SANDOSTATIN

국가: 인도네시아

언어: 인도네시아어

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

패키지 단위:

DUS, 5 AMPUL @ 1 ML

승인 날짜:

2023-01-05

제품 특성 요약

1
TRADE NAME
0.1 MG/1 ML AMPOULES
SANDOSTATIN
®
0.1 mg/1 mL ampoules, solution for injection (s.c.) or concentrate for
solution for
infusion (i.v. infusion).
DESCRIPTION AND COMPOSITION
PHARMACEUTICAL FORMS
Solution for injection (s.c) or concentrate for solution for infusion
(i.v. infusion).
The solution is clear and colourless.
ACTIVE SUBSTANCE
The active substance is octreotide acetate.
1 mL ampoules containing 0.1 mg octreotide (as free peptide).
Sandostatin
®
solution for injection contains less than 1 mmol (23 mg) of sodium per
dose, i.e.
essentially ‘sodium-free’.
EXCIPIENTS
Lactic acid, mannitol, sodium hydrogen carbonate, water for
injections.
INDICATIONS
Symptomatic control and reduction of GH and somatomedin C plasma
levels in patients with
acromegaly who are inadequately controlled by surgery, radiotherapy,
or dopamine agonist
treatment.
Relief of symptoms associated with gastro-entero-pancreatic endocrine
tumors:

Carcinoid tumors with features of the carcinoid syndrome

VIPomas

Glucagonomas
Sandostatin is not an antitumor therapy and not curative in these
patients.
Emergency management to stop bleeding and to protect from re-building
owing to gastro-
esophageal varices in patients with cirrhosis. Sandostatin is to be
use in association with specific
treatment such as endoscopic sclerotherapy.
DOSAGE REGIMEN AND ADMINISTRATION
DOSAGE REGIMEN
GENERAL TARGET POPULATION
ACROMEGALY
Initially 0.05 to 0.1 mg by s.c injection every 8 or 12 hours. Dosage
adjustment should be based on
monthly assessment of GH levels and clinical symptoms, and on
tolerability. In most patients the
DISETUJUI OLEH BPOM : 21/04/2021
ID : EREG10000512000210
2
optimal daily dose will be 0.2 to 0.3 mg. A maximum dose of 1.5 mg per
day should not be
exceeded.
If no relevant reduction in GH levels and no improvement in clinical
symptoms have been achieved
within 3 months of starting treatments with Sandostatin, therapy
should be discontinued.
GASTRO-ENTERO-PANCREATIC ENDOCRINE TUMORS
Initially 0.05 mg once or twice dai