about the product
The reconstituted solution is a clear, colorless or light yellow liquid.
Specifications
use
Always use the drug in full accordance with the recommendations of your doctor. If in doubt, consult your doctor.
Recommended dose
The dose of oxaliplatin depends on the surface area of your body, which is calculated based on your height and weight. The usual recommended dose for adults over 18 years of age, including the elderly, is 85 mg/m2 of body surface area.
The dose you receive will also depend on the results of blood tests and whether you have previously experienced adverse reactions when taking oxaliplatin.
The way and method of administration
Treatment with OXALIPLATIN-PROMOMED is carried out only in a specialized oncology department and under the supervision of an oncologist with experience in the use of cytotoxic drugs.
You will receive OXALIPLATIN PROMOMED by intravenous administration (infusion).
Intravenous infusion of the drug is carried out through an infusion system into peripheral veins or through a central venous catheter simultaneously with intravenous infusion of calcium folinate in 5% dextrose solution for 2-6 hours using a Y-shaped intravenous system connected directly in front of the injection site. As a rule, the infusion should be administered once every 2 weeks.
When combined with fluorouracil, oxaliplatin infusion precedes the administration of fluorouracil.
Duration of therapy
The duration of therapy will be determined by your doctor according to your condition. After surgical removal of the tumor, treatment lasts up to 6 months. If you have been given OXALIPLATIN-PROMOMED more than you should have because the drug will be administered by a doctor, it is highly unlikely that you will receive more of the drug than you need. If an accidental overdose occurs, the medical staff will closely monitor your condition and provide appropriate treatment. If you have any questions about the use of the drug, contact your doctor.
Help
Package leaflet
The drug OXALIPLATIN-PROMOMED contains the active ingredient oxaliplatin. This drug is an antitumor agent, a platinum compound. It is activated in the tumor tissue and has a selective toxic effect on it.
OXALIPLATIN-PROMOMED is intended for the treatment of adult patients over the age of 18 with the following diseases:
- additional (adjuvant) therapy of stage III colon cancer (Duke classification stage C) after radical removal (resection) of the primary tumor (in combination with fluorouracil/calcium folinate);
- disseminated colorectal cancer (in combination with fluorouracil/calcium folinate);
- metastatic colorectal cancer (as first-line therapy in combination with fluorouracil/calcium folinate and bevacizumab); ovarian cancer (as a second-line therapy).
Since the drug will be administered by a doctor, it is highly unlikely that you will receive more of the drug than you need.
If an accidental overdose occurs, the medical staff will closely monitor your condition and provide appropriate treatment.
If you have any questions about the use of the drug, contact your doctor.
Like all medications, OXALIPLATIN-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 have developed so that he can take appropriate measures (for example, temporarily suspend treatment, reduce the dose of the drug, or prescribe additional therapy).
When treated with OXALIPLATIN-PROMOMED , the results of blood tests may worsen: a decrease in the number of white blood cells in the blood (leukopenia and its varieties – neutropenia, lymphopenia). White blood cells protect the body from infections, so when they are deficient, the risk of infections increases, including severe and life-threatening ones such as pneumonia, blood poisoning (sepsis) and their complications.
Against the background of oxaliplatin therapy, a decrease in the number of platelets in the blood (thrombocytopenia) is possible. Platelets play an important role in blood clotting. If they are not enough, the risk of bleeding (nasal, gastrointestinal, and others) increases, as well as spontaneous bruising. In rare cases, bleeding and bruising are combined with the formation of blood clots (blood clots) in small vessels (the so-called disseminated intravascular coagulation syndrome, a severe and life-threatening condition).
When using oxaliplatin, it is possible to reduce the number of red blood cells in the blood (anemia).
Red blood cells provide oxygen to organs and tissues, and their deficiency can be manifested by pallor and rapid fatigue.
Your doctor will monitor your test results and inform you of any changes, if any, and the necessary measures.
For more information about all possible adverse reactions and the frequency of their occurrence, see the instructions in the leaflet
Do not use the drug OXALIPLATIN-PROMOMED:
- if you are allergic to oxaliplatin or any other components of the drug listed in section 6 of the leaflet;
- if you have myelosuppression (number of neutrophils <2×109/l and/or platelets <100×109/l) before the start of the first course of treatment;
- if you have peripheral sensory neuropathy with functional disorders (tingling and numbness of fingers or toes and it is difficult for you to perform small movements, for example, to fasten buttons) before the start of the first course of treatment;
- if you have severe renal impairment (creatinine clearance less than 30 ml/min);
- if you are breastfeeding
Tell your doctor if you are taking, have recently taken, or are about to start taking any other medications.
Taking other medications may increase the risk of adverse reactions, so it is important for your doctor to be aware of any medications you are taking, including over-the-counter medications, vitamins, medicinal plants, and dietary supplements.
Registration certificate holder
JSC Biochemist, Russian Federation
15A Vasenko St., Saransk, Republic of Mordovia, 430030
Manufacturer
JSC Biochemist, Russian Federation
Address: 15A Vasenko St., Saransk, 430030, Republic of Mordovia
Phone number: +7 (8342) 38 03 68
Email: biohimic@promomed.pro
Internet address: promomed.ru
Organization that accepts consumer claims
JSC Biochemist, Russian Federation
Address: 15A Vasenko str., 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 the product at temperatures below 25 °C. Store in the original packaging (pack/box). Do not freeze. The prepared infusion solution is recommended to be administered immediately after preparation. If the solution was not introduced immediately after preparation, it can be stored for 24 hours at a temperature of +2 to +8 ° C, except in cases where the dilution of the drug was carried out under controlled, validated aseptic conditions (in these cases, storage of the diluted solution at a temperature of +2 to +8 ° C should not exceed 48 hours).
Do not use the drug in children aged 0 to 18 years due to the risk of inefficiency and possible insecurity (the safety and efficacy of 4 OXALIPLATIN-PROMOMED drugs in children under the age of 18 have not been established)
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