Riik: Kanada
keel: inglise
Allikas: Health Canada
GANCICLOVIR (GANCICLOVIR SODIUM)
CHEPLAPHARM ARZNEIMITTEL GMBH
J05AB06
GANCICLOVIR
500MG
POWDER FOR SOLUTION
GANCICLOVIR (GANCICLOVIR SODIUM) 500MG
INTRAVENOUS
10 ML
Prescription
NUCLEOSIDES AND NUCLEOTIDES
Active ingredient group (AIG) number: 0128037002; AHFS:
APPROVED
2018-07-23
PRODUCT MONOGRAPH PR CYTOVENE ® ganciclovir for injection, Manufacturer’s Standard (as ganciclovir sodium) 500 mg/vial, (50 mg/mL when reconstituted) Sterile powder Antiviral Agent CHEPLAPHARM Arzneimittel GmbH Ziegelhof 24 Date of Revision: July 20, 2018 17489 Greifswald Germany www.cheplapharm.com Imported By: MSD Inc., 8449 Lawson Road, Unit 102 Milton ON, L9T 9L1 Submission Control No: 217911 CYTOVENE ® is a registered trade-mark of CHEPLAPHARM Arzneimittel GmbH. © Copyright 1999 - 2018 CHEPLAPHARM Arzneimittel GmbH _ _ _Page 2 of 52_ 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 ............................................................................................... 10 DRUG INTERACTIONS ................................................................................................ 21 DOSAGE AND ADMINISTRATION ............................................................................ 24 OVERDOSAGE .............................................................................................................. 27 ACTION AND CLINICAL PHARMACOLOGY .......................................................... 28 STORAGE AND STABILITY........................................................................................ 29 SPECIAL HANDLING INSTRUCTIONS ..................................................................... 29 DOSAGE FORMS, COMPOSITION AND PACKAGING ........................................... 29 PART II: SCIENTIFIC INFORMATION .................................................... Lugege kogu dokumenti