APO-NAPRO-NA TABLET

País: Canadá

Língua: inglês

Origem: Health Canada

Ingredientes ativos:

NAPROXEN SODIUM

Disponível em:

APOTEX INC

Código ATC:

M01AE02

DCI (Denominação Comum Internacional):

NAPROXEN

Dosagem:

275MG

Forma farmacêutica:

TABLET

Composição:

NAPROXEN SODIUM 275MG

Via de administração:

ORAL

Unidades em pacote:

100/500

Tipo de prescrição:

Prescription

Área terapêutica:

OTHER NONSTEROIDAL ANTIIMFLAMMATORY AGENTS

Resumo do produto:

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

Status de autorização:

MARKETED

Data de autorização:

1989-12-31

Características técnicas

_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
..............................................................................