Gemcitabine Ebeve concentrate for solution for infusion 2000 mg bottle 50 ml No. 1

Gemcitabine Ebewe powder for solution for infusion is indicated for:

Composition

Active ingredient: gemcitabine;

1 ml of concentrate for solution for infusion contains 40 mg of gemcitabine (as gemcitabine hydrochloride);

Excipients: diluted hydrochloric acid, water for injections.

Contraindication

Method of application

Gemcitabine therapy is prescribed exclusively by an oncologist who is sufficiently qualified to perform anticancer chemotherapy.

The drug should be diluted before use. It is recommended to choose large vessels for drug administration to prevent vascular damage and extravasation.

The required amount of solution should be placed in an infusion bag or bottle, observing the requirements of sterility. The drug should be used in the obtained concentration or after further dilution with 0.9% sodium chloride solution or 5% glucose solution. The solution should be mixed thoroughly by gently shaking the bag or bottle.

Gemcitabine Ebewe is well tolerated during infusion and can be administered on an outpatient basis. In the event of a hematoma, the infusion should be stopped immediately and continued into another vessel. The patient should be closely monitored after the infusion.

Application features

Pregnant women

Gemcitabine should not be used during pregnancy unless clearly necessary.

Children

Not recommended for use.

Drivers

Patients should be warned not to drive or operate machinery until it is determined that they are free of signs of drowsiness.

Overdose

There is no known antidote for gemcitabine overdose.

Clinically acceptable toxicity was observed when doses up to 5700 mg/m2 were administered.

30-minute infusion every 2 weeks.

In case of suspected overdose, it is necessary to monitor the patient's condition, conduct appropriate blood tests, and, if necessary, prescribe symptomatic therapy.

Side effects

General effects and local reactions: Flu-like symptoms (most commonly fever, headache, chills, myalgia, asthenia and anorexia; cough, rhinitis, malaise, increased sweating, sleep disturbances have also been reported) edema/peripheral edema, including facial edema (in most cases, edema regresses after discontinuation of treatment).

Interaction

Yellow fever vaccines and other live attenuated vaccines are not recommended during treatment with gemcitabine due to the risk of developing systemic, potentially fatal disease, especially in immunocompromised patients.

Storage conditions

Store at 2° - 8°C. Do not freeze.

Keep out of reach of children.

Shelf life - 2 years.