MONUROL POWDER FOR SOLUTION

Kraj: Kanada

Język: angielski

Źródło: Health Canada

Składnik aktywny:

FOSFOMYCIN (FOSFOMYCIN TROMETHAMINE)

Dostępny od:

PALADIN LABS INC.

Kod ATC:

J01XX01

INN (International Nazwa):

FOSFOMYCIN

Dawkowanie:

3G

Forma farmaceutyczna:

POWDER FOR SOLUTION

Skład:

FOSFOMYCIN (FOSFOMYCIN TROMETHAMINE) 3G

Droga podania:

ORAL

Sztuk w opakowaniu:

15G/50G

Typ recepty:

Prescription

Dziedzina terapeutyczna:

URINARY ANTI-INFECTIVES

Podsumowanie produktu:

Active ingredient group (AIG) number: 0137036002; AHFS:

Status autoryzacji:

APPROVED

Data autoryzacji:

2012-09-07

Charakterystyka produktu

_MONUROL_
_®_
_ (fosfomycin tromethamine) Product Monograph _
_Page 1 of 30_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
MONUROL
®
Fosfomycin (as fosfomycin tromethamine) powder for solution
powder for solution, 3g/sachet, oral
Antibiotic
Paladin Labs Inc.
100 Alexis-Nihon Blvd., Suite 600
Saint-Laurent, Quebec, Canada
H4M 2P2
Date of Initial Authorization:
June 09, 1999
Date of Revision:
July 27, 2021
Version 6.0
Monurol
®
is a registered trademark of Zambon S.p.A.
Submission Control Number: 250260
_ _
_ _
_MONUROL (fosfomycin tromethamine) Product Monograph _
_Page 2 of 30_
RECENT MAJOR LABEL CHANGES
2 Contraindications
07/2021
7 Warnings and Precautions
07/2021
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
4
DOSAGE AND
ADMINISTRATION...................................................................................4
4.1
Dosing Considerations
.........................................................................................4
4.2
Recommended Dose and Dosage
Adjustment.......................................................5
4.3
Reconstitution
..............................