Leaflet TOPOTECAN EBEWE 1mg / ml concentrate for solution for infusion

Indicated for: ovarian cancer; small cell lung cancer

Route of administration: infusion

Substance: topotecan (topoisomerase inhibitor)

ATC: L01XX17 (Antineoplastic and immunomodulating agents | Other antineoplastic agents)

Precautions:
Fertility warning
Fertility warning

This medicine may affect fertility.

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.

Topotecan is an antineoplastic agent from the class of topoisomerase I inhibitors, used in the treatment of recurrent ovarian cancer, small cell lung cancer, and other types of cancer. It works by inhibiting the enzyme topoisomerase I, which is essential for DNA replication, thereby causing tumor cell death.

Topotecan is administered intravenously or orally, usually in treatment cycles, with the dose adjusted based on the patient's body weight and tolerability. It is often used in combination with other chemotherapeutic agents to enhance treatment efficacy.

Common side effects include neutropenia, anemia, nausea, vomiting, diarrhea, and fatigue. In rare cases, severe adverse reactions such as serious infections or pulmonary toxicity may occur. Careful monitoring of hematological parameters and the patient's overall condition is essential during treatment.

Topotecan is an important therapeutic option for patients with advanced cancer, contributing to disease control and prolonged survival.

General data about TOPOTECAN EBEWE 1mg / ml

  • Substance: topotecan
  • Date of latest medicines list: 01-06-2018
  • Product code: W56261007
  • Concentration: 1mg / ml
  • Pharmaceutical form: 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: EBEWE PHARMA GES.M.B.H. NFG. KG - AUSTRIA
  • Holder: EBEWE PHARMA GES.M.B.H. NFG. KG - AUSTRIA
  • Number: 9779/2017/07
  • Shelf life: 30 months-after packing for marketing;dupa dilutie-it is used immediately

Concentrations available for topotecan

  • 0.25mg
  • 1mg
  • 1mg/1ml
  • 1mg/ml
  • 4mg
  • 4mg/4ml
  • 500mg