about the product

The drug OXALIPLATIN-PROMOMED is a lyophilizate for the preparation of a concentrate for the preparation of an infusion solution, externally it is a lyophilized powder or a porous mass of white or almost white color.
The reconstituted solution is a clear, colorless or light yellow liquid.

Specifications

Name
Oxaliplatin-Promomed
Dosage form
Lyophilizate for preparation of concentrate for preparation of solution for infusion
Nosological classification
Antitumor drugs
INN
Oxaliplatin
Dosages
50 mg; 100 mg; 150 mg; 200 mg
ATC code
L01XA03
Active substance
Oxaliplatin
Pharmacotherapeutic group
Cancer drugs

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.
Route 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.

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 Blood test results may worsen.: decrease in the number of leukocytes 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 infections 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 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 (neutrophil count <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 your fingers or toes and it is difficult for you to perform small movements, such as buttoning) before starting 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.

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 str., 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 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 at temperatures below 25 °C. Store in the original packaging (bottle in a pack/box). The prepared infusion solution should be used immediately. If the solution is not used immediately, the time and conditions of its storage are the responsibility of the user and should not exceed 24 hours at a temperature of 2-8 °C. Oxaliplatin should not get into the eyes or on the skin. If accidental spillage occurs, inform your doctor or nurse immediately. The prepared solution of the drug should be transparent and should not contain undissolved particles. A solution with signs of precipitation must be disposed of. When the infusion is finished, the doctor or nurse disposes of oxaliplatin.

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)