Leaflet ERWINASE 10000 U / vial powder for solution for injection / infusion

Indicated for: leukemia

Route of administration: injectable / infusion

Substance: asparaginase (recombinant enzyme replacement)

ATC: L01XX02 (Antineoplastic and immunomodulating agents | Other antineoplastic agents)

Precautions:
Anaphylaxis
Anaphylaxis

Risk of severe allergic reaction. Seek urgent medical help if serious symptoms occur.

Additional monitoring
Additional monitoring

This medicine is subject to additional monitoring.

Asparaginase is a medication used in the treatment of acute lymphoblastic leukemia (ALL), particularly in children but also in adults. It is an enzyme that breaks down asparagine, an amino acid essential for the growth and survival of cancer cells. Since cancer cells cannot produce asparagine, the lack of this amino acid causes their death, while normal cells are less affected.

Asparaginase is usually administered via intramuscular or intravenous injection as part of a combination chemotherapy regimen. The dosage and frequency of administration are determined by the doctor based on the patient's age, weight, and overall condition.

Common side effects include allergic reactions (such as rashes, itching, or difficulty breathing), nausea, vomiting, fatigue, increased blood sugar levels, and impaired liver or pancreatic function. In rare cases, it may cause severe reactions, such as blood clotting issues or pancreatitis.

Asparaginase is a critical medication in the treatment of acute lymphoblastic leukemia, but its use requires close monitoring by the medical team to manage potential side effects and ensure the effectiveness of the therapy.

General data about ERWINASE 10000 U / vial

  • Substance: asparaginase
  • Date of latest medicines list: 01-12-2021
  • Product code: W64915001
  • Concentration: 10000 U / vial
  • Pharmaceutical form: powder for solution for injection / infusion
  • Quantity: 5
  • Product type: Original
  • Prescription status: P-RF - Medicines dispensed with a medical prescription that is retained by the pharmacy and cannot be renewed.

Marketing authorisation

  • Manufacturer: PORTON BIOPHARMA LIMITED - MAREA BRITANIE
  • Holder: DIRECT PHARMA LOGISTICS S.R.L. - ROMANIA
  • Number: 497/2020/01
  • Shelf life: 3 years

Concentrations available for asparaginase

  • 10.000E
  • 10000 U/vial
  • 10000E./vial
  • 10000UI
  • 3750UI
  • 5000ui