Pays: Israël
Langue: anglais
Source: Ministry of Health
VORETIGENE NEPARVOVEC
NOVARTIS ISRAEL LTD
CONCENTRATE AND SOLVENT FOR SOLUTION FOR INJECTION
VORETIGENE NEPARVOVEC 5X10^12 VECTOR GENOMES/ML
SUBRETINAL INJECTION
Required
NOVA LABORATORIES LTD, UK
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.
2019-11-24
LUXTURNA ® Concentrate and solvent for solution for injection RMP 2022-001-ENG PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS (PREPARATIONS) - 1986 The medicine is dispensed with a doctor’s prescription only ACTIVE INGREDIENT: voretigene neparvovec Each mL of concentrate contains 5x10 12 vector genomes (vg) Inactive and allergenic ingredients: see section 6 “Further information” and section 2 “Important information about some of the ingredients of the medicine”. READ THE LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE USING THE MEDICINE. This leaflet contains concise information about the medicine. If you have further questions, refer to the doctor or pharmacist. 1. WHAT IS THE MEDICINE INTENDED FOR? Luxturna is used for the treatment of adults and children with vision loss due to inherited retinal dystrophy caused by a genetic mutation called biallelic RPE65, and who have a sufficient amount of live retinal cells. Biallelic RPE65 mutations prevent the body from producing a protein needed for vision, and thereby lead to loss of sight and eventual blindness. THERAPEUTIC GROUP: Still undetermined. Luxturna is a gene therapy product. The active ingredient in Luxturna, voretigene neparvovec, is a modified virus that contains a working copy of the RPE65 gene. After injection, it delivers this gene into the cells of the retina, the layer at the back of the eye that detects light. This enables the retina to produce the proteins needed for vision. The virus used to deliver the gene does not cause disease in humans. Luxturna will only be given to you if genetic testing shows that your vision loss is caused by mutations in the RPE65 gene. IN ADDITION TO THIS LEAFLET, LUXTURNA HAS A PATIENT LEAFLET PRINTED IN LARGE FONT SIZE, AND A SAFETY INFORMATION CARD THAT CONTAIN IMPORTANT SAFETY INFORMATION, WHICH YOU SHOULD KNOW BEFORE STARTING AND DURING TREATMENT WITH LUXTURNA, AND ACT ACCORDINGLY. READ THE INFORMATION CARD AND THE PATIENT LEAFLET BEFORE STARTING TO USE THE PREPARATION. KEEP THE CARD F Lire le document complet
LUX API DEC23 V5 Based on EU SmPC JUL23 1 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 × 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 Patient Alert Card The arketi g of Lu tur a is sujet to a risk aage et pla RMP i ludi g Patiet Alert Card and a patient information leaflet - both available in a large print. These materials emphasize important safety information that the patient should be aware of before and during treatment. Please explain to the patient the need to review these materials before starting treatment. Healthcare Professional Guide This product is marketed with Healthcare Professional Guide providing important safety information. Please ensure you are familiar with this material as it contains important safety information. LUX API DEC23 V5 Based Lire le document complet