Buy Gemcitabin-Ebeve solution concentrate 10 mg/ml 20 ml bottle 1 pc.
  • Buy Gemcitabin-Ebeve solution concentrate 10 mg/ml 20 ml bottle 1 pc.

Gemcitabine

Ebeve Pharma
1881 Items
2019-09-19
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Clinical Pharmacology

Antineoplastic 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 are formed in the cell, which are necessary for DNA synthesis, which leads to a decrease in their concentration in the cell.
Triphosphate nucleosides actively compete for incorporation into the DNA strand, and can also be incorporated into RNA.
After the incorporation of intracellular metabolites of gemcitabine into the DNA chain, one additional nucleotide is added to its growing chains, which leads to a complete inhibition of further DNA synthesis and programmed cell death.

Gemcitabine is marketed under different brands and generic names, and comes in different dosage forms:

Brand nameManufacturerCountryDosage form
Gemcitabin-Ebeve Ebeve Pharma Austria solution concentrate
gemcytar Biocad Russia Other
Gemita® Fresenius Kabi Germany bottle
Gemcitover Lance farm Russia bottle
Gemzar Eli lilly USA bottle

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Gemcitabine

IV drip (for 30 min).
Bladder cancer - 1.25 g / m2 at 1, 8, and 15 days every 28 days with monotherapy or 1 g / m2 at 1, 8, and 15 days in combination with cisplatin, which is administered immediately after administration of gemcitabine at a dose of 70 mg / sq.m in 1 or 2 day of each 28-day cycle.
Non-small cell lung cancer - monotherapy: - 1 g / m2 once a week for 3 weeks, followed by a week-long break. Then repeat the same 4-week cycles.
Appointment in combination with cisplatin - gemcitabine is administered at a dose of 1.25 g / m2 on days 1 and 8 of each 21-day cycle or at a dose of 1 g / m2 at 1, 8, and 15 days of each 28-day cycle.
Pancreatic cancer - 1 g / m2 once a week for 7 weeks, followed by a week break. Subsequent cycles should consist of injections conducted once a week for 3 weeks, followed by a week break.
The following scheme is possible: for adults - 1 g / m2 of body surface. Infusions are carried out 1 time per week for 3 weeks, after which they take a break for 1 week, and the course is repeated.
In the course of treatment, before each administration, it is necessary to monitor the number of platelets, leukocytes and granulocytes.
If hematologic toxicity develops, the gemcitabine dose may be reduced or its administration may be postponed in accordance with the following scheme: when the number of granulocytes is more than 1 thousand / μl and platelets is more than 100 thousand / μl, use the full recommended dose; when the number of granulocytes 0.5-1 thousand / μl or platelets 50-100 thousand / μl, the dose is reduced to 75% of the recommended; if the number of granulocytes is less than 500 / μl or platelets less than 50 thousand / μl, the introduction is postponed.
To identify non-hematological toxicity, it is necessary to conduct regular examination of the patient and monitor liver and kidney function. Depending on the degree of toxicity, the dose can be reduced during each cycle or with the beginning of a new cycle in steps. The decision to postpone the next injection of the drug should be based on the clinical evaluation by the doctor of the dynamics of toxicity.
No dosing regimen is required in patients over 65 years of age.
Terms of preparation of the infusion solution: solvent - 0.9% NaCl solution for injection without preservatives. To dissolve 200 mg of gemcitabine, at least 5 ml of solvent is added to the vial; to dissolve 1 g, at least 25 ml of solvent and shake until complete dissolution.
The maximum concentration of gemcitabine should not exceed 40 mg / ml.
The prepared solution containing the desired dose of the drug, before administration, is diluted with a sufficient amount of solvent for 30 minutes by IV infusion. Prior to administration, make sure that there are no suspended particles in the solution.

Adverse reactions

From the nervous system: headache, drowsiness, insomnia.
On the part of the respiratory system: shortness of breath, cough, rhinitis, bronchospasm, interstitial pneumonia, pulmonary edema, acute respiratory distress syndrome.
On the part of the cardiovascular system: decrease in blood pressure, myocardial infarction, heart failure, arrhythmias.
From the side of blood-forming organs: leukopenia, thrombocytopenia, anemia; rarely - thrombocytosis.
On the part of the digestive system: nausea, vomiting, constipation or diarrhea, stomatitis, hyperbilirubinemia, increased activity of liver transaminases, alkaline phosphatase.
On the part of the urinary system: proteinuria, hematuria; rarely, renal failure, hemolytic Co-rhythmic syndrome (decreased Hb, thrombocytopenia, hyperbilirubinemia, hypercreatininemia, increased LDH activity and urea concentration).
On the part of the skin: rash, itching, alopecia
Other: flu-like syndrome, peripheral edema, hyperthermia, chills, back pain, myalgia, swelling of the face, anaphylactic reactions.

Contraindications

Hypersensitivity, myelosuppression, severely impaired liver and kidney function, viral (chicken pox, shingles) and other infections, childhood, pregnancy, breastfeeding.

Drug interactions

Concomitant radiation therapy causes an additive inhibition of bone marrow function (when gemcitabine is administered in a dose of 1 g / m2 (up to 6 weeks of treatment) against the background of radiation therapy applied to the chest area in patients with non-small cell lung cancer, there was significant toxicity in the form of severe and potentially life-threatening esophagitis ipneumonia).
Immunosuppressants (azathioprine, chlorambucil, corticosteroids, cyclophosphamide, cyclosporine, mercaptopurine) increase the risk of infections.
Reduces the production of antibodies and increases the side effects with the simultaneous use of inactivated or live virus vaccines (the interval between the use of drugs should be from 3 to 12 months).

Pregnancy and Lactation

Use during pregnancy and lactation is contraindicated.

Special instructions

Prior cytostatic treatment increases the frequency and severity of leukopenia and thrombocytopenia (a progressive decrease in the number of leukocytes and platelets can occur after completion of therapy).
It is necessary to regularly monitor the pattern of peripheral blood, the activity of liver transaminases and serum creatinine content.
Increasing the duration of infusion and frequency of injections leads to greater toxicity.
When bone marrow is inhibited, it is necessary to suspend treatment or adjust the dose.
Women of reproductive age and men need to apply effective contraceptive measures.
The prepared solution should be kept at room temperature (from 15 to 30 degrees C) and used for 24 hours, should not be frozen, as crystallization may occur.
The optimal regimen for the safe administration of gemcitabine in combination with therapeutic regimens of radiotherapy has not yet been determined.
During the period of treatment, care must be taken when driving and engaging in other potentially hazardous activities that require increased concentration and psychomotor reactions.

Overdosage

Symptoms: inhibition of bone marrow function (anemia, leukopenia or neutropenia, possibly with an infection, thrombocytopenia), paresthesia (feeling of numbness or tingling in the hands or feet), severe skin rash. Treatment: monitor the number of blood corpuscles, supportive therapy if necessary. With a strong inhibition of bone marrow function, transfusion of essential blood components is possible. Patients with advanced leukopenia are observed to detect signs of infection, and if necessary, antibiotics are prescribed. Patients with neutropenia with increasing body temperature, broad-spectrum antibiotics are prescribed empirically to obtain the results of bacteriological studies and related diagnostic tests. The specific antidote is absent.

  • Brand name: Gemcitabin-Ebeve
  • Active ingredient: Gemcitabine
  • Manufacturer: Ebeve Pharma
  • Country of Origin: Austria

Studies and clinical trials of Gemcitabine (Click to expand)

  1. Inhibitory effects of the nucleoside analogue gemcitabine on prostatic carcinoma cells
  2. Activity of gemcitabine in patients with advanced pancreatic carcinoma: A review
  3. Fatal pulmonary toxicity resulting from treatment with gemcitabine
  4. Efficacy of gemcitabine in the treatment of patients with gallbladder carcinoma : A case report
  5. Fatal pulmonary toxicity resulting from treatment with gemcitabine
  6. Efficacy of gemcitabine in the treatment of patients with gallbladder carcinoma : A case report
  7. An investigational new drug treatment program for patients with gemcitabine : Results for over 3000 patients with pancreatic carcinoma
  8. Phase I/II trial of paclitaxel by 1-hour infusion, carboplatin, and gemcitabine in the treatment of patients with advanced nonsmall cell lung carcinoma
  9. A review of hemolytic uremic syndrome in patients treated with gemcitabine therapy
  10. A phase II study of gemcitabine in patients with malignant pleural mesothelioma
  11. Gemcitabine plus vinorelbine in nonsmall cell lung carcinoma patients age 70 years or older or patients who cannot receive cisplatin
  12. A phase I study of gemcitabine and docetaxel in patients with metastatic solid tumors
  13. Gemcitabine and vinorelbine in advanced nonsmall cell lung carcinoma : A Phase II study
  14. Gemcitabine and vinorelbine in the second-line treatment of nonsmall cell lung carcinoma patients : A Minnie Pearl Cancer Research Network Phase II trial
  15. Schedule-dependent interaction of doxorubicin, paclitaxel and gemcitabine in human breast cancer cell lines
  16. Enhancement of radiation-induced regrowth delay by gemcitabine in a human tumor xenograft model
  17. Phase II trial of gemcitabine in patients with advanced gastric cancer
  18. A phase II trial of biweekly high dose gemcitabine for patients with metastatic pancreatic adenocarcinoma
  19. Treatment of patients with advanced nonsmall cell lung carcinoma using docetaxel and gemcitabine plus granulocyte-colony stimulating factor
  20. A phase II study of gemcitabine plus oral etoposide in the treatment of patients with advanced nonsmall cell lung carcinoma
  21. Phase II study of gemcitabine in patients with advanced hepatocellular carcinoma
  22. Gemcitabine plus vinorelbine as first-line chemotherapy in advanced nonsmall cell lung carcinoma a Phase II trial
  23. Phase II trial of gemcitabine and UFT modulated by leucovorin in patients with advanced pancreatic carcinoma
  24. A randomized study comparing two different schedules of administration of cisplatin in combination with gemcitabine in advanced nonsmall cell lung carcinoma

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