Locametz

البلد: الاتحاد الأوروبي

اللغة: الإنجليزية

المصدر: EMA (European Medicines Agency)

العنصر النشط:

gozetotide

متاح من:

Novartis Europharm Limited 

ATC رمز:

V09I

INN (الاسم الدولي):

gozetotide

المجموعة العلاجية:

Diagnostic radiopharmaceuticals

المجال العلاجي:

Radionuclide Imaging

الخصائص العلاجية:

This medicinal product is for diagnostic use only. Locametz, after radiolabelling with gallium 68, is indicated for the detection of prostate specific membrane antigen (PSMA) positive lesions with positron emission tomography (PET) in adults with prostate cancer (PCa) in the following clinical settings:Primary staging of patients with high risk PCa prior to primary curative therapy,Suspected PCa recurrence in patients with increasing levels of serum prostate specific antigen (PSA) after primary curative therapy,Identification of patients with PSMA positive progressive metastatic castration resistant prostate cancer (mCRPC) for whom PSMA targeted therapy is indicated (see section 4.4).

ملخص المنتج:

Revision: 2

الوضع إذن:

Authorised

تاريخ الترخيص:

2022-12-09

نشرة المعلومات

26
B. PACKAGE LEAFLET
27
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
LOCAMETZ 25 MICROGRAMS KIT FOR RADIOPHARMACEUTICAL PREPARATION
gozetotide
This medicine is subject to additional monitoring. This will allow
quick identification of new
safety information. You can help by reporting any side effects you may
get. See the end of section 4
for how to report side effects.
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 Locametz is and what it is used for
2.
What you need to know before Locametz is used
3.
How Locametz is used
4.
Possible side effects
5.
How Locametz is stored
6.
Contents of the pack and other information
1.
WHAT LOCAMETZ IS AND WHAT IT IS USED FOR
WHAT LOCAMETZ IS
This medicine is a radiopharmaceutical product for diagnostic use
only.
Locametz contains a substance called gozetotide. Before use,
gozetotide (the powder in the vial) is
coupled with a radioactive substance called gallium-68 to make gallium
(
68
Ga) gozetotide solution
(this procedure is called radiolabelling).
WHAT LOCAMETZ IS USED FOR
After radiolabelling with gallium-68, Locametz is used in a medical
imaging procedure called positron
emission tomography (PET) to detect specific types of cancer cells
with a protein called
prostate-specific membrane antigen (PSMA) in adults with prostate
cancer. This is done:
-
to find out whether prostate cancer has spread to lymph nodes and
other tissues outside the
prostate, before primary curative therapy (e.g. therapy involving
surgical removal of the
prostate, radiation therapy)
-
to identify cancer cells when recurrence of prostate cancer is
suspected in patients who have
received primary cu

خصائص المنتج

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
This medicinal product is subject to additional monitoring. This will
allow quick identification of
new safety information. Healthcare professionals are asked to report
any suspected adverse reactions.
See section 4.8 for how to report adverse reactions.
1.
NAME OF THE MEDICINAL PRODUCT
Locametz 25 micrograms kit for radiopharmaceutical preparation
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
The vial contains 25 micrograms of gozetotide.
The radionuclide is not part of the kit.
Excipient with known effect
The vial contains 28.97 mg of sodium.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Kit for radiopharmaceutical preparation
One vial of white lyophilised powder (powder for solution for
injection).
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
This medicinal product is for diagnostic use only.
Locametz, after radiolabelling with gallium-68, is indicated for the
detection of prostate-specific
membrane antigen (PSMA)-positive lesions with positron emission
tomography (PET) in adults with
prostate cancer (PCa) in the following clinical settings:
•
Primary staging of patients with high-risk PCa prior to primary
curative therapy,
•
Suspected PCa recurrence in patients with increasing levels of serum
prostate-specific antigen
(PSA) after primary curative therapy,
•
Identification of patients with PSMA-positive progressive metastatic
castration-resistant
prostate cancer (mCRPC) for whom PSMA-targeted therapy is indicated
(see section 4.4).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
This medicinal product should only be administered by trained
healthcare professionals with technical
expertise in using and handling nuclear medicine imaging agents and
only in a designated nuclear
medicine facility.
Posology
The recommended dose of gallium (
68
Ga) gozetotide is 1.8-2.2 MBq/kg of body weight, with a
minimum dose of 111 MBq up to a maximum dose of 259 MBq.
3
_Special populations_
_Elderly_
No dose adjustment is required in patients aged 65