Leaflet COSMEGEN LYOVAC 500mcg powder for solution for injection

Indicated for: cancer

Route of administration: injectable

Substance: dactynomicin (antineoplastic agent)

ATC: L01DA01 (Antineoplastic and immunomodulating agents | Cytotoxic antibiotics and related substances | Actinomycines)

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.

Dactinomycin is a chemotherapy medication used for the treatment of certain types of cancer, such as Wilms tumors, rhabdomyosarcoma, and choriocarcinoma. It works by inhibiting RNA synthesis, leading to the cessation of cell division and the destruction of cancer cells.

The medication is administered via intravenous infusion, with the dose determined by the physician based on the type of cancer and the patient's weight. Common side effects include nausea, vomiting, bone marrow suppression, and stomatitis.

Dactinomycin is contraindicated in patients with hypersensitivity to the active substance or any of its excipients. It should also be used with caution in patients with hepatic or renal impairment.

This medication is an important option in cancer treatment, helping to reduce tumor size and improve the prognosis of affected patients.

General data about COSMEGEN LYOVAC 500mcg

  • Substance: dactynomicin
  • Date of latest medicines list: 01-06-2026
  • Product code: W69339001
  • Concentration: 500mcg
  • Pharmaceutical form: powder for solution for injection
  • Quantity: 1
  • Product type: Generic medicine
  • Price: 370.46 RON
  • Prescription status: P-RF - Medicines dispensed with a medical prescription that is retained by the pharmacy and cannot be renewed.

Marketing authorisation

  • Manufacturer: RECORDATI RARE DISEASES - FRANTA
  • Holder: CN UNIFARM S.A. - ROMANIA
  • Number: 770/2022/01
  • Shelf life: 36 months

Pharmaceutical forms available for dactynomicin

Concentrations available for dactynomicin

  • 0.5mg
  • 500mcg

Compensation lists for COSMEGEN LYOVAC 500mcg Unifarm

NHP 3 (C2) - NHP oncology

Price

Copayment

Patient

370.46 RON

370.46 RON

0.00 RON