PMS-FLUCONAZOLE TABLET

Država: Kanada

Jezik: angleščina

Source: Health Canada

Aktivna sestavina:

FLUCONAZOLE

Dostopno od:

PHARMASCIENCE INC

Koda artikla:

J02AC01

INN (mednarodno ime):

FLUCONAZOLE

Odmerek:

100MG

Farmacevtska oblika:

TABLET

Sestava:

FLUCONAZOLE 100MG

Pot uporabe:

ORAL

Enote v paketu:

50

Tip zastaranja:

Prescription

Terapevtsko območje:

AZOLES

Povzetek izdelek:

Active ingredient group (AIG) number: 0122529002; AHFS:

Status dovoljenje:

APPROVED

Datum dovoljenje:

2002-06-05

Lastnosti izdelka

_pms-FLUCONAZOLE – Product Monograph _
_ _
_Page 1 of 56_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
PMS-FLUCONAZOLE
Fluconazole Tablets
Tablets, 50 mg and 100 mg, Oral
House Standard
Antifungal Agent
PHARMASCIENCE INC.
6111 Royalmount Ave., Suite 100
Montréal, Québec
H4P 2T4
www.pharmascience.com
Date of Initial Authorization:
June 5, 2002
Date of Revision:
May 16, 2023
Submission Control Number: 273867
_pms-FLUCONAZOLE – Product Monograph _
_ _
_Page 2 of 56_
RECENT MAJOR LABEL CHANGES
7 WARNINGS AND PRECAUTIONS
10/2022
9 DRUG INTERACTIONS
05/2023
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED.
RECENT MAJOR LABEL CHANGES
.........................................................................................
2
TABLE OF CONTENTS
...........................................................................................................
2
PART I: HEALTH PROFESSIONAL INFORMATION
................................................................... 4
1
INDICATIONS
............................................................................................................
4
1.1
Pediatrics (<18 years of age)
..................................................................................
4
1.2
Geriatrics
.................................................................................................................
4
2
CONTRAINDICATIONS
..............................................................................................
5
4
DOSAGE AND ADMINISTRATION
..............................................................................
5
4.1
Dosing Considerations
............................................................................................
5
4.2
Recommended Dose and Dosage Adjustment
....................................................... 5
4.5
Missed Dose
............................................................................................................
8
5
OVERDOSAGE
....................................