ELIGARD 7.5 MG

País: Israel

Língua: inglês

Origem: Ministry of Health

Ingredientes ativos:

LEUPRORELIN ACETATE

Disponível em:

KAMADA LTD, ISRAEL

Forma farmacêutica:

POWDER AND SOLVENT FOR SOLUTION FOR INJECTION

Composição:

LEUPRORELIN ACETATE 7.5 MG

Via de administração:

S.C

Tipo de prescrição:

Required

Fabricado por:

ASTELLAS PHARMA EUROPE B.V, THE NETHERLANDS

Indicações terapêuticas:

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 combination with radiotherapy.

Data de autorização:

2016-08-07

Folheto informativo - Bula

CONSUMER’S LEAFLET IN ACCORDANCE WITH PHARMACISTS REGULATIONS (5746
– 1986)
The medication is marketed by a physician’s prescription only
ELIGARD 7.5 MG
POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
COMPOSITION:
Syringe B contains: Leuprorelin acetate 7.5mg
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 MEDICATIONIS 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. The r

Características técnicas

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
_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 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
and an anti-androgen, 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 castration levels within 3 - 4
_ _
weeks. Once attained, castrate levels were maintained
as long a