FLAGYL CREAM

Χώρα: Καναδάς

Γλώσσα: Αγγλικά

Πηγή: Health Canada

Δραστική ουσία:

METRONIDAZOLE

Διαθέσιμο από:

SANOFI-AVENTIS CANADA INC

Φαρμακολογική κατηγορία (ATC):

G01AF01

INN (Διεθνής Όνομα):

METRONIDAZOLE

Δοσολογία:

10%

Φαρμακοτεχνική μορφή:

CREAM

Σύνθεση:

METRONIDAZOLE 10%

Οδός χορήγησης:

VAGINAL

Μονάδες σε πακέτο:

60G

Τρόπος διάθεσης:

Prescription

Θεραπευτική περιοχή:

MISCELLANEOUS LOCAL ANTI-INFECTIVES

Περίληψη προϊόντος:

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

Καθεστώς αδειοδότησης:

APPROVED

Ημερομηνία της άδειας:

2000-10-19

Αρχείο Π.Χ.Π.

_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
................