Somatuline Autogel 60 mg, solution for injection in a prefilled syringe

Ülke: İrlanda

Dil: İngilizce

Kaynak: HPRA (Health Products Regulatory Authority)

Aktif bileşen:

Lanreotide acetate

Mevcut itibaren:

Ipsen Pharmaceuticals Limited

ATC kodu:

H01CB; H01CB03

INN (International Adı):

Lanreotide acetate

Doz:

60 milligram(s)

Farmasötik formu:

Solution for injection in pre-filled syringe

Reçete türü:

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

Terapötik alanı:

Somatostatin and analogues; lanreotide

Yetkilendirme durumu:

Marketed

Yetkilendirme tarihi:

2002-02-22

Bilgilendirme broşürü

Page 1 of 11
PACKAGE LEAFLET: INFORMATION FOR THE USER
SOMATULINE AUTOGEL 60 MG, SOLUTION FOR INJECTION IN A PRE-FILLED
SYRINGE
SOMATULINE AUTOGEL 90 MG, SOLUTION FOR INJECTION IN A PRE-FILLED
SYRINGE
SOMATULINE AUTOGEL 120 MG, SOLUTION FOR INJECTION IN A PRE-FILLED
SYRINGE
Lanreotide
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 or pharmacist.
•
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 or pharmacist. This
includes any possible side effects not
listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Somatuline Autogel is and what it is used for
2.
What you need to know before you use Somatuline Autogel
3.
How to use Somatuline Autogel
4.
Possible side effects
5.
How to store Somatuline Autogel
6.
Contents of the pack and other information
1.
WHAT SOMATULINE AUTOGEL IS AND WHAT IT IS USED FOR
WHAT SOMATULINE AUTOGEL IS AND HOW IT WORKS
The name of your medicine is Somatuline Autogel.
It is a long acting formulation of Somatuline.
Lanreotide, the active substance, belongs to a group of medicines
called ‘antigrowth hormones’. It is similar
to another substance (a hormone) called ‘somatostatin’.
Lanreotide lowers the levels of hormones in the body such as growth
hormone (GH), and insulin-like growth
factor 1 (IGF-1) and inhibits the release of some hormones in the
gastrointestinal tract and intestinal
secretions. Additionally, it has an effect on some advanced type of
tumours (called neuroendocrine tumours)
of the intestine and pancreas by stopping or delaying their growth.
WHAT SOMATULINE AUTOGEL IS USED FOR:
•
The long term treatment of acromegaly (a condition where your body
produces too much growth
hormone)
•
The relief of symptoms associated wi

Ürün özellikleri

Health Products Regulatory Authority
21 August 2023
CRN00DF4D
Page 1 of 10
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Somatuline Autogel 60 mg, solution for injection in a prefilled
syringe
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each pre-filled syringe contains a supersaturated solution of
lanreotide acetate corresponding to 0.246 mg of lanreotide
base/mg of solution, which ensures an actual injection dose of 60 mg
of lanreotide.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection in a pre-filled syringe.
White to pale yellow semi solid formulation.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Somatuline Autogel is indicated for:

The long-term treatment of individuals with acromegaly when the
circulating levels of Growth Hormone (GH)
and/or Insulin-like Growth Factor-1 (IGF-1) remain abnormal after
surgery and/or radiotherapy, or in patients who
otherwise require medical treatment. The goal of treatment in
acromegaly is to reduce GH and IGF-1 levels and
where possible to normalise these values.

The relief of symptoms associated with acromegaly.

The treatment of grade 1 and a subset of grade 2 (Ki67 index up to
10%) gastroenteropancreatic neuroendocrine
tumours (GEP-NETs) of midgut, pancreatic or unknown origin where
hindgut sites of origin have been excluded, in
adult patients with unresectable locally advanced or metastatic
disease (see section 5.1).

The treatment of symptoms associated with carcinoid tumours.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
ACROMEGALY
The recommended starting dose is 60 to 120 mg administered every 28
days.
For example, in patients previously treated with Somatuline LA 30 mg
with a dose every 14 days, the initial dose of Somatuline
Autogel should be 60 mg every 28 days, and in patients previously
treated with Somatuline LA 30 mg with a dose every 10
days, the initial dose of Somatuline Autogel should be 90 mg every 28
days.
Thereafter the dose should be individualised according to the r