LUPRON DEPOT POWDER FOR SUSPENSION, SUSTAINED-RELEASE
Țară: Canada
Limbă: engleză
Sursă: Health Canada
Caracteristicilor produsului
(SPC)
03-01-2018
Unele documente pentru acest produs nu sunt disponibile în prezent, puteți trimite o solicitare la serviciul nostru pentru clienți și vă vom anunța de îndată ce vom putea să le obținem.
Trimite cerere.
Trimite cerere.
Ingredient activ:
LEUPROLIDE ACETATE
Disponibil de la:
ABBVIE CORPORATION
Codul ATC:
L02AE02
INN (nume internaţional):
LEUPRORELIN
Dozare:
11.25MG
Forma farmaceutică:
POWDER FOR SUSPENSION, SUSTAINED-RELEASE
Compoziție:
LEUPROLIDE ACETATE 11.25MG
Calea de administrare:
INTRAMUSCULAR
Unități în pachet:
100
Tip de prescriptie medicala:
Prescription
Zonă Terapeutică:
GONADOTROPINS
Rezumat produs:
Active ingredient group (AIG) number: 0116959003; AHFS:
Statutul autorizaţiei:
CANCELLED PRE MARKET
Data de autorizare:
2016-06-22
Caracteristicilor produsului
_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
........
Citiți documentul complet
