País: Canadá
Língua: inglês
Origem: Health Canada
SILDENAFIL (SILDENAFIL CITRATE)
PHARMASCIENCE INC
C02KX
ANTIHYPERTENSIVES FOR PULMONARY ARTERIAL HYPERTENSION
20MG
TABLET
SILDENAFIL (SILDENAFIL CITRATE) 20MG
ORAL
90/100
Prescription
PHOSPHODIESTERASE TYPE 5 INHIBITORS
Active ingredient group (AIG) number: 0136261004; AHFS:
APPROVED
2013-09-11
PRODUCT MONOGRAPH PR PMS-SILDENAFIL R Sildenafil Tablets 20 mg sildenafil (as sildenafil citrate) BP Standard CGMP-SPECIFIC PHOSPHODIESTERASE TYPE 5 INHIBITOR TREATMENT OF PULMONARY ARTERIAL HYPERTENSION PHARMASCIENCE INC. 6111 Royalmount Ave., Suite 100 Montréal, Québec H4P 2T4 www.pharmascience.com DATE OF REVISION: June 8, 2021 Submission Control No: 252093 _pms-SILDENAFIL R Product Monograph _ _Page 2 of 55_ 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............................................................................................ 10 DRUG INTERACTIONS ............................................................................................ 15 DOSAGE AND ADMINISTRATION ......................................................................... 21 OVERDOSAGE ......................................................................................................... 22 ACTION AND CLINICAL PHARMACOLOGY......................................................... 22 STORAGE AND STABILITY .................................................................................... 26 SPECIAL HANDLING INSTRUCTIONS ................................................................... 26 DOSAGE FORMS, COMPOSITION AND PACKAGING .......................................... 27 PART II: SCIENTIFIC INFORMATION .......................................................................... 28 PHARMACEUTICAL INFORMATION ..................................................................... 28 CLINICAL TRIALS ............................... Leia o documento completo