Somatuline Autogel

Šalis: Naujoji Zelandija

kalba: anglų

Šaltinis: Medsafe (Medicines Safety Authority)

Veiklioji medžiaga:

Lanreotide acetate 149.4mg equivalent to lanreotide 120 mg

Prieinama:

Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics

INN (Tarptautinis Pavadinimas):

Lanreotide acetate 149.4 mg (equivalent to lanreotide 120 mg)

Dozė:

120 mg

Vaisto forma:

Solution for injection

Sudėtis:

Active: Lanreotide acetate 149.4mg equivalent to lanreotide 120 mg Excipient: Glacial acetic acid Water for injection

Recepto tipas:

Prescription

Pagaminta:

Ipsen Manufacturing Ireland Limited

Terapinės indikacijos:

Treatment of acromegaly when circulating levels of GH and IGF-1 remain abnormal after surgery and/or radiotherapy, or in patients who are dopamine agonist treatment refractory. Treatment of symptoms of carcinoid syndrome associated with carcinoid tumours. The treatment of well or moderately differentiated gastroenteropancreatic neuroendocrine tumours (GEP-NETs) in adult patients with unresectable locally advanced or metastatic disease.

Produkto santrauka:

Package - Contents - Shelf Life: Syringe, plastic, pre-filled, PP stopper - 1 dose units - 36 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light. short term excursions up to 40C allowed (no more than three, and no more than 72 h cumulatively).

Leidimo data:

2016-08-04

Pakuotės lapelis

SOMATULINE
®
AUTOGEL
®
1
SOMATULINE
®
AUTOGEL
®
60, 90 AND 120 MG
_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
®
Autogel
®
. Somatuline
Autogel is a solution for injection in
a pre-filled syringe, ready to use and
fitted with an automatic safety
system. It is a white to pale yellow
semi-solid formulation. The active
substance is lanreotide. The dose of
lanreotide you will receive is 60, 90
or 120 mg. There is an extra amount
filled into the syringe to ensure that
the correct dose can be injected. The
other ingredients are sterile water and
acetic acid.
The product is for single use only.
WHAT IS SOMATULINE
AUTOGEL?
Somatuline Autogel 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
AUTOGEL USED FOR?
Somatuline Autogel is used 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.
Somatuline Autogel is used for the
treatment of symptoms associated
with carcinoid syndrome, such as
flushing and diarrhoea.
Somatuline Autogel is used for the
treatment and control of the growth
of some advanced tumours of the
intestine and pancreas that cannot be
removed by surgery (called
gastroenteropancreatic
neuroendocrine tumours or GEP-
NETs).
BEFORE YOU ARE GIVEN
SOMATULINE
AUTOGEL
_WHEN YOU MUST NOT BE GIVEN _
_IT _
Do not be given Somatuline Autogel
if:
•
you are breastfeeding
•
you have a tumour blocking your
intestines
•
you are allergic to lanreot

Prekės savybės

Somatuline Autogel Data Sheet v8
Page 1
NEW ZEALAND DATASHEET
1.
PRODUCT NAME
SOMATULINE AUTOGEL
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Lanreotide acetate 60, 90 and 120 mg solution for Injection in a
pre-filled syringe.
3.
PHARMACEUTICAL FORM
Lanreotide (presented as lanreotide acetate 60 mg, 90 mg, 120 mg)
solution for injection in a
pre-filled
syringe.
White
to
pale-yellow
semi-solid
formulation.
Somatuline
Autogel
is
formulated as a prolonged-release solution of lanreotide acetate for
deep subcutaneous
injection. Prolonged release of the peptide is achieved by the
physical nature of the
supersaturated solution.
Each pre-filled syringe contains a supersaturated solution of
lanreotide acetate corresponding
to 24.6 mg of lanreotide base per 100 mg of solution, which ensures an
actual injection dose
of 60 mg, 90 mg and 120 mg of lanreotide, respectively.
The formulation contains water for injections and glacial acetic acid
(for pH adjustment) as
excipients. The pH of Somatuline Autogel solution is around 6.1.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Somatuline Autogel is indicated 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
are dopamine
agonist treatment refractory
•
the treatment of symptoms of carcinoid syndrome associated with
carcinoid tumours
•
the
treatment
of
well
or
moderately
differentiated
gastroenteropancreatic
neuroendocrine tumours (GEP-NETs) in adult patients with unresectable
locally
advanced or metastatic disease.
4.2
DOSAGE AND METHOD OF ADMINISTRATION
POSOLOGY:
_ACROMEGALY: _
In patients receiving a somatostatin analogue for the first time, the
recommended starting
dose is 60 mg of Somatuline Autogel administered every 28 days.
Thereafter, in all patients, the dosage strength (60 mg, 90 mg and 120
mg) should be
individualised according to the response to treatment (as judged by a
reduction in GH and/or
IGF-1 levels).
If the desired response is not obtained, th