SOMATULINE AUTOGEL 90 MG

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

LANREOTIDE AS ACETATE

Available from:

MEDISON PHARMA LTD

ATC code:

H01CB03

Pharmaceutical form:

SOLUTION FOR INJECTION

Composition:

LANREOTIDE AS ACETATE 90 MG/DOSE

Administration route:

DEEP S.C.

Prescription type:

Required

Manufactured by:

IPSEN PHARMA, FRANCE

Therapeutic group:

LANREOTIDE

Therapeutic area:

LANREOTIDE

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 treatmfent .The goal of treatment in acromegaly is to reduce GH and IGF-1 levels and where possible to normalize these values. Somatuline autogel is also indicated for the treatment of symptoms associated with neuroendocrine (particularly carcinoid) tumors.Somatuline autogel is also indicated for the treatment of grade 1 and a subset of grade 2 (Ki67 index up to 10%) gastroenteropancreatic neuroendocrine tumors (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.

Authorization date:

2017-12-31

Patient Information leaflet

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Somatuline-Autogel-60-90-120-mg-ENG-D30-F
Patient leaflet in accordance with the Pharmacists' Regulations
(Preparations) -
1986
This medicine is dispensed with a doctor’s prescription only
Somatuline Autogel 60 mg
Somatuline Autogel 90 mg
Somatuline Autogel 120 mg
Solution for injection in a pre-filled syringe
Each pre-filled syringe contains lanreotide acetate at a ratio of
0.246 mg lanreotide
base in 1 mg of solution.
Name and quantity of active ingredient:
Somatuline Autogel 60 mg:
Each pre-filled syringe contains 60 mg
lanreotide (as acetate)
Somatuline Autogel 90 mg:
Each pre-filled syringe contains 90 mg
lanreotide (as acetate)
Somatuline Autogel 120 mg:
Each pre-filled syringe contains 120 mg
lanreotide (as acetate)
For a list of inactive ingredients: see section 6
'Additional information'.
Read the entire leaflet carefully before you start using this
medicine. This leaflet
contains concise information about this medicine. If you have any
further questions,
consult your doctor or pharmacist.
This medicine has been prescribed to treat your illness. Do not pass
it on to others. It
may harm them, even if it seems to you that their illness is similar
to yours.
1. What is this medicine intended for?
This medicine is intended for:

The treatment of acromegaly (a condition where your body produces too
much growth hormone) when growth hormone and/or IGF-1 levels remain
abnormal after surgery and/or radiotherapy.

The treatment of symptoms associated with neuroendocrine tumors.

The treatment and control of some advanced tumors of the intestine and
pancreas (called gastroenteropancreatic neuroendocrine tumors or GEP-
NETs) when these tumors cannot be removed by surgery.
Therapeutic group: somatostatin analogs.
2. Before using this medicine
Do not use this medicine if:

You are sensitive (allergic) to the active ingredient lanreotide,
somatostatin or
medicines from the same family (analogs of somatostatin) or any of the
other
ingredients that this medicine contains (listed

Summary of Product characteristics

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1223
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SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Somatuline
®
Autogel
®
60 mg
Somatuline
®
Autogel
®
90 mg
Somatuline
®
Autogel
®
120 mg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Somatuline
®
Autogel
®
60 mg:
Each pre-filled syringe contains 60 mg of lanreotide (as acetate)
Somatuline
®
Autogel
®
90 mg:
Each pre-filled syringe contains 90 mg of lanreotide (as acetate)
Somatuline
®
Autogel
®
120 mg:
Each pre-filled syringe contains 120 mg of lanreotide (as acetate)
Each pre-filled 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 section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection in a pre-filled 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.
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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
red