Leaflet MELPHALAN RATIOPHARM 50mg powder and solvent for solution for injection / infusion

Indicated for: cancer

Route of administration: injectable / infusion

Substance: melphalan (alkylating antineoplastic agent)

ATC: L01AA03 (Antineoplastic and immunomodulating agents | Alkylating agents | Nitrogen mustard 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.

Melphalan is a chemotherapy agent primarily used to treat certain types of cancer, such as multiple myeloma and ovarian cancer. It works by interfering with the DNA of cancer cells, preventing them from dividing and spreading.

Melphalan is administered either orally or intravenously, depending on the type and stage of cancer being treated. The treatment may be associated with side effects such as nausea, vomiting, decreased blood cell counts, and an increased risk of infections.

Patients undergoing melphalan treatment must be closely monitored by their doctor to assess effectiveness and manage any adverse reactions. It is important to strictly follow the prescribed doses.

This medication is used only under strict medical supervision and is not recommended for pregnant or breastfeeding women due to risks to the fetus or child.

General data about MELPHALAN RATIOPHARM 50mg

  • Substance: melphalan
  • Date of latest medicines list: 01-07-2021
  • Product code: W65219001
  • Concentration: 50mg
  • Pharmaceutical form: powder and solvent for solution for injection / infusion
  • Quantity: 1
  • Product type: Original
  • Prescription status: P-RF - Medicines dispensed with a medical prescription that is retained by the pharmacy and cannot be renewed.

Marketing authorisation

  • Manufacturer: SINDAN PHARMA S.R.L. - ROMANIA
  • Holder: CN UNIFARM S.A. - ROMANIA
  • Number: 463/2019/01
  • Shelf life: 2 years

Concentrations available for melphalan

  • 200mg
  • 2mg
  • 50mg