Riik: Kanada
keel: inglise
Allikas: Health Canada
FEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE
SANOFI CONSUMER HEALTH INC
R01BA52
PSEUDOEPHEDRINE, COMBINATIONS
60MG; 120MG
TABLET (IMMEDIATE AND EXTENDED RELEASE)
FEXOFENADINE HYDROCHLORIDE 60MG; PSEUDOEPHEDRINE HYDROCHLORIDE 120MG
ORAL
10/20/30
OTC
SECOND GENERATION ANTIHISTAMINES
Active ingredient group (AIG) number: 0236381001; AHFS:
APPROVED
2000-06-02
_ALLEGRA_ _®_ _-D (fexofenadine hydrochloride/pseudoephedrine hydrochloride) _ _Page 1 of 35 _ PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION ALLEGRA ® -D Fexofenadine hydrochloride and pseudoephedrine hydrochloride caplets (Sustained-Release) Caplets, 60 mg & 120 mg, Oral Manufacturer’s Standard Histamine H 1 -Receptor Antagonist/Sympathomimetic Amine Sanofi Consumer Health Inc. 2905 Place Louis-R.-Renaud Laval, Québec H7V 0A3 Date of Revision: February 14, 2022 Submission Control Number: 253801 _ _ _ALLEGRA_ _®_ _-D (fexofenadine hydrochloride/pseudoephedrine hydrochloride) _ _Page 2 of 35 _ RECENT MAJOR LABEL CHANGES Part 1, Health Professional Information [05/2021] Part 3, Patient Medication Information [05/2021] TABLE OF CONTENTS 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 ...................................................................... 5 4.1 Dosing Considerations ............................................................................................. 5 4.2 Recommended Dose and Dosage Adjustment ......................................................... 5 4.3 Administration ......................................................................................................... 5 4.4 Missed D Lugege kogu dokumenti