País: Canadá
Idioma: inglés
Fuente: Health Canada
PAMIDRONATE DISODIUM
PFIZER CANADA ULC
M05BA03
PAMIDRONIC ACID
3MG
SOLUTION
PAMIDRONATE DISODIUM 3MG
INTRAVENOUS
10ML
Prescription
BONE RESORPTION INHIBITORS
Active ingredient group (AIG) number: 0123608001; AHFS:
APPROVED
2003-07-09
PRODUCT MONOGRAPH PR PAMIDRONATE DISODIUM FOR INJECTION (PAMIDRONATE DISODIUM) 3 MG / ML, 6 MG / ML AND 9 MG / ML Sterile Solution for Injection For intravenous infusion only THERAPEUTIC CLASSIFICATION Bone Metabolism Regulator Pfizer Canada ULC 17300 Trans-Canada Highway Kirkland, Québec H9J 2M5 Submission Control No.: 220092 Date of Revision: December 11, 2018 _Product Monograph - _ _Pr_ _Pamidronate Disodium for Injection _ _Page 2 of 39 _ TABLE OF CONTENTS PART I: HEALTH PROFESSIONAL INFORMATION ......................................................... 3 SUMMARY PRODUCT INFORMATION .................................................................... 3 INDICATIONS AND CLINICAL USE ............................................................................. 3 CONTRAINDICATIONS .................................................................................................. 3 WARNINGS AND PRECAUTIONS ................................................................................. 3 ADVERSE REACTIONS ................................................................................................. 10 DOSAGE AND ADMINISTRATION ............................................................................. 15 OVERDOSAGE ............................................................................................................... 19 ACTION AND CLINICAL PHARMACOLOGY ........................................................... 19 STORAGE AND STABILITY ......................................................................................... 23 DOSAGE FORMS, COMPOSITION AND PACKAGING ............................................ 23 PART II: SCIENTIFIC INFORMATION .............................................................................. 24 PHARMACEUTICAL INFORMATION ......................................................................... 24 CLINICAL TRIALS ......................................................................................................... 24 DETAILED PHARMACOLOGY .............................. Leer el documento completo