ORGALUTRAN SOLUTION

Land: Canada

Språk: engelsk

Kilde: Health Canada

Aktiv ingrediens:

GANIRELIX (GANIRELIX ACETATE)

Tilgjengelig fra:

ORGANON CANADA INC.

ATC-kode:

H01CC01

INN (International Name):

GANIRELIX

Dosering :

250MCG

Legemiddelform:

SOLUTION

Sammensetning:

GANIRELIX (GANIRELIX ACETATE) 250MCG

Administreringsrute:

SUBCUTANEOUS

Enheter i pakken:

0.5ML SYR

Resept typen:

Prescription

Terapeutisk område:

GONADOTROPIN-RELEASING HORMONE ANTAGONISTS

Produkt oppsummering:

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

Autorisasjon status:

APPROVED

Autorisasjon dato:

2002-05-01

Preparatomtale

_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
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_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
.............................................................................................