PROSTAP 6 DCS 30 mg Powder and Solvent for Prolonged-release Suspension for Injection in Pre-filled Syringe

Kraj: Irlandia

Język: angielski

Źródło: HPRA (Health Products Regulatory Authority)

Składnik aktywny:

Leuprorelin acetate

Dostępny od:

Takeda Products Ireland Ltd

Kod ATC:

L02AE; L02AE02

INN (International Nazwa):

Leuprorelin acetate

Dawkowanie:

30 milligram(s)

Forma farmaceutyczna:

Powder and solvent for prolonged-release suspension for injection in pre-filled syringe

Typ recepty:

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

Dziedzina terapeutyczna:

Gonadotropin releasing hormone analogues; leuprorelin

Status autoryzacji:

Marketed

Data autoryzacji:

2011-04-08

Ulotka dla pacjenta

Prostap 6 DCS IE
1
PACKAGE LEAFLET: INFORMATION FOR THE USER
PROSTAP
® 6 DCS
30 mg Powder and Solvent for Prolonged-release Suspension for
Injection in Pre-filled Syringe
leuprorelin acetate
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN 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 or pharmacist.

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 or pharmacist. This
includes any possible side effects
not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1. What PROSTAP 6 is and what it is used for
2.
What you need to know before
you are given PROSTAP 6
3. How to use PROSTAP 6
4. Possible side effects
5. How to store PROSTAP 6
6.
Contents of the pack and other
information
1.
WHAT PROSTAP 6 IS AND WHAT IT IS USED FOR
PROSTAP 6 is a synthetic hormone, which can be used to reduce levels
of testosterone (sex steroid)
circulating in the body. PROSTAP 6 is used to treat prostate cancer in
men.
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE PROSTAP 6
PROSTAP 6 IS NOT RECOMMENDED FOR USE IN CHILDREN UNDER THE AGE OF 18
YEARS.
DO NOT TAKE PROSTAP 6:

If you are allergic (hypersensitive) to leuprorelin or any of the
other ingredients of PROSTAP 6
(listed in section 6).

If you are allergic (hypersensitive) to similar medicines to
leuprorelin (such as goserelin,
triptorelin) or medicines/products related to a natural hormone called
gonadotrophin
releasing hormone (GnRH).

If you are a man with prostate cancer, and have had injections of a
synthetic hormone in the past
that has not worked, or you have had an operation to remove your
testicles.
WARNINGS AND PRECAUTIONS:
When you begin treatment with PROSTAP 6, existing symptoms may
initially get worse as a result of
levels of sex steroids in the body increasing. These wors

Charakterystyka produktu

Health Products Regulatory Authority
10 October 2023
CRN00D597
Page 1 of 10
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
PROSTAP 6 DCS 30 mg Powder and Solvent for Prolonged-release
Suspension for Injection in Pre-filled Syringe
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
POWDER: Each single-dose syringe contains 30 mg leuprorelin acetate
When reconstituted with Sterile Solvent, the suspension contains 30 mg
leuprorelin acetate.
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Powder and solvent for prolonged–release suspension for injection in
pre-filled syringe (Dual Chamber Syringe)
POWDER: A sterile, lyophilised, white, odourless powder.
SOLVENT: A colourless, odourless, slightly viscous, aqueous sterile
solvent.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
(i) Metastatic prostate cancer
(ii) Locally advanced prostate cancer, as an alternative to surgical
castration
(iii) As an adjuvant treatment to radiotherapy in patients with
high-risk localised or locally advanced prostate cancer
(iv) As an adjuvant treatment to radical prostatectomy in patients
with locally advanced prostate cancer at high risk of disease
progression
(See Section 5.1)
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
Male Adults: The recommended dose is 11.25mg presented as a 3 month
depot injection and administered as a single
subcutaneous or intramuscular injection at intervals of 3 months. The
majority of patients will respond to this dosage.
PROSTAP 3 therapy should not be discontinued when remission or
improvement occurs.
Response to PROSTAP 3 therapy should be monitored by clinical
parameters and by measuring prostate-specific antigen (PSA)
and testosterone serum levels. Clinical studies have shown that
testosterone levels increased during the first 4 days of
treatment in the majority of non-orchidectomised patients. They then
decreased and reached castrate levels in 2-4 weeks.
Once attained, castrate levels were maintained as long as drug therapy
continued. Transient increases in