GANCICLOVIR FOR INJECTION USP POWDER FOR SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

GANCICLOVIR (GANCICLOVIR SODIUM)

Available from:

STERIMAX INC

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:

25 VIALS

Prescription type:

Prescription

Therapeutic area:

NUCLEOSIDES AND NUCLEOTIDES

Product summary:

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

Authorization status:

APPROVED

Authorization date:

2018-05-04

Summary of Product characteristics

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