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

Product code:
W65809003
Quantity:
1
Indicated for:
ovarian cancer; small cell lung cancer
Route of administration:
infusion
Substance:
topotecan (topoisomerase inhibitor)
ATC
L01CE01 — Antineoplastic and immunomodulating agents | Plant alkaloids and other natural products | Topoisomerase 1 (TOP1) inhibitors

Precautions:

Fertility warning

This medicine may affect fertility.

Cytotoxic / special handling

Handle with special care.

Contraception required

Effective contraception is required during treatment.

Contraindicated during breastfeeding

Do not use this medicine while breastfeeding.

Contraindicated during pregnancy

Do not use this medicine during pregnancy.

Hepatotoxicity

This medicine may affect the liver.

Major drug interactions

This medicine may have important interactions with other medicines.

Myelosuppression / agranulocytosis

This medicine may lower blood cell counts.

Additional monitoring

This medicine is subject to additional monitoring.

Requires periodic laboratory tests

Periodic laboratory tests may be required during treatment.

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 ACCORD 1mg / ml

Substance:
topotecan
Date of latest medicines list:
01-06-2026
Product code:
W65809003
Concentration:
1mg / ml
Pharmaceutical form:
concentrate for solution for infusion
Quantity:
1
Product type:
Generic medicine
Price:
340.17 RON
Prescription status:
P-RF — Medicines dispensed with a medical prescription that is retained by the pharmacy and cannot be renewed.

Marketing authorisation

Manufacturer:
ACCORD HEALTHCARE LIMITED - MAREA BRITANIE
Holder:
ACCORD HEALTHCARE POLSKA SP. Z O.O. - POLONIA
Number:
11187/2018/03
Shelf life:
3 years-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

Compensation lists for TOPOTECAN ACCORD 1mg / ml Accord

NHP 3 (C2) - NHP oncology

Price
340.17 RON
Copayment
340.17 RON
Patient
0.00 RON