Somatuline LA 30mg, powder and solvent for prolonged-release suspension for injection

País: Irlanda

Idioma: anglès

Font: HPRA (Health Products Regulatory Authority)

ingredients actius:

Lanreotide

Disponible des:

Ipsen Pharmaceuticals Limited

Codi ATC:

H01CB; H01CB03

Designació comuna internacional (DCI):

Lanreotide

Dosis:

30 milligram(s)

formulario farmacéutico:

Powder and solvent for suspension for injection

tipo de receta:

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

Área terapéutica:

Somatostatin and analogues; lanreotide

Estat d'Autorització:

Marketed

Data d'autorització:

1998-06-15

Informació per a l'usuari

_________________________________________________________________________________________________________
Page 1 of 9
PACKAGE LEALET: INFORMATION FOR THE USER
SOMATULINE LA 30MG
POWDER AND SOLVENT FOR PROLONGED RELEASE SUSPENSION FOR INJECTION
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 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 or pharmacist or
nurse. This includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Somatuline LA 30 mg is and what it is used for
2.
What you need to know before you use Somatuline LA 30 mg
3.
How to use Somatuline LA 30 mg
4.
Possible side effects
5.
How to store Somatuline LA 30 mg
6.
Contents of the pack and other information
1.
WHAT SOMATULINE LA 30 MG IS AND WHAT IT IS USED FOR
Somatuline LA 30 mg is a long acting formulation of lanreotide.
Lanreotide – the active substance – belongs to the group of
antigrowth A hormones. It is similar to the
naturally occurring hormone called somatostatin.
Lanreotide lowers the levels of hormones in the body such as GH
(Growth Hormone) and IGF-1 (Insulin-
like Growth Factor-1) and inhibits the release of some
gastro-intestinal hormones and intestinal
secretions.
SOMATULINE LA 30 MG IS INDICATED FOR

The long-term treatment of acromegaly (a condition where too much
Growth Hormone is produced)

The treatment of symptoms that occur with certain endocrine tumours of
the gastrointestinal tract.

The treatment of primary thyrotropic adenomas (pituitary tumour
associated with hyperthyroidism)

The treatment of post-operative digestive fistulae (abnormal passage
in the intestinal tract).
2.
WHAT YOU NEED TO

Fitxa tècnica

Health Products Regulatory Authority
25 October 2019
CRN009719
Page 1 of 7
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Somatuline LA 30mg, powder and solvent for prolonged-release
suspension for injection
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 30 mg of lanreotide presented as lanreotide
acetate.
After reconstitution with the solvent, 1 ml of the suspension contains
15 mg lanreotide as lanreotide acetate.
Each vial contains 2.64 mg of sodium.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Powder and solvent for prolonged-release suspension for injection.
Powder: A practically white lyophilisate with the presence of bubbles
at the top.
Solvent: A clear colourless solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
_Acromegaly_:
Somatuline LA is indicated for the treatment of acromegaly when the
circulating levels of Growth Hormone (GH) and/or
Insulin-like Growth Factor-I (IGF-I) remain abnormal after surgery
and/or radiotherapy, or in patients who require treatment
prior to such intervention.
_Thyrotropic Adenomas_:
Somatuline LA is indicated for the treatment of primary thyrotropic
adenomas.
_Neuroendocrine Tumours_:
Somatuline LA is indicated for the relief of symptoms associated with
carcinoid tumours.
_Digestive Fistulae:_
Somatuline LA is indicated for the treatment of post-operative,
simple, externalised, pancreatic, duodenal and small intestine
fistulae.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
ADULTS:
_Acromegaly/ Neuroendocrine tumours/Thyrotropic Adenomas_
For intramuscular injection only.
Initially, one injection every 14 days. The frequency of injection may
be varied in accordance with the individual patient’s
response (as judged by symptomatology and/or biochemical monitoring).
Injection sites should be varied.
_Digestive fistulae_
Initially, one intramuscular injection should be given to assess the
patient’s response.
In patients with fistulae volume drainage reduction of at least 50%
after 72h, 1 injection should be gi