Leaflet FLURACEDYL 5% 50mg / ml solution for injection

Indicated for: cancer

Route of administration: injectable

Substance: fluorouracil (antimetabolite antineoplastic)

ATC: L01BC02 (Antineoplastic and immunomodulating agents | Antimetabolites | Pyrimidine 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.

Genetic test recommended
Genetic test recommended

A genetic test may be needed before treatment.

Fluorouracil is a chemotherapy drug used to treat various types of cancer, including colorectal cancer, gastric cancer, breast cancer, pancreatic cancer, and esophageal cancer. It belongs to the class of antimetabolites and works by inhibiting the synthesis of DNA and RNA in cancer cells, leading to the cessation of cell division and, ultimately, cell death.

The mechanism of action of fluorouracil involves interference with pyrimidine metabolism, blocking the enzyme thymidylate synthase, which is essential for DNA synthesis. It is administered intravenously or as a topical cream (for dermatological conditions such as actinic keratosis or superficial basal cell carcinoma). In oncology, fluorouracil is often used in combination with other chemotherapy drugs to enhance efficacy.

While effective, fluorouracil can cause side effects. The most common include nausea, vomiting, diarrhea, stomatitis (inflammation of the mouth lining), hair loss, and myelosuppression (reduction in blood cell counts). In rare cases, more severe reactions may occur, such as cardiac toxicity, hand-foot syndrome (redness and pain in the palms and soles), or severe allergic reactions. Careful monitoring is essential to adjust the dose and prevent complications.

Fluorouracil must be administered under the strict supervision of an oncologist, and patients should be regularly monitored to assess their response to treatment and detect potential side effects. It is contraindicated in patients with hypersensitivity to the active substance, severe liver impairment, or severe myelosuppression. During treatment, patients should avoid excessive sun exposure and follow their doctor’s recommendations.

General data about FLURACEDYL 5% 50mg / ml

  • Substance: fluorouracil
  • Date of latest medicines list: 01-07-2013
  • Product code: W58572001
  • Concentration: 50mg / ml
  • Pharmaceutical form: solution for injection
  • 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.

Pharmaceutical forms available for fluorouracil

Concentrations available for fluorouracil

  • 250mg/5ml
  • 50mg/g
  • 50mg/ml