LORATADINE SOFT GEL CAPSULES
Land: Canada
Sprog: engelsk
Kilde: Health Canada
Produktets egenskaber
(SPC)
31-05-2019
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Aktiv bestanddel:
LORATADINE
Tilgængelig fra:
APOTEX INC
ATC-kode:
R06AX13
INN (International Name):
LORATADINE
Dosering:
10MG
Lægemiddelform:
CAPSULE
Sammensætning:
LORATADINE 10MG
Indgivelsesvej:
ORAL
Enheder i pakken:
6/10/12/18/20/24/30/36/48/72
Recept type:
OTC
Terapeutisk område:
SECOND GENERATION ANTIHISTAMINES
Produkt oversigt:
Active ingredient group (AIG) number: 0120416001; AHFS:
Autorisation status:
APPROVED
Autorisation dato:
2012-02-10
Produktets egenskaber
Page 2 of 20
PRODUCT MONOGRAPH
LORATADINE SOFT GEL CAPSULES
LORATADINE CAPSULES, 10 MG
HISTAMINE H
1 RECEPTOR ANTAGONIST
APOTEX INC.
DATE OFREVISION:
150 SIGNET DRIVE
MAY 31, 2019
WESTON, ONTARIO
CANADA M9L 1T9
CONTROL #: 218233
Page 3 of 20
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.......................................................................
4
SUMMARY PRODUCT INFORMATION
.............................................................................................
4
INDICATIONS AND CLINICAL USE
...................................................................................................
4
CONTRAINDICATIONS
........................................................................................................................
4
WARNINGS AND PRECAUTIONS
.......................................................................................................
4
ADVERSE REACTIONS
.........................................................................................................................
5
DRUG INTERACTIONS
.........................................................................................................................
6
DOSAGE AND ADMINISTRATION
.....................................................................................................
7
OVERDOSAGE
.......................................................................................................................................
7
ACTION AND CLINICAL
PHARMACOLOGY....................................................................................
8
STORAGE AND STABILITY
.................................................................................................................
9
SPECIAL HANDLING INSTRUCTIONS
..............................................................................................
9
DOSAGE FORMS, COMPOSITION AND PACKAGING
.................................................................... 9
PART II: SCIENTIFIC INFORMATION
.........................................................
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