5-Ftorulacyl concentrate for infusions 50 mg/ml. 10 ml.

Description

5-Ftorulacyl INSTRUCTION

for medical use of the drug

5-FLUORURACIL “EBEVE”

(5-Fluorouracil “Ebewe”)

5-Ftorulacyl Storage:

active substance: fluorouracil;

1 ampoule or vial contains 250 mg, 500 mg or 1000 mg of uracil fluorine;

Excipients: sodium hydroxide, water for injections.

Dosage form. Concentrate for solution for infusion.

Pharmacotherapeutic group. Antineoplastic agents. Antimetabolites. Structural analogues of pyrimidine. ATC code L01B C02.

Clinical characteristics.

5-Ftorulacyl Indication.

Treatment of breast cancer and rectal cancer (in the form of monotherapy or in combination with other antineoplastic agents).

Treatment of gastric cancer, head and neck cancer and pancreatic cancer.

Contraindication.

· Hypersensitivity to uracil fluoride.

· Suppression of bone marrow function, especially after radiation therapy or treatment with other anticancer drugs.

· Significant deviations in the number of formed elements in the blood.

· Bleeding.

· Stomatitis, ulcers of the oral mucosa and gastrointestinal tract.

· Severe diarrhea.

· Severe hepatic and / or renal impairment.

· Severe infectious diseases.

· Severe exhaustion.

· Plasma bilirubin level> 85 μmol / l.

· Active vaccination should be avoided during treatment with fluoride uracil.

5-Ftorulacyl Method of application and dosage.

Doses and treatment regimens are determined individually depending on the patient’s condition and type of cancer, as well as depending on whether 5-fluoro uracil “Ebeve” is used as monotherapy or in combination with other treatments.

It is necessary to start treatment with 5-fluorine uracil “Ebeve” in a hospital. The total daily dose for adults should not exceed 1 g

Usually adults dose is determined per 1 kg of real mass of the patient, but patients with significant overweight, edema, ascites and other forms of abnormal fluid retention in the body dose is determined per 1 kg of ideal body weight.

Ebeve 5-fluoro uracil is administered by intravenous injection, intravenous infusion or intra-arterial infusion.

The following are indicative dose recommendations.

Treatment for rectal cancer

During the initial course of therapy, the drug can be administered by infusion or injection. Infusions are better because with this method of administration there are fewer toxic effects.

Intravenous infusions. The daily dose of 15 mg / kg body weight (600 mg / m2 body surface area), but not more than 1 g / infusion, is diluted with 300-500 ml of 5% glucose solution or 0.9% sodium chloride solution. The solution for infusion is administered intravenously over 4 hours. In the following days, the drug is administered in the same dose until toxic effects appear or the total dose reaches 12-15 g. Some patients were administered up to 30 g of uracil fluoride 1 g per day (maximum daily dose). In the event of undesirable side effects from the hematopoietic system or gastrointestinal tract, the next administration of the drug is postponed until the restoration of hematological parameters and the disappearance of toxic effects. Alternatively, Ebeve 5-fluoro uracil can be administered by continuous 24-hour intravenous infusion.

Intravenous injections. 12 mg / kg body weight (480 mg / m2 body surface area) is administered by intravenous injection daily for 3 days. In the absence of signs of toxic effects, you can continue to administer the drug at a dose of 6 mg / kg body weight (240 mg / m2 body surface) on the fifth, seventh and ninth days of the course.

For maintenance therapy, the drug is administered at a dose of 5-10 mg / kg body weight (200-400 mg / m2 body surface) once a week.

In the event of unwanted side effects, the next administration of the drug is postponed until the toxic effects disappear!

Breast cancer treatment

For the treatment of breast cancer, 5-fluoro uracil “Ebeve” is used in combination with other chemotherapeutics, such as methotrexate and cyclophosphamide or doxorubicin and cyclophosphamide.

In such treatment regimens 5-fluoro uracil “Ebeve” is administered intravenously 10-15 mg / kg body weight (400-600 mg / m2 body surface) in the first and eighth days of the course lasting 28 days.

Ebeve 5-fluoro uracil can also be administered by continuous 24-hour intravenous infusion, with the usual dose being 8.25 mg / kg body weight (350 mg / m2 body surface area).

Other methods of administration

Intra-arterial infusions. The daily dose of 5-7.5 mg / kg body weight (200-300 mg / m2 body surface) is administered by continuous 24-hour intra-arterial infusion. In some cases, regional intra-arterial infusions may be used to treat primary tumors or metastases.

Special patient populations

Dose reduction is recommended in case of cachexia, major surgery in the previous 30 days, decreased bone marrow function, as well as in the presence of liver or kidney dysfunction.

There is no need to adjust the dose in the treatment of elderly patients.

Staff instructions

The solution should be collected from the vial / ampoule immediately before use.

If a precipitate formed as a result of cooling in the preparation, it is dissolved by heating to 60 ° C and intense