DECAPEPTYL DEPOT 3.75 MG

Țară: Israel

Limbă: engleză

Sursă: Ministry of Health

Ingredient activ:

TRIPTORELIN AS EMBONATE

Disponibil de la:

FERRING PHARMACEUTICALS LTD

Codul ATC:

L02AE04

Forma farmaceutică:

POWDER AND SOLVENT FOR SUSPENSION FOR INJECTION

Compoziție:

TRIPTORELIN AS EMBONATE 3.75 MG ML

Calea de administrare:

I.M

Tip de prescriptie medicala:

Required

Produs de:

DEBIOPHARM RESEARCH & MANUFACTURING S.A, SWITZERLAND

Grupul Terapeutică:

TRIPTORELIN

Zonă Terapeutică:

TRIPTORELIN

Indicații terapeutice:

- Lowering of sexual hormones and - treatment of advanced hormone-dependent prostate cancer. - Central precocious puberty.- As adjuvant treatment in combination with tamoxifen or an aromatase inhibitor of hormone receptor-positive early stage breast cancer in women at high risk of recurrence and who are confirmed as pre-menopausal after completion of chemotherapy and in men at high risk of recurrence

Data de autorizare:

2019-08-31

Prospect

ل
ّ
وبتلا يف تابارطضا ،يليل ل
ّ
وبت
فنلأا نم فيزن
10000 نيب نم نيلمعتسم 1-10 ىدل رهظت ضارعأ
)rare( ةردان ةيبناج ضارعأ
دلجلا ىلع ةيجسفنب وأ ءارمح عقب
ةيؤرلا يف تابارطضا ،نيعلا يف ميلس ريغ
ساسحإ
قوذلا ةساح يف تارييغت ،تازاغ ،نطبلاب
خافتنلاا ساسحإ
ردصلا يف ملأ
فوقولا يف تابوعص
مسجلا ةرارح يف عافترا ،ازنولفنلإاب
ةهيبش ضارعأ
)سفنتلا يف تابوعصو راود ىلإ يدؤي نأ
نكمم يذلا ديدش لعف در( ةيقأت لعف دودر
قلحلاو فنلأا يف باهتلا
يلصفم باهتلا( )Osteoarthritis( يمظع لاصف
،تلاضعلا بلصت ،لصافملا خافتنا
،لصافملا يف بلصت
)يرومض
ةركاذلا يف ةباصإ
ةجهبلاب ساسحإ ،ءادلأا يف ضافخنا
،كابترلااب ساسحإ
ءاقلتسلاا ءانثأ سفنت قيض
روثب
مدلا طغض يف ضافخنا
دبكلا تاميزنإ يف عافترا
:)دعب اهرتاوت ديدحت
ّ
متي مل ة
ّ
يبناج ضارعأ( ةفورعم ريغ اهعويش ةبسن ة
ّ
يبناج ضارعأ
،)مدلا طغض يف ضافخنا انايحأو خافتنا
،يدلج حفط ،ةنوخسب ةبوحصم ةديدش ة
ّ
يسسحت لعف دودر( ةيقأت لعف دودر
،موعلبلا يف وأ ناسللا يف ،هجولا يف
خافتنا ،قلق ،ضرملاب ماع ساسحإ ،)QT عطقم
ةلاطإ( ECG يف تارييغت
.لوبلا سابتحا ،)Angioedema – ةيئاعو ةمذو(
سفنت تابوعصو ىرش ،علبلا يف تابوعص
.ةقطنملا هذه يف فيزن ثودح رطخ يف عافترا
،ةيماخنلا ةدغلا يف مرو دوجو ةلاح يف
نم ددع نم نوناعي دق ،تاعاعشإ عم جمدلاب
GnRH رئاظنب دملأا ليوط جلاع ىلع ن

Caracteristicilor produsului

_ _
_Page 1 of 18 _
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Decapeptyl Depot 3.75 mg.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 vial contains 3.75 mg triptorelin embonate equivalent to 3.75 mg
triptorelin.
1 ml of reconstituted suspension contains 1.875 mg triptorelin after
dissolution in 2 ml solvent.
_ _
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder and solvent for prolonged-release suspension for injection
The powder is white to off-white powder and the solvent is a clear
solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
DECAPEPTYL DEPOT 3.75 MG
is indicated for lowering of sexual hormone;
treatment of advanced hormone-dependent prostatic cancer and for the
treatment of central precocious
puberty.
As adjuvant treatment in combination with tamoxifen or an aromatase
inhibitor of hormone receptor-
positive early stage breast cancer in women at high risk of recurrence
and who are confirmed as pre-
menopausal after completion of chemotherapy (see sections 4.3, 4.4,
4.8 and 5.1) and in men at high
risk of recurrence.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
The usual dosage is one intramuscular injection of Decapeptyl Depot
3.75mg every month under
medical supervision.
CENTRAL PRECOCIOUS PUBERTY
: Initially, 3.75 mg on days 0, 14, 28 and then 3.75 mg every 28 days.
If
the effect is insufficient, injections may be given every 21 days.
Dosing should be based on body
weight. Children weighing less than 20 kg are injected with 1.875 mg
(half-dose), children between 20
and 30 kg receive 2.5 mg (2/3 dose), and children weighing more than
30 kg are injected with 3.75 mg
(full dose). Treatment should be stopped if a bone maturation of older
than 12 years in girls and older
than 13 years in boys has been achieved.
BREAST CANCER
The content from a vial, equal 3.75 mg triptorelin, is injected
intramuscularly once a month (every 4
weeks) in combination with tamoxifen or an aromatase inhibitor (AI).
Triptorelin should be commenced after compl