ATECTURA BREEZHALER CAPSULE
देश: कनाडा
भाषा: अंग्रेज़ी
स्रोत: Health Canada
उत्पाद विशेषताएं
(SPC)
12-11-2021
इस उत्पाद के लिए कुछ दस्तावेज़ वर्तमान में उपलब्ध नहीं हैं, आप हमारी ग्राहक सेवा को अनुरोध भेज सकते हैं और जैसे ही हम उन्हें प्राप्त करने में सक्षम होंगे, हम आपको सूचित करेंगे।
अनुरोध भेजा।
अनुरोध भेजा।
सक्रिय संघटक:
INDACATEROL (INDACATEROL ACETATE); MOMETASONE FUROATE
थमां उपलब्ध:
NOVARTIS PHARMACEUTICALS CANADA INC
ए.टी.सी कोड:
R03AK14
INN (इंटरनेशनल नाम):
INDACATEROL AND MOMETASONE
डोज़:
150MCG; 160MCG
फार्मास्यूटिकल फॉर्म:
CAPSULE
रचना:
INDACATEROL (INDACATEROL ACETATE) 150MCG; MOMETASONE FUROATE 160MCG
प्रशासन का मार्ग:
INHALATION
पैकेज में यूनिट:
15G/50G
प्रिस्क्रिप्शन प्रकार:
Prescription
चिकित्सीय क्षेत्र:
ADRENALS
उत्पाद समीक्षा:
Active ingredient group (AIG) number: 0262235003; AHFS:
प्राधिकरण का दर्जा:
APPROVED
प्राधिकरण की तारीख:
2020-05-06
उत्पाद विशेषताएं
_ATECTURA_
_®_
_ BREEZHALER_
_®_
_ Product Monograph _
_Page 1 of 39_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
ATECTURA® BREEZHALER®
Indacaterol (as acetate)/mometasone furoate inhalation powder hard
capsules
150 mcg/80 mcg
150 mcg/160 mcg
150 mcg/320 mcg
ATECTURA BREEZHALER capsules to be used only with the supplied
ATECTURA BREEZHALER inhalation
device
Bronchodilator (Long-Acting Beta
2
-Adrenergic Agonist (LABA)) and Inhaled Corticosteroid (ICS)
Combination for Oral Inhalation
Novartis Pharmaceuticals Canada Inc.
385 Bouchard Blvd.
Dorval, Quebec
H9S 1A9
Date of Initial Authorization:
May 5, 2020
Date of Revision:
Nov 12, 2021
Submission Control Number: 246914
ATECTURA and BREEZHALER are registered trademarks.
_ _
_ATECTURA_
_®_
_ BREEZHALER_
_®_
_ Product Monograph _
_Page 2 of 39_
RECENT MAJOR LABEL CHANGES
7 Warnings and Precautions, Endocrine and Metabolism
11/2021
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED
.
RECENT MAJOR LABEL CHANGES
...........................................................................................
2
TABLE OF CONTENTS
.............................................................................................................
2
PART I: HEALTH PROFESSIONAL INFORMATION
.....................................................................
4
1
INDICATIONS
..............................................................................................................
4
1.1
Pediatrics
...................................................................................................................
4
1.2
Geriatrics
...................................................................................................................
4
2
CONTRAINDICATIONS
.................................................................................................
4
4
DOSAGE AND ADMINISTRATION
.................................................................................
4
4.1
Dosing Considerations
..........
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