LUPIN-TIOTROPIUM CAPSULE

국가: 캐나다

언어: 영어

출처: Health Canada

유효 성분:

TIOTROPIUM (TIOTROPIUM BROMIDE MONOHYDRATE)

제공처:

LUPIN PHARMA CANADA LIMITED

ATC 코드:

R03BB04

INN (International Name):

TIOTROPIUM BROMIDE

복용량:

18MCG

약제 형태:

CAPSULE

구성:

TIOTROPIUM (TIOTROPIUM BROMIDE MONOHYDRATE) 18MCG

관리 경로:

INHALATION

패키지 단위:

15G/50G

처방전 유형:

Prescription

제품 요약:

Active ingredient group (AIG) number: 0148683001; AHFS:

승인 상태:

APPROVED

승인 날짜:

2023-05-12

제품 특성 요약

_LUPIN-TIOTROPIUM Product Monograph _
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_Page 1 of 44_
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PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
LUPIN-TIOTROPIUM
Tiotropium inhalation powder capsules
Inhalation powder capsules, 18 mcg tiotropium (as tiotropium bromide
monohydrate), Oral
Inhalation
Bronchodilator (Long-Acting Muscarinic Antagonist (LAMA))
Capsules to be used only with the supplied LupinHaler inhalation
device
ATC R03BB04
Lupin Pharma Canada Limited
550-1111 rue St-Charles Ouest
Longueuil QC J4K 5G4
Date of Initial Authorization:
May 10, 2023
Submission Control Number: 259779
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_LUPIN-TIOTROPIUM Product Monograph _
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_Page 2 of 44_
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RECENT MAJOR LABEL CHANGES
N/A
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
............................................................................................
4
4.2
Recommended Dose and Dosage Adjustment
........................................................ 5
4.4
Administration
..............................