APO-LORATADINE TABLET
Land: Canada
Sprog: engelsk
Kilde: Health Canada
Produktets egenskaber
(SPC)
27-08-2019
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Aktiv bestanddel:
LORATADINE
Tilgængelig fra:
APOTEX INC
ATC-kode:
R06AX13
INN (International Name):
LORATADINE
Dosering:
10MG
Lægemiddelform:
TABLET
Sammensætning:
LORATADINE 10MG
Indgivelsesvej:
ORAL
Enheder i pakken:
12/18/100
Recept type:
OTC
Terapeutisk område:
SECOND GENERATION ANTIHISTAMINES
Produkt oversigt:
Active ingredient group (AIG) number: 0120416001; AHFS:
Autorisation status:
APPROVED
Autorisation dato:
2010-10-08
Produktets egenskaber
Page 1 of 20
PRODUCT MONOGRAPH
APO-LORATADINE
LORATADINE TABLETS USP
10 MG
HISTAMINE H
1 RECEPTOR ANTAGONIST
APOTEX INC.
DATE OF REVISION:
150 SIGNET DRIVE
AUGUST 26, 2019
TORONTO, ONTARIO
M9L 1T9
SUBMISSION CONTROL NO: 229215
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 INF
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