Варилрикс

General characteristics. Structure:

Lyophilisate for preparation of solution for п / to introduction in the form of the amorphous weight or powder from cream-yellow till light yellow color.

Active ingredient: 0.5 ml (1 dose) a live attenuated virus of Varicella zoster (Oka strain) received by reproduction in culture of diploid cells of the person of MRC-5 with specific activity not less than 3.3 lg FIGHTS

Excipients: albumine of the person serumal, Neomycinum sulfate, lactose, sorbitol, Mannitolum, amino acids.

Solvent: water for and - 0.5 ml.

Pharmacological properties:

Live attenuirovanny vaccine for prevention of chicken pox.

Introduction of the vaccine Varilriks® causes development of antibodies to a virus of chicken pox, providing specific protection against this infection.

Immunological efficiency

Healthy subjects

The seroconversion level at healthy children aged from 9 months up to 12 years inclusive determined in 6 weeks after vaccination exceeded 98% and remains, at least, within 7 years after vaccination.

The seroconversion level determined at children at the age of 13 years after double vaccination, made 100% and remained within at least 1 year.

In clinical trials it was shown that the majority vaccinated, being afterwards in contact with the diseased, either infections are not subject, or have a disease in much easier form (smaller quantity of rashes, absence of fever). In one of researches protection against standard clinical displays of chicken pox and 88% protection against any displays of the infection caused by the Varicella virus (estimated as at least one rash) was also shown to 100%.

Patients from groups of high risk

Chicken pox represents the important risk factor worsening a current and the forecast of the available serious illness in the following groups of patients:

— patients with an acute leukosis;

— the patients receiving therapy by immunodepressants including use of corticosteroids;

— patients to whom it is planned to make transplantation operation;

— the patients having a serious chronic illness, such as metabolic and endocrine frustration chronic diseases of lungs and cardiovascular system, a mucoviscidosis and neuromuscular disturbances can also be the factors worsening the forecast at a disease of chicken pox;

— the healthy people who are in close contact with the diseased or groups of high risk, not having chicken pox and are not imparted earlier.

The patients from the above-stated groups receiving therapy by immunodepressants (including use of corticosteroids) concerning malignant solid tumors or concerning a serious chronic illness (a renal failure, autoimmune diseases, collagenoses, heavy bronchial asthma), are predisposed to a disease of chicken pox in a severe form.

At patients the level of seroconversion makes 80% of group of high risk, and patients with a leukosis have about 90%.

At patients of groups of high risk periodic definition of antiserum capacities to a virus of chicken pox for making decision on need of a revaccination is recommended.

During one research it was established that incidence of chicken pox among patients with a leukosis was lower at the vaccinated patients, than at patients to whom vaccination was not carried out and who were infected in the natural way.

Transfer of a virus of a vaccine between brothers and sisters with an immunodeficiency was registered, however at the caught children skin manifestations were poorly expressed.

Indications to use:

— prevention of chicken pox since 12 months, first of all at the faces carried to groups of high risk, which were not hurting chicken pox and not imparted earlier;

— the emergency prevention of chicken pox at the persons who did not have chicken pox and are not imparted earlier, being in close contact with patients with chicken pox (members of families, doctors, average and junior medical staff, and also other persons).

Route of administration and doses:

The vaccine Varilriks® is intended for п / to introduction.

For preparation of solution for injections it is necessary to transfer contents of an ampoule or the syringe with solvent to a bottle with lyophilisate, it is good to stir up the formed suspension before full dissolution of lyophilisate (about 3 min.), then again to gather in the syringe.

The prepared solution transparent from yellow-pink till pink color, without deposit and visible foreign inclusions.

Before introduction of a vaccine it is necessary to examine bottle contents regarding identification of foreign debris and change of outward. If in a vaccine any aberrations are found, then such packaging is liable to destruction. After processing of the venue of an injection the alcohol or other substance which is applied to disinfection it is necessary to wait until this substance evaporates as at contact with similar connections there can be an inactivation of a vaccinal virus.

The vaccine should be entered right after its cultivation by solvent.

Scheme of vaccination

Children from 12 months to 13 years - 1 dose of a vaccine (0.5 ml) once.

Persons are more senior than 13 years (including contact with groups of high risk and the diseased) - on 1 dose (0.5 ml) with an interval between introductions of 6-10 weeks twice.

Vaccination of groups of high risk

Patients with an acute leukosis, patients with a serious chronic illness and the patients receiving therapy by immunodepressants and radiation therapy.

Immunization of such patients is carried out in a condition of full hematologic remission of a basic disease. At the same time it is necessary to make sure that total quantity of lymphocytes makes not less 1200/mkl, and there are no symptoms indicating insufficiency of cellular immunity.

If vaccination of patients is planned to be carried out in an acute phase of a leukosis, it is necessary to interrupt chemotherapy for the term equal to one week to and one week after vaccination. It is not necessary to carry out vaccination to the periods of radiation therapy.

Patients to whom it is planned to make transplantation of body

If transplantation of body is necessary to patients (for example, kidneys), then vaccination should be carried out for several weeks prior to performing therapy by immunodepressants.

Emergency prevention

Vaccination is carried out once by 1 dose of a vaccine (0.5 ml) during the first 96 h after contact (preferably during the first 72 h).

Features of use:

At introduction of the vaccine Varilriks® there have to be all necessary drugs and means for stopping of possible anaphylactic reaction. Vaccinated has to be under medical observation within 30 min. after immunization.

It is necessary to take adequate measures of contraception within 3 months after vaccination by Varilriks.

In the presence of primary or acquired immunodeficiency it is necessary to carry out determination of quantity of lymphocytes.

The vaccine Varilriks® should not be entered vnutrikozhno and it is impossible to enter in / century.

At patients who receive massive therapy by immunodepressants after vaccination chicken pox with clinical signs can develop.

In exclusively exceptional cases transfer of a vaccinal virus was registered. Therefore the vaccinated persons have to avoid contacts with pregnant women as they are especially sensitive to chicken pox (preferential in the I trimester), and also with persons from group of high risk of a disease of chicken pox in a severe form (for example, with patients with leukoses or immunodepressants receiving treatment). In cases, when there is no an opportunity to prevent contact with above-mentioned persons, it is necessary to weigh potential risk of transfer of a virus of a vaccine and to compare it to risk to catch and transmit a natural virus of chicken pox.

The vaccinated patients at whom rashes within 3 weeks after vaccination come to light have to exclude any contacts with pregnant women (preferential in the I trimester) and immunodeficiency.

Influence on ability to driving of motor transport and to control of mechanisms

Influence on ability of concentration of attention is improbable.

Side effects:

Healthy faces

The profile of safety of a vaccine is based on the data obtained for 5369 doses of the vaccine entered to children, teenagers and adults. Reactions were registered within 42 days after vaccination.

Frequency of reactions was defined as follows: very often (≥10%), it is frequent (≥1%, but <10%), sometimes (≥0.1%, but <1%), is rare (≥0.01%, but <0.1%), is very rare (<0.01%).

From TsNS: sometimes - a headache, drowsiness.

From an organ of sight: seldom - conjunctivitis.

From respiratory system: sometimes - rhinitis, cough, infections of upper parts of respiratory tracts, pharyngitis.

From the alimentary system: sometimes - diarrhea, vomiting; seldom - abdominal pains.

Dermatological reactions: often - rash; sometimes - the rash similar to rash at chicken pox prurit; seldom - a small tortoiseshell.

From skeletal and muscular system: sometimes - an arthralgia, a mialgiya.

From an organism in general: sometimes - a lymphadenopathy, it is frequent - temperature increase (rectal ≥38 °C, an axillary hollow / an oral cavity of ≥37.5 °C); sometimes - temperature increase (rectal ≥39.5 °C, an axillary hollow / an oral cavity of ≥39 °C), weakness, an indisposition.

Local reactions: very often - pain and reddening in the place of an injection; often - hypostasis in the place of an injection.

At observation of mass use of a vaccine messages on the reactions and symptoms regarded as temporarily associated (not necessarily connected) with vaccination arrived.

From TsNS: spasms, ataxy.

Are possible: the infections caused by the Varicella zoster virus, hypersensitivity reactions, allergic reactions (including anaphylactic and anaphylactoid reactions).

On average reactogenicity of a vaccine at introduction of the second dose (revaccination) does not exceed reactogenicity of the first dose. Also distinctions in a profile of safety of a vaccine at seronegative and seropositive subjects were not noted.

Patients from group of high risk

Reactions in a vaccine injection site usually happen not heavy.

The papular and vesicular rash which in rare instances is followed by not heavy or medium-weight fever can develop during the period from several days to several weeks after vaccination.

Interaction with other medicines:

Introduction of the vaccine Varilriks® is possible not earlier than in 3 months after administration of immunoglobulins or after a hemotransfusion.

It is necessary to avoid purpose of salicylates within 6 weeks after vaccination by Varilriks as there were separate messages on development of a syndrome to Reja against the background of the infection caused by a virus of chicken pox.

The vaccine can be entered along with the inactivated vaccines of the National calendar of preventive inoculations of the Russian Federation and a calendar of inoculations according to epidemic indications of the Russian Federation, except for an antirabic vaccine.

Co-administration of the vaccine Varilriks® with a vaccine against measles rubella-parotitis or with a vaccine against diphtheria-tetanus-whooping cough does not reduce an immune response and does not increase reactogenicity of the vaccine Varilriks®.

The combined vaccine against measles rubella-parotitis and vaccine against chicken pox can be entered at the same time at introduction them into different places. However, if these vaccines were not appointed at the same time, then the interval between their appointment for achievement of the maximum level of antibodies has to make not less than 30 days.

Between vaccination by Varilriks and other vaccines, in addition to stated above, the interval between introductions has to make not less than 1 month.

When performing single-step vaccination by several drugs it is necessary to consider contraindications to each of the applied vaccines.

All vaccines enter different syringes into different places of injections.

Patients from group of high risk Varilriks® cannot enter along with other live attenuirovanny vaccines. At the same time other vaccines for introduction in the form of injections should be entered into different places.

Contraindications:

— primary or acquired immunodeficiency (which developed owing to a leukosis, a lymphoma, a dyscrasia of blood, clinical displays of HIV infection, use of immunodepressants, including high-dose therapy by corticosteroids), determined by quantity of lymphocytes (<1200/mkl), and also in the presence of other signs of cellular immune deficiency;

— acute infectious and noninfectious diseases, an exacerbation of chronic diseases are temporary contraindications for carrying out inoculations; at not heavy SARS, acute intestinal diseases of an inoculation carry out right after normalization of temperature;

— pregnancy or the planned pregnancy within 3 months;

— period of a lactation (breastfeeding);

— hypersensitivity to any component of a vaccine (including to Neomycinum);

— hypersensitivity symptoms on the previous introduction of the vaccine Varilriks®.

Use of the drug VARILRIKS® at pregnancy and feeding by a breast

The vaccine is contraindicated to use at pregnancy or the planned pregnancy (within 3 months) and during breastfeeding.

Overdose:

Separate messages on accidental overdose of a vaccine are registered. Some messages included the description of such symptoms as a lethargy, spasms.

Storage conditions:

It is necessary to store and transport a vaccine at a temperature from 2 ° to 8 °C; not to freeze.

It is necessary to store solvent (on 100 ampoules) in packagings at a temperature from 2 ° to 25 °C.

To store in the place, unavailable to children.

Vaccine period of validity - 2 years, solvent - 5 years.

Issue conditions:

According to the recipe

Packaging:

1 dose (0.5 ml) - bottles glass with a capacity of 3 ml (1) complete with solvent (amp. 1) - blisters polyethylene (1) - packs cardboard.
1 dose (0.5 ml) - bottles glass with a capacity of 3 ml (1) complete with solvent (syringe 1) - blisters polyethylene (1) - packs cardboard.
1 dose (0.5 ml) - bottles glass with a capacity of 3 ml (1) complete with solvent (the syringe 1 with 1 or 2 needles) - blisters polyethylene (1) - packs cardboard.