APO-NAPRO-NA TABLET

Maa: Kanada

Kieli: englanti

Lähde: Health Canada

Aktiivinen ainesosa:

NAPROXEN SODIUM

Saatavilla:

APOTEX INC

ATC-koodi:

M01AE02

INN (Kansainvälinen yleisnimi):

NAPROXEN

Annos:

275MG

Lääkemuoto:

TABLET

Koostumus:

NAPROXEN SODIUM 275MG

Antoreitti:

ORAL

Kpl paketissa:

100/500

Prescription tyyppi:

Prescription

Terapeuttinen alue:

OTHER NONSTEROIDAL ANTIIMFLAMMATORY AGENTS

Tuoteyhteenveto:

Active ingredient group (AIG) number: 0113934001; AHFS:

Valtuutuksen tilan:

MARKETED

Valtuutus päivämäärä:

1989-12-31

Valmisteyhteenveto

_APO-NAPRO-NA/APO-NAPRO-NA DS (naproxen sodium)_
Page 1 of 48
_ _
PRODUCT
MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
APO-NAPRO-NA
PR
APO-NAPRO-NA
DS
Naproxen Sodium Tablets
Tablets, 275 mg and 550 mg, Oral
USP
Non-Steroidal Anti-Inflammatory Drug (NSAID)
APOTEX INC.
150 Signet Drive,
Toronto, Ontario
M9L 1T9
Submission Control No: 260918
Date of Initial Authorization:
DEC 31, 1989
Date of Revision:
August 17, 2022
_APO-NAPRO-NA/APO-NAPRO-NA DS (naproxen sodium)_
Page 2 of 48
_ _
RECENT MAJOR LABEL CHANGES
2 CONTRAINDICATIONS
[08/2022]
3 SERIOUS WARNING AND PRECAUTIONS BOX
[08/2022]
7 WARNINGS AND PRECAUTIONS, Monitoring and
Laboratory Tests, _Pregnancy _
[08/2022]
7 WARNINGS AND PRECAUTIONS, Psychiatric
[08/2022]
7 WARNINGS AND PRECAUTIONS, Skin
[08/2022]
7 WARNINGS AND PRECAUTIONS, 7.1.1 Pregnant Women
[08/2022]
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
......................................................................................................
4
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
................................................................. 5
4
DOSAGE AND ADMINISTRATION
..............................................................................