CLOTRIMAZOLE-FLUCONAZOLE COMBI KIT

Land: Canada

Språk: engelsk

Kilde: Health Canada

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Last ned Preparatomtale (SPC)
28-03-2022

Aktiv ingrediens:

FLUCONAZOLE; CLOTRIMAZOLE

Tilgjengelig fra:

TARO PHARMACEUTICALS INC

ATC-kode:

J02AC01

INN (International Name):

FLUCONAZOLE

Dosering :

150MG; 1%

Legemiddelform:

KIT

Sammensetning:

FLUCONAZOLE 150MG; CLOTRIMAZOLE 1%

Administreringsrute:

ORAL

Enheter i pakken:

15G/50G

Resept typen:

OTC

Terapeutisk område:

AZOLES

Produkt oppsummering:

Active ingredient group (AIG) number: 0252465001; AHFS:

Autorisasjon status:

APPROVED

Autorisasjon dato:

2016-02-04

Preparatomtale

                                _Fluconazole 150 (150 mg Fluconazole)_
_Clotrimazole-Fluconazole _
_Combi (150 mg Fluconazole and 1% Clotrimazole) _
_Extra Strength Clotrimazole Extra fort -Fluconazole _
_Combi (150 mg Fluconazole and _
_2% Clotrimazole)_
_Page 1 of 42_
PRODUCT MONOGRAPH
FLUCONAZOLE 150
Fluconazole Capsule 150 mg
CLOTRIMAZOLE-FLUCONAZOLE
COMBI
Fluconazole 150 (Fluconazole Capsule 150 mg
Clotrimazole External Cream (1% Clotrimazole Cream, USP)
EXTRA STRENGTH CLOTRIMAZOLE EXTRA FORT -FLUCONAZOLE
COMBI
Fluconazole 150 (Fluconazole Capsule 150 mg)
Clotrimazole External Cream (2% Clotrimazole Cream, USP)
Antifungal Agent
Taro Pharmaceuticals Inc.
Date of Preparation:
130 East Drive
March 28, 2022
Brampton, ON
L6T 1C1
Control No: TBT
_Fluconazole 150 (150 mg Fluconazole)_
_Clotrimazole_
-
_Fluconazole_
_Combi (150 mg Fluconazole and 1% Clotrimazole) _
_Extra Strength Clotrimazole Extra fort _
-
_Fluconazole_
_Combi (150 mg Fluconazole and 2% _
_Clotrimazole)_
_Page 2 of 48_
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
...................................................................................................
7
DRUG INTERACTIONS
...................................................................................................
9
DOSAGE AND ADMINISTRATION
.............................................................................
15
OVERDOSAGE
...............................................................................................................
15
ACTION AND CLINICAL PHARMACOLOGY
.................
                                
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