Azacitidine-Promomed

The drug AZACITIDINE-PROMOMED is used to treat adult patients,
who cannot be transplanted with hematopoietic stem cells
(HSCT, the process of obtaining healthy hematopoietic stem cells to replace
destroyed as a result of illness or high doses of chemotherapy and/or radiation
therapy), having:

• myelodysplastic syndrome (MDS, a common name for diseases of the hematopoiesis system characterized by a decrease in the number of certain blood cells in the blood combined with signs of hematopoiesis disorders) with a high or intermediate – 2 degree of risk according to the IPSS scale (International Predictive Scoring System);
• acute myeloid leukemia (AML, a malignant disease of the blood system characterized by the rapid growth of abnormal cells that accumulate in the bone marrow and blood and interfere with the normal formation of blood cells);
• chronic myelomonocytic leukemia (CMML, a malignant disease of the blood system characterized by the formation of an excessive number of cells in the bone marrow – myelocytes and monocytes, which displace other blood cells, accumulating in the bone marrow and other organs) with 10-29% of blast cells (immature, rapidly growing blood cells) in the bone marrow without myeloproliferative disorders (disorders, associated with the uncontrolled growth of certain types of blood cells in the bone marrow).

Overdose symptoms One case of azacitidine overdose has been reported during a clinical trial.
The patient had loose, multiple stools (diarrhea), nausea and vomiting after a single intravenous injection of the drug at a dose of 290 mg / m2, which exceeded the recommended starting dose by almost 4 times.
Treatment In case of overdose, the doctor will monitor the concentration of the relevant blood cells and prescribe, if necessary, supportive treatment. There is no specific antidote for azacitidine overdose.

Like all medications, AZACITIDINE-PROMOMED can cause undesirable reactions, but they do not occur in everyone.
It is important that you inform your doctor about any adverse reactions that occur so that he can take appropriate measures (for example, temporarily suspend or cancel treatment, change the dose and duration of the drug, and prescribe additional therapy).
Some adverse reactions can be serious and life-threatening. Tell your doctor immediately if you experience any of the following adverse reactions when using AZACITIDINE-PROMOMED: Very often, they can occur in more than 1 person out of 10

• inflammation of the lungs (pneumonia, including bacterial, viral, fungal), the manifestations of which are fever, weakness, cough (initially dry, turning into wet), chills, pain in the chest or right side, shortness of breath;
• repeated loose stools (diarrhea) and vomiting, as they can lead to dehydration.;
• Febrile neutropenia is a life–threatening condition that manifests itself as an increase in the patient's temperature above 38 °C against a background of a decrease in the absolute number of circulating neutrophils in the blood (determined by the results of a blood test).

• infectious blood poisoning (sepsis, including bacterial, viral and fungal; sepsis due to a decrease in the number of blood cells involved in the body's defense response against infections (neutrophils)). Possible symptoms may include fever, chills, decreased blood pressure, increased pulse rate, shortness of breath, decreased urine output, general weakness, and exhaustion.;
• dehydration of the body (dehydration);
• Intracranial hemorrhage is a hemorrhage in the cranial cavity that can manifest as a sudden headache, loss of consciousness, nausea, vomiting, and seizures. It is a serious pathology that requires urgent medical attention, since the blood that has poured into the cranial cavity causes an increase in intracranial pressure, which can lead to damage to the nervous tissue and disruption of its blood supply.;
• syncope is a sudden short–term loss of consciousness due to a decrease in cerebral blood supply.;
• gastrointestinal bleeding (including oral bleeding), hemorrhoidal bleeding;
• Kidney failure is a life–threatening condition that requires urgent care. The main signs are renal colic, decreased urine output, gastrointestinal disorders, weakness, nausea, decreased blood pressure, and muscle pain.

Do not use the drug AZACITIDINE-PROMOMED:

• if you are allergic to azacitidine or any other components of the drug listed in section 6 of the leaflet;
• if you have common malignant liver tumors;
• if you are pregnant or breastfeeding.

Tell your doctor that you are using, have recently used, or may start using any other medications.
Your doctor needs to know about the medications you are using in order to take into account possible adverse reactions that may develop due to the interaction of various medications with AZACITIDINE-PROMOMED, and possibly adjust the doses of the medications you use.
There have been no targeted clinical studies on the interaction of azacitidine with other drugs.

The holder of the registration certificate
JSC Biochemist, Russian Federation
15A Vasenko St., Saransk, 430030, Republic of Mordovia
Manufacturer
JSC Biochemist, Russian Federation
Address: 15A Vasenko St., Saransk, 430030, Republic of Mordovia
Phone: +7 (8342) 38 03 68
Email: biohimic@promomed.pro
Internet address: promomed.pro
The organization that accepts consumer claims
JSC Biochemist, Russian Federation
Address: 15A Vasenko St., Saransk, 430030, Republic of Mordovia
Phone number: 8 800 222 95 63; 8 800 777 86 04 ( around the clock)
Email: hot_line@promomed.pro

Store at temperatures below 30 °C. Store in the original packaging (pack/box).

From a microbiological point of view, the reconstituted drug should be used immediately. If the drug is not used immediately, the user is responsible for the terms and conditions of storage.