Decapeptyl SR 3mg powder and solvent for suspension for injection vials

Држава: Велика Британија

Језик: Енглески

Извор: MHRA (Medicines & Healthcare Products Regulatory Agency)

Активни састојак:

Triptorelin acetate

Доступно од:

Ipsen Ltd

АТЦ код:

L02AE04

INN (Међународно име):

Triptorelin acetate

Дозирање:

3mg

Фармацеутски облик:

Powder and solvent for suspension for injection

Пут администрације:

Intramuscular

Класа:

No Controlled Drug Status

Тип рецептора:

Valid as a prescribable product

Резиме производа:

BNF: 08030402; GTIN: 5036611000059

Информативни летак

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Page 1 of 11
PACKAGE LEAFLET: INFORMATION FOR THE USER
DECAPEPTYL
®
SR 3 MG
POWDER 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 SR 3 mg is and what it is used for
2. What you need to know before you use Decapeptyl SR 3 mg
3. How to use Decapeptyl SR 3 mg
4. Possible side effects
5. How to store Decapeptyl SR 3 mg
6. Contents of the pack and other information
1.
WHAT DECAPEPTYL SR 3 MG IS AND WHAT IT IS USED FOR
The active ingredient in Decapeptyl SR 3 mg 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 SR 3 MG IS USED IN MEN AND WOMEN TO TREAT COMPLETELY
DIFFERENT CONDITIONS.
Decapeptyl SR is available in two other strengths: Decapeptyl SR 11.25
mg is used once every 3 months and
Decapeptyl SR 22.5 mg is used once every 6 months. Not all dose
strengths are approved for all indications.
Ask your doctor if you would like to discuss changing your treatment.
THIS LEAFLET GIVES INFORMATION FOR THE USE OF DECAPEPTYL SR 3 MG IN
MEN AND WOMEN.
PLEASE READ ALL THE
SECTIONS THAT ARE ABOUT YOU AND YOUR CONDITION.
MEN
IN MEN, DECAPEPTYL SR 3 M

Карактеристике производа

OBJECT 1
DECAPEPTYL SR 3MG
Summary of Product Characteristics Updated 15-Sep-2017 | Ipsen Ltd
1. Name of the medicinal product
Decapeptyl SR 3 mg, powder for suspension for injection.
2. Qualitative and quantitative composition
Triptorelin (I.N.N.) 4.2 mg, as triptorelin acetate.
The vial contains an overage to ensure that a dose of 3 mg is
administered to the patient.
For a full list of excipients, see section 6.1.
3. Pharmaceutical form
Powder for suspension for injection, sustained release formulation.
4. Clinical particulars
4.1 Therapeutic indications
Treatment of patients with locally advanced, non-metastatic prostate
cancer, as an alternative to surgical
castration (see section 5.1).
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 endometriosis.
Treatment of uterine fibroids prior to surgery or when surgery is not
appropriate.
As adjuvant treatment in combination with tamoxifen or an aromatase
inhibitor, of endocrine responsive
early stage breast cancer in women at high risk of recurrence who are
confirmed as pre-menopausal after
completion of chemotherapy (see sections 4.3, 4.4, 4.8 and 5.1).
4.2 Posology and method of administration
PROSTATE CANCER
One intramuscular injection should be administered every 4 weeks (28
days). No dosage adjustment is
necessary in the elderly.
Decapeptyl is also available as a 3-month treatment (Decapeptyl SR
11.25 mg) and as a 6-month
treatment (Decapeptyl SR 22.5 mg) for prostate cancer.
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.
ENDOMETRIOSIS AN