Leaflet IDARUBICINA ACCORD 20mg / 20ml solution for injection

Product code:
W66329001
Quantity:
1
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 IDARUBICINA ACCORD 20mg / 20ml

Substance:
idarubicin
Date of latest medicines list:
01-12-2019
Product code:
W66329001
Concentration:
20mg / 20ml
Pharmaceutical form:
solution for injection
Quantity:
1
Product type:
Generic medicine
Prescription status:
P-RF — Medicines dispensed with a medical prescription that is retained by the pharmacy and cannot be renewed.

Marketing authorisation

Manufacturer:
ACCORD HEALTHCARE LIMITED - MAREA BRITANIE
Holder:
ACCORD HEALTHCARE POLSKA SP. Z O.O. - POLONIA
Number:
9746/2017/01
Shelf life:
2 years;after the first opening-it is used immediately

Pharmaceutical forms available for idarubicin

Concentrations available for idarubicin

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