Maa: Kanada
Kieli: englanti
Lähde: Health Canada
DAPTOMYCIN
ACCORD HEALTHCARE INC
J01XX09
DAPTOMYCIN
500MG
POWDER FOR SOLUTION
DAPTOMYCIN 500MG
INTRAVENOUS
15G/50G
Prescription
CYCLIC LIPOPEPTIDES
Active ingredient group (AIG) number: 0152298001; AHFS:
APPROVED
2020-10-01
PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION PR DAPTOMYCIN FOR INJECTION Lyophilized Powder for Solution, For Intravenous Use Only 500 mg/vial Antibacterial Agent Accord Healthcare Inc. 3535 boul. St-Charles, Suite 704 Kirkland, Quebec H9H 5B9 Date of Revision: August 31, 2020 Submission Control Number: 242602 _Page 2 of 60_ _Product Monograph of Daptomycin for Injection _ 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 ................................................................................................. 19 DOSAGE AND ADMINISTRATION ............................................................................. 22 ACTION AND CLINICAL PHARMACOLOGY ............................................................ 27 STORAGE AND STABILITY ......................................................................................... 32 SPECIAL HANDLING INSTRUCTIONS ....................................................................... 33 DOSAGE FORMS, COMPOSITION AND PACKAGING ............................................ 33 PART II: SCIENTIFIC INFORMATION .............................................................................. 34 PHARMACEUTICAL INFORMATION ......................................................................... 34 CLINICAL TRIALS ......................................................................................................... 35 DETA Lue koko asiakirja