LUTATHERA 370 MBqML SOLUTION FOR INFUSION

Land: Israel

Språk: engelsk

Kilde: Ministry of Health

Aktiv ingrediens:

LUTETIUM (177LU) OXODOTREOTIDE

Tilgjengelig fra:

NOVARTIS ISRAEL LTD

ATC-kode:

V10XX04

Legemiddelform:

SOLUTION FOR INFUSION

Sammensetning:

LUTETIUM (177LU) OXODOTREOTIDE 370 MBQ/ML

Administreringsrute:

I.V

Resept typen:

Required

Produsert av:

ADVANCED ACCELERATOR APPLICATIONS, FRANCE

Terapeutisk område:

LUTETIUM (177LU) OXODOTREOTIDE

Indikasjoner:

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.

Autorisasjon dato:

2019-05-30

Preparatomtale

LUT API DEC23 V4.0
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 in the vial ranges between 20.5 and 25.0 mL in order to
provide the required amount of
radioactivity at the date and time of infusion.
Physical characteristics
Lutetium-177 has a half-life of 6.647 days. Lutetium-177 decays by β
-
emission to stable hafnium-177
with the most abundant β
-
(79.3%) having a maximum energy of 0.498 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 up to 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
Important safety instructions
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.
Patient identification
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).
LUT API DEC23 V4.0