CYTOVENE POWDER FOR SOLUTION

Country: Կանադա

language: անգլերեն

source: Health Canada

active_ingredient:

GANCICLOVIR (GANCICLOVIR SODIUM)

MAH:

CHEPLAPHARM ARZNEIMITTEL GMBH

ATC_code:

J05AB06

INN:

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

leaflet_short:

Active ingredient group (AIG) number: 0128037002; AHFS:

authorization_status:

APPROVED

authorization_date:

2018-07-23

SPC

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
....................................................