ZENHALE AEROSOL, METERED DOSE

দেশ: কানাডা

ভাষা: ইংরেজি

সূত্র: Health Canada

সক্রিয় উপাদান:

MOMETASONE FUROATE; FORMOTEROL FUMARATE DIHYDRATE

থেকে পাওয়া:

ORGANON CANADA INC.

এটিসি কোড:

R03AK09

INN (আন্তর্জাতিক নাম):

FORMOTEROL AND MOMETASONE

ডোজ:

50MCG; 5MCG

ফার্মাসিউটিকাল ফর্ম:

AEROSOL, METERED DOSE

রচনা:

MOMETASONE FUROATE 50MCG; FORMOTEROL FUMARATE DIHYDRATE 5MCG

প্রশাসন রুট:

INHALATION

প্যাকেজ ইউনিট:

100

প্রেসক্রিপশন টাইপ:

Prescription

থেরাপিউটিক এলাকা:

SELECTIVE BETA 2-ADRENERGIC AGONISTS

পণ্য সারাংশ:

Active ingredient group (AIG) number: 0252871006; AHFS:

অনুমোদন অবস্থা:

CANCELLED POST MARKET

অনুমোদন তারিখ:

2022-10-13

পণ্য বৈশিষ্ট্য

_ZENHALE_
®
_ (mometasone furoate / formoterol fumarate dihydrate inhalation
aerosol) _
_Page 1 of 44_
PRODUCT MONOGRAPH
ZENHALE
®
mometasone furoate and formoterol fumarate dihydrate
Inhalation aerosol
50 mcg / 5 mcg per actuation
100 mcg / 5 mcg per actuation
200 mcg / 5 mcg per actuation
Corticosteroid and long-acting beta
2
-agonist combination
for oral inhalation
ORGANON CANADA INC.
16766 route Transcanadienne
Kirkland, QC Canada H9H 4M7
www.organon.ca
Date of Revision:
April 23, 2021
Submission
Control No: 239493
_ZENHALE_
®
_ (mometasone furoate / formoterol fumarate dihydrate inhalation
aerosol) _
_Page 2 of 44_
RECENT MAJOR LABEL CHANGES
Serious Warnings and Precautions, General
MAY2020
Dosage and Administration, Recommended dose and dosage adjustment
MAY2020
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............................................................................................
11
DRUG INTERACTIONS
............................................................................................
14
DOSAGE AND ADMINISTRATION
.........................................................................
15
OVERDOSAGE
.........................................................................................................
18
ACTION AND CLINICAL
PHARMACOLOGY.........................................................
18
STORAGE AND STABILITY
....................................................................................
22
SPECIAL HANDLING INSTRUCTIONS
..................................................