Somatuline Autogel 120mg/0.5ml solution for injection pre-filled syringes with safety system
Country: United Kingdom
Language: English
Source: MHRA (Medicines & Healthcare Products Regulatory Agency)
Patient Information leaflet
(PIL)
19-06-2018
Summary of Product characteristics
(SPC)
19-06-2018
Active ingredient:
Lanreotide acetate
Available from:
Ipsen Ltd
ATC code:
H01CB03
INN (International Name):
Lanreotide acetate
Dosage:
240mg/1ml
Pharmaceutical form:
Solution for injection
Administration route:
Subcutaneous
Class:
No Controlled Drug Status
Prescription type:
Valid as a prescribable product
Product summary:
BNF: 08030403; GTIN: 5036611000240
Patient Information leaflet
Page 1 of 9 PACKAGE LEAFLET: INFORMATION FOR THE USER
SOMATULINE
® AUTOGEL
® 60 MG, SOLUTION FOR INJECTION IN A PREFILLED SYRINGE.
SOMATULINE
® AUTOGEL
® 90 MG, SOLUTION FOR INJECTION IN A PREFILLED SYRINGE.
SOMATULINE
® AUTOGEL
® 120 MG, SOLUTION FOR INJECTION IN A PREFILLED 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 symptoms and 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.
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 treatment of acromegaly (a condition where your body produces too
much growth hormone)
The relief of symptom
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Summary of Product characteristics
OBJECT 1
SOMATULINE AUTOGEL 60 MG, SOLUTION FOR INJECTION
IN A PREFILLED SYRINGE
Summary of Product Characteristics Updated 04-Jan-2018 | Ipsen Ltd
1. Name of the medicinal product
Somatuline
®
Autogel
®
60 mg, solution for injection in a prefilled syringe
Somatuline
®
Autogel
®
90 mg, solution for injection in a prefilled syringe
Somatuline
®
Autogel
®
120 mg, solution for injection in a prefilled syringe
2. Qualitative and quantitative composition
Lanreotide (I.N.N.), 60 mg, 90 mg or 120 mg (as acetate)
Each prefilled syringe contains a supersaturated solution of
lanreotide acetate corresponding to 0.246 mg
lanreotide base/mg of solution, which ensures an actual injection dose
of 60 mg, 90 mg or 120 mg of
lanreotide, respectively.
For excipients, see 6.1.
3. Pharmaceutical form
Solution for injection in a prefilled syringe.
White to pale yellow semi-solid formulation.
4. Clinical particulars
4.1 Therapeutic indications
Somatuline Autogel is indicated for:
• The 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 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 neuroendocrine
(particularly carcinoid) tumours.
4.2 Posology and method of administration
POSOLOGY
ACROMEGALY
The recommended starting dose is 60 mg to 120 mg administered every 28
days. The dose should be
individualised according to the response of the patient (as judged by
a reduction in symptoms and/or a
reduction in GH and/or IGF-1 le
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