LUPIN-TIOTROPIUM CAPSULE

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

TIOTROPIUM (TIOTROPIUM BROMIDE MONOHYDRATE)

Available from:

LUPIN PHARMA CANADA LIMITED

ATC code:

R03BB04

INN (International Name):

TIOTROPIUM BROMIDE

Dosage:

18MCG

Pharmaceutical form:

CAPSULE

Composition:

TIOTROPIUM (TIOTROPIUM BROMIDE MONOHYDRATE) 18MCG

Administration route:

INHALATION

Units in package:

15G/50G

Prescription type:

Prescription

Product summary:

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

Authorization status:

APPROVED

Authorization date:

2023-05-12

Summary of Product characteristics

_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
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2
TABLE OF CONTENTS
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2
PART I: HEALTH PROFESSIONAL INFORMATION
......................................................................
4
1
INDICATIONS
...............................................................................................................
4
1.1
Pediatrics
................................................................................................................
4
1.2
Geriatrics
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4
2
CONTRAINDICATIONS
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4
4
DOSAGE AND ADMINISTRATION
..................................................................................
4
4.1
Dosing Considerations
............................................................................................
4
4.2
Recommended Dose and Dosage Adjustment
........................................................ 5
4.4
Administration
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