DECAPEPTYL 0.1

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

TRIPTORELIN ACETATE

Available from:

FERRING PHARMACEUTICALS LTD

ATC code:

L02AE04

Pharmaceutical form:

SOLUTION FOR INJECTION

Composition:

TRIPTORELIN ACETATE 0.1 MG/ML

Administration route:

S.C

Prescription type:

Required

Manufactured by:

FERRING GmbH ,GERMANY

Therapeutic area:

TRIPTORELIN

Therapeutic indications:

Precocius puberty, prostatic cancer, endomethriosis, uterus myomatoses and IVF.

Authorization date:

2017-10-29

Patient Information leaflet

1
1. NAME OF THE MEDICINAL PRODUCT.
DECAPEPTYL
®
0.1 MG
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
1 disposable syringe with 1 ml solution for injection contains 100 ug
triptorelin acetate,
corresponding to 95.6 ug triptorelin.
For excipients see 6.1.
3. PHARMACEUTICAL FORM.
Solution for injection
4. CLINICAL PARTICULARS.
4.1 THERAPEUTIC INDICATIONS
Precocious puberty, prostatic cancer, endometriosis, uterus
myomatoses, IVF.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
_PROSTATIC CANCER _
_Dosage. _
Initially, Decapeptyl 0.5 mg is administered once a day for 7 days.
From the 8th day on,
Decapeptyl 0.1 mg is administered once a day. Alternativelly,
Decapeptyl Depot (3.75
mg triptorelin as controleed-release preparation for IM application
once every 28 days) is
available.
_Mehtod and duration of administration. _
Decapeptyl 0.1 mg and 0.5 mg are injected subcutaneously.
Decapeptyl is foreseen for long-term treatment. The duration of
therapy is fixed by the
physician in charge. Decapeptyl 0.5 mg is foressen for the initial
phase of treatment over
7 days; long-term treatment is carried out by Decapeptyl Depot and/or
Decapeptyl 0.1
mg. A switch from other forms of application of GnRH-analogues is
possible without
problems any time.
4.3 CONTRAINDICATIONS
- Hypersensitivity to the active substance or to any of the excipients
listed in section 6.1
- Hypersensitivity to gonadotrophin-releasing hormone (GnRH) or any
other GnRH
analogue
- Pregnancy and Lactation period
Non hormone dependent carcinoma.
Prostatic cancer: Decapeptyl should not be prescribed to patients
presenting with spinal
cord compression or evidence of spinal cord metastases.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
The use of GnRH agonists may cause reduction in bone mineral density.
In men,
preliminary data suggest that the use of a bisphosphonate in
combination with an GnRH
agonist may reduce bone mineral loss.
Particular caution is necessary in patients with additional risk
factors for osteoporosis
(e.g. chronic alcohol abuse, smokers, long-term the