nbsp; 8 71894-137-08
11.6–12.0 0 8 8 71894-138-08
12.1–12.5 2 7 9 71894-139-09
12.6–13.0 1 8 9 71894-140-09
13.1–13.5 0 9 9 71894-141-09
小瓶标称浓度为2.0×1013 vg/mL，可萃取体积不少于5.5mL。
bVial标称浓度为2.0×1013vg/mL，可萃取体积不少于8.3mL。
储存和处理
产品以透明小瓶冷冻(≤-60°C[-76°F]) 运输和交付。
收到后，立即将套件放入 2°C至8°C（36°F 至 46°F）的冰箱中。
ZOLGENSMA在2°C至8°C（36°F至46°F）下储存时，自收到之日起14天内保持稳定。
不要重新冷冻。
必须在收到后14天内使用。
请参阅随附的ZOLGENSMA完整处方信息：
https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=68cd4f06-70e1-40d8-bedb-609ec0afa471
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US Food and Drug Administration(FDA)has approved Zolgensma(onasemnogene abeparvovec-xioi)for the treatment of pediatric patients less than 2years of age with spinal muscular atrophy(SMA)with bi-allelic mutations in the survival motor neuron 1(SMN1)gene.
Zolgensma is designed to address the genetic root cause of SMA by providing a functional copy of the human SMN gene to halt disease progression through sustained SMN protein expression with a single, one-time intravenous(IV)infusion.
Zolgensma is the first and only gene therapy approved by the FDA for the treatment of SMA, including those who are pre-symptomatic at diagnosis.
PRINCIPAL DISPLAY PANEL
NDC 71894-115-01
8.3mL Vial Label
onasemnogene abeparvovec-xioi
ZOLGENSMA
Rx ONLY
Suspension for intravenous infusion.
See enclosed prescribing information
for dosage and directions for use.
Manufactured by Novartis Gene Therapies, Inc.
Bannockburn, IL 60015. US License No: 2250
NOVARTIS
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PRINCIPAL DISPLAY PANEL
NDC 71894-110-01
5.5mL Vial Label
onasemnogene abeparvovec-xioi
ZOLGENSMA
Rx ONLY
Suspension for intravenous infusion.
See enclosed prescribing information
for dosage and directions for use.
Manufactured by Novartis Gene Therapies, Inc.
Bannockburn, IL 60015. US License No: 2250
NOVARTIS |
