GANCICLOVIR FOR INJECTION USP POWDER FOR SOLUTION

Country: Կանադա

language: անգլերեն

source: Health Canada

active_ingredient:

GANCICLOVIR (GANCICLOVIR SODIUM)

MAH:

STERIMAX INC

ATC_code:

J05AB06

INN:

GANCICLOVIR

dosage:

500MG

pharmaceutical_form:

POWDER FOR SOLUTION

composition:

GANCICLOVIR (GANCICLOVIR SODIUM) 500MG

administration_route:

INTRAVENOUS

units_in_package:

25 VIALS

prescription_type:

Prescription

therapeutic_area:

NUCLEOSIDES AND NUCLEOTIDES

leaflet_short:

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

authorization_status:

APPROVED

authorization_date:

2018-05-04

SPC

PRODUCT MONOGRAPH
Pr
GANCICLOVIR FOR INJECTION USP
500 mg/vial ganciclovir
(as ganciclovir sodium)
USP
Sterile Powder for Solution
Antiviral Agent
SteriMax Inc.
Date of Preparation:
2770 Portland Drive
May 3, 2018
Oakville, ON L6H 6R4
Submission Control No: 201580
_Ganciclovir for Injection USP _
_Page 2 of 60_
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
................................................................................................
23
DOSAGE AND ADMINISTRATION ...
………………………………………………27
OVERDOSAGE
..............................................................................................................
31
ACTION AND CLINICAL PHARMACOLOGY ..
………………………………...…32
STORAGE AND STABILITY
........................................................................................
33
SPECIAL HANDLING INSTRUCTIONS
.....................................................................
33
DOSAGE FORMS, COMPOSITION AND PACKAGING
........................................... 34
PART II: SCIENTIFIC INFORMATION
..............................................................................
35
PHARMACEUTICAL INFORMATION
.......................................................................
35
CLINICAL TRIALS
........................................................................................................
36
DETAILED PHA