CYTOVENE POWDER FOR SOLUTION

Pays: Canada

Langue: anglais

Source: Health Canada

Ingrédients actifs:

GANCICLOVIR (GANCICLOVIR SODIUM)

Disponible depuis:

CHEPLAPHARM ARZNEIMITTEL GMBH

Code ATC:

J05AB06

DCI (Dénomination commune internationale):

GANCICLOVIR

Dosage:

500MG

forme pharmaceutique:

POWDER FOR SOLUTION

Composition:

GANCICLOVIR (GANCICLOVIR SODIUM) 500MG

Mode d'administration:

INTRAVENOUS

Unités en paquet:

10 ML

Type d'ordonnance:

Prescription

Domaine thérapeutique:

NUCLEOSIDES AND NUCLEOTIDES

Descriptif du produit:

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

Statut de autorisation:

APPROVED

Date de l'autorisation:

2018-07-23

Résumé des caractéristiques du produit

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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_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
....................................................