ELIGARD 22.5 MG

Држава: Израел

Језик: Енглески

Извор: Ministry of Health

Активни састојак:

LEUPRORELIN ACETATE

Доступно од:

KAMADA LTD, ISRAEL

Фармацеутски облик:

POWDER AND SOLVENT FOR SOLUTION FOR INJECTION

Састав:

LEUPRORELIN ACETATE 22.5 MG

Пут администрације:

S.C

Тип рецептора:

Required

Произведен од:

ASTELLAS PHARMA EUROPE B.V, THE NETHERLANDS

Терапеутске индикације:

ELIGARD 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.

Датум одобрења:

2016-08-07

Информативни летак

CONSUMER’S LEAFLET IN ACCORDANCE WITH PHARMACISTS REGULATIONS (5746
– 1986)
The medication is marketed by a physician’s prescription only
ELIGARD 22.5 MG
POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
COMPOSITION:
Syringe B contains: Leuprorelin acetate 22.5mg
EXCIPIENTS AND ALLERGENS IN THE PRODUCT –
see section 6 “additional information”
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE. THIS LEAFLET CONTAINS
ESSENTIAL INFORMATION FOR YOU. IF YOU HAVE ANY FURTHER QUESTIONS, ASK
YOUR DOCTOR OR
PHARMACIST.
•
This medicine has been prescribed for you. Do not pass it on to
others. It may harm them,
even if their symptoms are the same as yours.
1.
WHAT THIS MEDICATION IS USED FOR?
ELIGARD is used to treat hormone dependent advanced
PROSTATE CANCER
and for the treatment of
high-risk non-metastatic hormone dependent prostate cancer in
combination with radiotherapy.
Therapeutic group: analogs to gonadotropin releasing hormones.
These medicines are used to decrease the production of certain sex
hormones (such as testosterone).
2.
BEFORE USING THIS MEDICATION
DO NOT USE THE MEDICATION
•
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 cancer.
SPECIAL WARNINGS REGARDING THE USE OF THE MEDICATION
•
TALK TO YOUR DOCTOR
BEFORE USING
ELIGARD
if you have any of the following: Any heart or
blood vessel conditions, including heart rhythm problems (arrhythmia),
or are being treated with
medicines for these conditions. Th

Карактеристике производа

1.
NAME OF THE MEDICINAL PRODUCT
ELIGARD 22.5 mg
Powder and solvent for solution for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
_ _
One prefilled syringe with powder for solution for injection contains
22.5 mg leuprorelin acetate,
equivalent to 20.87 mg leuprorelin.
For a 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 solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
ELIGARD
22.5 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 should be administered under the direction of a healthcare
professional having available the
appropriate expertise for monitoring the response to treatment.
ELIGARD 22.5 mg is administered as a single subcutaneous injection
every three months. The injected
solution forms a solid medicinal product delivery depot and provides
continuous release of leuprorelin
acetate over a three-month period.
As a rule, therapy of advanced prostate cancer with ELIGARD 22.5 mg
entails long-term treatment and
therapy should not be discontinued when remission or improvement
occurs.
ELIGARD 22.5 mg may be used as neoadjuvant or adjuvant therapy in
combination with radiotherapy
and an anti-androgen, in high-risk localised and locally advanced
prostate cancer.
Response to ELIGARD 22.5 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 castration levels within 3 - 4 weeks. Once
attained, castrate levels were
maintained as long