JAMP-SILDENAFIL TABLET

Држава: Канада

Језик: Енглески

Извор: Health Canada

Активни састојак:

SILDENAFIL (SILDENAFIL CITRATE)

Доступно од:

JAMP PHARMA CORPORATION

АТЦ код:

G04BE03

INN (Међународно име):

SILDENAFIL

Дозирање:

25MG

Фармацеутски облик:

TABLET

Састав:

SILDENAFIL (SILDENAFIL CITRATE) 25MG

Пут администрације:

ORAL

Јединице у пакету:

4

Тип рецептора:

Prescription

Терапеутска област:

PHOSPHODIESTERASE TYPE 5 INHIBITORS

Резиме производа:

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

Статус ауторизације:

CANCELLED POST MARKET

Датум одобрења:

2022-09-07

Карактеристике производа

_Jamp-SILDENAFIL (Sildenafil Citrate Tablets) 25 mg, 50 mg, 100 mg _
_Page 1 of 44_
_ _
PRODUCT MONOGRAPH
PR JAMP-SILDENAFIL
sildenafil (as sildenafil citrate) tablets
25 mg, 50 mg and 100 mg
cGMP-Specific Phosphodiesterase Type 5 Inhibitor
Treatment of Erectile Dysfunction
SPONSOR:
Jamp Pharma Corporation
DATE OF PREPARATION:
1380-203 Newton
April 24, 2013
Boucherville, Québec
J4B 5H2
SUBMISSION CONTROL NO: 163804
_Jamp-SILDENAFIL (Sildenafil Citrate Tablets) 25 mg, 50 mg, 100 mg _
_Page 2 of 44_
_ _
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
....................................................................................................10
DOSAGE AND
ADMINISTRATION................................................................................13
OVERDOSAGE
..................................................................................................................14
ACTION AND CLINICAL PHARMACOLOGY
..............................................................15
STORAGE AND
STABILITY............................................................................................18
SPECIAL HANDLING INSTRUCTIONS
.........................................................................18
DOSAGE FORMS, COMPOSITION AND PACKAGING
...............................................18
PART II: SCIENTIFIC INFORMATION
.....................................................................