Երկիր: Ինդոնեզիա
Լեզու: ինդոնեզերեն
Աղբյուրը: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
OCTREOTIDE ACETATE
NOVARTIS INDONESIA - Indonesia
OCTREOTIDE ACETATE
22.4 MG
SERBUK INJEKSI
DUS, 1 VIAL @ 625 MG + 1 PRE FILLED SYRINGE @ 2 ML PELARUT + 1 VI...
SANDOZ GMBH - Austria
2021-04-19
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 Page 2 4 DOSAGE REGIMEN AND ADMINISTRATION Sandostat Կարդացեք ամբողջական փաստաթուղթը