البلد: كندا
اللغة: الإنجليزية
المصدر: Health Canada
FLUTICASONE PROPIONATE; SALMETEROL (SALMETEROL XINAFOATE)
PHARMASCIENCE INC
R03AK06
SALMETEROL AND FLUTICASONE
100MCG; 50MCG
POWDER
FLUTICASONE PROPIONATE 100MCG; SALMETEROL (SALMETEROL XINAFOATE) 50MCG
INHALATION
15G/50G
Prescription
ADRENALS
Active ingredient group (AIG) number: 0238341001; AHFS:
APPROVED
2019-12-10
PR PMS-FLUTICASONE PROPIONATE / SALMETEROL DPI Fluticasone Propionate and Salmeterol Inhalation Powder USP Pr pms-FLUTICASONE PROPIONATE / SALMETEROL DPI _ _ 100 mcg Fluticasone Propionate and 50 mcg Salmeterol (as the Xinafoate salt) Dry Powder Inhaler Pr pms-FLUTICASONE PROPIONATE / SALMETEROL DPI 250 mcg Fluticasone Propionate and 50 mcg Salmeterol (as the Xinafoate salt) Dry Powder Inhaler Pr pms-FLUTICASONE PROPIONATE / SALMETEROL DPI 500 mcg Fluticasone Propionate and 50 mcg Salmeterol (as the Xinafoate salt) Dry Powder Inhaler CORTICOSTEROID AND BRONCHODILATOR FOR ORAL INHALATION PHARMASCIENCE INC. 6111 Royalmount Ave., Suite 100 Montréal, Canada H4P 2T4 www.pharmascience.com DATE OF PREPARATION: November 9, 2020 Submission Control No: 242762 _pms-FLUTICASONE PROPIONATE-SALMETEROL DPI Product Monograph _ _ _ _ _ _ Page 2 of 53_ _ _ TABLE OF CONTENTS PART I: HEALTH PROFESSIONAL INFORMATION ...................................................... 3 SUMMARY PRODUCT INFORMATION ............................................................................. 3 INDICATIONS AND CLINICAL USE................................................................................... 3 CONTRAINDICATIONS ........................................................................................................ 4 WARNINGS AND PRECAUTIONS ...................................................................................... 4 ADVERSE REACTIONS ...................................................................................................... 14 DRUG INTERACTIONS ....................................................................................................... 21 DOSAGE AND ADMINISTRATION ................................................................................... 23 OVERDOSAGE ..................................................................................................................... 25 ACTION AND CLINICAL PHARMACOLOGY ................................................................. 25 STORAGE AND STABILITY .. اقرأ الوثيقة كاملة