Riik: Indoneesia
keel: indoneesia
Allikas: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
TRIPTORELIN EMBONATE
DEXA MEDICA - Indonesia
TRIPTORELIN EMBONATE
17.8 Mg (16.3-19.4) Mg
SERBUK INJEKSI LIOFILISASI
DUS, 1 VIAL @ 11,25 MG + 1 AMPUL PELARUT @ 2 ML + 1 SYRINGE 3 ML ...
DEBIOPHARM RESEARCH & MANUFACTURING SA - Switzerland
2021-07-05
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 Lugege kogu dokumenti