LUTATHERA SOLUTION FOR INFUSION 370 MBQML

Krajina: Singapur

Jazyk: angličtina

Zdroj: HSA (Health Sciences Authority)

Aktívna zložka:

Lutetium (177Lu) oxodotreotide

Dostupné z:

NOVARTIS (SINGAPORE) PTE LTD

ATC kód:

V10XX04

Forma lieku:

INJECTION, SOLUTION (RADIOPHARMACEUTICAL)

Zloženie:

Lutetium (177Lu) oxodotreotide 370 Mbq/ml

Spôsob podávania:

INTRAVENOUS

Typ predpisu:

Prescription Only

Výrobca:

Advanced Accelerator Applications (Italy) s.r.l.

Stav Autorizácia:

ACTIVE

Dátum Autorizácia:

2020-06-01

Súhrn charakteristických

Lutathera Jan 2024.SIN Page 1 of 31
1
TRADENAME
LUTATHERA
®
0.37 GBq/mL solution for infusion.
2
DESCRIPTION AND COMPOSITION
PHARMACEUTICAL FORM
Solution for infusion.
Clear, colorless to slightly yellow solution.
pH: 4.5 to 6.0
ACTIVE SUBSTANCE
One mL of solution contains 0.37 GBq of lutetium (
177
Lu) oxodotreotide at the date and time
of calibration.
The total amount of radioactivity per single dose vial is 7.4 GBq (200
mCi) ± 10% at the date
and time of infusion. Given the fixed volumetric activity of 0.37
GBq/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
beta-emission to stable
hafnium-177 with the most abundant beta-minus (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%).
EXCIPIENTS
Acetic acid (0.48 mg/mL), sodium acetate (0.66 mg/mL), gentisic acid
(0.63 mg/mL),
ascorbic acid (2.80 mg/mL), pentetic acid (0.05 mg/mL), sodium
chloride (6.85 mg/mL) ,
sodium hydroxide (0.64 mg/mL), water for injections (ad to 1 mL).
This information might differ in some countries.
3
INDICATIONS
Lutathera
®
is indicated for the treatment of unresectable or metastatic,
progressive, well
differentiated
(G1
and
G2),
somatostatin
receptor-positive
gastroenteropancreatic
neuroendocrine tumors (GEP-NETs), including foregut, midgut, and
hindgut neuroendocrine
tumors in adults.
Lutathera Jan 2024.SIN Page 2 of 31
4
DOSAGE REGIMEN AND ADMINISTRATION
IMPORTANT SAFETY INSTRUCTIONS
Lutathera is a radiopharmaceutical and should be handled with
appropriate safety measures to
minimize radiation exposure in accordance with national regulations
and/or institutional
guidelines (see section Warnings and precautions). Waterproof gloves
and effective radiation
shielding sh