ELIGARD 45 MG

Country: Իսրայել

language: անգլերեն

source: Ministry of Health

active_ingredient:

LEUPRORELIN ACETATE

MAH:

KAMADA LTD, ISRAEL

pharmaceutical_form:

POWDER AND SOLVENT FOR SOLUTION FOR INJECTION

composition:

LEUPRORELIN ACETATE 45 MG

administration_route:

S.C

prescription_type:

Required

manufactured_by:

ASTELLAS PHARMA EUROPE B.V, THE NETHERLANDS

therapeutic_indication:

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.

authorization_date:

2016-08-07

PIL

CONSUMER’S LEAFLET IN ACCORDANCE WITH PHARMACISTS REGULATIONS (5746
– 1986)
The medication is marketed by a physician’s prescription only
ELIGARD 45 MG
POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
COMPOSITION:
Syringe B contains: Leuprorelin acetate 45mg
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. The ri

SPC

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