ELIGARD 45 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 45 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 45 MG
POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
ACTIVE INGREDIENT AND ITS QUANTITY:
Syringe B contains: Leuprorelin acetate 45 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 be

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 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