ELIGARD 7.5 mg powder and solvent for solution for injection

Krajina: Írsko

Jazyk: angličtina

Zdroj: HPRA (Health Products Regulatory Authority)

Aktívna zložka:

Leuprorelin acetate

Dostupné z:

Recordati Industria Chimica e Farmaceutica SpA

ATC kód:

L02AE; L02AE02

INN (Medzinárodný Name):

Leuprorelin acetate

Dávkovanie:

7.5 milligram(s)

Forma lieku:

Powder and solvent for solution for injection

Terapeutické oblasti:

Gonadotropin releasing hormone analogues; leuprorelin

Stav Autorizácia:

Marketed

Dátum Autorizácia:

2005-10-13

Príbalový leták

PACKAGE LEAFLET: INFORMATION FOR THE USER
ELIGARD 7.5 MG
POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
LEUPRORELIN ACETATE.
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 symptoms 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 ELIGARD is and what it is used for
2. What you need to know before you use ELIGARD
3. How to use ELIGARD
4. Possible side effects
5. How to store ELIGARD
6. Contents of the pack and other information
1.
WHAT ELIGARD IS AND WHAT IT IS USED FOR
The active substance of ELIGARD belongs to the group of so-called
gonadotropin releasing
hormones. These medicines are used to decrease the production of
certain sex hormones
(testosterone).
ELIGARD is used to treat hormone dependent metastatic
PROSTATE CANCER
in adult men and for the
treatment of high-risk non-metastatic hormone dependent prostate
cancer in combination with
radiotherapy.
_ _
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE ELIGARD
DO NOT USE ELIGARD
•
If you are a
WOMAN OR A CHILD
•
If you are
HYPERSENSITIVE (ALLERGIC)
to the active substance leuprorelin acetate, products with an
activity comparable to the naturally occurring hormone gonadotropin,
or to any of the other
ingredients of ELIGARD (listed in section 6).
•
Following
SURGICAL REMOVAL OF YOUR TESTES
, as in that case ELIGARD does not lead to a further
decrease in serum testosterone levels.
•
As the only treatment if you suffer from symptoms related to pressure
on the spinal cord or
tumour in the spinal column. In this case, ELIGARD may only be used in
combination with
other medicinal products for prostate ca

Súhrn charakteristických

Health Products Regulatory Authority
18 January 2024
CRN00F2CC
Page 1 of 13
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
ELIGARD 7.5 mg powder and solvent for solution for injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One prefilled syringe with powder for solution for injection contains
7.5 mg leuprorelin acetate, equivalent to 6.96 mg
leuprorelin.
For the full listof excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Powder and solvent for solution for injection.
Powder (Syringe B):
Pre-filled syringe with a white to off-white powder.
Solvent (Syringe A):
Pre-filled syringe with a clear, colourless to pale yellow/brown
solution
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
ELIGARD 7.5 mg is indicated for the treatment of hormone dependent
advanced prostate cancer and for the treatment of
high-risk localized and locally advanced hormone dependent prostate
cancer in combination with radiotherapy.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adult Males_
ELIGARD 7.5 mg should be administered under the direction of a
healthcare professional having available the appropriate
expertise for monitoring the response to treatment.
ELIGARD 7.5 mg is administered as a single subcutaneous injection
every month _. _
The injected solution forms a solid medicinal
product delivery depot and provides continuous release of leuprorelin
acetate for one month.
As a rule, therapy of advanced prostate cancer with ELIGARD
7.5 mg entails long-term treatment and therapy should not be
discontinued when remission or improvement occurs.
ELIGARD 7.5 mg may be used as neoadjuvant or adjuvant therapy in
combination with radiotherapy in high-risk localised and
locally advanced prostate cancer.
Response to ELIGARD 7.5 mg should be monitored by clinical parameters
and by measuring prostate specific antigen (PSA)
serum levels. Clinical studies have shown that testosterone levels
increased during the first 3 days of treatment in the majority
of non-orchiectomised patients and then decreased to below medical
ca