FLAGYSTATIN OVULE

Țară: Canada

Limbă: engleză

Sursă: Health Canada

Ingredient activ:

METRONIDAZOLE; NYSTATIN

Disponibil de la:

SANOFI-AVENTIS CANADA INC

Codul ATC:

G01AA51

INN (nume internaţional):

NYSTATIN, COMBINATIONS

Dozare:

500MG; 100000UNIT

Forma farmaceutică:

OVULE

Compoziție:

METRONIDAZOLE 500MG; NYSTATIN 100000UNIT

Calea de administrare:

VAGINAL

Unități în pachet:

10

Tip de prescriptie medicala:

Prescription

Zonă Terapeutică:

ANTIBIOTICS

Rezumat produs:

Active ingredient group (AIG) number: 0202573001; AHFS:

Statutul autorizaţiei:

APPROVED

Data de autorizare:

2000-10-12

Caracteristicilor produsului

_FLAGYSTATIN (metronidazole and nystatin) _
_Page 1 of 29 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
FLAGYSTATIN®
(500 mg metronidazole and 100,000 IU nystatin)
Vaginal Ovules
Trichomonacide – Moniliacide
Sanofi-aventis Canada Inc.
2905 Place Louis R.-Renaud
Laval, Quebec H7V 0A3
Date of Initial Authorization:
December 31, 1979
Date of Revision:
May 9, 2022
Submission Control Number: 259350
_ _
_FLAGYSTATIN (metronidazole and nystatin) _
_Page 2 of 29 _
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.................................................................................
4
4.1
Dosing Considerations
.......................................................................................
4
4.2
Recommended Dose and Dosage
Adjustment..................................................... 5
4.5
Missed Dose
.............................................................................