ALLERTIN CAPSULE
Država: Kanada
Jezik: angleščina
Source: Health Canada
Lastnosti izdelka
(SPC)
25-09-2019
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Aktivna sestavina:
LORATADINE
Dostopno od:
APOTEX INC
Koda artikla:
R06AX13
INN (mednarodno ime):
LORATADINE
Odmerek:
10MG
Farmacevtska oblika:
CAPSULE
Sestava:
LORATADINE 10MG
Pot uporabe:
ORAL
Enote v paketu:
12/24
Tip zastaranja:
OTC
Terapevtsko območje:
SECOND GENERATION ANTIHISTAMINES
Povzetek izdelek:
Active ingredient group (AIG) number: 0120416001; AHFS:
Status dovoljenje:
APPROVED
Datum dovoljenje:
2012-08-02
Lastnosti izdelka
Page 2 of 20
PRODUCT MONOGRAPH
ALLERTIN
LORATADINE CAPSULES, 10 MG
HISTAMINE H
1 RECEPTOR ANTAGONIST
APOTEX INC.
DATE OF REVISION:
150 SIGNET DRIVE
SEPTEMBER 25, 2019
TORONTO, ONTARIO
CANADA M9L 1T9
CONTROL #: 231181
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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