Leaflet FLUDARABINA TEVA 25mg / ml powder for injection / infusion solution


Indicated for: cancer

Route of administration: injectable / infusion

Substance: fludarabine (antimetabolite antineoplastic)

ATC: L01BB05 (Antineoplastic and immunomodulating agents | Antimetabolites | Purine 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.


Fludarabine is a medication used to treat certain types of blood cancer, especially chronic lymphocytic leukemia. This medicine works by inhibiting the growth and multiplication of cancer cells, helping to control the disease and prolong patient survival. Fludarabine is often used when other treatments have not been successful or are not suitable for the patient.

Fludarabine is usually administered by intravenous infusion under the strict supervision of medical staff. The dose and duration of treatment are determined by the doctor based on the patient's general condition, type, and stage of the disease. It is essential to follow the treatment as directed to achieve the best results.

Side effects of fludarabine may include a decrease in blood cell counts, which increases the risk of infections, bleeding, or severe fatigue. Other reactions may include nausea, vomiting, diarrhea, or skin rashes. In rare cases, severe reactions such as nervous system damage or serious allergic reactions may occur.

Fludarabine is a powerful medication, and its administration requires careful monitoring and regular tests. Inform your doctor about any unusual symptoms or other medications you are taking. Following medical recommendations is essential for the safety and effectiveness of the treatment.

General data about FLUDARABINA TEVA 25mg / ml

  • Substance: fludarabine
  • Date of last drug list: 01-06-2026
  • Commercial code: W64515001
  • Concentration: 25mg / ml
  • Pharmaceutical form: powder for injection / infusion solution
  • Quantity: 1
  • Product type: generic
  • Price: 179.92 RON
  • Prescription restrictions: P-RF - Medicines prescription that is retained in the pharmacy (not renewable).

Marketing authorisation

  • Manufacturer: SINDAN PHARMA S.R.L. - ROMANIA
  • Holder: TEVA B.V. - OLANDA
  • Number: 11989/2019/01
  • Shelf life: 4 years

Concentrations available for fludarabine

  • 10mg
  • 25mg/ml
  • 50mg

Compensation lists for FLUDARABINA TEVA 25mg / ml Teva

NHP 3 (C2) - NHP oncology

Price

Copayment

Patient

179.92 RON

179.92 RON

0.00 RON

NHP 9.1 (C2) - Spinal cord transplant

Price

Copayment

Patient

179.92 RON

179.92 RON

0.00 RON