DECAPEPTYL DEPOT 22.5 MG

البلد: إسرائيل

اللغة: الإنجليزية

المصدر: Ministry of Health

العنصر النشط:

TRIPTORELIN AS EMBONATE

متاح من:

FERRING PHARMACEUTICALS LTD

ATC رمز:

L02AE04

الشكل الصيدلاني:

POWDER AND SOLVENT FOR SUSPENSION FOR INJECTION

تركيب:

TRIPTORELIN AS EMBONATE 22.5 MG

طريقة التعاطي:

I.M

نوع الوصفة الطبية :

Required

المصنعة من قبل:

DEBIOPHARM RESEARCH & MANUFACTURING S.A, SWITZERLAND

المجال العلاجي:

TRIPTORELIN

الخصائص العلاجية:

Symptomatic treatment of advanced hormone-dependent prostate cancer. As an alternative treatment, if orchiectomy or the administration of oestrogens are not indicated or are unacceptable to the patient. Treatment of central precocious puberty (CPP) in children 2 years and older with an onset of CPP before 8 years in girls and 10 years in boys.

تاريخ الترخيص:

2020-09-30

نشرة المعلومات

Patient leaflet in accordance with the Pharmacists’
Regulations (Preparations) - 1986
This medicine is dispensed with a doctor’s prescription only
Decapeptyl Depot 22.5 mg
Powder and solvent for reconstituting a
suspension for intramuscular injection
Composition:
Each vial of Decapeptyl Depot 22.5 mg contains 22.5 mg triptorelin
(as embonate).
Inactive ingredients and allergens: See section 2 under ‘Important
information about some of this medicine’s ingredients’, and
section
6 ‘Additional Information’.
Read the entire leaflet carefully before using this medicine.
This leaflet contains concise information about this medicine. If you
have any further questions, consult your doctor or pharmacist. This
medicine has been prescribed to treat your illness. Do not pass it on
to others. It may harm them, even if it seems to you that their
illness
is similar to yours.
1. What is this medicine intended for?
This medicine is intended
for treating advanced hormone-dependent prostate cancer as an
alternative treatment, if surgical testicle resection or
administration
of estrogens is not indicated or not suitable for the patient.
for treating early puberty in children over two years old who have
started puberty before 8 years old in girls and before 10 years old
in boys.
Therapeutic group: long-term analogue of GnRH (gonadotropin
releasing hormone)
2. Before using this medicine
Do not use this medicine if:
you are sensitive (allergic) to triptorelin embonate, gonadotropin
releasing hormone (GnRH), other analogues of the gonadotropin
releasing hormone (GnRH is also called LHRH), or to any of the
other ingredients that this medicine contains (see Section 6).
you are pregnant or breastfeeding.
Special warnings about using this medicine
_Before using this medicine, tell your doctor if:_
you are depressed. There have been reports of depression, which
may be serious, among patients taking Decapeptyl Depot.
you are using anticoagulants, because you may get a bruise at the
injection site.
you are a heavy drinker, a smoke

خصائص المنتج

_ _
_Page 1 of 13 _
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Decapeptyl depot 22.5 mg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains triptorelin embonate equivalent to 22.5 mg
triptorelin. After reconstitution in
2 ml solvent, 1 ml of reconstituted suspension contains 11.25 mg of
triptorelin.
For a full list of excipients see section 6.1.
3.
PHARMACEUTICAL FORM
Powder and solvent for prolonged-release suspension for injection
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
DECAPEPTYL DEPOT 22.5 MG
is indicated for
symptomatic treatment of advanced hormone-
dependent prostate cancer. As an alternative treatment, if orchiectomy
or the administration of
oestrogens are not indicated or are unacceptable to the patient.
Decapeptyl 22.5 mg is also indicated for the treatment of central
precocious puberty (CPP) in
children 2 years and older with an onset of CPP before 8 years in
girls and 10 years in boys.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
_POSOLOGY _
The usual dosage is one intramuscular injection of Decapeptyl depot
22.5mg every 24 weeks
under medical supervision.
_Paediatric population _
PRECOCIOUS PUBERTY (BEFORE 8 YEARS IN GIRLS AND 10 YEARS IN BOYS)
The treatment of children with Decapeptyl 22.5 mg should be under the
overall supervision of a
paediatric endocrinologist or of a paediatrician or an endocrinologist
with expertise in the
treatment of central precocious puberty.
Treatment should be stopped around the physiological age of puberty in
boys and girls and
should not be continued in girls with a bone maturation of more than
12-13 years. There are
limited data available in boys relating to the optimum time to stop
treatment based on bone age,
however it is advised that treatment is stopped in boys with a bone
maturation age of 13-14
years.
TREATMENT MONITORING
_Prostate cancer _
The efficacy of treatment can be monitored by measuring serum levels
of testosterone and
prostate specific agent (PSA) and by subjective evaluation
(symptomatic improvement e.g.
ur