DIFLUNISAL TABLET

Երկիր: Կանադա

Լեզու: անգլերեն

Աղբյուրը: Health Canada

Ակտիվ բաղադրիչ:

DIFLUNISAL

Հասանելի է:

AA PHARMA INC

ATC կոդը:

N02BA11

INN (Միջազգային անվանումը):

DIFLUNISAL

Դոզան:

500MG

Դեղագործական ձեւ:

TABLET

Կազմը:

DIFLUNISAL 500MG

Կառավարման երթուղին:

ORAL

Միավորները փաթեթում:

100/500

Ռեկվիզորի տեսակը:

Prescription

Թերապեւտիկ տարածք:

OTHER NONSTEROIDAL ANTIIMFLAMMATORY AGENTS

Ապրանքի ամփոփագիր:

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

Լիազորման կարգավիճակը:

APPROVED

Հաստատման ամսաթիվը:

2014-04-11

Ապրանքի հատկությունները

_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