Država: Kanada
Jezik: angleščina
Source: Health Canada
TIOTROPIUM (TIOTROPIUM BROMIDE MONOHYDRATE)
LUPIN PHARMA CANADA LIMITED
R03BB04
TIOTROPIUM BROMIDE
18MCG
CAPSULE
TIOTROPIUM (TIOTROPIUM BROMIDE MONOHYDRATE) 18MCG
INHALATION
15G/50G
Prescription
Active ingredient group (AIG) number: 0148683001; AHFS:
APPROVED
2023-05-12
_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 .............................. Preberite celoten dokument