Država: Kanada
Jezik: engleski
Izvor: Health Canada
TERBUTALINE SULFATE
ASTRAZENECA CANADA INC
R03AC03
TERBUTALINE
0.5MG
POWDER (METERED DOSE)
TERBUTALINE SULFATE 0.5MG
INHALATION
200
Prescription
SELECTIVE BETA 2-ADRENERGIC AGONISTS
Active ingredient group (AIG) number: 0110482003; AHFS:
APPROVED
2000-05-01
_ _ BRICANYL ® TURBUHALER ® Product Monograph_ _ _Page 1 of 23_ PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION BRICANYL ® TURBUHALER ® terbutaline sulfate Dry powder, 0.5 mg/dose, Oral Inhalation Bronchodilator AstraZeneca Canada Inc. 1004 Middlegate Road Mississauga, Ontario L4Y 1M4 www.astrazeneca.ca Date of Initial Authorization: NOV 16, 1988 Date of Revision: MAY 24, 2023 Submission Control Number: 270964 BRICANYL ® , TURBUHALER ® and the AstraZeneca logo are registered trademarks of AstraZeneca AB, used under license by AstraZeneca Canada Inc. © AstraZeneca Canada Inc. 2023 _ _ BRICANYL ® TURBUHALER ® Product Monograph_ _ _Page 2 of 23_ RECENT MAJOR LABEL CHANGES 1 INDICATIONS, 1.1 Pediatrics 06/2021 1 INDICATIONS, 1.2 Geriatrics 06/2021 2 CONTRAINDICATIONS 06/2021 7 WARNINGS AND PRECAUTIONS, General 12/2022 7 WARNINGS AND PRECAUTIONS, Sensitivity/Resistance 06/2021 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 ................. Pročitajte cijeli dokument