SANDOSTATIN LAR

Land: Indonesien

Språk: indonesiska

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

Aktiva substanser:

OCTREOTIDE

Tillgänglig från:

NOVARTIS INDONESIA - Indonesia

INN (International namn):

OCTREOTIDE

Dos:

20 MG + PELARUT

Läkemedelsform:

SERBUK INJEKSI

Enheter i paketet:

DUS, VIAL @ 625 MG + 1 PRE FILLED SYRINGE PELARUT @ 2 ,5 ML + 2 J...

Tillverkad av:

SANDOZ GMBH - Austria

Tillstånd datum:

2019-02-28

Produktens egenskaper

Page 1
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