SANDOSTATIN LAR

البلد: أندونيسيا

اللغة: الإندونيسية

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

العنصر النشط:

OCTREOTIDE

متاح من:

NOVARTIS INDONESIA - Indonesia

INN (الاسم الدولي):

OCTREOTIDE

جرعة:

30 MG + PELARUT

الشكل الصيدلاني:

SERBUK INJEKSI

الوحدات في الحزمة:

DUS, VIAL @ 900 MG + 1 PREFILLED SYRINGE @ 2,5 ML + 2 JARUM SUNTI...

المصنعة من قبل:

SANDOZ GMBH - Austria

تاريخ الترخيص:

2019-02-28

خصائص المنتج

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1
TRADE NAME(S)
SANDOSTATIN
®
LAR
®
10 mg* powder and solvent for suspension for injection.
SANDOSTATIN
®
LAR
®
20 mg powder and solvent for suspension for injection.
SANDOSTATIN
®
LAR
®
30 mg powder and solvent for suspension for injection.
2
DESCRIPTION AND COMPOSITION
PHARMACEUTICAL FORM(S)
Powder and solvent for suspension for injection.
KIT WITH VIAL ADAPTER AND SAFETY NEEDLE:
Powder: white to off-white powder.
Solvent for suspension for injection: clear, colourless to slightly
yellow or brown solution.
Sandostatin
®
LAR
®
is a long-acting depot injection form of octreotide. Powder
(microspheres for
suspension for injection) to be suspended in a vehicle immediately
prior to i.m. injection.
Sandostatin LAR suspension contain less than 1 mmol (23 mg) of sodium
per dose, i.e. essentially
‘sodium-free’.
ACTIVE SUBSTANCE(S)
The active substance is octreotide free peptide. 10 mg*, 20 mg or 30
mg nominally 4.15% of fill weight
equivalent to 4.65% of octreotide acetate.
EXCIPIENTS
VIAL
Poly (DL-lactide-co-glycolide) 78.35% of nominal fill weight; sterile
mannitol 17.0% of nominal fill
weight.
PREFILLED SYRINGE
KIT WITH VIAL ADAPTER AND SAFETY NEEDLE:
One PREFILLED SYRINGE (solvent for parenteral use), containing: sodium
carboxymethylcellulose (14 mg),
mannitol (12 mg), poloxamer 188 (4 mg); water for injection qs ad 2
mL.
3
INDICATIONS
Treatment of patients with acromegaly:
-
Who are adequately controlled on s.c. treatment with Sandostatin
-
_In whom_ surgery, radiotherapy or dopamine agonist treatment is
inappropriate or ineffective, or in the
interim period until radiotherapy becomes fully effective (see Dosage
regimen and administration)
Relief of symptoms associated with gastro-entero-pancreatic endocrine
tumors:
-
Carcinoid tumors with features of the carcinoid syndrome
-
VIPomas
-
Glucagonomas
Treatment of patients with advanced Neuroendocrine Tumors of the
midgut.
DISETUJUI OLEH BPOM : 12/04/2022
ID : EEREG10000512000212
REG10000512000213
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DOSAGE REGIMEN AND ADMINISTRATION
Sandostat