البلد: كندا
اللغة: الإنجليزية
المصدر: Health Canada
FOSFOMYCIN (FOSFOMYCIN TROMETHAMINE)
PALADIN LABS INC.
J01XX01
FOSFOMYCIN
3G
POWDER FOR SOLUTION
FOSFOMYCIN (FOSFOMYCIN TROMETHAMINE) 3G
ORAL
15G/50G
Prescription
URINARY ANTI-INFECTIVES
Active ingredient group (AIG) number: 0137036002; AHFS:
APPROVED
2012-09-07
_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 .............................. اقرأ الوثيقة كاملة