IVOZFO POWDER FOR SOLUTION

Pays: Canada

Langue: anglais

Source: Health Canada

Ingrédients actifs:

FOSFOMYCIN (FOSFOMYCIN SODIUM)

Disponible depuis:

VERITY PHARMACEUTICALS INC.

Code ATC:

J01XX01

DCI (Dénomination commune internationale):

FOSFOMYCIN

Dosage:

4G

forme pharmaceutique:

POWDER FOR SOLUTION

Composition:

FOSFOMYCIN (FOSFOMYCIN SODIUM) 4G

Mode d'administration:

INTRAVENOUS

Unités en paquet:

15G/50G

Type d'ordonnance:

Prescription

Domaine thérapeutique:

URINARY ANTI-INFECTIVES

Descriptif du produit:

Active ingredient group (AIG) number: 0137036004; AHFS:

Statut de autorisation:

APPROVED

Date de l'autorisation:

2019-05-01

Résumé des caractéristiques du produit

_Product Monograph _
_ _
_Pr_
_IVOZFO_
_TM_
_ (Fosfomycin) COPYRIGHT 2021, Verity Pharmaceuticals Inc. _
_Page 1 of 28_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
IVOZFO
™
Fosfomycin for Injection
Powder for solution, 2 g/vial, 4 g/vial and 8 g/vial fosfomycin (as
fosfomycin sodium),
Intravenous
Antibiotic
ATC Code: J01XX01
Verity Pharmaceuticals Inc
2560 Matheson Blvd E, Suite 220
Mississauga, ON
L4W 4Y9
www.veritypharma.com
Date of Initial Authorization:
May 01, 2019
Date of Revision:
October 18, 2022
Submission Control Number: 256308
_ _
_Product Monograph _
_ _
_Pr_
_IVOZFO_
_TM_
_ (Fosfomycin) COPYRIGHT 2021, Verity Pharmaceuticals Inc. _
_Page 2 of 28_
RECENT MAJOR LABEL CHANGES
INDICATIONS (1)
10/2022
SERIOUS WARNINGS AND PRECAUTIONS BOX
10/2022
DOSAGE AND ADMINISTRATION (4)
10/2022
WARNINGS AND PRECAUTIONS
10/2022
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...........................................................................................................
5
2
CONTRAINDICATIONS
.................................................................................................
5
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
............................................................ 5
4
DOSAGE AND
ADMINISTRATION.................................................................................
5
4.1
Dosin