Leaflet BENDAMUSTINA KABI 2.5mg / ml powder for concentrate for solution for infusion

Indicated for: hematologic malignancies

Route of administration: infusion

Substance: bendamustine (alkylating antineoplastic agent)

ATC: L01AA09 (Antineoplastic and immunomodulating agents | Alkylating agents | Nitrogen mustard analogues)

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.

Bendamustine is a medication used for the treatment of certain types of cancer, including non-Hodgkin's lymphoma, chronic lymphocytic leukemia, and multiple myeloma. It is an alkylating chemotherapeutic agent that interferes with the DNA of cancer cells, inhibiting cell division and causing cell death.

The medication is administered via intravenous infusion, usually in treatment cycles, as directed by a doctor. The dosage and duration of treatment are adjusted based on the type of cancer and the patient's response.

Common side effects include nausea, vomiting, fatigue, decreased blood cell counts, and infections. In rare cases, more severe adverse effects such as liver failure or severe allergic reactions may occur.

Bendamustine is not recommended for pregnant or breastfeeding women, as it may affect fetal development. Patients should inform their doctor about all medications they are taking to avoid drug interactions.

General data about BENDAMUSTINA KABI 2.5mg / ml

  • Substance: bendamustine
  • Date of latest medicines list: 01-08-2023
  • Product code: W65002005
  • Concentration: 2.5mg / ml
  • Pharmaceutical form: powder for concentrate for solution for infusion
  • 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: FRESENIUS KABI ONCOLOGY PLC. - MAREA BRITANIE
  • Holder: FRESENIUS KABI ROMANIA S.R.L. - ROMANIA
  • Number: 9853/2017/05
  • Shelf life: 3 years-after packing for marketing;after reconstitution-it is used immediately

Concentrations available for bendamustine

  • 2.5mg/ml
  • 25mg/ml