Valsts: Kanāda
Valoda: angļu
Klimata pārmaiņas: Health Canada
FOSFOMYCIN (FOSFOMYCIN SODIUM)
VERITY PHARMACEUTICALS INC.
J01XX01
FOSFOMYCIN
8G
POWDER FOR SOLUTION
FOSFOMYCIN (FOSFOMYCIN SODIUM) 8G
INTRAVENOUS
100
Prescription
URINARY ANTI-INFECTIVES
Active ingredient group (AIG) number: 0137036005; AHFS:
APPROVED
2019-05-01
_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 Izlasiet visu dokumentu