Cytotect
Instructions for use:
- 1. Release form and composition
- 2. Indications for use
- 3. Contraindications
- 4. Method of application and dosage
- 5. Side effects
- 6. Special instructions
- 7. Drug interactions
- 8. Analogs
- 9. Terms and conditions of storage
- 10. Terms of dispensing from pharmacies
Cytotect is an immunological drug. Increases the amount of antibodies against human CMV (cytomegalovirus).
Release form and composition
Cytotect is available in the form of a solution for intravenous administration, which is a clear or slightly opalescent, light yellow or colorless liquid (10 ml and 20 ml in ampoules, 50 ml in vials, in a cardboard box 1 ampoule or 1 bottle).
Composition of 1 ml solution:
- active substance: human plasma proteins - 100 mg (including at least 95% of immunoglobulins, not more than 5 mg of immunoglobulin A and 50 units of human immunoglobulin against CMV);
- auxiliary components: water for injection and sodium chloride.
Indications for use
- treatment of CMV infection in immunocompromised patients (newborns, premature babies, patients with drug-suppressed immunity, persons with immunodeficiency due to other reasons, etc.);
- prevention of disease manifestation after CMV infection;
- prevention of CMV infection in patients with drug-suppressed immune systems, in particular after organ transplantation.
Contraindications
Absolute:
- hypersensitivity to human immunoglobulin, especially with a deficiency of immunoglobulin A and the presence of antibodies against it;
- hypersensitivity to any ingredient of the drug.
Relative (Cytotect is used with caution):
- high blood pressure;
- history of thrombosis or vascular disease;
- chronic diseases in which blood viscosity increases;
- acquired or hereditary thrombophilia;
- severe hypovolemia;
- prolonged immobility;
- diabetes;
- overweight;
- elderly age.
Method of administration and dosage
Cytotect is administered intravenously.
Before the introduction of the drug, it is necessary to visually assess the contents of the vial. If the solution becomes cloudy or there is a sediment in it, the use of the drug is prohibited. Before administration, the solution should be warmed to body temperature or room temperature.
At the beginning of the infusion, the rate of administration should not exceed 0.08 ml / kg of body weight per hour. If the drug is well tolerated, 10 minutes after the start of administration, the rate is gradually increased to 0.8 ml / kg body weight per hour and maintained until the end of administration.
Cytotect can only be mixed with isotonic sodium chloride solution, since when other solutions are added, denaturation or protein precipitation is possible.
The solution bottle should be used immediately after opening. It is forbidden to use unused drug, as there is a high risk of bacterial contamination.
Recommended doses of Cytotect:
- treatment of CMV infection: a single dose - 2 ml / kg of body weight, frequency of application - every 48 hours. The administration of the drug is continued until the symptoms of the disease disappear;
- prevention of CMV infection in patients with suppressed immunity: the solution is administered in a single dose of 1 ml / kg of body weight (unless otherwise prescribed).
For organ transplantation in CMV seronegative patients, Cytotect is administered on the day of transplantation or one day before surgery (for example, in bone marrow transplantation).
Prevention of CMV infection in CMV-seropositive patients begins 10 days before the planned organ transplant.
In the prevention of CMV infection, the course is at least 6 single doses, the interval between which is 2-3 weeks.
Side effects
During the use of the drug Cytotect, the following side reactions may occur:
- often: headache, nausea, chills, vomiting, joint aches, fever, decreased blood pressure, mild back pain, allergic reactions;
- rarely: a sharp decrease in blood pressure, transient skin reactions (hyperemia or rash), completely disappearing after stopping treatment;
- very rare: stroke, myocardial infarction, deep vein thrombosis, pulmonary embolism;
- isolated cases: hemolysis / hemolytic anemia, reversible aseptic meningitis, anaphylactic shock, acute renal failure and / or increased serum creatinine (especially in patients with additional risk factors for renal failure).
In the event of adverse reactions indicating poor tolerance of the drug, it is necessary to reduce the rate of administration of the solution or to suspend the infusion until the symptoms disappear.
With a negative effect of Cytotect on renal function, the issue of canceling immunoglobulin should be resolved.
In case of shock, it is necessary to adhere to modern recommendations for anti-shock measures.
special instructions
Some side effects of Cytotect may be due to a high infusion rate, therefore it is necessary to strictly follow the recommendations for the rate of administration of the drug.
Careful observation of the patient during the entire infusion time and for at least 20 minutes after its completion helps to avoid possible complications. In patients to whom immunoglobulins are administered for the first time or were last administered a very long time ago, the observation time after the end of the infusion should be increased to one hour.
When treating with Cytotect, all patients should consume a sufficient amount of liquid before starting the administration of the solution. During therapy, regular monitoring of urine output and serum creatinine is required. Do not take diuretics at the same time as the drug.
After the administration of immunoglobulins, false positive test results are possible in serological tests (for example, a false positive Coombs' test).
Cytotect does not affect the ability of patients to drive vehicles or operate potentially dangerous machinery.
Drug interactions
Cytotect can reduce the effectiveness of live vaccines against viral diseases such as rubella, chickenpox, measles and mumps, so vaccination against these diseases must be carried out at least 3 months after the administration of immunoglobulins. The interval between the administration of Cytotect and the measles vaccine can be increased to one year. Before starting the measles vaccination, it is necessary to examine the patient for the presence of specific antibodies.
Analogs
The analogue of Cytotect is NeoCyotect.
Terms and conditions of storage
Store and transport in a dry, dark place at a temperature of + 2 … + 8 ° C. The drug must not be frozen. Keep out of the reach of children.
The shelf life is 3 years.
Terms of dispensing from pharmacies
Dispensed by prescription.
Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!
