DIPHERELINE P.R. POWDER AND SOLVENT FOR SUSPENSION FOR INJECTION 11.25 mgvial

Country: Singapura

Bahasa: Inggeris

Sumber: HSA (Health Sciences Authority)

Bahan aktif:

TRIPTORELIN PAMOATE eqv. TRIPTORELIN

Boleh didapati daripada:

IPSEN PHARMA SINGAPORE PTE. LTD.

Kod ATC:

L02AE04

Dos:

11.25 mg/vial

Borang farmaseutikal:

INJECTION, POWDER, FOR SUSPENSION, EXTENDED RELEASE

Komposisi:

TRIPTORELIN PAMOATE eqv. TRIPTORELIN 11.25 mg/vial

Laluan pentadbiran:

SUBCUTANEOUS, INTRAMUSCULAR

Jenis preskripsi:

Prescription Only

Dikeluarkan oleh:

IPSEN PHARMA BIOTECH (Lyophilisate manufacturer)

Status kebenaran:

ACTIVE

Tarikh kebenaran:

2014-09-25

Risalah maklumat

1 

DIPHERELINE
®
 P.R. POWDER AND SOLVENT FOR SUSPENSION FOR 
INJECTION 11.25MG/VIAL

Triptorelin pamoate

PRESENTATION AND FORM 
Diphereline PR 11.25 mg, powder and solvent for suspension for injection for intramuscular 
injection, 3-month prolonged release form. This pack contains a glass vial of powder, an 
ampoule of 2 ml solvent, 1 syringe and 2 needles. 

COMPOSITION PER UNIT DOSE 
Active ingredient: Triptorelin 11.25 mg* (as triptorelin pamoate) 
* Taking into account the characteristics of the pharmaceutical form, each vial contains a 
quantity of triptorelin pamoate corresponding to 15 mg of triptorelin. 
Excipients: D, L Lactide-coglycolide Polymer, Mannitol, Sodium carmellose, and Polysorbate 
80  
Solvent: Mannitol and water for injection 

THERAPEUTIC INDICATIONS 
•  PROSTATE CANCER  
Treatment of locally advanced or metastatic, hormone-dependent prostate cancer. 
As adjuvant treatment to radiotherapy in patients with locally advanced prostate cancer. 
•  ENDOMETRIOSIS  
•  CENTRAL PRECOCIOUS PUBERTY (BEFORE 8 YEARS IN GIRLS AND 10 YEARS IN BOYS).  

DOSAGE AND METHOD OF ADMINISTRATION 
PROSTATE CANCER 

One intramuscular injection of Diphereline PR 11.25 mg every 3 months. 

ENDOMETRIOSIS 
One  intramuscular  injection of Diphereline PR 11.25 mg  every 3  months. The treatment must 
be initiated in the first five days of the menstrual cycle. 
Duration of treatment: this depends on the initial severity of the endometriosis and the changes 
observed  in  the  clinical  features  (functional  and  anatomical)  during  treatment.  The  treatment 
should not be administered for more than 6 months (_see Undesirable effects_). A further course 
of  treatment  by  triptorelin  or  by  another  GnRH  anal

Ciri produk

1
1
NAME OF THE MEDICINAL PRODUCT
Diphereline
®
P.R. Powder and Solvent for Suspension for Injection 11.25 mg/vial
2
PRESENTATION AND FORM
Diphereline P.R. 11.25 mg, powder and solvent for suspension for
injection for intramuscular and
subcutaneous injection, 3-month prolonged release form. This pack
contains a glass vial of powder, an
ampoule of 2 mL solvent, 1 syringe and 3 needles.
3
COMPOSITION PER UNIT DOSE
ACTIVE INGREDIENT
Triptorelin 11.25 mg* (as triptorelin pamoate)
*Taking into account the characteristics of the pharmaceutical form,
each vial contains a quantity of
triptorelin pamoate corresponding to 15 mg of triptorelin.
EXCIPIENTS
Composition of the powder
D,L lactide-coglycolide polymer, mannitol, sodium carmellose and
polysorbate 80
Composition of the solvent
Mannitol and water for injection
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
•
PROSTATE CANCER
Treatment of locally advanced or metastatic, hormone-dependent
prostate cancer.
As adjuvant treatment to radiotherapy in patients with high-risk
localised or locally advanced
prostate cancer.
•
ENDOMETRIOSIS
•
CENTRAL PRECOCIOUS PUBERTY (BEFORE 8 YEARS IN GIRLS AND 10 YEARS IN
BOYS)
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
•
PROSTATE CANCER
One intramuscular or subcutaneous injection of Diphereline P.R. 11.25
mg every 3 months.
2
Duration of the treatment: In high-risk localised or locally advanced
hormone-dependent prostate
cancer as concomitant to and following radiation therapy clinical data
have shown that radiotherapy
followed by long-term androgen deprivation therapy is preferable to
radiotherapy followed by short-
term androgen deprivation therapy (see section 5.1).
The treatment duration of androgen deprivation therapy recommended by
medical guidances for
patients with high-risk localised or locally advanced prostate cancer
receiving radiotherapy is 2 – 3
years.
In patients who are not surgically castrated and treated with GnRH
analogues for metastatic prostate
cancer, treatment is usually continued upon developme