GANCICLOVIR FOR INJECTION POWDER FOR SOLUTION
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
12-04-2023
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Active ingredient:
GANCICLOVIR (GANCICLOVIR SODIUM)
Available from:
FORMATIVE PHARMA 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:
15G/50G
Prescription type:
Prescription
Product summary:
Active ingredient group (AIG) number: 0128037002; AHFS:
Authorization status:
APPROVED
Authorization date:
2023-04-12
Summary of Product characteristics
PRODUCT MONOGRAPH
PR
GANCICLOVIR FOR INJECTION
500 mg / vial, (50 mg / mL when reconstituted)
Ganciclovir (as ganciclovir sodium)
Manufacturer’s Standard
Sterile Powder for Solution
Antiviral Agent
FORMATIVE PHARMA INC.
4145 North Service Road, Suite 200,
Burlington, Ontario, L7L 6A3
DATE OF PREPARATION:
April 12, 2023
SUBMISSION CONTROL NO: 266119
GANCICLOVIR FOR INJECTION
Page 2 of 54
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
............................................................................................
22
DOSAGE AND ADMINISTRATION
.......................................................................
25
OVERDOSAGE
..........................................................................................................
28
ACTION AND CLINICAL PHARMACOLOGY
...................................................... 29
STORAGE AND STABILITY
....................................................................................
29
SPECIAL HANDLING INSTRUCTIONS
................................................................. 30
DOSAGE FORMS, COMPOSITION AND PACKAGING
....................................... 30
PART II: SCIENTIFIC INFORMATION
...........................................................................
31
PHARMACEUTICAL INFORMATION
....................................................................
31
CLINICAL TRIALS
...................................................................
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