SOMATULINE P.R. 30 MG

Country: Israel

Language: English

Source: Ministry of Health

Active ingredient:

LANREOTIDE ACETATE

Available from:

MEDISON PHARMA LTD

ATC code:

H01CB03

Pharmaceutical form:

POWDER AND SOLVENT FOR SUSPENSION FOR INJECTION

Composition:

LANREOTIDE ACETATE 0.03 G/VIAL

Administration route:

I.M

Prescription type:

Required

Manufactured by:

IPSEN PHARMA, FRANCE

Therapeutic group:

LANREOTIDE

Therapeutic area:

LANREOTIDE

Therapeutic indications:

Treatment of acromegaly (when the treatment of growth hormone is not normalized after surgery and/or radiotherapy). Treatment of the clinical symptoms of carcinoid tumors (after a test injection). Treatment of primary thyrotropic adenomas responsible for hypethyroidism as a preparation for / or as a complement to surgery and/or radiotherapy or where these therapies are unsuitable.

Authorization date:

2015-02-28

Patient Information leaflet

לע העדוה לע העדוה לע העדוה
( הרמחה
( הרמחה
( הרמחה עדימ עדימ עדימ
ל ןולעב )תוחיטב
ל ןולעב )תוחיטב
ל ןולעב )תוחיטב אפור אפור אפור
ךיראת
:
61
02.
62
0
22
תילגנאב רישכת םש
םושירה רפסמו :
00
22911
3
9
17
1
OMATULINE PR 30 MG
S
םושירה לעב םש
:
מ"עב המראפ ןוסידמ
ה טורפל דעוימ הז ספוט
דבלב תורמחה
!
תושקובמה תורמחהה
ןולעב קרפ
יחכונ טסקט
סקט
שדח ט
4.4
SPECIAL
WARNINGS AND
PRECAUTIONS FOR
USE
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
▪ Lanreotide may reduce gallbladder motility and lead to gallstone
formation.
Therefore patients may need to be monitored periodically. It is
advised, during
prolonged
treatment,
to
perform
before
treatment
and
every
6
months,
an
echography of the gallbladder
▪ Pharmacological studies in animals and humans show that
lanreotide, like
somatostatin and other somatostatin analogues, inhibits secretion of
insulin and
glucagon. Hence, patients treated with lanreotide may experience
hypoglycaemia
or hyperglycaemia. Blood glucose levels should be monitored when
lanreotide
treatment is initiated, or when the dose is altered. Any antidiabetic
treatment
should be adjusted accordingly. In insulin-treated diabetic patients,
the insulin
doses will initially be reduced by 25%, then adapted to the blood
glucose level,
which must be carefully controlled in these patients as soon as
treatment begins.
▪ Slight decreases in thyroid function have been seen during
treatment with
lanreotide in acromegalic patients, though clinical hypothyroidism is
rare. Thyroid
function tests are recommended where clinically indicated.
▪
In
acromegalic
patients
and
patients
presenting
with
primitive
thyrotropic
4.4
SPECIAL WARNINGS AND PRECAUTIONS FOR USE
▪
Lanreotide
may
reduce
gallbladder
motility
and
lead
to
gallstone
formation. Therefore patients may need to be monitored periodically.
It is
advised, du

Summary of Product characteristics

PHYSICIAN'S PRESCRIBING INFORMATION
1
TRADE NAME OF THE MEDICINAL PRODUCT
SOMATULINE P.R. 30 MG
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Lanreotide acetate, expressed as lanreotide
.......................................
0.03000 g *
For one vial
* Taking into account the characteristics of the pharmaceutical form,
each vial contains a
quantity of lanreotide acetate corresponding to 0.04 g of lanreotide.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Powder and solvent for prolonged release suspension for injection (I.
M.).
The powder is made of lyophilised microspheres.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment of acromegaly (when the treatment of growth hormone is not
normalized after
surgery and/or radiotherapy).
Treatment of clinical symptoms of carcinoid tumours (after a test
injection).
Treatment of primary thyrotropic adenomas responsible for
hyperthyroidism as a preparation
for /or as a complement to surgery and/or radiotherapy, or where these
therapies are
unsuitable.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
The treatment should be adjusted to each patient in a specialised
unit.
POSOLOGY
Taking
into
account
the
variability
of
the
sensitivity
of
the
tumours
to
somatostatin
analogues, it is recommended to start treatment with a test injection,
in order to assess the
quality of the response (GH secretion, symptoms related to the
carcinoid tumour, tumoral
secretions...).
If no response to the first test injection is seen, the treatment
should be reviewed.
In acromegaly
The frequency of administration of the prolonged release form can
initially be set to one
intramuscular injection every 14 days. In case of an insufficient
response, judged by the
levels of growth hormone and IGF-1 (measured prior to the next
injection), the frequency of
injection may be increased to 1 every 10 days.
In carcinoid tumours
The frequency of administration of the prolonged release form can
initially be set to one
intramuscular injection every 14 days. In case of an insufficient
respons