CYTOVENE POWDER FOR SOLUTION
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
20-07-2018
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Active ingredient:
GANCICLOVIR (GANCICLOVIR SODIUM)
Available from:
CHEPLAPHARM ARZNEIMITTEL GMBH
ATC code:
J05AB06
INN (International Name):
GANCICLOVIR
Dosage:
500MG
Pharmaceutical form:
POWDER FOR SOLUTION
Composition:
GANCICLOVIR (GANCICLOVIR SODIUM) 500MG
Administration route:
INTRAVENOUS
Units in package:
10 ML
Prescription type:
Prescription
Therapeutic area:
NUCLEOSIDES AND NUCLEOTIDES
Product summary:
Active ingredient group (AIG) number: 0128037002; AHFS:
Authorization status:
APPROVED
Authorization date:
2018-07-23
Summary of Product characteristics
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
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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
....................................................
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