LUPIN-TIOTROPIUM CAPSULE

Χώρα: Καναδάς

Γλώσσα: Αγγλικά

Πηγή: Health Canada

Δραστική ουσία:

TIOTROPIUM (TIOTROPIUM BROMIDE MONOHYDRATE)

Διαθέσιμο από:

LUPIN PHARMA CANADA LIMITED

Φαρμακολογική κατηγορία (ATC):

R03BB04

INN (Διεθνής Όνομα):

TIOTROPIUM BROMIDE

Δοσολογία:

18MCG

Φαρμακοτεχνική μορφή:

CAPSULE

Σύνθεση:

TIOTROPIUM (TIOTROPIUM BROMIDE MONOHYDRATE) 18MCG

Οδός χορήγησης:

INHALATION

Μονάδες σε πακέτο:

15G/50G

Τρόπος διάθεσης:

Prescription

Περίληψη προϊόντος:

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

Καθεστώς αδειοδότησης:

APPROVED

Ημερομηνία της άδειας:

2023-05-12

Αρχείο Π.Χ.Π.

_LUPIN-TIOTROPIUM Product Monograph _
_ _
_Page 1 of 44_
_ _
`
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
_ _
_LUPIN-TIOTROPIUM Product Monograph _
_ _
_Page 2 of 44_
_ _
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
..............................