Decapeptyl SR 22.5mg powder and solvent for suspension for injection vials

Land: Storbritannien

Sprog: engelsk

Kilde: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktiv bestanddel:

Triptorelin embonate

Tilgængelig fra:

Ipsen Ltd

ATC-kode:

L02AE04

INN (International Name):

Triptorelin embonate

Dosering:

22.5mg

Lægemiddelform:

Powder and solvent for suspension for injection

Indgivelsesvej:

Intramuscular

Klasse:

No Controlled Drug Status

Recept type:

Valid as a prescribable product

Produkt oversigt:

BNF: 08030402; GTIN: 5036611000202

Indlægsseddel

Page 1 of 11
PACKAGE LEAFLET: INFORMATION FOR THE USER
Decapeptyl
®
SR 22.5mg 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, 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 SR 22.5mg is and what it is used for
2.
What you need to know before you use Decapeptyl SR 22.5mg
3.
How to use Decapeptyl SR 22.5mg
4.
Possible side effects
5.
How to store Decapeptyl SR 22.5mg
6.
Contents of the pack and other information
1.
WHAT DECAPEPTYL SR 22.5MG IS AND WHAT IT IS USED FOR
Decapeptyl SR 22.5 mg contains triptorelin, which is similar to a
hormone called gonadotropin
releasing hormone (GnRH analogue).
Triptorelin belongs to a group of medicines called GnRH analogues. It
is a long acting formulation
designed to slowly deliver 22.5 mg of triptorelin over a 6-month
period (twenty four weeks). In men,
triptorelin lowers the levels of the hormone testosterone. In women,
it lowers the levels of the hormone
oestrogen.
IN MEN:
Decapeptyl SR 22.5 mg is used to treat prostate cancer.
IN CHILDREN 2 YEARS OF AGE AND OLDER
Decapeptyl SR 22.5 mg is used to treat puberty that occurs at a
very young age, i.e. before 8 years in girls and 10 years in boys
(Precocious Puberty). This is called
‘early puberty’ in the rest of this leaflet.
Decapeptyl SR is available in two other strengths: Decapeptyl SR 3 mg
is used once a month, and
Decapeptyl SR 11.25 mg is used once every 3 months. Ask your doctor if
you would like to discuss
changing your treatment.
2.
WHAT YOU NEED TO KNO

Produktets egenskaber

OBJECT 1
DECAPEPTYL SR 22.5MG
Summary of Product Characteristics Updated 07-Sep-2017 | Ipsen Ltd
1. Name of the medicinal product
Decapeptyl SR 22.5 mg powder and solvent for suspension for injection.
2. Qualitative and quantitative composition
Triptorelin (I.N.N) 28 mg as triptorelin pamoate.
The vial contains an overage to ensure that a dose of 22.5 mg is
administered to the patient.
For a full list of excipients see section 6.1.
3. Pharmaceutical form
Powder and solvent for suspension for injection, sustained release
formulation.
Powder: White to off-white powder. Solvent: Clear solution.
4. Clinical particulars
4.1 Therapeutic indications
Treatment of patients with locally advanced, non-metastatic prostate
cancer, as an alternative to surgical
castration.
Treatment of metastatic prostate cancer.
As adjuvant treatment to radiotherapy in patients with high-risk
localised or locally advanced prostate
cancer.
As neoadjuvant treatment prior to radiotherapy in patients with
high-risk localised or locally advanced
prostate cancer.
As adjuvant treatment to radical prostatectomy in patients with
locally advanced prostate cancer at high
risk of disease progression.
Treatment of central precocious puberty (CPP) in children 2 years and
older with an onset of CPP before
8 years in girls and 10 years in boys).
4.2 Posology and method of administration
POSOLOGY
The recommended dose of Decapeptyl SR 22.5 mg is 22.5 mg of
triptorelin (1 vial) administered every
six months (twenty four weeks) as a single intramuscular injection.
In patients treated with GnRH analogues for metastatic prostate
cancer, treatment is usually continued
upon development of castrate-resistant prostate cancer.
Reference should be made to relevant guidelines.
Decapeptyl is also available as a 1-month treatment (Decapeptyl SR 3
mg) and as a 3-month treatment
(Decapeptyl SR 11.25 mg).
_Patients with renal or hepatic impairment _
No dosage adjustment is necessary for patients with renal or hepatic
impairment.
_Paediatric population _
PRECOCIOUS PUBERTY (BE