APO-SILDENAFIL TABLET

দেশ: কানাডা

ভাষা: ইংরেজি

সূত্র: Health Canada

সক্রিয় উপাদান:

SILDENAFIL (SILDENAFIL CITRATE)

থেকে পাওয়া:

APOTEX INC

এটিসি কোড:

G04BE03

INN (আন্তর্জাতিক নাম):

SILDENAFIL

ডোজ:

100MG

ফার্মাসিউটিকাল ফর্ম:

TABLET

রচনা:

SILDENAFIL (SILDENAFIL CITRATE) 100MG

প্রশাসন রুট:

ORAL

প্যাকেজ ইউনিট:

4/30

প্রেসক্রিপশন টাইপ:

Prescription

থেরাপিউটিক এলাকা:

PHOSPHODIESTERASE TYPE 5 INHIBITORS

পণ্য সারাংশ:

Active ingredient group (AIG) number: 0136261003; AHFS:

অনুমোদন অবস্থা:

APPROVED

অনুমোদন তারিখ:

2012-11-09

পণ্য বৈশিষ্ট্য

_ _
_APO-SILDENAFIL (sildenafil citrate) _
_–_
_ Product Monograph _
_Page 1 of 57_
PRODUCT MONOGRAPH
PR
APO-SILDENAFIL
Sildenafil Tablets
Tablets, 25 mg, 50 mg and 100 mg sildenafil (as sildenafil citrate)
Apotex Standard
cGMP-Specific Phosphodiesterase Type 5 Inhibitor
Treatment of Erectile Dysfunction
Apotex Inc.
150 Signet Drive
Toronto, Ontario
M9L 1T9
Date of Revision:
April 5, 2023
Submission Control No: 268822
_APO-SILDENAFIL (sildenafil citrate) _
_–_
_ Product Monograph _
_Page 2 of 57_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
..........................................................3
SUMMARY PRODUCT INFORMATION
...............................................................................3
INDICATIONS AND CLINICAL USE
.....................................................................................3
CONTRAINDICATIONS
...........................................................................................................3
WARNINGS AND PRECAUTIONS
.........................................................................................4
ADVERSE REACTIONS
...........................................................................................................7
DRUG INTERACTIONS
.........................................................................................................12
DOSAGE AND ADMINISTRATION
.....................................................................................16
OVERDOSAGE
........................................................................................................................17
ACTION AND CLINICAL PHARMACOLOGY
....................................................................18
STORAGE AND STABILITY
.................................................................................................21
SPECIAL HANDLING INSTRUCTIONS
...............................................................................21
DOSAGE FORMS, COMPOSITION AND PACKAGING
....................................................21
PART II: SCIENTIFIC IN