ELIGARD 22.5 MG

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

LEUPRORELIN ACETATE

Available from:

KAMADA LTD, ISRAEL

Pharmaceutical form:

POWDER AND SOLVENT FOR SOLUTION FOR INJECTION

Composition:

LEUPRORELIN ACETATE 22.5 MG

Administration route:

S.C

Prescription type:

Required

Manufactured by:

ASTELLAS PHARMA EUROPE B.V, THE NETHERLANDS

Therapeutic indications:

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:

2021-07-31

Patient Information leaflet

PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS'
REGULATIONS (PREPARATIONS) - 1986
The medicine is dispensed with a doctor's prescription only
ELIGARD 22.5 MG
POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
ACTIVE INGREDIENT AND ITS QUANTITY:
Syringe B contains: Leuprorelin acetate 22.5 mg
EXCIPIENTS AND ALLERGENS IN THE PRODUCT
–
see section 6 “additional information”
.
READ THIS LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE YOU START USING THE
MEDICINE. This leaflet contains
concise information about the medicine. If you have any further
questions, refer to the doctor or
pharmacist.
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them, even if
it seems to you that their ailment is similar.
1.
WHAT IS THE MEDICINE INTENDED 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 (testosterone).
2.
BEFORE USING THE MEDICINE
DO NOT USE THE MEDICINE:
•
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 MEDICINE
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 b

Summary of Product characteristics

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 as