Gemcitabine-Ebeve 10mg / ml concentrate for infusions 50ml No. 1 bottle


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Gemcitabine-Ebeve 10mg / ml concentrate for infusions 50ml No. 1 bottle

pharmachologic effect

Antitumor agent. It has a cytostatic effect, which is associated with inhibition of DNA synthesis. In the cell, it is metabolized to the active diphosphate and triphosphate nucleosides. Diphosphate nucleosides inhibit the action of ribonucleotide reductase, with the participation of which the cell produces deoxynucleoside triphosphates necessary for DNA synthesis, which leads to a decrease in their concentration in the cell. Triphosphate nucleosides actively compete for incorporation into the DNA chain, and can also be incorporated into RNA. After embedding intracellular metabolites of gemcitabine in the DNA chain, one additional nucleotide is added to its growing chains, which leads to complete inhibition of further DNA synthesis and programmed cell death.


With the intravenous infusion of gemcitabine in doses of 500–2592 mg / m2 for 0.4–1.2 h, Cmax in plasma was 3.2–45.5 mcg / ml and was determined for 5 min at the end of the infusion. Vd in the central part is 12.4 l / m2 for women and 17.5 l / m2 for men (individual differences - 91.9%). Vd in the peripheral part is 47.4 l / m2 and does not depend on the floor. Binding to proteins is practically absent.
System clearance varies from 29.2 l / h / m2 to 92.2 l / h / m2. In women, clearance is approximately 25% lower than in men. Less than 10% is excreted in the urine unchanged. Renal clearance is 2-7 l / h / m2. T1 / 2 depends on age and gender and is 42-94 minutes. When administered once a week, gemcitabine does not accumulate.
Gemcitabine is rapidly metabolized with the participation of cytidine deaminase in the liver, kidneys, blood and other tissues. During the intracellular metabolism of the active substance, mono-, di-, and triphosphates of gemcitabine are formed, which have pharmacological activity. These metabolites are not detected either in plasma or in the urine.
The main metabolite of 2-deoxy-2,2-difluorouridin does not possess pharmacological activity and is determined in plasma and in urine.


They establish individually, depending on the evidence and the stage of the disease, the state of the hematopoietic system, the scheme of antitumor therapy.

Drug interaction

The risk of development and the severity of leukopenia and thrombocytopenia increases after previous treatment with cytostatics.

Pregnancy and lactation

The safety of gemcitabine during pregnancy in humans has not been studied.
Experimental studies have shown that gemcitabine exerts an embryo and fetotoxic effect, negatively influences the course of pregnancy and postnatal development.
The use of gemcitabine during pregnancy should be avoided. Women of childbearing age during treatment should use reliable methods of contraception.
If necessary, use during lactation should decide on the termination of breastfeeding.

Side effects

From the hemopoietic system: leukopenia, thrombocytopenia, anemia.
On the part of the digestive system: nausea, vomiting, diarrhea; rarely - constipation.
From the urinary system: proteinuria, hematuria; rarely, peripheral edema; in rare cases - renal failure.
Dermatological reactions: skin rash, itching, alopecia, stomatitis; rarely - peeling, vesicular rash, eczema.
From the laboratory indicators: transient increase in liver transaminases, alkaline phosphatase, an increase in plasma bilirubin concentration.
On the part of the respiratory system: rarely - bronchospasm, shortness of breath.
From the side of the central nervous system and peripheral nervous system: rarely - drowsiness, weakness, paresthesias.
Since the cardiovascular system: rarely - arterial hypotension, pulmonary edema; in isolated cases - myocardial infarction, arrhythmias.
Other: flu-like syndrome.


Non-small cell lung cancer (stage IIIa-IV); late pancreatic carcinomas.


Hypersensitivity to gemcitabine.

special instructions

It has some activity in the advanced stages of breast, ovarian, kidney, bladder and prostate cancer, small cell lung cancer.
With caution used for violations of the blood; dysfunction of the liver and / or kidneys. During the period of treatment should regularly monitor the pattern of peripheral blood. With the development of toxic hematological effect, correction of the dosage regimen is required depending on the degree of leukopenia and thrombocytopenia.
The safety and efficacy of gemcitabine in children has not been studied.

Influence on ability to drive motor transport and control mechanisms

During treatment, one should refrain from potentially dangerous activities that require increased attention and quickness of psychomotor reactions.

When kidney damage

With caution used for violations of the kidneys, while conducting periodic monitoring of their functional state.

With abnormal liver function

With caution used for violations of the liver, while conducting periodic monitoring of its functional state.

Use in childhood

The safety and efficacy of gemcitabine in children has not been studied.

It is a pharmaceutical drug. Use only as directed by your doctor.