Application instruction:
International name: Immunoglobulin against a cytomegalovirus (Immunoglobulin cytomegalovirus).
Immunoglobulin of the person contains the specific antibodies (first of all IgG) directed against the causative agent of a cytomegaly.
Цитотект it is applied to prevention and treatment of a Cytomegaloviral infection at patients with the suppressed immune system by which immunity was suppressed for carrying out organ transplantation.
For treatment of TsMV of an infection at the immunodeficiency caused by other reasons, for example HIV infection.
Individual intolerance of immunoglobulin of the person.
The entered solution has to be heated a minimum to temperature of 22 °C or to body temperature. Speed of infusion should not exceed 20 caps/min. Before introduction it is necessary to be convinced of lack of discoloration and lack of suspended particles in solution, in the presence of these signs, according to the instruction, Tsitotekt cannot be entered.
The single dose makes 50 ME/kg. To patients to whom transplantation is carried out, 1 ml/kg is entered, since day of operation, and at bone marrow transplantation administration of drug begins a day before operation. Preventive reception of Tsitotekt begins in 10 days prior to operation on transplantation. Preliminary reception of Tsitotekt is especially important for TsMV-seropolozhitelnykh patients who have to receive not less than 6 doses with an interval of 2-3 weeks.
At treatment of infections it is entered not to exchange of 2 ml/kg at an interval of two days before disappearance of symptoms.
At therapy of a Cytomegaloviral infection the minimum single dose makes 100 Ekg of body weight, accepted at an interval of 48 hours.
To bowl of all the overdose happens at patients to excess weight, patients of advanced age, and also persons to disturbance of functions of kidneys (including patients with diabetes).
The overdose at elderly patients and patients with bounded function of kidneys can become the reason of hyper viscosity of blood and a hypervolemia. In the presence of symptoms of cardiac or cerebral ischemia increase in viscosity of blood can cause complications. In this regard at the mentioned groups exceeding of a daily dose of 8 ml/kg of body weight is inadmissible.
After Tsitotekt's reception it is necessary to control the content of creatine daily for 3 days.
Tsitotekt's use can show such side effects as: a headache, a fever, nausea, temperature increase, vomiting, an easy dorsodynia, an ache in joints, allergic reactions.
In rare instances, especially at high doses of intravenous administration of immunoglobulins, cases of manifestation of symptoms of aseptic meningitis, such as are recorded: nausea, temperature, vomiting, severe headache, rigidity of a nape, consciousness disturbance, photosensitivity. Extra care should be shown at treatment of the patients by Tsitotekt inclined to migraines.
Isolated cases when patients to disturbances of functions of kidneys can have an aggravation of a renal failure up to an anury are recorded. Symptoms can be shown at introduction of high doses of Tsitotekt and completely disappear after the treatment termination.
Lowering of blood pressure and, extremely seldom, the acute anaphylaxis can sometimes become side effect of Tsitotekt. At anaphylactic reactions treatment according to regulations of therapy of shock is carried out.
Clinically controlled tests of use of Tsitotekt by pregnant women it was not carried out therefore Tsitotekt's use during pregnancy and at chest feeding has to be made with care. Long medical experience of use of immunoglobulins demonstrates that the adverse effect on the course of pregnancy, fetation and the newborn is improbable. Immunoglobulins are partially removed with maternal milk and can be the cause of transfer of antibodies to the child.
The probability of by-effects depends on rate of administering. At increase in speed of infusion the number of side effects grows, and therefore it is important to observe the rate of administering recommended by Tsitotekt's instruction. The patient throughout all process of infusion has to be under observation of the doctor for the purpose of early detection of possible symptoms of side effects.
At the first use of Tsitotekt manifestation of insignificant side effects it is observed more often than at the patients who are regularly receiving drug. Therefore after the first infusion it is necessary to continue observation of the patient not less than one hour, and at the subsequent infusions up to 20 minutes, from the moment of the termination of introduction of Tsitotekt.
Instructions on the fact that immunoglobulins exert impact on ability to manage motor transport were not received.
Immunoglobulins can exert negative impact from 1,5 to 3 months on live virus vaccines, such as: measles, rubella, chicken pox, epidemic parotitis. At introduction of high doses of Tsitotekt, his influence on live virus vaccines can be traced for one year.
Tsitotekt's mixing from 0,9% chloride sodium solution is admissible. Addition of other drugs in Tsitotekt's solution the instruction inadmissibly as it can lead to change of PH value or level of concentration of electrolyte that in turn can lead to sedimentation or a denaturation of protein.
Цитотект has to it is stored at temperature condition 2-8 °C in the place protected from light. It is impossible to freeze Tsitotekt. Drug from the opened bottles or ampoules has to be used at once. The solution remains because of danger of bacterial pollution need to be utilized.
Period of validity - 2 years. After the period of validity of Tsitotekt specified on packaging it has to be utilized.
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