2010/06/07

VARILRIX

INDICATIONS: Healthy persons

The vaccine is indicated for active immunization against varicella of healthy individuals (ranging from 9 months of age). People in close contact with patients at high risk of disease should be vaccinated to reduce the risk of transmission of the agent in such patients. These include the parents and close relatives of patients at high risk, medical (including nursing) staff and other persons in close contact with patients, patients with varicella or with patients with high risk of disease.

Patients with high risk of disease chickenpox

Patients with leukemia receiving immunosuppressive therapy (including therapy GCS), patients with malignant tumors or severe chronic diseases (chronic renal failure, autoimmune diseases, collagen, BA), as well as those who planned organ transplantation are at high risk of disease and tend to a severe course of varicella. Such patients show vaccination to reduce the risk of chicken pox. Given the limited clinical trials for the vaccine Varilriks, immunization of patients at risk should be prescribed with the following caveats:

- When vaccinated patients in the acute phase of leukemia maintenance chemotherapy should be abolished for 1 week before and during 1 week after immunization. Patients receiving a radiation therapy is not recommended to vaccinate throughout the entire period of treatment.

It is desirable that the number of lymphocytes in the peripheral blood was at least 1200/mm 3, and no other manifestations of immunodeficiency.

APPLICATION: 0,5 ml dose of vaccine (after reconstitution) contains a single immunizing dose.

For children from 9 months of age and under 12 years of age inclusive appoint 1 dose of vaccine (0.5 ml), children under the age of 13 years and older - 2 doses with an interval between them at least 6 weeks. For the vaccination of patients at risk may require the introduction of additional doses of vaccine.

The vaccine is designed to Varilriks sc injection. The recommended injection site - the shoulder in place of the projection of the deltoid muscle.

Due to minor variations in pH color ready for the introduction of the vaccine may have a tinge of pink to red. Before injection of the solvent and the vaccine must be carefully visually assess for the presence of any impurities and / or rejection of physical characteristics. In case of deviations of the solvent or the vaccine do not apply.

Varilriks dissolved, adding to the vial containing a dry lyophilized powder, attached solvent. After adding the solvent to the powder mixture should be shaken until complete dissolution of the powder. When processing the injection site should await the complete drying alcohol or other antiseptic on the skin surface before the introduction of the vaccine because they may result in partial inactivation of the virus. The vaccine should be administered immediately after reconstitution.

Contraindicated intradermal and intravascular injection Varilriksa.

CONTRAINDICATIONS: vaccination Varilriksom contraindicated in individuals who have the total number of lymphocytes in the peripheral blood of less than 1200/mm 3 or if other manifestations of immune deficiency, persons with known systemic hypersensitivity to neomycin (a history of contact dermatitis due to the action of neomycin is not a contraindication to vaccination); during pregnancy. Moreover, it should avoid pregnancy for 3 months after vaccination.

SIDE EFFECTS: Healthy persons

More than 7900 people participated in clinical studies on reactogenicity of the vaccine.

Children (ages 9 months to 12 years)

The most frequent side effects were injection site reactions (moderate pain, hyperemia, edema).

Also notes the following side effects: general reactions may be in the form of fever - body temperature of 37,5 ° C (under the arms) / 38 ° C (rectal) to 39 ° C (under the arms) / 39,5 ° C (rectal) . There have been reports of cases of papules, vesicular rash (like a rash varicella). In double-blind, placebo-controlled study with a 4-week monitoring period, which included 513 children aged 12-30 months, there was no statistically significant differences in the nature or frequency of clinical symptoms in patients who received the vaccine or placebo.

Adolescents (≥ 13 years and adults). The most frequent side effects are reactions at the site of reference (moderate pain, hyperemia, edema). It was also reported such side-effects: Common reactions may occur in the form of fever with body temperature of 37,5 ° C (under the arms) / 38 ° C (rectal) to 39 ° C (under the arms) / 39,5 ° C (rectal ). There have been reports of cases of papules, vesicular rash (like a rash varicella) in about 5% of persons within 6 weeks after vaccination. In general, the reactogenicity after the second dose was not higher than after the introduction of the first.

In double-blind, placebo-controlled study involving 513 children aged 12-30 months found no statistically significant differences in the nature or frequency of occurrence of fever and skin rash in children who received vaccine or placebo. There were no differences between reactogenicity in initially seropositive and seronegative reacting reacting individuals.

Patients with high risk

For this group of patients, systematic clinical trial data are limited. Yet the reaction associated with the use of vaccines (mostly papules, vesicular rash and fever), tended to be moderate. As in healthy individuals, congestion, swelling and pain at the injection site were inconspicuous and quickly passing (from several days to several weeks). The symptoms are often observed in patients with leukemia receiving immunosuppressive therapy, are at the maintenance phase of chemotherapy. The appearance of the rash does not affect the clinical status of patients. IQ that immunization can adversely affect the course of the disease, no.

Cautions: Like other vaccines, immunization Varilriksom should be delayed in people with acute illnesses that occur with a fever. However, the existence of minor manifestations of infection is not a contraindication for vaccination.

Like all other injectable vaccines, immunization must be conducted under the supervision of medical staff. It should take the necessary measures in case of rare anaphylactic reaction observed after vaccine administration.

As with other vaccines for the prevention of varicella, chickenpox cases have identified and the patients who were previously immunized Varilriksom. These cases are rare and the fever and other clinical symptoms were less pronounced than that of unvaccinated patients.

It was shown that the transmission of the virus (Oka strain) vaccine in seronegative contacts of vaccinees responding with individuals is very rare.

Moderately pronounced rash in healthy contact persons indicates that the virus is weakened (attenuated) after transmission through people - carriers of the virus.

During pregnancy and lactation appointment Varilriksa contraindicated, since the effect on fetal development are unknown. In addition, you should avoid pregnancy for 3 months after vaccination. Data on the use of vaccine in breast-feeding are not available.

In carrying out immunization in Ukraine on immunization, contraindications and interactions with other drugs, should be guided by existing orders MH of Ukraine.

INTERACTION: in patients treated with immunoglobulins, or who made blood transfusion, vaccination should be postponed for at least 3 months in connection with the passive acquisition of antibodies to varicella zoster virus.

For 6 weeks after vaccination against chickenpox should avoid use of salicylates, as reported on the development of Reye syndrome, occurring after the use of salicylates during spontaneous infection caused by the varicella zoster virus.

Healthy persons

Varilriks can be assigned in conjunction with any other vaccine. Different injectable vaccines should always be installed in different areas. The vaccine can enter at any time against the introduction of this vaccine. If a vaccine containing measles virus is not introduced concurrently with Varilriksom are encouraged to observe an interval of at least 1 month, because they believe that measles vaccination can cause a short depression of cellular component of the immune response.

Patients with high risk

Varilriks should not be given simultaneously with other live attenuated vaccines. The vaccine may be used at any time against the introduction of this vaccine. Different injection vaccine must always be installed in different places.

Varilriks not be mixed with other vaccines in one syringe.

STORAGE CONDITIONS: shelf life of freeze-dried vaccine Varilriks in the refrigerator at +2 +8 ° C is 24 months. Date of expiry vaccine is indicated on the label and packaging. At the lyophilized vaccine does not affect freezing. Diluent should be stored in the refrigerator or at room temperature (not above 25 ° C). The vaccine should be administered immediately after dissolution. For transportation of vaccines, especially in hot climates, you should use refrigerators.

DESCRIPTION: mechanism of action of vaccine Varilriks is that in susceptible individuals the vaccine causes a weakening of clinically asymptomatic form of varicella. Some level of protection can be achieved by immunization for up to 72 hours after contact with sick chicken pox.

Healthy persons

In children aged 9 months to 12 years the overall level of seroconversion within 6 weeks after vaccination was more than 98%. Children immunized at the age of 12-15 months, antibodies persisted for at least 7 years after vaccination.

Persons aged 13 and over rate of seroconversion was 100% after 6 weeks after the second dose. One year after vaccination, all persons remained seropositive.

In the study of the effectiveness in children under the age of 10 to 30 months of protective efficacy was 100% compared with conventional clinical cases of varicella (≥ 30 vesicles). In comparison with mild cases of varicella (a mild form, at least with the presence of a vesicle or papule) protective efficacy was 88%. However, the cases were mild (the average number of vesicles - 1; reports of fever was not).

Patients with high risk of disease chickenpox

Patients at high risk of disease chickenpox overall seroconversion rates exceeded 80%. In these patients, it is desirable to periodically examine the level of antibodies to varicella zoster virus in order to determine the persons to whom it is expedient to revaccination.