Leaflet EPISINDAN 10mg powder for injection


Indicated for: cancer

Route of administration: injectable

Substance: epirubicin (antineoplastic agent)

ATC: L01DB03 (Antineoplastic and immunomodulating agents | Cytotoxic antibiotics and related substances | Anthracyclines and related substances)

Precautions:
Fertility warning
Fertility warning

This medicine may affect fertility.

Dose adjustment in hepatic impairment
Dose adjustment in hepatic impairment

Dose adjustment may be needed in liver disease.

Cytotoxic / special handling
Cytotoxic / special handling

Handle with special care.

Contraception required
Contraception required

Effective contraception is required during treatment.

Contraindicated during breastfeeding
Contraindicated during breastfeeding

Do not use this medicine while breastfeeding.

Contraindicated during pregnancy
Contraindicated during pregnancy

Do not use this medicine during pregnancy.

Hepatotoxicity
Hepatotoxicity

This medicine may affect the liver.

Major drug interactions
Major drug interactions

This medicine may have important interactions with other medicines.

Myelosuppression / agranulocytosis
Myelosuppression / agranulocytosis

This medicine may lower blood cell counts.

Additional monitoring
Additional monitoring

This medicine is subject to additional monitoring.

Requires periodic laboratory tests
Requires periodic laboratory tests

Periodic laboratory tests may be required during treatment.

Severe skin reactions
Severe skin reactions

Stop taking the medicine and seek urgent medical help if a severe rash occurs.

Epirubicin is a cytostatic medication used in the treatment of various types of cancer, such as breast cancer, bladder cancer, or sarcoma. It works by destroying cancer cells and stopping their multiplication. Administration is usually by intravenous infusion, under the strict supervision of a medical oncology team.

Treatment with epirubicin requires close monitoring, as it can affect healthy cells as well as cancer cells. It is important for patients to follow the treatment schedule and have regular tests to assess heart and blood function.

Side effects may include nausea, vomiting, hair loss, fatigue, decreased blood cell counts, or impaired heart function. In rare cases, severe allergic reactions or inflammation at the injection site may occur.

Epirubicin is an important medication in cancer treatment, but it requires constant medical supervision to manage side effects and ensure the effectiveness of therapy. Open communication with the doctor is essential throughout the treatment.

General data about EPISINDAN 10mg

  • Substance: epirubicin
  • Date of last drug list: 01-04-2025
  • Commercial code: W52209001
  • Concentration: 10mg
  • Pharmaceutical form: powder for injection
  • Quantity: 1
  • Product type: generic
  • Prescription restrictions: S - Medicines prescription reserved for use in certain specialized fields.

Marketing authorisation

  • Manufacturer: SINDAN-PHARMA S.R.L. - ROMANIA
  • Holder: TEVA B.V. - OLANDA
  • Number: 10048/2017/01
  • Shelf life: 4 years-after packing for marketing;after reconstitution-it is used immediately

Concentrations available for epirubicin

  • 10mg
  • 10mg/5ml
  • 2mg/ml
  • 50mg
  • 50mg/25ml