País: Canadà
Idioma: anglès
Font: Health Canada
ZOLEDRONIC ACID (ZOLEDRONIC ACID MONOHYDRATE)
PFIZER CANADA ULC
M05BA08
ZOLEDRONIC ACID
5MG
SOLUTION
ZOLEDRONIC ACID (ZOLEDRONIC ACID MONOHYDRATE) 5MG
INTRAVENOUS
100ML
Prescription
BONE RESORPTION INHIBITORS
Active ingredient group (AIG) number: 0141761003; AHFS:
CANCELLED PRE MARKET
2022-06-01
PRODUCT MONOGRAPH PR ZOLEDRONIC ACID INJECTION A Solution for Intravenous Infusion 5 mg /100 mL zoledronic acid (as zoledronic acid monohydrate) (0.05 mg/mL) Bone Metabolism Regulator Pfizer Canada Inc. 17300 Trans-Canada Highway Kirkland, Québec H9J 2M5 Date of Revision: July 27, 2018 Control Number: 217662 TABLE OF CONTENTS PART I: HEALTH PROFESSIONAL INFORMATION ...................................................... 3 SUMMARY PRODUCT INFORMATION ..................................................................... 3 INDICATIONS AND CLINICAL USE ........................................................................... 3 CONTRAINDICATIONS ............................................................................................... 4 WARNINGS AND PRECAUTIONS .............................................................................. 4 ADVERSE REACTIONS .............................................................................................. 11 DRUG INTERACTIONS .............................................................................................. 26 DOSAGE AND ADMINISTRATION ........................................................................... 27 OVERDOSAGE ............................................................................................................ 29 ACTION AND CLINICAL PHARMACOLOGY .......................................................... 29 STORAGE AND STABILITY ...................................................................................... 32 SPECIAL HANDLING INSTRUCTIONS .................................................................... 32 DOSAGE FORMS, COMPOSITION AND PACKAGING ........................................... 33 PART II: SCIENTIFIC INFORMATION ............................................................................ 34 PHARMACEUTICAL INFORMATION....................................................................... 34 CLINICAL TRIALS...................................................................................................... 35 DET Llegiu el document complet