Kraj: Kanada
Język: angielski
Źródło: Health Canada
BECLOMETHASONE DIPROPIONATE
TEVA CANADA LIMITED
R01AD01
BECLOMETHASONE
80MCG
METERED-DOSE AEROSOL
BECLOMETHASONE DIPROPIONATE 80MCG
NASAL
50 ACTUATIONS, 120 ACTUATIONS
Prescription
CORTICOSTEROIDS
Active ingredient group (AIG) number: 0106320007; AHFS:
CANCELLED PRE MARKET
2023-11-16
QNASL™ (beclomethasone dipropionate) Nasal Aerosol Product Monograph_ _ _Page 1 of 38_ PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION PR QNASL™ beclomethasone dipropionate Metered Dose Aerosol 40 mcg/actuation and 80 mcg/actuation Corticosteroid for Nasal Use Teva Canada Innovation Montréal, Quebec H2Z 1S8 Distributed by: Teva Canada Limited Toronto, Ontario M1B 2K9 Date of Preparation: September 16, 2015 ™ Teva Canada Innovation, 2014 Submission Control No: 168323 _ _ QNASL™ (beclomethasone dipropionate) Nasal Aerosol Product Monograph_ _ _Page 2 of 38_ 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 ..................................................................................................11 DOSAGE AND ADMINISTRATION ..............................................................................11 OVERDOSAGE ................................................................................................................12 ACTION AND CLINICAL PHARMACOLOGY ............................................................12 STORAGE AND STABILITY ..........................................................................................14 DOSAGE FORMS, COMPOSITION AND PACKAGING .............................................15 PART II: SCIENTIFIC INFORMATION ...............................................................................16 PHARMACEUTICAL INFORMATIO Przeczytaj cały dokument