FIRMAGON POWDER FOR SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

DEGARELIX (DEGARELIX ACETATE)

Available from:

FERRING INC

ATC code:

L02BX02

INN (International Name):

DEGARELIX

Dosage:

120MG

Pharmaceutical form:

POWDER FOR SOLUTION

Composition:

DEGARELIX (DEGARELIX ACETATE) 120MG

Administration route:

SUBCUTANEOUS

Units in package:

120MG

Prescription type:

Prescription

Therapeutic area:

ANTINEOPLASTIC AGENTS

Product summary:

Active ingredient group (AIG) number: 0152667002; AHFS:

Authorization status:

APPROVED

Authorization date:

2009-11-16

Summary of Product characteristics

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PRODUCT MONOGRAPH
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FIRMAGON
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Degarelix for Injection
120 mg degarelix (as degarelix acetate) per vial
80 mg degarelix (as degarelix acetate) per vial
Gonadotropin-Releasing Hormone Receptor Antagonist
Ferring Pharmaceuticals
200 Yorkland Blvd., Suite 500
North York, Ontario
M2J 5C1
DATE OF REVISION:
March 18, 2016
SUBMISSION CONTROL NO: 180927
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_FIRMAGON_
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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
....................................................................................................8
DRUG INTERACTIONS
..................................................................................................11
DOSAGE AND ADMINISTRATION
..............................................................................12
OVERDOSAGE
................................................................................................................26
ACTION AND CLINICAL PHARMACOLOGY
............................................................26
STORAGE AND STABILITY
..........................................................................................30
SPECIAL HANDLING INSTRUCTIONS
.......................................................................30
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................30
PART II: SCIENTIFIC INFORMATION
...............................................................................31
PHARMACEUTICAL INFORMATION
............................................