ORGALUTRAN SOLUTION

Pays: Canada

Langue: anglais

Source: Health Canada

Ingrédients actifs:

GANIRELIX (GANIRELIX ACETATE)

Disponible depuis:

ORGANON CANADA INC.

Code ATC:

H01CC01

DCI (Dénomination commune internationale):

GANIRELIX

Dosage:

250MCG

forme pharmaceutique:

SOLUTION

Composition:

GANIRELIX (GANIRELIX ACETATE) 250MCG

Mode d'administration:

SUBCUTANEOUS

Unités en paquet:

0.5ML SYR

Type d'ordonnance:

Prescription

Domaine thérapeutique:

GONADOTROPIN-RELEASING HORMONE ANTAGONISTS

Descriptif du produit:

Active ingredient group (AIG) number: 0146941001; AHFS:

Statut de autorisation:

APPROVED

Date de l'autorisation:

2002-05-01

Résumé des caractéristiques du produit

_ORGALUTRAN® (Ganirelix Acetate Injection) _
_Page 1 of 26 _
[Organon] Confidential
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
ORGALUTRAN
®
(Ganirelix Injection)
250 mcg /0.5 mL ganirelix (as ganirelix acetate)
Subcutaneous use
Gonadotropin-releasing hormone (GnRH) antagonist
Organon Canada Inc.
16766 route Transcanadienne
Kirkland QC Canada H9H 4M7
www.organon.ca
Date of Initial Authorization:
August 23, 2002
Date of Revision:
January 10, 2024
Submission Control Number:
276208
_ _
_ _
_ _
_ORGALUTRAN® (Ganirelix Injection) _
_ _
_Page 2 of 26_
[Organon] Confidential
RECENT MAJOR LABEL CHANGES
CONTRAINDICATION
Jan 2024
WARNINGS AND PRECAUTIONS
Jan 2024
TABLE OF CONTENTS
RECENT MAJOR LABEL CHANGES
............................................................................................
2
TABLE OF CONTENTS
..............................................................................................................
2
1
INDICATIONS
...............................................................................................................
4
1.1 Pediatrics
....................................................................................................................
4
1.2 Geriatrics
....................................................................................................................
4
2
CONTRAINDICATIONS
.................................................................................................
4
4
DOSAGE AND ADMINISTRATION
.................................................................................
4
4.1 Dosing Considerations
................................................................................................
4
4.2 Recommended Dose and Dosage Adjustment
........................................................... 4
4.4 Administration
............................................................................................................
4
4.5 Missed Dose
.............................................................................................