APO-DICLO TABLET (ENTERIC-COATED)

Country: কানাডা

ভাষা: ইংরেজি

সূত্র: Health Canada

সক্রিয় উপাদান:

DICLOFENAC SODIUM

থেকে পাওয়া:

APOTEX INC

এটিসি কোড:

M01AB05

INN (International Name):

DICLOFENAC

ডোজ:

50MG

ফার্মাসিউটিকাল ফর্ম:

TABLET (ENTERIC-COATED)

রচনা:

DICLOFENAC SODIUM 50MG

প্রশাসন রুট:

ORAL

প্যাকেজ ইউনিট:

100/500

প্রেসক্রিপশন টাইপ:

Prescription

Therapeutic area:

OTHER NONSTEROIDAL ANTIIMFLAMMATORY AGENTS

পণ্য সারাংশ:

Active ingredient group (AIG) number: 0114417002; AHFS:

অনুমোদন অবস্থা:

MARKETED

অনুমোদন তারিখ:

1989-12-31

পণ্য বৈশিষ্ট্য

_APO-DICLO and APO-DICLO SR diclofenac sodium Page 1 of 52 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
APO-DICLO
Diclofenac Sodium Delayed-Release Tablets
Delayed-Release Tablets, 25 mg and 50 mg, for oral use
USP
PR
APO-DICLO SR
Diclofenac Sodium Slow-Release Tablets
Slow Release Tablets, 75 mg and 100 mg, for oral use
Apotex Standard
Non-Steroidal Anti-Inflammatory Drug (NSAID)
APOTEX INC.
150 Signet Drive
Toronto, Ontario
M9L 1T9
Date of Initial Authorization:
DEC 31, 1989
Date of Revision:
SEP 22, 2022
Submission Control Number: 260911
_APO-DICLO and APO-DICLO SR diclofenac sodium Page 2 of 52 _
RECENT MAJOR LABEL CHANGES
3 SERIOUS WARNINGS AND PRECAUTIONS BOX- Risk in Pregnancy
09/2022
7 WARNINGS AND PRECAUTIONS, Monitoring and Laboratory Tests,
_Pregnancy_
09/2022
7 WARNINGS AND PRECAUTIONS, Skin, _Serious skin reactions_
09/2022
7 WARNINGS AND PRECAUTIONS, 7.1.1 Pregnant Women
09/2022
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED.
RECENT MAJOR LABEL
CHANGES.............................................................................................
2
TABLE OF CONTENTS
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2
PART I: HEALTH PROFESSIONAL INFORMATION
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4
1
INDICATIONS
................................................................................................................
4
1.1
Pediatrics
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4
1.2
Geriatrics
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4
2
CONTRAINDICATIONS
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5
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
.............................................................. 5
4
DOSAGE AND
ADMINISTRATION......