SomaKit TOC

Country: Եվրոպական Միություն

language: անգլերեն

source: EMA (European Medicines Agency)

active_ingredient:

edotreotide

MAH:

Advanced Accelerator Applications

ATC_code:

V09IX

INN:

edotreotide

therapeutic_group:

Diagnostic radiopharmaceuticals

therapeutic_area:

Neuroendocrine Tumors; Radionuclide Imaging

therapeutic_indication:

This medicinal product is for diagnostic use only.After radiolabelling with gallium (68Ga) chloride solution, the solution of gallium (68Ga) edotreotide obtained is indicated for Positron Emission Tomography (PET) imaging of somatostatin receptor overexpression in adult patients with confirmed or suspected well-differentiated gastro-enteropancreatic neuroendocrine tumours (GEP-NET) for localizing primary tumours and their metastases.

leaflet_short:

Revision: 15

authorization_status:

Authorised

authorization_date:

2016-12-08

PIL

29
B. PACKAGE LEAFLET
30
PACKAGE LEAFLET: INFORMATION FOR THE USER
SOMAKIT TOC 40 MICROGRAMS KIT FOR RADIOPHARMACEUTICAL PREPARATION
edotreotide
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN 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 nuclear medicine doctor
who will supervise the
procedure.
-
If you get any side effects, talk to your nuclear medicine doctor.
This includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What SomaKit TOC is and what it is used for
2.
What you need to know before SomaKit TOC is used
3.
How SomaKit TOC is used
4.
Possible side effects
5.
How SomaKit TOC is stored
6.
Contents of the pack and other information
1.
WHAT SOMAKIT TOC IS AND WHAT IT IS USED FOR
This medicine is a radiopharmaceutical for diagnostic use only. It
contains the active substance
edotreotide. Before it can be used, the powder in the vial is mixed
with a radioactive substance called
gallium (
68
Ga) chloride to make gallium (
68
Ga) edotreotide (this procedure is called radiolabelling).
Gallium (
68
Ga) edotreotide contains a small amount of radioactivity. After
injection into a vein, it can
make parts of the body visible to doctors during a medical imaging
procedure called positron emission
tomography (PET). This medical procedure obtains images of your organs
to help locate abnormal
cells or tumours, giving valuable information about your disease.
The use of SomaKit TOC involves exposure to small amounts of
radioactivity. Your doctor and the
nuclear medicine doctor have considered that the clinical benefit from
the procedure with the
radiopharmaceutical outweighs the risk due to radiation.
31
2.
WHAT YOU NEED TO KNOW BEFORE SOMAKIT TOC IS USED
SOMAKIT TOC MUST NOT BE USED
-
if you are allergic to edotreotide or any of the other ingredients of
this medicine (listed in
section 6).
WARNINGS AND PRECAUTIONS
Talk to your nuclear medicine docto

SPC

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
SomaKit TOC 40 micrograms kit for radiopharmaceutical preparation
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial of powder contains 40 micrograms of edotreotide.
The radionuclide is not part of the kit.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Kit for radiopharmaceutical preparation containing:
-
Powder for solution for injection: the vial contains a white
lyophilised powder.
-
Reaction buffer: the vial contains a clear, colourless solution.
For radiolabelling with gallium (
68
Ga) chloride solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
This medicinal product is for diagnostic use only.
After radiolabelling with gallium (
68
Ga) chloride solution, the solution of gallium (
68
Ga) edotreotide
obtained is indicated for positron emission tomography (PET) imaging
of somatostatin receptor
overexpression in adult patients with confirmed or suspected
well-differentiated gastro-
enteropancreatic neuroendocrine tumours (GEP-NET) for localising
primary tumours and their
metastases.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
The medicinal product should only be administered by trained
healthcare professionals with technical
expertise in using and handling nuclear medicine diagnostic agents and
only in a designated nuclear
medicine facility.
Posology
The recommended activity for an adult weighing 70 kg is 100 to 200
MBq, administered by direct
slow intravenous injection.
The activity will be adapted to patient characteristics, the type of
PET camera used and acquisition
mode.
_Elderly _
No special dose regimen for elderly patients is required.
_Renal/Hepatic impairment _
The safety and efficacy of gallium (
68
Ga) edotreotide have not been studied in patients with renal or
hepatic impairment.
3
_Paediatric population _
The safety and efficacy of gallium (
68
Ga) edotreotide have not been established in paediatric
populations, where the effective dose might be different than in
adults. There is