SANDOSTATIN 0.1 MGML

Nazione: Israele

Lingua: inglese

Fonte: Ministry of Health

Principio attivo:

OCTREOTIDE

Commercializzato da:

NOVARTIS ISRAEL LTD

Codice ATC:

H01CB02

Forma farmaceutica:

SOLUTION FOR INJECTION / INFUSION

Composizione:

OCTREOTIDE 0.1 MG/ML

Via di somministrazione:

S.C, I.V

Tipo di ricetta:

Required

Prodotto da:

NOVARTIS PHARMA STEIN AG, SWITZERLAND

Gruppo terapeutico:

OCTREOTIDE

Area terapeutica:

OCTREOTIDE

Indicazioni terapeutiche:

Prevention of complications following pancreatic surgery. Symptomatic control and reduction of GH and IGF-1plasma 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 gastroenteropancreatic endocrine tumours: - Carcinoid tumours with features of the carcinoid syndrome - VIPomas - Glucagonomas - Gastrinomas / zollinger-Ellison syndrome usually in conjunction with proton pump inhibitors or H2- antagonist therapy - Insulinomas for pre-operative control of hypoglycaemia and for maintenance therapy - GRFomas. Sandostatin is not an antitumour therapy and is not curative in these patients.Emergency management of bleeding gastro-oesophageal varices secondary to cirrhosis in combination with specific therapy such as endoscopic sclerotherapy.

Data dell'autorizzazione:

2020-03-31

Foglio illustrativo

PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS’
REGULATIONS )PREPARATIONS( - 1986
This medicine is dispensed with a doctor’s prescription only
SANDOSTATIN
® 0.05 MG/ML,
SOLUTION FOR INJECTION/INFUSION
Name and quantity of active ingredient:
EACH 1 ML AMPOULE CONTAINS 0.05 MG OCTREOTIDE
SANDOSTATIN
® 0.1 MG/ML,
SOLUTION FOR INJECTION/INFUSION
Name and quantity of active ingredient:
EACH 1 ML AMPOULE CONTAINS 0.1 MG OCTREOTIDE
SANDOSTATIN
® 0.5 MG/ML,
SOLUTION FOR INJECTION/INFUSION
Name and quantity of active ingredient:
EACH 1 ML AMPOULE CONTAINS 0.5 MG OCTREOTIDE
Inactive ingredients and allergens: see section 6 ‘Additional
information’. See also ‘Important information about some of
this medicine’s ingredients’.
READ THE ENTIRE LEAFLET CAREFULLY BEFORE YOU START USING
THIS MEDICINE. This leaflet contains concise information
about this medicine. If you have any further questions,
consult your doctor or pharmacist.
This medicine has been prescribed for you. Do not pass it on
to others. It may harm them, even if it seems to you that their
medical condition is similar to yours.
1. WHAT IS THIS MEDICINE INTENDED FOR?
This medicine is intended for:
Preventing complications following pancreatic surgery.
Controlling symptoms and reducing plasma levels of growth
hormone (GH) and insulin like growth factor 1 (IGF 1) in
patients with acromegaly whose illness is inadequately
controlled
by
surgery
or
radiotherapy.
Treatment
with
SANDOSTATIN
is
also
intended
for
patients
with
acromegaly who are unfit or unwilling to undergo surgery
or are in the interim period until radiotherapy becomes fully
effective.
Relief of symptoms associated with functional endocrine
gastro entero pancreatic (GEP) tumors:
• Carcinoid tumors with features of the carcinoid syndrome
• VIPomas
• Glucagonomas
• Zollinger-Ellison syndrome, usually in combination with
proton pump inhibitors or H
2
antagonists therapy
• Insulinomas, for pre-operative control of hypoglycemia
and maintenance treatment
• GRFomas
SANDOSTATIN is no

Scheda tecnica

SAS API DEC21 V4
1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Sandostatin

0.05mg/ml
Sandostatin

0.1 mg/ ml
Sandostatin

0.5 mg/ml
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One ampoule of 1 ml contains 0.05, 0.1 or 0.5 mg octreotide (as
octreotide acetate)
For the full list of excipients see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection /infusion.
Clear, colourless solution.
4.
CLINICAL PARTICULARS
4.1.
Therapeutic Indications
Prevention of complications following pancreatic surgery.
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 tumors with features of the carcinoid syndrome.
•
VIPomas.
•
Glucagonomas.
•
Gastrinomas/Zollinger-Ellison syndrome, usually in conjunction with
proton pump inhibitors, or
H2-antagonist therapy.
•
Insulinomas, for pre-operative control of hypoglycemia and for
maintenance therapy.
•
GRFomas.
Sandostatin is not an anti-tumors therapy and is not curative in these
patients.
Emergency management of bleeding gastro-esophageal varices secondary
to cirrhosis in combination
with specific therapy such as endoscopic sclerotherapy.
4.2.
Posology and method of administration
SAS API DEC21 V4
2
_ _
Posology
General target population
_Acromegaly _
Initially 0.05 to 0.1 mg by subcutaneous (s.c.) injection every 8 or
12 hours. Dosage
adjustment should be based on monthly assessment of GH and IGF-1
levels (target: GH
<2.5 ng/mL; IGF-1 within normal range) and clinical symptoms, and on
tolerability. In most
patients, the optimal daily dose will be 0.3 mg. A maximum dose of 1.5
mg per day should
not be exceeded. For patients on a stable dose of Sandost