about the product
5 ml, 10 ml of the drug in colorless glass vials of the 1st hydrolytic class, hermetically sealed with rubber stoppers, compressed with aluminum or combined caps.
Specifications
use
Always use the drug in full accordance with the recommendations of your doctor.
If in doubt, consult your doctor.
Recommended dose
Your doctor will select an individual dose and duration of treatment for you, taking into account your condition and therapeutic effect.
The recommended dose is 0.09–0.1 mg/kg /day for 7 days.
Route and method of administration
Intravenous drip in the form of 2-hour or 24-hour infusions.
Duration of therapy
Usually, only one course of therapy is performed.
Help
Package leaflet
The drug Cladribine-Promomed is used in adults over the age of 18 for the treatment of hairy cell leukemia (a rare chronic oncological disease affecting the bone marrow and spleen).
Symptoms
Mainly, there are symptoms associated with the manifestation of irreversible disorders of the nervous system (weakness in the extremities, twitching of the hands, a feeling of numbness in some parts of the body, slow speech), heaviness and discomfort in the lower back, blood in the urine, a decrease or increase in urine output.
Treatment
If an overdose has occurred, your doctor will prescribe the appropriate treatment for you.
Like all medications, the drug Cladribine-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, or 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 the drug Kladribin-Promomed:
− malaise, nausea, vomiting, constipation or diarrhea, loss of appetite, cardiac arrhythmias, muscle cramps or cramps, fainting, fatigue, abdominal pain, swelling (tumor lysis syndrome);
− constant weakness, dizziness, decreased performance, pallor of the skin (pancytopenia).
(For more information about all possible adverse reactions, see the leaflet)
Do not use the drug Kladribin-Promomed:
- if you are allergic to cladribine or any other components of the drug listed in section 6 of the leaflet;
- if you have moderate or severe renal insufficiency (creatinine clearance (creatinine clearance) <50 ml/min);
- if you have moderate or severe liver failure (> 4 points on the Child-Pugh scale);
- 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 to take into account possible adverse reactions that may develop due to the interaction of various medications with the drug Cladribine-Promomed, and possibly adjust the doses of the medications you are taking.
In particular, tell your doctor if you are using any of the medications listed below.:
- myelotoxic drugs (drugs that have toxic effects on the bone marrow);
- Cyclophosphamide is a drug that is used in oncology to treat various types of cancer.;
- allopurinol (a drug that reduces the concentration of uric acid in the blood and urine) and antibiotics – in combination with cladribine, skin rash increases.
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, Republic of Mordovia, 430030
Phone: +7 (8342) 38 03 68
Email: biohimic@promomed.pro
Internet address: promomed.ru
The organization that accepts consumer claims
JSC Biochemist, Russian Federation
Address: 15A Vasenko str., Saransk, Republic of Mordovia, 430030
Phone number: 8 800 222 95 63; 8 800 777 86 04 ( around the clock)
Email: hot_line@promomed.pro
Store and transport in the refrigerator (2-8 °C). Store in the original packaging (pack/box). Do not freeze. The prepared solution remains stable for 24 hours at temperatures up to 25 ° C. It should be administered immediately after preparation. If the solution was not used immediately, then the medical staff is responsible for the duration and conditions of its storage. In any case, the storage time of the finished solution should not exceed 24 hours, including the time required for infusion.
Do not give the drug to children aged 0 to 18 years, as efficacy and safety have not been established.
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