SANDOSTATIN 100 Microgram/ML Solution for Inj/Inf

Страна: Ірландія

мова: англійська

Джерело: HPRA (Health Products Regulatory Authority)

Активний інгредієнт:

OCTREOTIDE ACETATE

Доступна з:

Novartis Pharmaceuticals UK Ltd

Код атс:

H01CB02

ІПН (Міжнародна Ім'я):

OCTREOTIDE ACETATE

Дозування:

100 Microgram/ML

Фармацевтична форма:

Solution for Inj/Inf

Тип рецепту:

Product subject to prescription which may not be renewed (A)

Терапевтична области:

Somatostatin and analogues

Статус Авторизація:

Authorised

Дата Авторизація:

1988-11-18

інформаційний буклет

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
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
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 specif

Характеристики продукта

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Sandostatin 100 micrograms/ml solution for injection / infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One ampoule of 1ml contains 100 micrograms octreotide (as octreotide
acetate)
Excipient(s) with known effect:
Contains less than 1 mmol (23 mg) sodium per dose, .i.e. is
essentially "sodium free".
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 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, 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.
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
monthly assessment of GH and IGF
-
1 levels (target: GH <2.5 ng/mL; IGF
-
1 within normal range) and clinical
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