Expiration date: 04/2026

Composition and form of issue:

1 ml of the solution for intravascular and intracavitary administration contains fluorouracil 50 mg in vials of 5, 10, 20 and 100 ml, in a box of 1 vial, and in ampoules of 5 ml, in a box of 5 ampoules.

Pharmacological action:

In cancer cells is converted into 5-fluoro?2-deoxyuridine?5'-monophosphate, which is a competitive inhibitor of timeidentity, which leads to stoppage of DNA synthesis, RNA and suppression of cell division.

Indications:

Cancer of the esophagus, stomach, pancreas, liver (hepatocellular), ovary, cervix, breast, bladder and prostate carcinoma anal, colorectal metastases to the liver malignant tumors of the head and neck (mono - and combination therapy).

Contraindications:

Hypersensitivity marked changes in blood composition, inhibition of bone marrow hematopoiesis, hemorrhage significant violations of liver and kidney function severe infections, including viral (shingles, chickenpox) stomatitis, ulceration of the oral cavity and gastrointestinal tract, pseudomembranous enteritis, pregnancy, breast-feeding.

Use during pregnancy and breast-feeding:

Contraindicated. At the time of treatment should stop breastfeeding.

Side effect:

Myelosuppression anorexia, stomatitis, sore throat, pharyngitis, esophagitis, enteritis, and ulceration of the mucous membrane of the gastrointestinal tract (including oral cavity), bleeding, dyspeptic symptoms heart pain, ischemia, myocardial infarction, confusion, drowsiness, ataxia, euphoria, blurred vision and other CNS disorders kidney and liver failure, dermatitis, dry skin, furunculosis and other violations of regeneration of the skin, nails, hair, allergic reactions (up to anaphylactic shock).

Dosage and administration:

In/, in / a, intracavitary (as a concentrate or after dilution in 0, 9% sodium chloride solution or 5% glucose solution). With daily administration (1 time per day) by/in infusion — 600 mg/m2 of body surface before side effects or by/in injection — first , the first 3 days of 480 mg/m2, then — 240 mg/m2 with weekly administration (1 time per week) — in the initial dose of 200 mg/m2 (24-hour infusion) or 600 mg/m2 (infusion), in a maintenance dose — 200-400 mg/m2 once a week. The maximum daily dose-no more than 1 g. The course of therapy is determined by a specialist (depending on the type of disease and course). The dose is adjusted in patients with myelosuppression, cachexia, after surgery, in combination with radiation therapy and other cytostatics.

Precautionary measures:

In the event of side effects from the gastrointestinal tract, blood, Central nervous system and heart treatment should be discontinued immediately. Use with caution in patients with severe bone metastasis.