APO-NAPROXEN SR TABLETS 750MG TABLET (EXTENDED-RELEASE)

Valsts: Kanāda

Valoda: angļu

Klimata pārmaiņas: Health Canada

Aktīvā sastāvdaļa:

NAPROXEN

Pieejams no:

APOTEX INC

ATĶ kods:

M01AE02

SNN (starptautisko nepatentēto nosaukumu):

NAPROXEN

Deva:

750MG

Zāļu forma:

TABLET (EXTENDED-RELEASE)

Kompozīcija:

NAPROXEN 750MG

Ievadīšanas:

ORAL

Vienības iepakojumā:

100

Receptes veids:

Prescription

Ārstniecības joma:

OTHER NONSTEROIDAL ANTIIMFLAMMATORY AGENTS

Produktu pārskats:

Active ingredient group (AIG) number: 0109634005; AHFS:

Autorizācija statuss:

APPROVED

Autorizācija datums:

1999-05-04

Produkta apraksts

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_Page 1 of 44 _
PRODUCT MONOGRAPH
PR
APO-NAPROXEN
Naproxen Tablets
125 mg, 250 mg, 375 mg and 500 mg
USP
PR
APO-NAPROXEN SR
Naproxen Sustained-Release Tablets
750 mg
Apotex Standard
PR
APO-NAPROXEN EC
Naproxen Enteric-Coated Tablets
250 mg, 375 mg and 500 mg
Apotex Standard
Non-Steroidal Anti-Inflammatory Drug (NSAID)
APOTEX INC.
DATE OF REVISION:
150 SIGNET DRIVE
JUNE 29, 2015
TORONTO, ONTARIO
M9L 1T9
_Control No# 168736 _
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_Page 2 of 44 _
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
........................................................................................
3
SUMMARY PRODUCT INFORMATION
...............................................................................................................
3
INDICATIONS AND CLINICAL USE
.....................................................................................................................
3
CONTRAINDICATIONS
...........................................................................................................................................
4
WARNINGS AND PRECAUTIONS
.........................................................................................................................
5
ADVERSE REACTIONS
.........................................................................................................................................
14
OVERDOSAGE
.........................................................................................................................................................
22
ACTION AND CLINICAL PHARMACOLOGY
..................................................................................................
22
STORAGE AND STABILITY
.................................................................................................................................
24
DOSAGE FORMS, COMPOSITION AND
PACKAGING...................................................................................
24
PART II: SCIENTIFIC INFORMATION
....................................................