NABUMETONE TABLET

Land: Kanada

Tungumál: enska

Heimild: Health Canada

Virkt innihaldsefni:

NABUMETONE

Fáanlegur frá:

APOTEX INC

ATC númer:

M01AX01

INN (Alþjóðlegt nafn):

NABUMETONE

Skammtar:

500MG

Lyfjaform:

TABLET

Samsetning:

NABUMETONE 500MG

Stjórnsýsluleið:

ORAL

Einingar í pakka:

100

Gerð lyfseðils:

Prescription

Lækningarsvæði:

OTHER NONSTEROIDAL ANTIIMFLAMMATORY AGENTS

Vörulýsing:

Active ingredient group (AIG) number: 0122821001; AHFS:

Leyfisstaða:

APPROVED

Leyfisdagur:

2021-06-07

Vara einkenni

_NABUMETONE (Nabumetone tablets) _
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_Page 1 of 53 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
NABUMETONE
Nabumetone Tablets
Tablet, 500 mg, Oral
BP
Nonsteroidal Anti-Inflammatory Agent
APOTEX INC.
150 Signet Drive
Toronto, Ontario
M9L 1T9
Date of Initial Authorization:
JUL 14, 1998
Date of Revision:
JAN 05, 2023
Submission Control Number. 266570
_NABUMETONE (Nabumetone tablets) _
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_Page 2 of 53 _
RECENT MAJOR LABEL CHANGES
1 INDICATIONS
05/2022
1 INDICATIONS, 1.1 Pediatrics
05/2022
1 INDICATIONS, 1.2 Geriatrics
05/2022
2 CONTRAINDICATIONS
05/2022
3 SERIOUS WARNINGS AND PRECAUTIONS BOX, Risk of
Cardiovascular (CV) Adverse Events
05/2022
3 SERIOUS WARNINGS AND PRECAUTIONS BOX, Risk of
Gastrointestinal (GI) Adverse Events
05/2022
3 SERIOUS WARNINGS AND PRECAUTIONS BOX, Risk in
Pregnancy
05/2022
4 Dosage and Administration, 4.1 Dosing Considerations
01/2023
4 Dosage and Administration, 4.2 Recommended Dose and
Dosage Adjustment
01/2023
7 WARNINGS AND PRECAUTIONS, General
05/2022
7 WARNINGS AND PRECAUTIONS, Cardiovascular
05/2022
7 WARNINGS AND PRECAUTIONS, Driving and Operating
Machinery
01/2023
7 WARNINGS AND PRECAUTIONS, Endocrine and Metabolism
05/2022
7 WARNINGS AND PRECAUTIONS, Gastrointestinal
05/2022
7 WARNINGS AND PRECAUTIONS, Hematologic
05/2022
7 WARNINGS AND PRECAUTIONS, Hepatic/Biliary/Pancreatic
05/2022
7 WARNINGS AND PRECAUTIONS, Immune
05/2022
7 WARNINGS AND PRECAUTIONS, Monitoring and Laboratory
Tests
05/2022
7 WARNINGS AND PRECAUTIONS, Neurologic
05/2022
7 WARNINGS AND PRECAUTIONS, Psychiatric
05/2022
7 WARNINGS AND PRECAUTIONS, Renal
05/2022
7 WARNINGS AND PRECAUTIONS, Reproductive Health:
Female and Male Potential, Fertility
05/2022
7 WARNINGS AND PRECAUTIONS, Reproductive Health:
01/2023
_NABUMETONE (Nabumetone tablets) _
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_Page 3 of 53 _
Teratogenic Risk
7 WARNINGS AND PRECAUTIONS, Respiratory
05/2022
7 WARNINGS AND PRECAUTIONS, Skin
05/2022
7 WARNINGS AND PRECAUTIONS, 7.1.1 Pregnant women
05/2022
7 WARNINGS AND PRECAUTIONS, 7.1.2 Breast-feeding
05/2022
7