Luxturna
Country: Unjoni Ewropea
Lingwa: Ingliż
Sors: EMA (European Medicines Agency)
Fuljett ta 'informazzjoni
(PIL)
28-07-2023
Karatteristiċi tal-prodott
(SPC)
28-07-2023
Rapport ta 'Valutazzjoni Pubblika
(PAR)
11-01-2019
Ingredjent attiv:
voretigene neparvovec
Disponibbli minn:
Novartis Europharm Limited
Kodiċi ATC:
S01XA27
INN (Isem Internazzjonali):
voretigene neparvovec
Grupp terapewtiku:
Other ophthalmologicals
Żona terapewtika:
Leber Congenital Amaurosis; Retinitis Pigmentosa
Indikazzjonijiet terapewtiċi:
Luxturna is indicated for the treatment of adult and paediatric patients with vision loss due to inherited retinal dystrophy caused by confirmed biallelic RPE65 mutations and who have sufficient viable retinal cells.
Sommarju tal-prodott:
Revision: 7
L-istatus ta 'awtorizzazzjoni:
Authorised
Data ta 'l-awtorizzazzjoni:
2018-11-22
Fuljett ta 'informazzjoni
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
Luxturna 5 × 10
12
vector genomes/mL concentrate and solvent for solution for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
2.1
GENERAL DESCRIPTION
Voretigene neparvovec is a gene transfer vector that employs an
adeno-associated viral vector
serotype 2 (AAV2) capsid as a delivery vehicle for the human retinal
pigment epithelium 65 kDa
protein (hRPE65) cDNA to the retina. Voretigene neparvovec is derived
from wild-type AAV2 using
recombinant DNA techniques.
2.2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each mL of concentrate contains 5 × 10
12
vector genomes (vg).
Each vial of Luxturna contains 0.5 extractable mL of concentrate
(corresponding to 2.5 × 10
12
vector
genomes) which requires a 1:10 dilution prior to administration, see
section 6.6.
After dilution of 0.3 mL of concentrate with 2.7 mL of solvent, each
mL contains 5 × 10
11
vector
genomes. Each dose of 0.3 mL Luxturna contains 1.5 x 10
11
vector genomes.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Concentrate and solvent for solution for injection.
Following thaw from their frozen state, both the concentrate and the
solvent are clear, colourless
liquids with a pH of 7.3.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Luxturna is indicated for the treatment of adult and paediatric
patients with vision loss due to inherited
retinal dystrophy caused by confirmed biallelic
_RPE65_
mutations and who have sufficient viable
retinal cells.
3
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Treatment should be initiated and administered by a retinal surgeon
experienced in performing
macular surgery.
Posology
Patients will receive a single dose of 1.5 × 10
11
vector genomes voretigene neparvovec i
Aqra d-dokument sħiħ
Karatteristiċi tal-prodott
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
Luxturna 5 × 10
12
vector genomes/mL concentrate and solvent for solution for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
2.1
GENERAL DESCRIPTION
Voretigene neparvovec is a gene transfer vector that employs an
adeno-associated viral vector
serotype 2 (AAV2) capsid as a delivery vehicle for the human retinal
pigment epithelium 65 kDa
protein (hRPE65) cDNA to the retina. Voretigene neparvovec is derived
from wild-type AAV2 using
recombinant DNA techniques.
2.2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each mL of concentrate contains 5 × 10
12
vector genomes (vg).
Each vial of Luxturna contains 0.5 extractable mL of concentrate
(corresponding to 2.5 × 10
12
vector
genomes) which requires a 1:10 dilution prior to administration, see
section 6.6.
After dilution of 0.3 mL of concentrate with 2.7 mL of solvent, each
mL contains 5 × 10
11
vector
genomes. Each dose of 0.3 mL Luxturna contains 1.5 x 10
11
vector genomes.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Concentrate and solvent for solution for injection.
Following thaw from their frozen state, both the concentrate and the
solvent are clear, colourless
liquids with a pH of 7.3.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Luxturna is indicated for the treatment of adult and paediatric
patients with vision loss due to inherited
retinal dystrophy caused by confirmed biallelic
_RPE65_
mutations and who have sufficient viable
retinal cells.
3
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Treatment should be initiated and administered by a retinal surgeon
experienced in performing
macular surgery.
Posology
Patients will receive a single dose of 1.5 × 10
11
vector genomes voretigene neparvovec i
Aqra d-dokument sħiħ
