ELIGARD 45 mg powder and solvent for solution for injection

Država: Irska

Jezik: angleščina

Source: HPRA (Health Products Regulatory Authority)

Aktivna sestavina:

Leuprorelin acetate

Dostopno od:

Astellas Pharma Co. Ltd

Koda artikla:

L02AE; L02AE02

INN (mednarodno ime):

Leuprorelin acetate

Odmerek:

45 milligram(s)

Farmacevtska oblika:

Powder and solvent for solution for injection

Tip zastaranja:

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

Terapevtsko območje:

Gonadotropin releasing hormone analogues; leuprorelin

Status dovoljenje:

Marketed

Datum dovoljenje:

2007-10-26

Navodilo za uporabo

PACKAGE LEAFLET: INFORMATION FOR THE USER
ELIGARD 45 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 cance

Lastnosti izdelka

Health Products Regulatory Authority
08 September 2020
CRN008RD8
Page 1 of 14
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
ELIGARD 45 mg powder and solvent for solution for injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One prefilled syringe with powder for solution for injection contains
45 mg leuprorelin acetate, equivalent to 41.7 mg
leuprorelin.
For the full list of 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 solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
ELIGARD 45 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 45 mg should be administered under the direction of a
healthcare professional having available the appropriate
expertise for monitoring the response to treatment.
ELIGARD 45 mg is administered as a single subcutaneous injection every
six months
_. _ The injected solution forms a solid
medicinal product delivery depot and provides continuous release of
leuprorelin acetate over a six-month period.
As a rule, therapy of advanced prostate cancer with ELIGARD 45 mg
entails long-term treatment and therapy should not be
discontinued when remission or improvement occurs.
ELIGARD 45 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 45 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