Leaflet ONKOTRONE 2mg / ml concentrate for solution for injection

Product code:
W70296002
Quantity:
1
Indicated for:
cancer
Route of administration:
injectable
Substance:
mitoxantrone (antineoplastic agent)
ATC
L01DB07 — 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.

Mitoxantrone is an antineoplastic agent used for the treatment of acute myeloid leukemia, non-Hodgkin's lymphomas, and advanced prostate cancer. It works by intercalating into DNA and inhibiting its synthesis, leading to tumor cell death.

The medication is administered via intravenous infusion, usually in treatment cycles, with the dose adjusted based on the patient's weight and response to therapy. Common side effects include nausea, vomiting, myelosuppression, and alopecia.

Mitoxantrone is contraindicated in patients with severe hepatic impairment or hypersensitivity to the active substance. Its use also requires careful monitoring of cardiac function and blood counts.

This medication is an effective option for the treatment of hematological cancers and other tumor types, helping to improve patient outcomes.

General data about ONKOTRONE 2mg / ml

Substance:
mitoxantrone
Date of latest medicines list:
01-06-2026
Product code:
W70296002
Concentration:
2mg / ml
Pharmaceutical form:
concentrate for solution for injection
Quantity:
1
Product type:
Generic medicine
Price:
645.59 RON
Prescription status:
P-RF — Medicines dispensed with a medical prescription that is retained by the pharmacy and cannot be renewed.

Marketing authorisation

Manufacturer:
BAXTER ONCOLOGY GMBH - GERMANIA
Holder:
BAXTER HEALTHCARE S.R.L. - ROMANIA
Number:
8636/2016/02
Shelf life:
3 years

Pharmaceutical forms available for mitoxantrone

Concentrations available for mitoxantrone

  • 20mg/10ml
  • 2mg/ml

Compensation lists for ONKOTRONE 2mg / ml Baxter

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