APO-SILDENAFIL TABLET

国: カナダ

言語: 英語

ソース: Health Canada

有効成分:

SILDENAFIL (SILDENAFIL CITRATE)

から入手可能:

APOTEX INC

ATCコード:

G04BE03

INN（国際名）:

SILDENAFIL

投薬量:

25MG

医薬品形態:

TABLET

構図:

SILDENAFIL (SILDENAFIL CITRATE) 25MG

投与経路:

ORAL

パッケージ内のユニット:

4

処方タイプ:

Prescription

治療領域:

PHOSPHODIESTERASE TYPE 5 INHIBITORS

製品概要:

Active ingredient group (AIG) number: 0136261001; AHFS:

認証ステータス:

APPROVED

承認日:

2012-11-09

製品の特徴

_ _
_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