LUXTURNA Concentrate and solvent for solution for injection (2020)
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Περιεχόμενα
Name of the medicinal product
Luxturna 5 10<sup>12</sup> vector genomes/mL concentrate and solvent for solution for injection.
Qualitative and quantitative composition
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) ...
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.
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 ...
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<sup>11</sup> vg voretigene neparvovec ...
Contraindications
Hypersensitivity to the active substance(s) or to any of the excipients listed in section 6.1. Ocular or periocular infection. Active intraocular inflammation.
Special warnings and precautions for use
Proper aseptic techniques should always be used for the preparation and administration of Luxturna. The following adverse reactions have been observed with the administration procedure: Eye inflammation ...
Interaction with other medicinal products and other forms of interaction
There are no known clinically significant interactions. No interaction studies have been performed.
Fertility, pregnancy and lactation
Based on non-clinical studies and clinical data from trials of AAV2 vectors, and considering the subretinal route of administration of Luxturna, inadvertent germ-line transmission with AAV vectors is highly ...
Effects on ability to drive and use machines
Voretigene neparvovec has minor influence on the ability to drive and use machines. Patients may experience temporary visual disturbances after receiving subretinal injection of Luxturna. Patients should ...
Undesirable effects
Summary of the safety profile There were three non-serious adverse reactions of retinal deposits in three of 41 (7%) subjects that were considered to be related to voretigene neparvovec. All three of these ...
Overdose
There is no clinical experience with overdose of voretigene neparvovec. Symptomatic and supportive treatment, as deemed necessary by the treating physician, is advised in case of overdose.
Pharmacodynamic properties
Pharmacotherapeutic group: not yet assigned ATC code: not yet assigned Mechanism of action The retinal pigment epithelium-specific 65 kilodalton protein (RPE65) is located in the retinal pigment epithelial ...
Pharmacokinetic properties
Voretigene neparvovec is expected to be taken up by cells through heparin sulphate proteoglycan receptors and be degraded by endogenous proteins and DNA catabolic pathways. Nonclinical biodistribution ...
Preclinical safety data
Ocular histopathology of dog and non-human primate eyes exposed to voretigene neparvovec showed only mild changes, which were mostly related to healing from surgical injury. In an earlier toxicology study, ...
List of excipients
Concentrate: Sodium chloride Sodium dihydrogen phosphate monohydrate (for pH adjustment) Disodium hydrogen phosphate dihydrate (for pH adjustment) Poloxamer 188 Water for injections Solvent: Sodium chloride ...
Incompatibilities
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
Shelf life
Unopened frozen vials: 2 years. After thawing and dilution: Once thawed, the medicinal product should not be re-frozen and be left at room temperature (below 25°C). Following dilution under aseptic conditions, ...
Special precautions for storage
Concentrate and solvent must be stored and transported frozen at ≤65°C. For storage conditions after thawing and dilution of the medicinal product, see section 6.3.
Nature and contents of container
0.5 mL extractable volume of concentrate in 2 mL cyclic olefin polymer vial with a chlorobutyl rubber stopper sealed in place with an aluminium flip-off seal. 1.7 mL extractable volume of solvent in a ...
Special precautions for disposal and other handling
Each carton containing 1 vial of concentrate and 2 vials of solvent is for single use only. Luxturna should be inspected visually prior to administration. If particulates, cloudiness, or discoloration ...
Marketing authorization holder
Novartis Europharm Limited, Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland
Marketing authorization number(s)
EU/1/18/1331/001
Date of first authorization / renewal of the authorization
22 November 2018
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