DECAPEPTYL DEPOT 11.25 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 11.25 MG

طريقة التعاطي:

I.M

نوع الوصفة الطبية :

Required

المصنعة من قبل:

DEBIOPHARM RESEARCH & MANUFACTURING S.A, SWITZERLAND

المجموعة العلاجية:

TRIPTORELIN

المجال العلاجي:

TRIPTORELIN

الخصائص العلاجية:

- Lowering of sexual hormones and- treatment of advanced hormone-dependent prostate cancer.

تاريخ الترخيص:

2022-01-31

نشرة المعلومات

PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS’
REGULATIONS (PREPARATIONS) - 1986
This medicine is dispensed with a doctor’s prescription only
DECAPEPTYL DEPOT 11.25 MG
POWDER AND SOLVENT FOR RECONSTITUTING A
SUSPENSION FOR INTRAMUSCULAR INJECTION
COMPOSITION:
Each vial of Decapeptyl Depot 11.25 mg contains 11.25 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.
This medicine is intended for use in adults only.
1. WHAT IS THIS MEDICINE INTENDED FOR?
This medicine is intended for
treating advanced hormone-dependent prostate cancer
lowering sexual hormones level
THERAPEUTIC GROUP: long-term analog 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 analogs of the gonadotropin
releasing hormone )GnRH is also called LHRH(, or to any of the
other ingredients that this medicine contains )see Section 6(.
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 smoker, have osteoporosis or have
a
family
history
of
osteoporosis
)a
condition
that
weakens
your bones(, have a poor diet or take medicines )for example
anticonvulsants, steroids(. When Decapeptyl Depot is used for a
long period of time the ris

خصائص المنتج

_ _
_Page 1 of 10 _
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Decapeptyl Depot 11.25 mg.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
DECAPEPTYL DEPOT 11.25 MG
. Each vial of
_Decapeptyl Depot 11.25 mg_
contains triptorelin
embonate equivalent to 11.25 mg triptorelin. After reconstitution in 2
ml solvent, 1 ml of
reconstituted suspension contains 5.625 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 11.25 mg_
is indicated for lowering of sexual hormone; treatment of advanced
hormone-dependent prostate cancer
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
_POSOLOGY _
The usual dosage is one intramuscular injection of
_Decapeptyl Depot 11.25mg_
every 12 weeks
as under medical supervision.
DRUG 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. urinary symptoms,
cancer pain etc). Testosterone levels can be measured immediately
before or after injection.
PATIENTS WITH IMPAIRED HEPATIC FUNCTION
No dosage adjustment is necessary for patients suffering from limited
hepatic function.
PATIENTS WITH IMPAIRED RENAL FUNCTION
No dosage adjustment is necessary for patients suffering from limited
renal function.
ELDERLY PATIENTS
No dosage adjustment is necessary.
CHILDREN AND ADOLESCENTS
The safety and efficacy of Decapeptyl Depot 11.25 mg have not been
established in children and
adolescents, it is not indicated for use in these populations.
MODE OF ADMINISTRATION
Since Decapeptyl Depot 11.25 mg is a suspension of microgranules,
inadvertent intravascular injection
must be strictly avoided.
Decapeptyl Depot 11.25mg may only be administered by doctors or
medical personnel.
_ _
_Page 2 of 10 _
The injection site should be changed periodically.
For instructions on reconstitution