LUTATHERA 370 MBqML SOLUTION FOR INFUSION

Држава: Израел

Језик: Енглески

Извор: Ministry of Health

Активни састојак:

LUTETIUM (177LU) OXODOTREOTIDE

Доступно од:

MARSHALL ISOTOPE LTD, ISRAEL

АТЦ код:

V10XX04

Фармацеутски облик:

SOLUTION FOR INFUSION

Састав:

LUTETIUM (177LU) OXODOTREOTIDE 370 MBQ/ML

Пут администрације:

I.V

Тип рецептора:

Required

Произведен од:

ADVANCED ACCELERATOR APPLICATIONS, FRANCE

Терапеутска област:

LUTETIUM (177LU) OXODOTREOTIDE

Терапеутске индикације:

Lutathera is indicated for the treatment of unresectable or metastatic, progressive, well differentiated (G1 and G2), somatostatin receptor positive gastroenteropancreatic neuroendocrine tumours (GEP NETs) in adults.

Датум одобрења:

2019-05-30

Карактеристике производа

1
1.
NAME OF THE MEDICINAL PRODUCT
Lutathera 370 MBq/mL solution for infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One mL of solution contains 370 MBq of lutetium (
177
Lu) oxodotreotide at the date and time of
calibration.
The total amount of radioactivity per single dose vial is 7,400 MBq at
the date and time of infusion.
Given the fixed volumetric activity of 370 MBq/mL at the date and time
of calibration, the volume of
the solution is adjusted between 20.5 mL and 25.0 mL in order to
provide the required amount of
radioactivity at the date and time of infusion.
Lutetium (
177
Lu) has a half-life of 6.647 days. Lutetium (
177
Lu) decays by β
-
emission to stable
Hafnium (
177
Hf) with the most abundant β
-
(79.3%) having a maximum energy of 0.497 MeV. The
average beta energy is approximately 0.13 MeV. Low gamma energy is
also emitted, for instance at
113 keV (6.2%) and 208 keV (11%).
Excipient with known effect
Each mL of solution contains 0.14 mmol (3.2 mg) of sodium.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for infusion.
Clear, colourless to slightly yellow solution.
4.
CLINICAL
PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Lutathera is indicated for the treatment of unresectable or
metastatic, progressive, well differentiated
(G1 and G2), somatostatin receptor positive gastroenteropancreatic
neuroendocrine tumours
(GEP-NETs) in adults.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Lutathera should be administered only by persons authorised to handle
radiopharmaceuticals in
designated clinical settings (see section 6.6) and after evaluation of
the patient by a qualified
physician.
Before starting treatment with Lutathera, somatostatin receptor
imaging (scintigraphy or positron
emission tomography [PET]) must confirm the overexpression of these
receptors in the tumour tissue
with the tumour uptake at least as high as normal liver uptake (tumour
uptake score ≥ 2).
Posology
_Adults _
The recommended treatment regimen of Lutathera in adults consists of 4
infusions of 7,40