Valsts: Kanāda
Valoda: angļu
Klimata pārmaiņas: Health Canada
DAPTOMYCIN
PFIZER CANADA ULC
J01XX09
DAPTOMYCIN
350MG
POWDER FOR SOLUTION
DAPTOMYCIN 350MG
INTRAVENOUS
1VIAL
Prescription
CYCLIC LIPOPEPTIDES
Active ingredient group (AIG) number: 0152298002; AHFS:
CANCELLED PRE MARKET
2020-10-16
PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION PR DAPTOMYCIN FOR INJECTION Lyophilized Powder for Solution, For Intravenous Use Only Daptomycin (350 mg/vial and 500 mg/vial) Antibacterial Agent Pfizer Canada ULC 17300 Trans-Canada highway Kirkland, Québec H9J 2M5 Submission Control Number: 176067, 211077, 219633, 227098 Date of Preparation: May 3, 2019 _Product Monograph - Daptomycin for Injection _ _Page 2 of 68 _ TABLE OF CONTENTS PART I: HEALTH PROFESSIONAL INFORMATION ......................................................... 3 SUMMARY PRODUCT INFORMATION ........................................................................ 3 INDICATIONS AND CLINICAL USE .............................................................................. 3 CONTRAINDICATIONS ................................................................................................... 5 WARNINGS AND PRECAUTIONS .................................................................................. 5 ADVERSE REACTIONS.................................................................................................. 12 DRUG INTERACTIONS .................................................................................................. 21 DOSAGE AND ADMINISTRATION .............................................................................. 24 OVERDOSAGE ................................................................................................................ 30 ACTION AND CLINICAL PHARMACOLOGY ............................................................ 31 STORAGE AND STABILITY .......................................................................................... 36 SPECIAL HANDLING INSTRUCTIONS ....................................................................... 37 DOSAGE FORMS, COMPOSITION AND PACKAGING ............................................. 37 PART II: SCIENTIFIC INFORMATION ............................................................................... 38 PHARMACEUTICAL INFORMATION................................. Izlasiet visu dokumentu