Leaflet BLEOMYCINE BELLON 15mg powder for injection


Indicated for: cancer

Route of administration: injectable

Substance: bleomycin sulfate (antineoplastic agent)

ATC: L01DC01 (Antineoplastic and immunomodulating agents | Cytotoxic antibiotics and related substances | Other cytotoxic antibiotics)

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.

Bleomycin sulfate is a medication used in the treatment of certain types of cancer, including Hodgkin's lymphoma, non-Hodgkin's lymphoma, squamous cell carcinoma, and testicular cancer. It belongs to the class of cytotoxic antibiotics and works by damaging the DNA of cancer cells, thereby inhibiting their growth and division.

The medication is usually administered via intravenous, intramuscular, or subcutaneous injection, as directed by a doctor. The dosage and duration of treatment depend on the type of cancer and the patient's overall condition.

Common side effects include fever, chills, nausea, vomiting, and loss of appetite. In rare cases, bleomycin sulfate can cause pulmonary toxicity, manifested as difficulty breathing or persistent cough, which is why patients must be closely monitored.

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

General data about BLEOMYCINE BELLON 15mg

  • Substance: bleomycin sulfate
  • Date of last drug list: 01-03-2023
  • Commercial code: W68219001
  • Concentration: 15mg
  • Pharmaceutical form: powder for injection
  • Quantity: 1
  • Product type: original
  • Prescription restrictions: P-RF - Medicines prescription that is retained in the pharmacy (not renewable).

Marketing authorisation

  • Manufacturer: SANOFI AVENTIS DEUTSCHLAND GMBH - GERMANIA
  • Holder: SANOFI - AVENTIS FRANCE - FRANTA
  • Number: 668/2021/01

Concentrations available for bleomycin sulfate

  • 15000UI
  • 15mg