PAMORELIN

Country: Indoneżja

Lingwa: Indoneżjan

Sors: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency

Ingredjent attiv:

TRIPTORELIN

Disponibbli minn:

DEXA MEDICA - Indonesia

INN (Isem Internazzjonali):

TRIPTORELIN

Dożaġġ:

22,5 MG

Għamla farmaċewtika:

SERBUK INJEKSI LIOFILISASI

Unitajiet fil-pakkett:

DUS, 1 VIAL SERBUK LIOFILISASI + 1 AMPUL PELARUT WATER FOR INJECT...

Manifatturat minn:

DEXA MEDICA - Indonesia

Data ta 'l-awtorizzazzjoni:

2019-12-05

Karatteristiċi tal-prodott

MI/SAN/07.05.21/ver.04
1
REVISED PACKAGE INSERT
(ENGLISH VERSION)
REVISED PACKAGE INSERT
(INDONESIA VERSION)
Product document title:Triptorelin Embonate
Trade name: PAMORELIN
®
Date: 05.05.21
Product document title:_Triptorelin Embonate_
Trade name: PAMORELIN
®
Date: 05.05.21
PAMORELIN
®
LYOPHILIZED POWDER FOR INJECTION
COMPOSITION:
Each vial contains:
Triptorelin embonate equivalent to 22.5 mg triptorelin
Solvent:
Each ampoule contains:
Water for injection 2 ml
PHARMACOLOGY:
Triptorelin,
a
GnRH
(gonadotropin
releasing
hormone)
agonist,
acts
as
a
potent
inhibitor
of
gonadotropin
secretion
when
given
continuously
and
in
therapeutic
doses. After administration of triptorelin, there is an initial
and transient increase in circulating levels of luteinizing
hormone
(LH),
follicle
stimulating
hormone
(FSH),
testosterone in males and estradiol in females.
However,
chronic
and
continuous
administration
of
triptorelin results in decreased LH and FSH secretion and
suppression of testicular and ovarian steroidogenesis.
_IN MEN WITH PROSTATE CANCER _
A reduction of serum testosterone levels into the range
normally
seen
in
surgically
castrated
men
occurs
approximately 2 to 4 weeks after initiation of therapy.
PAMORELIN
®
22.5 mg is designed to deliver 22.5 mg of
triptorelin over a 6-month period. Once the castrate levels
of testosterone have been achieved by the end of the first
month, serum testosterone levels are maintained for as
long as the patients receive their injection every twenty
four weeks.
This results in accessory sexual organ atrophy. These
effects are generally reversible upon discontinuation of the
medicinal product. The effectiveness of treatment can be
monitored by measuring serum levels of testosterone and
prostate specific antigen.
In animals, administration of triptorelin resulted
in the
inhibition of growth of some hormone-sensitive prostate
tumors in experimental models.
In girls, initial ovarian stimulation at treatment initiation,
followed by the treatment-induced estrogen increase, may
lead, in t