Zolgensma

Country: New Zealand

Lingwa: Ingliż

Sors: Medsafe (Medicines Safety Authority)

Ingredjent attiv:

Onasemnogene abeparvovec 20TVG/mL (TVG = Tera Vector Genomes; equivalent to 2 x 10^13 vector genomes per mL); Onasemnogene abeparvovec 20TVG/mL (TVG = Tera Vector Genomes; equivalent to 2 x 10^13 vector genomes per mL)

Disponibbli minn:

Novartis New Zealand Ltd

Għamla farmaċewtika:

Solution for infusion

Kompożizzjoni:

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 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

Tip ta 'preskrizzjoni:

Prescription

Indikazzjonijiet terapewtiċi:

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.

Sommarju tal-prodott:

Package - Contents - Shelf Life: Vial, plastic, 1x 5.5 mL vial + 2x 8.3 mL vials - 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, 2x 5.5 mL vials + 1x 8.3 mL vial - 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, 2x 5.5 mL vials + 2x 8.3 mL vials - 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, 1x 5.5 mL vial + 3x 8.3 mL vials - 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, 2x 5.5 mL vials + 3x 8.3 mL vials - 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, 1x 5.5 mL vial + 4x 8.3 mL vials - 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 - 5.5 mL -   - Vial, plastic, 2x 5.5 mL vials + 4x 8.3 mL vials - 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, 1x 5.5 mL vial + 5x 8.3 mL vials - 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, 1x 5.5 mL vial + 6x 8.3 mL vials - 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, 2x 5.5 mL vials + 5x 8.3 mL vials - 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, 1x 5.5 mL vial + 7x 8.3 mL vials - 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, 2x 5.5 mL vials + 6x 8.3 mL vials - 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 - 8.3 mL -   - Vial, plastic, 2x 5.5 mL vials + 7x 8.3 mL vials - 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, 1x 5.5 mL vial + 8x 8.3 mL vials - 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, 2x 5.5 mL vials + 8x 8.3 mL vials - 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, 1x 5.5 mL vial + 9x 8.3 mL vials - 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, 2x 5.5 mL vials + 9x 8.3 mL vials - 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, 1x 5.5 mL vial + 10x 8.3 mL vials - 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, 2x 5.5 mL vials + 10x 8.3 mL vials - 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, 1x 5.5 mL vial + 11x 8.3 mL vials - 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, 2x 5.5 mL vials + 11x 8.3 mL vials - 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, 1x 5.5 mL vial + 12x 8.3 mL vials - 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, 1x 5.5 mL vial + 13x 8.3 mL vials - 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 - Vial, plastic, 2x 5.5 mL vials + 12x 8.3 mL vials - 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

Data ta 'l-awtorizzazzjoni:

2022-05-12