Decapeptyl 3-month, 11.25 mgPowder and solvent for suspension for injection

Negara: Irlandia

Bahasa: Inggris

Sumber: HPRA (Health Products Regulatory Authority)

Bahan aktif:

Triptorelin

Tersedia dari:

Ipsen Pharmaceuticals Limited

Kode ATC:

L02AE; L02AE04

INN (Nama Internasional):

Triptorelin

Dosis:

11.25 milligram(s)

Bentuk farmasi:

Powder and solvent for suspension for injection

Jenis Resep:

Product subject to prescription which may not be renewed (A)

Area terapi:

Gonadotropin releasing hormone analogues; triptorelin

Status otorisasi:

Marketed

Tanggal Otorisasi:

1998-10-02

Selebaran informasi

_______________________________________________________________________________________________________________
Document name: 171_DEC11.25_IE
Reason for change: Periodic Safety Update Report
(PSUSA/00003048/202203) recommendations
Document replaced: 164_DEC11.25_IE
Preparation Date: 12/01/2023
Page 1 of 15
PACKAGE LEAFLET: INFORMATION FOR THE USER
DECAPEPTYL
® 3-MONTH
11.25 MG POWDER AND SOLVENT FOR SUSPENSION FOR INJECTION
Triptorelin
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
•
Keep this leaflet. You may need to read it again.
•
If you have any further questions, please ask your doctor, pharmacist
or nurse.
•
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them, even if their
signs of illness are the same as yours.
•
If you get any side effects talk to your doctor, pharmacist or nurse.
This includes any possible side effects
not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1. What Decapeptyl 3-month is and what it is used for
2. What you need to know before you use Decapeptyl 3-month
3. How to use Decapeptyl 3-month
4. Possible side effects
5. How to store Decapeptyl 3-month
6. Contents of the pack and other information
1.
WHAT DECAPEPTYL 3-MONTH IS AND WHAT IT IS USED FOR
The active ingredient in Decapeptyl 3-month is triptorelin.
Triptorelin belongs to a group of medicines called
gonadotropin releasing hormone (GnRH) agonists. Triptorelin is similar
to the gonadotropin releasing hormone
which occurs naturally in your body.
In men, triptorelin lowers the levels of the hormone testosterone.
In women, it reduces oestrogen levels.
DECAPEPTYL 3-MONTH
HAS THREE DIFFERENT USES. IT IS USED IN MEN, WOMEN AND CHILDREN TO
TREAT COMPLETELY
DIFFERENT CONDITIONS.
THIS LEAFLET GIVES INFORMATION FOR ALL THREE USES OF DECAPEPTYL
3-MONTH.
PLEASE READ ALL THE SECTIONS THAT
ARE ABOUT YOU AND YOUR CONDITION.
MEN
IN MEN DECAPEPTYL 3-MONTH IS USED TO TREAT ADVANCED PROSTATE CANCER.
WOM

Karakteristik produk

Health Products Regulatory Authority
30 August 2023
CRN00DMLZ
Page 1 of 14
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Decapeptyl 3-month, 11.25 mgPowder and solvent for suspension for
injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains the quantity of triptorelin (as triptorelin
pamoate) to ensure that the minimum triptorelin quantity injected is
11.25mg.
Excipients:
Sodium < 1 mmol (23 mg)
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Powder for suspension for injection:
Sightly yellow lyophilised cake.
Solvent for suspension for injection:
Clear, colourless solution free of suspended particles.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Prostatic carcinoma.
In the management of advanced prostatic carcinoma.
Genital and extragenital endometriosis.
Central precocious puberty (onset before 8 years in girls and 10 years
in boys) -_see section 5.1_
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
_Prostatic carcinoma:_
Male Adults only: one intramuscular or subcutaneous injection every
three months.
In patients with metastatic castration-resistant prostate cancer not
surgically castrated, receiving a GnRH agonist such as
triptorelin and eligible to a treatment by abiraterone acetate, an
inhibitor of androgen biosynthesis or enzalutamide, an
inhibitor of signaling pathway of androgen receptors, the treatment by
a GnRH agonist must be continued.
_ _
_Endometriosis:_
Female adults only: one intramuscular injection every three months.
The treatment must be started in the first five days of the menstrual
cycle.
Treatment duration: this depends on the initial severity of the
endometriosis and the changes observed in the clinical features
(functional and anatomical) during treatment. In principle, the
treatment should be administered for at least 3 months and for
at most 6 months ( _see section 4.8 Undesirable Effects _
). It is not recommended to start a second treatment course with
triptorelin
or another GnRH analogue. In patients treated with GnRH anal