3W9
Date of Initial Authorization:
March 11, 1983
Date of Revision
November 14, 2023
_ _
Submission Control Number: 278690
_NAPROXEN (Naproxen Tablets) _
_Page 2 of 47_
RECENT MAJOR LABEL CHANGES
2 CONTRAINDICATIONS
11/2023
3 SERIOUS WARNING AND PRECAUTIONS BOX
11/2023
7 WARNINGS AND PRECAUTIONS
11/2023
7 WARNINGS AND PRECAUTIONS, 7.1.1 Pregnant Women
11/2023
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED.
RECENT MAJOR LABEL CHANGES
.............................................................................................
2
TABLE OF CONTENTS
...............................................................................................................
2
PART I: HEALTH PROFESSIONAL INFORMATION
.......................................................................
4
1
INDICATIONS
...................................................................................................................
4
1.1
Pediatrics
....................................................................................................................
4
1.2
Geriatrics
....................................................................................................................
4
2
CONTRAINDICATIONS
.......................................................................................................
5
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
.................................................................. 6
4
DOSAGE AND ADMINISTRATION
.......................................................................................
7
4.1
Dosing Considerations
..................................................................................