Land: Canada
Sprog: engelsk
Kilde: Health Canada
LORATADINE
APOTEX INC
R06AX13
LORATADINE
10MG
TABLET
LORATADINE 10MG
ORAL
2/6/12/18/30/100
OTC
SECOND GENERATION ANTIHISTAMINES
Active ingredient group (AIG) number: 0120416001; AHFS:
APPROVED
2011-04-26
Page 1 of 20 PRODUCT MONOGRAPH LORATADINE LORATADINE TABLETS USP 10 MG HISTAMINE H 1 RECEPTOR ANTAGONIST APOTEX INC. 150 SIGNET DRIVE TORONTO, ONTARIO M9L 1T9 DATE OF REVISION: APRIL 21, 2020 SUBMISSION CONTROL NO: 237715 Page 2 of 20 TABLE OF CONTENTS PART I: HEALTH PROFESSIONAL INFORMATION ................................................................................. 3 SUMMARY PRODUCT INFORMATION ................................................................................................... 3 INDICATIONS AND CLINICAL USE ......................................................................................................... 3 CONTRAINDICATIONS ............................................................................................................................ 3 WARNINGS AND PRECAUTIONS ........................................................................................................... 4 ADVERSE REACTIONS ........................................................................................................................... 4 DRUG INTERACTIONS ............................................................................................................................ 6 DOSAGE AND ADMINISTRATION ........................................................................................................... 6 OVERDOSAGE ......................................................................................................................................... 6 ACTION AND CLINICAL PHARMACOLOGY ........................................................................................... 7 STORAGE AND STABILITY ..................................................................................................................... 9 DOSAGE FORMS, COMPOSITION AND PACKAGING .......................................................................... 9 PART II: SCIENTIFIC INFORMATION ....................................................................................................... 10 PHARMACEUTICAL INFORMAT Læs hele dokumentet