FLUVOXAMINE TABLET

দেশ: কানাডা

ভাষা: ইংরেজি

সূত্র: Health Canada

সক্রিয় উপাদান:

FLUVOXAMINE MALEATE

থেকে পাওয়া:

APOTEX INC

এটিসি কোড:

N06AB08

INN (আন্তর্জাতিক নাম):

FLUVOXAMINE

ডোজ:

100MG

ফার্মাসিউটিকাল ফর্ম:

TABLET

রচনা:

FLUVOXAMINE MALEATE 100MG

প্রশাসন রুট:

ORAL

প্যাকেজ ইউনিট:

100

প্রেসক্রিপশন টাইপ:

Prescription

থেরাপিউটিক এলাকা:

SELECTIVE-SEROTONIN REUPTAKE INHIBITORS

পণ্য সারাংশ:

Active ingredient group (AIG) number: 0122450001; AHFS:

অনুমোদন অবস্থা:

APPROVED

অনুমোদন তারিখ:

2020-03-20

পণ্য বৈশিষ্ট্য

Page 1 of 51
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION
INFORMATION
PR
FLUVOXAMINE
Fluvoxamine Maleate Tablets
Tablets, 50 mg and 100 mg, Oral
BP
Antidepressant, Antiobsessional Agent
_ _
CONTROL NUMBER:_ _253928_ _
_ _
_ _
APOTEX INC.
150 SIGNET DRIVE
TORONTO, ONTARIO
M9L 1T9
DATE OF INITIAL AUTHORIZATION:
April 29, 1997
DATE OF REVISION:
December 06, 2021
Page 2 of 51
RECENT MAJOR LABEL CHANGES
7 WARNINGS AND PRECAUTIONS
12/2021
7 WARNINGS AND PRECAUTIONS, 7.1.1 Pregnant
Women
12/2021
7 WARNINGS AND PRECAUTIONS, Hematologic
12/2021
7 WARNINGS AND PRECAUTIONS,
Serotonin Toxicity/Neuroleptic Malignant
Syndrome
12/2021
7 WARNINGS AND PRECAUTIONS,
Reproductive Health: Male and Female Potential
12/2021
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
.................................................................................................................
2
PART I: HEALTH PROFESSIONAL INFORMATION
............................................................................
4
1 INDICATIONS
.........................................................................................................................
4
1.1 Pediatrics
....................................................................................................................
4
1.2 Geriatrics
....................................................................................................................
4
2 CONTRAINDICATIONS
..........................................................................................................
4
4 DOSAGE AND ADMINISTRATION
...........................................................................................
5
4.1 Dosing Considerations
....................................................................................................
5
4.2 Recommended Dose and Dosage Adjustment
...............