DIFLUNISAL TABLET

Država: Kanada

Jezik: angleščina

Source: Health Canada

Aktivna sestavina:

DIFLUNISAL

Dostopno od:

AA PHARMA INC

Koda artikla:

N02BA11

INN (mednarodno ime):

DIFLUNISAL

Odmerek:

500MG

Farmacevtska oblika:

TABLET

Sestava:

DIFLUNISAL 500MG

Pot uporabe:

ORAL

Enote v paketu:

100/500

Tip zastaranja:

Prescription

Terapevtsko območje:

OTHER NONSTEROIDAL ANTIIMFLAMMATORY AGENTS

Povzetek izdelek:

Active ingredient group (AIG) number: 0113161002; AHFS:

Status dovoljenje:

APPROVED

Datum dovoljenje:

2014-04-11

Lastnosti izdelka

_DIFLUNISAL (diflunisal tablets) _
_Page 1 of 47_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
DIFLUNISAL
Diflunisal Tablets
Tablet, 250 mg and 500 mg, Oral
USP
Non-Steroidal Anti-inflammatory Drug (NSAID)
AA PHARMA INC.
1165 Creditstone Road, Unit #1
Vaughan, Ontario
L4K 4N7
Date of Initial Authorization:
April 10, 2014
Date of Revision:
September 23, 2022
Submission Control Number: 262252
_ _
_DIFLUNISAL (diflunisal tablets) _
_Page 2 of 47_
RECENT MAJOR LABEL CHANGES
1 INDICATIONS
09/2022
2 CONTRAINDICATIONS
09/2022
3 SERIOUS WARNINGS AND PRECAUTIONS BOX, Risk of
Cardiovascular (CV) Adverse Events
09/2022
3 SERIOUS WARNINGS AND PRECAUTIONS BOX, Risk of
Gastrointestinal (GI) Adverse Events
09/2022
3 SERIOUS WARNINGS AND PRECAUTIONS BOX, Risk in
Pregnancy
09/2022
4 DOSAGE AND ADMINISTRATION, 4.1 Dosing Considerations
09/2022
4 DOSAGE AND ADMINISTRATION, 4.2 Recommended Dose
and Dosage Adjustment
09/2022
7 WARNINGS AND PRECAUTIONS, General
09/2022
7 WARNINGS AND PRECAUTIONS, Cardiovascular
09/2022
7 WARNINGS AND PRECAUTIONS, Driving and Operating
Machinery
09/2022
7 WARNINGS AND PRECAUTIONS, Endocrine and Metabolism
09/2022
7 WARNINGS AND PRECAUTIONS, Gastrointestinal
09/2022
7 WARNINGS AND PRECAUTIONS, Genitourinary
09/2022
7 WARNINGS AND PRECAUTIONS, Hematologic
09/2022
7 WARNINGS AND PRECAUTIONS, Hepatic/Biliary/Pancreatic
09/2022
7 WARNINGS AND PRECAUTIONS, Immune
09/2022
7 WARNINGS AND PRECAUTIONS, Monitoring and Laboratory
Tests
09/2022
7 WARNINGS AND PRECAUTIONS, Neurologic
09/2022
7 WARNINGS AND PRECAUTIONS, Psychiatric
09/2022
7 WARNINGS AND PRECAUTIONS, Renal
09/2022
7 WARNINGS AND PRECAUTIONS, Reproductive Health:
Female and Male Potential, Fertility
09/2022
7 WARNINGS AND PRECAUTIONS, Respiratory
09/2022
7 WARNINGS AND PRECAUTIONS, Skin
09/2022
7 WARNINGS AND PRECAUTIONS, 7.1.1 Pregnant women
09/2022
_ _
_DIFLUNISAL (diflunisal tablets) _
_Page 3 of 47_
7 WARNINGS AND PRECAUTIONS, 7.1.2 Breast-feeding
09/2022
7 WARNINGS AND PRECAUTIONS, 7.1.4 Geriatrics
09/2022
TABLE OF CONTENTS
SECTI