LORATADINE TABLET

Land: Canada

Språk: engelsk

Kilde: Health Canada

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Last ned Preparatomtale (SPC)
02-05-2013

Aktiv ingrediens:

LORATADINE

Tilgjengelig fra:

MYLAN PHARMACEUTICALS ULC

ATC-kode:

R06AX13

INN (International Name):

LORATADINE

Dosering :

10MG

Legemiddelform:

TABLET

Sammensetning:

LORATADINE 10MG

Administreringsrute:

ORAL

Enheter i pakken:

12/18/24/30

Resept typen:

OTC

Terapeutisk område:

SECOND GENERATION ANTIHISTAMINES

Produkt oppsummering:

Active ingredient group (AIG) number: 0120416001; AHFS:

Autorisasjon status:

CANCELLED PRE MARKET

Autorisasjon dato:

2016-11-02

Preparatomtale

                                PRODUCT MONOGRAPH
LORATADINE
Loratadine Tablets
10 mg
USP
Histamine H
1
receptor antagonist
Mylan Pharmaceutical ULC
85 Advance Road
Etobicoke, ON
M8Z 2S6
Revision Date: April 23, 2013
Control Number: 160783
2
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
........................................................ 3
SUMMARY
PRODUCT
INFORMATION
................................................................................
3
INDICATIONS
AND
CLINICAL
USE
.....................................................................................
3
CONTRAINDICATIONS
..........................................................................................................
4
WARNINGS
AND
PRECAUTIONS
.........................................................................................
4
ADVERSE
REACTIONS
...........................................................................................................
5
DRUG
INTERACTIONS
...........................................................................................................
7
DOSAGE
AND
ADMINISTRATION
.......................................................................................
8
OVERDOSAGE
.........................................................................................................................
8
ACTION
AND
CLINICAL
PHARMACOLOGY
......................................................................
9
STORAGE
AND
STABILITY
.................................................................................................
11
SPECIAL
HANDLING
INSTRUCTIONS
...............................................................................
11
DOSAGE
FORMS,
COMPOSITION
AND
PACKAGING ..................................................... 11
PART II: SCIENTIFIC INFORMATION
...............................................................................
12
PHARMACEUTICAL
INFORMATION
.................................................................................
12
CLINICAL
TRIALS
............................................................
                                
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