SANDOSTATIN INJECTION 0.1 mgml

Երկիր: Սինգապուր

Լեզու: անգլերեն

Աղբյուրը: HSA (Health Sciences Authority)

Ակտիվ բաղադրիչ:

OCTREOTIDE

Հասանելի է:

NOVARTIS (SINGAPORE) PTE LTD

ATC կոդը:

H01CB02

Դոզան:

0.1 mg/ml

Դեղագործական ձեւ:

INJECTION

Կազմը:

OCTREOTIDE 0.1 mg/ml

Կառավարման երթուղին:

SUBCUTANEOUS

Ռեկվիզորի տեսակը:

Prescription Only

Պատրաստված է:

Novartis Pharma Stein AG

Լիազորման կարգավիճակը:

ACTIVE

Հաստատման ամսաթիվը:

1990-02-01

Տեղեկատվական թերթիկ

SANDOSTATIN
®
Antigrowth hormone
COMPOSITION AND PHARMACEUTICAL FORM
The active substance is octreotide acetate.
1 mL ampoules containing 0.05, 0.1 or 0.5 mg octreotide (as free
peptide).
5 mL multidose vials containing 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’.
Solution for injection (s.c) or concentrate for solution for infusion
(i.v.infusion).
The solution is clear and colourless.
For a full list of excipients, see section EXCIPIENTS.
Certain dosage strengths and dosage forms may not be available in all
countries.
INDICATIONS
Symptomatic  control  and  reduction  of  growth  hormone  (GH)  and  IGF-1  plasma 
levels in patients with acromegaly who are inadequately controlled by surgery or 
radiotherapy. Sandostatin treatment is also indicated for acromegalic patients unfit 
or unwilling to undergo surgery, or in the interim period until radiotherapy becomes 
fully effective. 
Relief  of  symptoms  associated  with  functional  gastro-entero-pancreatic  (GEP) 
endocrine tumours:
•  Carcinoid tumours with features of the carcinoid syndrome.
•  VIPomas.
•  Glucagonomas.
•  Gastrinomas/Zollinger-Ellison  syndrome,  usually  in  conjunction  with  proton 
pump inhibitors, or H
2
 antagonist therapy.
•  Insulinomas, for pre-operative control of hypoglycaemia and for maintenance 
therapy.
•  GRFomas.
Sandostatin is not an anti-tumour therapy and is not curative in these
patients.
Control of refractory diarrhoea associated with AIDS.
Prevention of complications following pancreatic surgery.
Emergency management to stop bleeding and to protect from re-bleeding owing to 
gastro-oesophageal varices in patients with cirrhosis. Sandostatin is to be used in 
association with specific treatment such as endoscopic sclerotherapy.
DOSAGE AND ADMINI

Ապրանքի հատկությունները

Sandostatin Feb 2023.SIN
Page 1 of 15
SANDOSTATIN

Anti-growth hormone
DESCRIPTION AND COMPOSITION
PHARMACEUTICAL FORM(S)
Solution for injection (s.c) or concentrate for solution for infusion
(i.v. infusion).
The solution is clear and colourless.
ACTIVE SUBSTANCE(S)
The active substance is octreotide acetate.
1 mL ampoules containing 0.1 mg octreotide (as free peptide).
5 mL multidose vials containing 1 mg octreotide (as free peptide).
Certain dosage strengths and dosage forms may not be available in all
countries.
EXCIPIENTS
AMPOULES
Lactic acid, mannitol, sodium hydrogen carbonate, water for
injections.
MULTIDOSE VIALS
Lactic acid, phenol, mannitol, sodium hydrogen carbonate, water for
injections.
Pharmaceutical formulations may vary between countries.
INDICATIONS
Symptomatic control and reduction of growth hormone (GH) and IGF-1
plasma levels in
patients with acromegaly who are inadequately controlled by surgery or
radiotherapy.
Sandostatin treatment is also indicated for acromegalic patients unfit
or unwilling to undergo
surgery, or in the interim period until radiotherapy becomes fully
effective.
Relief of symptoms associated with functional gastro-entero-pancreatic
(GEP) endocrine
tumors:
•
Carcinoid tumours with features of the carcinoid syndrome.
•
VIPomas.
•
Glucagonomas.
•
Gastrinomas/Zollinger-Ellison
syndrome,
usually
in
conjunction
with
proton
pump
inhibitors, or H
2
-antagonist therapy.
•
Insulinomas, for pre-operative control of hypoglycaemia and for
maintenance therapy.
•
GRFomas.
Sandostatin Feb 2023.SIN
Page 2 of 15
Sandostatin is not an anti-tumor therapy and is not curative in these
patients.
Control of refractory diarrhea associated with AIDS.
Prevention of complications following pancreatic surgery.
Emergency management to stop bleeding and to protect from re-bleeding
owing to gastro-
esophageal varices in patients with cirrhosis. Sandostatin is to be
used in association with
specific treatment such as endoscopic sclerotherapy.
DOSAGE REGIMEN AND ADMINISTRATION
DOSAGE REGIMEN