Nazione: Nuova Zelanda
Lingua: inglese
Fonte: Medsafe (Medicines Safety Authority)
Onasemnogene abeparvovec 20TVG/mL (TVG = Tera Vector Genomes; equivalent to 2 x 10^13 vector genomes per mL)
Novartis New Zealand Ltd
Solution for infusion
Active: Onasemnogene abeparvovec 20TVG/mL (TVG = Tera Vector Genomes; equivalent to 2 x 10^13 vector genomes per mL) Excipient: Hydrochloric acid Magnesium chloride Poloxamer 188 Sodium chloride Trometamol Water for injection
Prescription
Zolgensma is an adeno-associated virus (AAV) vector-based gene therapy indicated for the treatment of paediatric patients with spinal muscular atrophy (SMA) with a bi allelic mutation in the survival motor neuron 1 (SMN1) gene.
Package - Contents - Shelf Life: Vial, plastic, Crystal zenith, cyclic olefin polymer vial closed with a chlorobutyl rubber stopper - 2 vials - 12 months from date of manufacture stored in the freezer at less than -60°C 14 days unopened stored at 2° to 8°C (Refrigerate, do not freeze) 8 hours opened stored in the infusion syringe - Vial, plastic, Crystal zenith, cyclic olefin polymer vial closed with a chlorobutyl rubber stopper - 3 vials - 12 months from date of manufacture stored in the freezer at less than -60°C 14 days unopened stored at 2° to 8°C (Refrigerate, do not freeze) 8 hours opened stored in the infusion syringe - Vial, plastic, Crystal zenith, cyclic olefin polymer vial closed with a chlorobutyl rubber stopper - 4 vials - 12 months from date of manufacture stored in the freezer at less than -60°C 14 days unopened stored at 2° to 8°C (Refrigerate, do not freeze) 8 hours opened stored in the infusion syringe - Vial, plastic, Crystal zenith, cyclic olefin polymer vial closed with a chlorobutyl rubber stopper - 5 vials - 12 months from date of manufacture stored in the freezer at less than -60°C 14 days unopened stored at 2° to 8°C (Refrigerate, do not freeze) 8 hours opened stored in the infusion syringe - Vial, plastic, Crystal zenith, cyclic olefin polymer vial closed with a chlorobutyl rubber stopper - 6 vials - 12 months from date of manufacture stored in the freezer at less than -60°C 14 days unopened stored at 2° to 8°C (Refrigerate, do not freeze) 8 hours opened stored in the infusion syringe - Vial, plastic, Crystal zenith, cyclic olefin polymer vial closed with a chlorobutyl rubber stopper - 7 vials - 12 months from date of manufacture stored in the freezer at less than -60°C 14 days unopened stored at 2° to 8°C (Refrigerate, do not freeze) 8 hours opened stored in the infusion syringe - Vial, plastic, Crystal zenith, cyclic olefin polymer vial closed with a chlorobutyl rubber stopper - 8 vials - 12 months from date of manufacture stored in the freezer at less than -60°C 14 days unopened stored at 2° to 8°C (Refrigerate, do not freeze) 8 hours opened stored in the infusion syringe - Vial, plastic, Crystal zenith, cyclic olefin polymer vial closed with a chlorobutyl rubber stopper - 9 vials - 12 months from date of manufacture stored in the freezer at less than -60°C 14 days unopened stored at 2° to 8°C (Refrigerate, do not freeze) 8 hours opened stored in the infusion syringe - Vial, plastic, Crystal zenith, cyclic olefin polymer vial closed with a chlorobutyl rubber stopper - 10 vials - 12 months from date of manufacture stored in the freezer at less than -60°C 14 days unopened stored at 2° to 8°C (Refrigerate, do not freeze) 8 hours opened stored in the infusion syringe - Vial, plastic, Crystal zenith, cyclic olefin polymer vial closed with a chlorobutyl rubber stopper - 11 vials - 12 months from date of manufacture stored in the freezer at less than -60°C 14 days unopened stored at 2° to 8°C (Refrigerate, do not freeze) 8 hours opened stored in the infusion syringe - Vial, plastic, Crystal zenith, cyclic olefin polymer vial closed with a chlorobutyl rubber stopper - 12 vials - 12 months from date of manufacture stored in the freezer at less than -60°C 14 days unopened stored at 2° to 8°C (Refrigerate, do not freeze) 8 hours opened stored in the infusion syringe - Vial, plastic, Crystal zenith, cyclic olefin polymer vial closed with a chlorobutyl rubber stopper - 13 vials - 12 months from date of manufacture stored in the freezer at less than -60°C 14 days unopened stored at 2° to 8°C (Refrigerate, do not freeze) 8 hours opened stored in the infusion syringe - Vial, plastic, Crystal zenith, cyclic olefin polymer vial closed with a chlorobutyl rubber stopper - 14 vials - 12 months from date of manufacture stored in the freezer at less than -60°C 14 days unopened stored at 2° to 8°C (Refrigerate, do not freeze) 8 hours opened stored in the infusion syringe
2022-05-12
NEW ZEALAND DATA SHEET 1. PRODUCT NAME ZOLGENSMA _®_ 2 x 10 13 vector genomes/mL injection for intravenous infusion_ _ 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Onasemnogene abeparvovec is a gene therapy medicinal product that expresses the human survival motor neuron (SMN) protein. It is a non-replicating recombinant adeno-associated virus serotype 9 (AAV9) based vector containing the cDNA of the human SMN gene under the control of the cytomegalovirus enhancer/chicken-β-actin-hybrid promoter. Onasemnogene abeparvovec is produced in human embryonic kidney cells by recombinant DNA technology. Each mL contains onasemnogene abeparvovec with a nominal concentration of 2 × 10 13 vector genomes (vg). Vials will contain an extractable volume of not less than either 5.5 mL or 8.3 mL. The total number of vials and combination of fill volumes in each finished pack will be customised to meet dosing requirements for individual patients depending on their weight (see sections 4.2 Dose and method of administration and 6.5 Nature and contents of container). Excipient with known effect Zolgensma contains 0.2 mmol sodium per mL. For the full list of excipients, see section 6.1 List of excipients. 3. PHARMACEUTICAL FORM Injection for intravenous infusion. When thawed, Zolgensma is a clear to slightly opaque, colorless to faint white solution. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Zolgensma is an adeno-associated virus (AAV) vector-based gene therapy indicated for the treatment of pediatric patients with spinal muscular atrophy (SMA) with a bi-allelic mutation in the survival motor neuron 1 (SMN1) gene. 4.2 DOSE AND METHOD OF ADMINISTRATION Zolgensma should only be infused by a healthcare professional. In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded. An immune response to the adeno-associated viral vector serotype 9 (AAV9) capsid will occur after infusion of Zolgensma, thus patients should not be re-dosed w Leggi il documento completo