FLURBIPROFEN TABLET

Ülke: Kanada

Dil: İngilizce

Kaynak: Health Canada

Aktif bileşen:

FLURBIPROFEN

Mevcut itibaren:

AA PHARMA INC

ATC kodu:

M01AE09

INN (International Adı):

FLURBIPROFEN

Doz:

50MG

Farmasötik formu:

TABLET

Kompozisyon:

FLURBIPROFEN 50MG

Uygulama yolu:

ORAL

Paketteki üniteler:

100/500

Reçete türü:

Prescription

Terapötik alanı:

OTHER NONSTEROIDAL ANTIIMFLAMMATORY AGENTS

Ürün özeti:

Active ingredient group (AIG) number: 0115998002; AHFS:

Yetkilendirme durumu:

APPROVED

Yetkilendirme tarihi:

2019-02-12

Ürün özellikleri

_FLURBIPROFEN (flurbiprofen) _
_Page 1 of 41_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
FLURBIPROFEN
Flurbiprofen tablets
Tablets, 50 mg and 100 mg, for oral use
BP
Non-Steroidal Anti-Inflammatory Drug (NSAID)
AA PHARMA INC
1165 Creditstone Road, Unit #1
Vaughan, Ontario
L4K 4N7
www.aapharma.ca
Date of Initial Authorization:
APR 16, 1991
Date of Revision:
MAR 28, 2022
Submission Control Number: 257529
_ _
_FLURBIPROFEN (flurbiprofen) _
_Page 2 of 41_
RECENT MAJOR LABEL CHANGES
1 INDICATIONS
03/2022
2 CONTRAINDICATIONS
03/2022
3 SERIOUS WARNINGS AND PRECAUTIONS BOX, Risk in
Cardiovascular Adverse Events
03/2022
3 SERIOUS WARNINGS AND PRECAUTIONS BOX, Risk of
Gastrointestinal (GI) Adverse Events
03/2022
3 SERIOUS WARNINGS AND PRECAUTIONS BOX, Risk in
Pregnancy
03/2022
4 DOSAGE AND ADMINISTRATION, 4.1 Dosing considerations
03/2022
4 DOSAGE AND ADMINISTRATION, 4.2 Recommended Dose
and Dosage Adjustment
03/2022
4 DOSAGE AND ADMINISTRATION, 4.4 Administration
03/2022
7 WARNINGS AND PRECAUTIONS, General
03/2022
7 WARNINGS AND PRECAUTIONS, Cardiovascular
03/2022
7 WARNINGS AND PRECAUTIONS, Endocrine and Metabolism
03/2022
7 WARNINGS AND PRECAUTIONS, Gastrointestinal
03/2022
7 WARNINGS AND PRECAUTIONS, Genitourinary
03/2022
7 WARNINGS AND PRECAUTIONS, Hematologic
03/2022
7 WARNINGS AND PRECAUTIONS, Immune
03/2022
7 WARNINGS AND PRECAUTIONS, Monitoring and Laboratory
Tests
03/2022
7 WARNINGS AND PRECAUTIONS, Peri-Operative
Considerations
03/2022
7 WARNINGS AND PRECAUTIONS, Psychiatric
03/2022
7 WARNINGS AND PRECAUTIONS, Renal
03/2022
7 WARNINGS AND PRECAUTIONS, Reproductive Health:
Female and Male Potential
03/2022
7 WARNINGS AND PRECAUTIONS, Sensitivity/Resistance
03/2022
7 WARNINGS AND PRECAUTIONS, Skin, _Serious skin reactions_
03/2022
7 WARNINGS AND PRECAUTIONS, 7.1 Special Population, 7.1.1
03/2022
_ _
_FLURBIPROFEN (flurbiprofen) _
_Page 3 of 41_
Pregnant Women
7 WARNINGS AND PRECAUTIONS, 7.1 Special Population, 7.1.2
Breast-feeding
03/2022
7 WARNINGS AND PRECAUTIONS, 7.1 Special Population, 7.1.3