DIPHERELINE 3.75 MG

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

TRIPTORELIN AS ACETATE

Available from:

MEDISON PHARMA LTD

ATC code:

L02AE04

Pharmaceutical form:

POWDER AND SOLVENT FOR SUSPENSION FOR INJECTION

Composition:

TRIPTORELIN AS ACETATE 3.75 MG/VIAL

Administration route:

I.M

Prescription type:

Required

Manufactured by:

IPSEN PHARMA, FRANCE

Therapeutic group:

TRIPTORELIN

Therapeutic area:

TRIPTORELIN

Therapeutic indications:

Prostate cancer: Treatment of prostate cancer with metastases. Patients who have not previously received hormone therapy show a more marked response to the treatment and respond more frequently if the patient has not previously receieved another hormone treatment. Precocious puberty: (Before 8 years in girls and 10 years in boys). Genital and extragenital endometriosis (stage I to stage IV): Treatment should not be administered for more than 6 months. It is not recomended to start a second treatment course with triptorelin or another GnRH analogue. Treatment of uterine fibromyomas prior to surgery: associated with Anaemia ( haemoglobin less than, or equal to 8 g/dl). When a reduction in the size of the fibromyoma is necessary to facilitate or modify the surgical technique: endoscopic surgery, transvaginal surgery. The treatment duration is restricted to 3 months. Female infertility: Supplementary treatment in combination with gonadotrophins (hMG, FSH, hCG) to induce ovulation with a view to in vitro fertilisa

Authorization date:

2011-01-31

Summary of Product characteristics

SUMMARY OF DRUG CHARACTERISTICS
1.
NAME OF DRUG
:
DIPHERELINE 3.75 MG, POWDER AND SOLVENT FOR SUSPENSION FOR INJECTION
(I.M
)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
_U_
Powder
_U_
:
Triptorelin, presented as acetate
..................................................................
3.75 mg
D,L Lactide-coglycolide polymer
........................................................... 170.00 mg
Mannitol
....................................................................................................
85.00 mg
Carmellose sodium
....................................................................................
30.00 mg
Polysorbate 80
.............................................................................................
2.00 mg
for one vial
_U_
Solvent
_U_
:
Mannitol
....................................................................................................
16.00 mg
Water for injectable
preparations.......................q.s.p.............................
2000.00 mg
for one ampoule
3.
PHARMACEUTICAL FORM:
Powder and solvent for suspension for injection (I.M.), sustained
release form.
4.
CLINICAL PARTICULARS
4.1
_Therapeutic indications_
PROSTATE CANCER
Treatment of prostate cancer with metastases.
Patients who have not previously received hormone therapy show a more
marked response to the treatment and respond more frequently if the
patient has
not previously received another hormone treatment.
PRECOCIOUS PUBERTY
(before 8 years in girls and 10 years in boys).
GENITAL AND EXTRAGENITAL ENDOMETRIOSIS (STAGE I TO STAGE IV)
Treatment should not be administered for more than 6 months (see
Undesirable
effects). It is not recommended to start a second treatment course
with triptorelin
or another GnRH analogue.
TREATMENT OF UTERINE FIBROMYOMAS PRIOR TO SURGERY
-
associated with anaemia (haemoglobin less than or equal to 8 g/dl),
-
when a reduction in the size of the fibromyoma is necessary to
facilitate or
modify the surgical technique: endoscopic surgery, transvaginal
surgery,
-
the treatment duration i