Somatuline Autogel Prolonged Release Solution for Injection in a Pre-filled Syringe 120 mg

Land: Singapúr

Tungumál: enska

Heimild: HSA (Health Sciences Authority)

Virkt innihaldsefni:

Lanreotide Acetate 149.4mg eqv lanreotide

Fáanlegur frá:

IPSEN PHARMA SINGAPORE PTE. LTD.

ATC númer:

H01C B03

Skammtar:

120 mg

Lyfjaform:

INJECTION, SOLUTION

Samsetning:

Lanreotide Acetate 149.4mg eqv lanreotide 120 mg

Stjórnsýsluleið:

SUBCUTANEOUS

Gerð lyfseðils:

Prescription Only

Framleitt af:

IPSEN PHARMA BIOTECH

Leyfisstaða:

ACTIVE

Leyfisdagur:

2013-01-16

Upplýsingar fylgiseðill

SOMATULINE
®
 AUTOGEL
®

60MG, 90MG, 120MG 

Lanreotide 

Prolonged-release solution for injection in a pre  
filled syringe 

Somatuline
®
 Autogel
® 
 60mg, 90mg and 120mg 
is a prolonged release solution for injection in a 
pre-filled  syringe  containing  60mg,  90mg  and 
120mg of lanreotide acetate respectively. 

SOMATULINE
®
 AUTOGEL
® 
 60MG 
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. 
For a full list of excipients, _see List of excipients_ 
SOMATULINE
®
 AUTOGEL
® 
 90MG 
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 90 mg. 
For a full list of excipients, _see List of excipients_ 
SOMATULINE
®
 AUTOGEL
® 
 120MG 
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  120 
mg.  For  a  full  list  of  excipients,  _see  List  of _
_excipients_ 

PHARMACEUTICAL FORM 
Prolonged-release solution for injection in a pre-
filled syringe. 
White to pale yellow semisolid formulation. 

CLINICAL PARTICULARS 

THERAPEUTIC INDICATIONS 
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 
require medical treatment. The goal of treatment 
i

Vara einkenni

1
NAME OF THE MEDICINAL PRODUCT
Somatuline® Autogel® prolonged-release solution for injection in a
pre-filled syringe 120 mg
Somatuline® Autogel® prolonged-release solution for injection in a
pre-filled syringe 90 mg
Somatuline® Autogel® prolonged-release solution for injection in a
pre-filled syringe 60 mg
2
QUALITATIVE AND QUANTITAVE COMPOSITION
Lanreotide 60 mg, 90 mg and 120 mg (presented as lanreotide acetate)
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, 90 mg and 120
mg, respectively.
3
PHARMACEUTICAL FORM
Prolonged-release solution for injection in a pre-filled syringe.
White to pale yellow semi-solid formulation.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
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 require medical treatment. The goal of
treatment in acromegaly is to
reduce GH and IGF-1 levels and where possible to normalize these
values.
For the relief of symptoms associated with acromegaly.
For the reduction of the symptoms associated with carcinoid syndrome.
For 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.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
INITIATION OF TREATMENT
Acromegaly
The recommended starting dose is 60 mg to 120 mg administered every 28
days.
For example:
-
in patients previously treated with SOMATULINE P.R. 30 mg powder and
solvent for
prolonged-release suspension for injection (I.M.) every 14 days, the
initial dose of Somatuline®
Autogel® should be 60 mg every 28 days;
_ _
-
in patients previously treated w