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

Country: Malaysia

Language: English

Source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Active ingredient:

TRIPTORELINE PAMOATE

Available from:

ZUELLIG PHARMA SDN BHD

INN (International Name):

TRIPTORELINE PAMOATE

Units in package:

1ampoule Ampoules; 1vial Vials

Manufactured by:

IPSEN PHARMA BIOTECH

Summary of Product characteristics

DIPHERELINE® P.R.
POWDER AND SOLVENT FOR SUSPENSION FOR INJECTION 11.25 MG/VIAL
TRIPTORELIN PAMOATE
_3 – MONTH PROLONGED RELEASE FORM _
PRESENTATION AND FORM
Diphereline P.R. Powder and Solvent for Suspension for Injection 11.25
mg/vial, 3-month
prolonged release form.
This pack contains a glass vial of powder, am ampoule of 2ml solvent,
1 syringe and 3 needles.
PRODUCT DESCRIPTION
Before reconstitution
Powder: Slightly yellow friable cake
Solvent: Colorless clear solution
After reconstitution
A homogenous white suspension
COMPOSITION PER UNIT DOSE
POWDER:
Active ingredient:
Triptorelin
…………………………………………………..11.25mg
(as triptorelin pamoate)
Excipients:
D, L Lactide-coglycolide Polymer, Mannitol, Carmellose sodium,
polysorbate 80.
SOLVENT:
Mannitol, water for injections
THERAPEUTIC INDICATIONS
•
PROSTATE CANCER
Treatment of locally advanced prostate cancer when used alone or as
concomitant and adjuvant
to radiotherapy
Treatment of metastatic prostate cancer
Patients who have not previously received hormone therapy show a more
marked response to
the treatment and response more frequently if the patient has not
previously received another
hormone treatment.
•
GENITAL AND EXTRAGENITAL ENDOMETRIOSIS (STAGE I TO STAGE IV).
Treatment should not be administered for more than 6 months. (see
Adverse Effects). It is not
recommended to undertake a second course of treatment by triptorelin
or another GnRH
analogue.
•
PRECOCIOUS PUBERTY (BEFORE 8 YEARS IN GIRLS AND 10 YEARS IN BOYS).
DOSAGE AND METHOD OF ADMINISTRATION
Strictly comply with your doctor’s prescription. Route of
administration is intramuscular and
subcutaneous.
The powder should be suspended in the provided solvent immediately
before injection by
shaking the vial until a homogenous liquid is obtained. Injection
should be strictly prepared by
following precisely the instructions at the end of this package
insert. Any incomplete injections
resulting in the loss of suspension volumes greater than the volume
generally r