Gemcitabine-Ebeve concentrate for infusion solution 10mg/ml 50ml vial, 1pc

Composition

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1 ml contains:

gemcitabine 10 mg

Pharmacological action

Antitumor agent.

It has a cytostatic effect, which is associated with inhibition of DNA synthesis.

In the cell, it is metabolized to active diphosphate and triphosphate nucleosides.

Diphosphate nucleosides inhibit the action of ribonucleotide reductase, with the participation of which deoxynucleoside triphosphates necessary for DNA synthesis are formed in the cell, which leads to a decrease in their concentration in the cell.

Triphosphate nucleosides actively compete for inclusion in the DNA chain, and can also be included in RNA.

After the intracellular metabolites of gemcitabine are incorporated into 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.

Indications

Non-small cell lung cancer (stages IIIa-IV); advanced pancreatic carcinomas.

Contraindications

Hypersensitivity to gemcitabine.

Side effects

From the hematopoietic system: leukopenia, thrombocytopenia, anemia.

From the digestive system: nausea, vomiting, diarrhea; rarely-constipation.

From the urinary system: proteinuria, hematuria; rarely-peripheral edema; in some cases-renal failure.

Dermatological reactions: skin rash, pruritus, alopecia, stomatitis; rarely-peeling, vesicular rash, eczema.

On the part of laboratory parameters: transient increase in the activity of hepatic transaminases, alkaline phosphatase, an increase in the concentration of bilirubin in plasma.

From the respiratory system: rarely-bronchospasm, shortness of breath.

From the central nervous system and peripheral nervous system: rarely-drowsiness, weakness, paresthesia.

From the cardiovascular system: rarely-hypotension, pulmonary edema; in isolated cases-myocardial infarction, arrhythmias.

Other: flu-like syndrome.

Interaction

The risk and severity of leukopenia and thrombocytopenia increases after previous cytostatic therapy.

How to take, course of use and dosage

Set individually, depending on the indications and stage of the disease, the state of the hematopoietic system, the scheme of antitumor therapy.

Special instructions

It has some activity in the late stages of breast, ovarian, kidney, bladder and prostate cancer, small cell lung cancer.

Use with caution in cases of hematopoietic disorders, liver and/or kidney function disorders. During the treatment period, the peripheral blood picture should be regularly monitored.

If a toxic hematological effect develops, the dosage regimen should be adjusted depending on the degree of leukopenia and thrombocytopenia. The safety and efficacy of gemcitabine in children has not been studied.

Influence on the ability to drive motor vehicles and manage mechanisms

During the treatment period, you should refrain from potentially dangerous activities that require increased attention and speed of psychomotor reactions.

Form of production

Clear solution, colorless or pale yellow in color.

Active ingredient

Gemcitabine

Conditions of release from pharmacies

By prescription

Dosage form

solution for infusions

Description

For adults as directed by your doctor

Indications

Cancer