DECAPEPTYL DEPOT 3.75 MG

国家: 以色列

语言: 英文

来源: Ministry of Health

有效成分:

TRIPTORELIN AS EMBONATE

可用日期:

FERRING PHARMACEUTICALS LTD

ATC代码:

L02AE04

药物剂型:

POWDER AND SOLVENT FOR SUSPENSION FOR INJECTION

组成:

TRIPTORELIN AS EMBONATE 3.75 MG ML

给药途径:

I.M

处方类型:

Required

厂商:

DEBIOPHARM RESEARCH & MANUFACTURING S.A, SWITZERLAND

治疗组:

TRIPTORELIN

治疗领域:

TRIPTORELIN

疗效迹象:

- 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

授权日期:

2019-08-31

资料单张

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产品特点

_ _
_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