DOM-FLUCONAZOLE CAPSULE

Nchi: Kanada

Lugha: Kiingereza

Chanzo: Health Canada

Nunua Sasa

Tabia za bidhaa Tabia za bidhaa (SPC)
29-04-2008

Viambatanisho vya kazi:

FLUCONAZOLE

Inapatikana kutoka:

DOMINION PHARMACAL

ATC kanuni:

J02AC01

INN (Jina la Kimataifa):

FLUCONAZOLE

Kipimo:

150MG

Dawa fomu:

CAPSULE

Tungo:

FLUCONAZOLE 150MG

Njia ya uendeshaji:

ORAL

Vitengo katika mfuko:

100

Dawa ya aina:

OTC

Eneo la matibabu:

AZOLES

Bidhaa muhtasari:

Active ingredient group (AIG) number: 0122529004; AHFS:

Idhini hali ya:

APPROVED

Idhini ya tarehe:

2008-05-01

Tabia za bidhaa

                                PRODUCT MONOGRAPH
PR
DOM-FLUCONAZOLE
(Fluconazole)
C
Tablets 50 &100 mg
C
Capsules 150 mg
ANTIFUNGAL AGENT
DOMINION PHARMACAL
DATE OF PREPARATION:
6111 Royalmount Ave., Suite 100
April 22, 2008
Montreal, Quebec
H4P 2T4
CONTROL NO. 121426
Page 2 of 47
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............................................................................................................
8
DRUG
INTERACTIONS
..........................................................................................................
12
DOSAGE
AND
ADMINISTRATION
......................................................................................
17
OVERDOSAGE
........................................................................................................................
20
STORAGE
AND
STABILITY
..................................................................................................
22
DOSAGE
FORMS,
COMPOSITION
AND
PACKAGING ...................................................... 22
PART II: SCIENTIFIC INFORMATION
...............................................................................
23
PHARMACEUTICAL
INFORMATION..................................................................................
23
C
LINICAL
T
RIALS
........................................................................................................................
23
DETAILED
PHARMACOLOGY
....................................................................................
                                
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