APO-SILDENAFIL R TABLET
Land: Kanada
Språk: engelska
Källa: Health Canada
Produktens egenskaper
(SPC)
11-02-2019
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Aktiva substanser:
SILDENAFIL (SILDENAFIL CITRATE)
Tillgänglig från:
APOTEX INC
ATC-kod:
C02KX
INN (International namn):
ANTIHYPERTENSIVES FOR PULMONARY ARTERIAL HYPERTENSION
Dos:
20MG
Läkemedelsform:
TABLET
Sammansättning:
SILDENAFIL (SILDENAFIL CITRATE) 20MG
Administreringssätt:
ORAL
Enheter i paketet:
100
Receptbelagda typ:
Prescription
Terapiområde:
PHOSPHODIESTERASE TYPE 5 INHIBITORS
Produktsammanfattning:
Active ingredient group (AIG) number: 0136261004; AHFS:
Bemyndigande status:
APPROVED
Tillstånd datum:
2013-12-17
Produktens egenskaper
Page 1 of 54
PRODUCT MONOGRAPH
Pr
APO-SILDENAFIL R
SILDENAFIL TABLETS USP
20 MG SILDENAFIL (AS SILDENAFIL CITRATE)
CGMP-SPECIFIC PHOSPHODIESTERASE TYPE 5 INHIBITOR
TREATMENT OF PULMONARY ARTERIAL HYPERTENSION
APOTEX INC. DATE OF REVISION:
150 SIGNET DRIVE
FEBRUARY 11, 2019
TORONTO, ONTARIO
M9L 1T9
SUBMISSION CONTROL NO:
224315
Page 2 of 54
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
...........................................................................................................
9
DOSAGE AND ADMINISTRATION
.......................................................................................
20
OVERDOSAGE
......................................................................................................................
21
ACTION AND CLINICAL PHARMACOLOGY
.......................................................................
21
STORAGE AND STABILITY
..................................................................................................
24
SPECIAL HANDLING INSTRUCTIONS
.................................................................................
24
DOSAGE FORMS, COMPOSITION AND PACKAGING
......................................................... 25
PART II: SCIENTIFIC INFORMATION ...................................................................................
26
PHARMACEUTICAL INFORMATION
...................................................................................
26
CLINICAL TRIALS
..............................
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