Erwinase
Product Images NDC 81561-413

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.

FDA Label Image

Erwinase Vial (Uk Crt Sm)

Packaging label for ERWINASE 10,000 IU powder for solution for injection/infusion, containing Erwinia asparaginase from Erwinia chrysanthemi. The label includes directions to read the package leaflet, storage instructions to keep in refrigerator between 2°C to 8°C, and cautionary notes to keep out of reach of children. The label also states 5 vials per package and identifies Porton Biopharma Limited as the marketing authorization holder located in Salisbury, UK.*

FDA Label Image

Erwinase Carton (Uk Crt)

Packaging label for ERWINASE 10,000 IU powder for solution for injection/infusion, containing Crisantaspase (L-asparaginase from Erwinia chrysanthemi). The label indicates storage instructions, excipients, package size of 5 vials, and mentions intravenous or intramuscular use. The marketing authorization holder is Porton Biopharma Limited.*

FDA Label Image

Uk Smpc Table 1 (Uk T1)

Table listing adverse reactions associated with ERWINASE, organized by system organ class, with corresponding adverse reactions and their frequency categories ranging from very common to rare or unknown. Categories include infections, blood disorders, immune reactions, metabolism, nervous system, vascular, respiratory, gastrointestinal, hepatobiliary, skin, musculoskeletal, renal, general disorders, and investigations.*

FDA Label Image

Uk Smpc Table 2 (Uk T2)

A data table comparing the proportion and 95% confidence intervals of patients with asparaginase activity levels at two thresholds, 0.1 IU/mL and 0.4 IU/mL, at 48-hour and 72-hour trough sampling times. Results are presented separately for Study 1 and Study 2 with respective patient counts and percentages.*

FDA Label Image

Erwinase Vial (Uk Vial)

The label is for ERWINASE 10,000 IU powder for solution for injection/infusion. It contains Crisantaspase (L-asparaginase from Erwinia chrysanthemi) 10,000 IU/vial. The label lists excipients including sodium chloride and glucose monohydrate, and states use is for intravenous or intramuscular administration. Storage instructions specify refrigeration between 2°C and 8°C. The marketing authorization holder is Porton Biopharma Limited, Salisbury, UK. Batch number WO0172 and expiration date 09/2023 are also visible.*

FDA Label Image

Erwinaze Carton (Us Crt)

Packaging label for ERWINASE asparaginase Erwinia chrysanthemi by Porton Biopharma Limited. The label indicates 10,000 International Units per vial for injection, intramuscular, or intravenous use. The package contains 5 vials with single-dose vials and requires refrigeration.*

FDA Label Image

Uspi Table 1 (Us T1)

A data table titled 'Per Patient Incidence of Non-Hematologic and Non-Infectious Adverse Events' reporting adverse events across three studies and the EMTP (IM&IV) cohort. It lists event types such as allergic reactions, liver abnormalities, hyperglycemia, gastrointestinal symptoms, pancreatitis, fever, clinical coagulation abnormalities, mucositis, and diarrhea, with counts and percentages for each group.*

FDA Label Image

Uspi Table 2 (Us T2)

A data table titled 'Incidence of Non-Hematologic, Non-Infectious, Grade 3 and 4 Adverse Reactions' comparing adverse reaction rates across three studies (Study 1 IV, Study 2 IV, EMTP IM&IV) for the product ERWINASE. The table details events such as allergic reactions, hyperglycemia, liver abnormalities, pancreatitis, clinical coagulation abnormalities, and gastrointestinal symptoms, with associated percentages of patients affected.*

FDA Label Image

Uspi Table 3 (Us T3)

A data table titled 'Proportion of Patients with Sustained Asparaginase Activity in Study 1 (IM) and Study 2 (IV).' It presents proportions and 95% confidence intervals of patients with asparaginase activity greater than 0.1 or 0.4 International Units/mL at trough sampling times of 48 and 72 hours, comparing Study 1 intramuscular dosing and Study 2 intravenous dosing.*

FDA Label Image

Erwinaze Vial (Us Vial)

Label for ERWINASE asparaginase injection by Porton Biopharma Limited, showing 10,000 International Units per vial for intramuscular or intravenous use. Includes lot number, expiry date, and Rx only designation, with Jazz Pharmaceuticals branding and an NDC barcode.*

* 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.