Product Images Erwinase

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Product Label Images

The following 10 images provide visual information about the product associated with Erwinase NDC 81561-413 by Porton Biopharma Limited, such as packaging, labeling, and the appearance of the drug itself. This resource could be helpful for medical professionals, pharmacists, and patients seeking to verify medication information and ensure they have the correct product.

Erwinase Vial - uk crt sm

Erwinase Vial - uk crt sm

Erwinase Carton - uk crt

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 1 - uk t1

UK SmPC Table 2 - uk t2

UK SmPC Table 2 - uk t2

Erwinase Vial - uk vial

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

Erwinaze Carton - us crt

USPI Table 1 - us t1

USPI Table 1 - us t1

USPI Table 2 - us t2

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

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

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.*

* The product label images have been analyzed using a combination of traditional computing and machine learning techniques. It should be noted that the descriptions provided may not be entirely accurate as they are experimental in nature. Use the information in this page at your own discretion and risk.