FIRMAGON POWDER FOR SOLUTION

Pays: Canada

Langue: anglais

Source: Health Canada

Ingrédients actifs:

DEGARELIX (DEGARELIX ACETATE)

Disponible depuis:

FERRING INC

Code ATC:

L02BX02

DCI (Dénomination commune internationale):

DEGARELIX

Dosage:

80MG

forme pharmaceutique:

POWDER FOR SOLUTION

Composition:

DEGARELIX (DEGARELIX ACETATE) 80MG

Mode d'administration:

SUBCUTANEOUS

Unités en paquet:

80MG

Type d'ordonnance:

Prescription

Domaine thérapeutique:

ANTINEOPLASTIC AGENTS

Descriptif du produit:

Active ingredient group (AIG) number: 0152667001; AHFS:

Statut de autorisation:

APPROVED

Date de l'autorisation:

2009-11-16

Résumé des caractéristiques du produit

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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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_Page 2 of 46 _
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
............................................