LUPRON DEPOT POWDER FOR SUSPENSION, SUSTAINED-RELEASE

Pays: Canada

Langue: anglais

Source: Health Canada

Ingrédients actifs:

LEUPROLIDE ACETATE

Disponible depuis:

ABBVIE CORPORATION

Code ATC:

L02AE02

DCI (Dénomination commune internationale):

LEUPRORELIN

Dosage:

11.25MG

forme pharmaceutique:

POWDER FOR SUSPENSION, SUSTAINED-RELEASE

Composition:

LEUPROLIDE ACETATE 11.25MG

Mode d'administration:

INTRAMUSCULAR

Unités en paquet:

100

Type d'ordonnance:

Prescription

Domaine thérapeutique:

GONADOTROPINS

Descriptif du produit:

Active ingredient group (AIG) number: 0116959003; AHFS:

Statut de autorisation:

CANCELLED PRE MARKET

Date de l'autorisation:

2016-06-22

Résumé des caractéristiques du produit

_LUPRON and LUPRON DEPOT _
_Page 1 of 54 _
PRODUCT MONOGRAPH
PR
LUPRON
®
leuprolide acetate injection
5 mg/mL
PR
LUPRON DEPOT
®
leuprolide acetate for depot suspension
pre-filled dual-chamber syringe containing sterile lyophilized
microspheres
7.5 mg/syringe (1-Month slow release), 22.5 mg/syringe (3-Month slow
release),
30.0 mg/syringe (4-Month slow release)
Gonadotropin-releasing hormone analog
AbbVie Corporation
Date of Revision:
8401 Trans-Canada Highway
January 3, 2018
St-Laurent, Qc H4S 1Z1
Submission Control No: 210907
_LUPRON and LUPRON DEPOT _
_Page 2 of 54 _
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
..........................................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
INDICATIONS AND CLINICAL USE
..............................................................................4
CONTRAINDICATIONS
...................................................................................................4
WARNINGS AND PRECAUTIONS
..................................................................................5
ADVERSE REACTIONS
..................................................................................................10
DRUG INTERACTIONS
..................................................................................................17
DOSAGE AND ADMINISTRATION
..............................................................................18
OVERDOSAGE
................................................................................................................21
ACTION AND CLINICAL PHARMACOLOGY
............................................................21
STORAGE AND STABILITY
..........................................................................................24
SPECIAL HANDLING INSTRUCTIONS
.......................................................................24
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................24
PART II: SCIENTIFIC INFORMATION
........