SANDOSTATIN 500 microgram/1 ml, solution for injection/infusion

Šalis: Malta

kalba: anglų

Šaltinis: Medicines Authority

Veiklioji medžiaga:

OCTREOTIDE

Prieinama:

Novartis Ireland Limited Vista Building, Elm Park, Merrion Road, Ballsbridge, Dublin 4,, Ireland

ATC kodas:

H01CB02

INN (Tarptautinis Pavadinimas):

OCTREOTIDE 0.5 mg/ml

Vaisto forma:

SOLUTION FOR INFUSION OR INJECTION

Sudėtis:

OCTREOTIDE 0.5 mg/ml

Recepto tipas:

POM

Gydymo sritis:

PITUITARY AND HYPOTHALAMIC HORMONES AND ANALOGUES

Autorizacija statusas:

Authorised

Leidimo data:

2005-10-27

Pakuotės lapelis

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
SANDOSTATIN® 500 MICROGRAM/1 ML, SOLUTION FOR INJECTION/INFUSION
octreotide
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor, pharmacist or
nurse.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them, even
if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Sandostatin is and what it is used for
2.
What you need to know before you use Sandostatin
3.
How to use Sandostatin
4.
Possible side effects
5.
How to store Sandostatin
6.
Contents of the pack and other information
1.
WHAT SANDOSTATIN IS AND WHAT IT IS USED FOR
Sandostatin is a synthetic compound derived from somatostatin, a
substance normally found in the human
body which inhibits the effects of certain hormones such as growth
hormone. The advantages of
Sandostatin over somatostatin are that it is stronger and its effects
last longer.
SANDOSTATIN IS USED
•
in
ACROMEGALY
, a condition where the body produces too much growth hormone.
Normally, growth
hormone controls growth of tissues, organs, and bones. Too much growth
hormone leads to an
increase in the size of bones and tissues, especially in the hands and
feet. Sandostatin markedly
reduces the symptoms of acromegaly, which include headache, excessive
perspiration, numbness of
the hands and feet, tiredness, and joint pain.
•
to relieve symptoms associated with some
TUMOURS OF THE GASTROINTESTINAL TRACT
(e.g. carcinoid
tumours, VIPomas, glucagonomas, gastrinomas, insulinomas). In these
conditions, there is
overproduction of some specific hormones and other related substances
by the stomach, bowels, or
pancreas. This overproduction upsets the natural hormonal

Prekės savybės

Page 1 of 14
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
SANDOSTATIN
50 microgram/1 ml, solution for injection/infusion
SANDOSTATIN 100 microgram/1 ml, solution for injection/infusion
SANDOSTATIN 500 microgram/1 ml, solution for injection/infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One ampoule of 1 ml contains 50 micrograms octreotide (as octreotide
acetate)
One ampoule of 1 ml contains 100 micrograms octreotide (as octreotide
acetate)
One ampoule of 1 ml contains 500 micrograms 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
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 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,
e.g. carcinoid tumours with features of the carcinoid syndrome (see
section 5.1).
Sandostatin is not an anti-tumour therapy and is not curative in these
patients.
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.
Treatment of TSH-secreting pituitary adenomas:
•
when secretion has not normalised after surgery and/or radiotherapy;
•
in patients in whom surgery is inappropriate;
•
in irradiated patients, until radiotherapy is effective.
Page 2 of 14
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Acromegaly _
Initially 0.05 to 0.1 mg by subcutaneous (s.c.) injection every 8 or
12 hours. Dosage adjustment
should be based on mon