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

Pays: Irlande

Langue: anglais

Source: HPRA (Health Products Regulatory Authority)

Ingrédients actifs:

Lanreotide

Disponible depuis:

Originalis B.V.

Code ATC:

H01CB; H01CB03

DCI (Dénomination commune internationale):

Lanreotide

forme pharmaceutique:

Solution for injection in pre-filled syringe

Domaine thérapeutique:

Somatostatin and analogues; lanreotide

Date de l'autorisation:

2023-02-10

Notice patient

PACKAGE LEAFLET: INFORMATION FOR THE USER
SOMATULINE® AUTOGEL® 60 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 with acromegaly such as feeling
tired, headaches, sweating, joint pain and numb hands and feet
•
The relief of symptoms such as flushing and diarrhoea that

Résumé des caractéristiques du produit

Health Products Regulatory Authority
10 February 2023
CRN00D4PQ
Page 1 of 2
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.
_ _
_Product imported from Italy._
White to pale yellow semi solid formulation.
4 CLINICAL PARTICULARS
As per PA0869/004/002
5 PHARMACOLOGICAL PROPERTIES
As per PA0869/004/002
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Water for injections
Glacial acetic acid (for pH adjustment)
6.2 INCOMPATIBILITIES
Not applicable.
6.3 SHELF LIFE
The shelf life expiry date for this product shall be the date shown on
the pouch, syringe and outer package of the product on
the market in the country of origin.
After opening the protective laminated pouch, the product should be
administered immediately.
6.4 SPECIAL PRECAUTIONS FOR STORAGE
Store in refrigerator between (2°C to 8°C) in the original package.
Once removed from the refrigerator, product left in its sealed pouch
may be returned to the refrigerator for continued storage
and later use, provided it has been stored for no longer than 24 hours
at below 40°C and the number of temperature
excursions does not exceed three.
6.5 NATURE AND CONTENTS OF CONTAINER
Somatuline Autogel is supplied in a pre-filled syringe (polypropylene)
fitted with an automatic safety system with a plunger
stopper (bromobutyl rubber) and a needle (stainless steel) covered by
a plastic cap.
Health Products Regulatory Authority
10 February 2023
CRN00D4PQ
Page 2 of 2
Each ready to use pre-filled syringe is placed into a plastic tray and
packed in a laminated pouch and a cardboard box.
Box of one 0.5 ml pre-filled syringe with