Somatuline LA

Land: Ástralía

Tungumál: enska

Heimild: Department of Health (Therapeutic Goods Administration)

Virkt innihaldsefni:

Lanreotide acetate

Fáanlegur frá:

Ipsen Pty Ltd

Tegund:

Medicine Registered

Upplýsingar fylgiseðill

SOMATULINE
® 
LA
30MG

_Lanreotide_
CONSUMER MEDICINE INFORMATION

WHAT IS IN THIS LEAFLET?
Please read this leaflet carefully. It
provides some information about
your medicine. If you have any
questions or are not sure about
anything after you have read this
leaflet, please ask your doctor or
pharmacist.
The name of your medicine is
Somatuline LA. Its active ingredient
is lanreotide. The dose of lanreotide
you will receive is 30 mg. There is an
extra amount (10 mg) filled into the
vial to ensure that the correct dose
can be injected. The formulation
contains a mixture of copolymers,
mannitol, polysorbate 80 and
carmellose sodium. For the injection,
the Somatuline LA will be made up
with the suspension vehicle which
contains mannitol in water for
injection.
The product is for single use only.
Your doctor or nurse will make up
the injection and give it to you as
described in the instructions.
WHAT IS SOMATULINE
LA?
Somatuline LA is a prolonged release
formulation of lanreotide. Lanreotide
is an octapeptide, an analogue of a
naturally occurring hormone,
somatostatin. Lanreotide lowers the
levels of hormones in the body such
as GH (growth hormone) and IGF-1
(insulin-like growth factor-1).
WHAT IS SOMATULINE
LA USED FOR?
Somatuline LA is recommended for
the treatment of acromegaly when
the circulating levels of growth
hormone and IGF-1 remain abnormal
after surgery and/or radiotherapy, or
in patients who do not respond to
therapy with drugs called dopamine
agonists.
BEFORE YOU ARE GIVEN
SOMATULINE LA
_WHEN YOU MUST NOT BE GIVEN_
_IT_
Do not be given Somatuline LA if
•
you are breastfeeding
•
you are allergic to lanreotide, the
active ingredient of Somatuline
LA, or any other somatostatin
analogue.
Signs of an allergic reaction may
include itchy skin rash, shortness of
breath and swelling of the face or
tongue.
_BEFORE YOU ARE GIVEN IT_
TELL YOUR DOCTOR IF:
•
you think you are allergic to any
ingredients contained in
Somatuline LA.
•
you are a diabetic.
•
you have ever experienced liver,
kidn

Vara einkenni

Somatuline  LA Product Information V2.4 23
rd
 July 2013 
1

PRODUCT INFORMATION 
SOMATULINE LA 30MG 

NAME OF MEDICINE 
Lanreotide (I.N.N., B.A.N.) _acetate_ 

DESCRIPTION 
Powder  for  suspension  for  injection.  Somatuline  LA  is  formulated  as  a  prolonged  -
release  depot  suspension  of  lanreotide  acetate  for  intramuscular  injection.  The  slow 
release properties of the formulation have been achieved by encapsulation of lanreotide 
in  microspheres  composed  of  a  biodegradable  matrix  of  copolymers.  The  gradual 
degradation of the matrix after injection results in prolonged
release of the active drug. 

Each vial is filled with a quantity of microparticles which ensures the injection of 30 mg of 
lanreotide. Lanreotide is a peptide containing eight amino acids as shown below: 
S -------------------------- S 
|                                      | 
D-ß-Nal-Cys-Tyr-D-Trp-Lys-Val-Cys-Thr-NH2 

Molecular formula : C
54
H
69
N
11
O
10
S
2 
   CAS : 108736-35-2

Excipients  include  polyglactin,  lactic-glycolic  copolymer,  mannitol,  carmellose  sodium, 
polysorbate 80. 

PHARMACOLOGY 
Like  natural  somatostatin,  lanreotide  is  a  peptide  inhibitor  of  a  number  of  endocrine, 
neuroendocrine,  exocrine  and  paracrine  functions.    It  shows  good  affinity  for  peripheral 
somatostatin receptors (anterior pituitary and pancreatic). 
In contrast, its affinity for central 
receptors is much lower.  This profile confers a good specificity of action at the level of 
growth hormone secretion.  

Lanreotide shows a much longer duration of action than natural somatostatin.  In addition, 
its  marked  selectivity  for  the  secretion  of  g