FLAGYL CREAM

Država: Kanada

Jezik: angleščina

Source: Health Canada

Aktivna sestavina:

METRONIDAZOLE

Dostopno od:

SANOFI-AVENTIS CANADA INC

Koda artikla:

G01AF01

INN (mednarodno ime):

METRONIDAZOLE

Odmerek:

10%

Farmacevtska oblika:

CREAM

Sestava:

METRONIDAZOLE 10%

Pot uporabe:

VAGINAL

Enote v paketu:

60G

Tip zastaranja:

Prescription

Terapevtsko območje:

MISCELLANEOUS LOCAL ANTI-INFECTIVES

Povzetek izdelek:

Active ingredient group (AIG) number: 0102572004; AHFS:

Status dovoljenje:

APPROVED

Datum dovoljenje:

2000-10-19

Lastnosti izdelka

_FLAGYL (metronidazole) _
_Page 1 of 33 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
FLAGYL®
(Metronidazole)
10% w/w Cream
Antibacterial - Antiprotozoal
sanofi-aventis Canada Inc.
2905 Place Louis R.-Renaud
Laval, Quebec H7V 0A3
Date of Initial Authorization:
December 31, 1970
Date of Revision:
May 9, 2022
Submission Control Number: 259355
s-a version dated
_ _
_FLAGYL (metronidazole) _
_Page 2 of 33 _
RECENT MAJOR LABEL CHANGES
7 Warnings and Precautions, Psychiatric
09/2021
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
..........................................................................................................
4
1.2
Geriatrics...........................................................................................................
4
2
CONTRAINDICATIONS
.................................................................................................
4
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
............................................................ 4
4
DOSAGE AND
ADMINISTRATION.................................................................................
5
4.1
Dosing Considerations
.......................................................................................
5
4.2
Recommended Dose and Dosage
Adjustment..................................................... 5
4.5
Missed Dose
......................................................................................................
6
5
OVERDOSAGE
................