Erwinase Vial (Uk Crt Sm)
Erwinase
Product Images NDC 81561-413
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Product Visual Gallery
This gallery contains 10 technical images submitted to the FDA as part of the official labeling for Erwinase (NDC 81561-413). Unlike standard consumer photos, these assets often include clinical data figures, molecular chemical structures, and official manufacturer packaging layouts.
As provided by Porton Biopharma Limited, these visuals offer a comprehensive scientific overview of the product's physical and chemical identity, aiding pharmacists and researchers in product verification and study.
Erwinase Carton (Uk Crt)
This text is about a pharmaceutical product called Grisantaspase (L-asparaginase) provided by Porton Biopharma Limited for intravenous or intramuscular use. It needs to be reconstituted before use and the dosage is mentioned as 10,000 IU powder for solution. The text also mentions certain ingredients used in the product such as Sodium Chloride and Glucose Monohydrate and the storage instructions specify that it should be kept refrigerated within the temperature range of +2°C to +6°C. The rest of the text seems to be random characters and not relevant to the information presented.*
Uk Smpc Table 1 (Uk T1)
Uk Smpc Table 2 (Uk T2)
Erwinase Vial (Uk Vial)
Erwinase is a powder for solution of injection/infusion with 10,0001U of Crisantaspase (L-asparaginase from Erwinia chrysanthemi), which is intended for intravenous or intramuscular use. It contains excipients such as sodium chloride and glucose monohydrate while also requires storage in a refrigerator (+2°C to +8°C). Its marketing authorization holder is PL 4440310002, and it is manufactured by Porton Biopharma Limited in Porton Down, Salisbury, SP4 0JG. The product has the batch number W060172 and expires in September 2023.*
Erwinaze Carton (Us Crt)
Uspi Table 1 (Us T1)
Uspi Table 2 (Us T2)
Table 2 shows the incidence of non-hematologic, non-infectious, Grade 3 and 4 adverse reactions in Study 10 and Study 20. The table lists various adverse events along with their occurrence rates. These include liver abnormalities, hypersensitivity, thrombosis, and hemorrhagic disorders. However, the table contains multiple errors and inconsistencies, making it difficult to interpret the data accurately.*
Uspi Table 3 (Us T3)
This is a table showing the proportion of patients with sustained asparaginase activity in two studies. The table displays the percentage of patients with asparaginase activity greater than 0. The first study included both IND and V data, while the second study included international data. The table shows the proportion of patients with sustained activity at different time intervals after the asparaginase dose. The sampling time after the dose ranged from 5 to 72 hours.*
Erwinaze Vial (Us Vial)
The text provides information about the medication called Erwinaze®, which contains asparaginase derived from Erwinia chrysanthemi bacteria. The medication is available in vials containing 10,000 International Units per vial, and the specific vial mentioned has the lot number 205K121.*
* About these descriptions: Image descriptions on this page are generated by automated AI analysis of the product label images from the manufacturer's FDA label submission (SPL). They are provided for reference only and may contain errors or omissions. Always rely on the printed label itself and the official FDA labeling, and consult a pharmacist or healthcare professional with any questions about this product.
