Leaflet ZAVEDOS 5mg lyophilized powder for injection

Indicated for: leukemia

Route of administration: injectable

Substance: idarubicin (antineoplastic agent)

ATC: L01DB06 (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.

Idarubicin is a chemotherapy drug used for the treatment of acute leukemia, including acute myeloid leukemia (AML). It belongs to the anthracycline class and works by inhibiting DNA synthesis in cancer cells, thereby preventing cell division.

The medication is administered intravenously, as directed by a doctor. It is important to monitor the patient for adverse effects during treatment.

Side effects may include nausea, vomiting, hair loss, bone marrow suppression, or cardiac toxicity. In rare cases, severe allergic reactions may occur.

Idarubicin is not recommended for patients with severe cardiac insufficiency, severe bone marrow suppression, or hypersensitivity to anthracyclines.

General data about ZAVEDOS 5mg

  • Substance: idarubicin
  • Date of latest medicines list: 01-07-2013
  • Product code: W08697001
  • Concentration: 5mg
  • Pharmaceutical form: lyophilized powder for injection
  • Quantity: 1
  • Product type: Original
  • Prescription status: S - Medicines dispensed with a restricted medical prescription, reserved for use in certain specialized fields.

Pharmaceutical forms available for idarubicin

Concentrations available for idarubicin

  • 10mg
  • 10mg/10ml
  • 20mg/20ml
  • 5mg
  • 5mg/5ml