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Varilrix - chickenpox vaccine

Live attenuated vaccine

Manufacturer: GlaxoSmithKline Biologicals, Belgium.

Protects against viral disease: chicken pox.

It is tried on: in children from the age of 12 months who have not had chickenpox and have not been vaccinated previously, as well as in adults.

Not included in the national vaccination calendar.

IMPORTANT: vaccinations with the Varilrix vaccine are not carried out in clinics

Varilrix price

Chickenpox is a highly contagious infectious disease caused by a virus from the herpes virus family. The varicella zoster virus, when it first enters the human body, causes the picture of “chickenpox”. The chickenpox virus “settles” in the nerve plexuses for life. And when the immune system weakens (usually in old age or with severe concomitant diseases), it becomes more active, causing herpes zoster. In childhood, the disease often progresses favorably, but in adults it is much more difficult to tolerate, and bacterial complications are more often observed. The varicella zoster virus poses a particular danger to pregnant women and the fetus.

Emergency prevention

Vaccination is carried out once with 1 dose of vaccine (0.5 ml) during the first 96 hours after contact (preferably within the first 72 hours). If the disease does not develop, then re-vaccination is carried out after 6-8 weeks.

Clinical studies have shown the high effectiveness of the Varilrix® vaccine. The rate of seroconversion (development of immunity) in healthy children aged 12 months to 12 years inclusive, determined 6 weeks after vaccination, exceeded 98% and persisted for at least 7 years after vaccination.

The seroconversion rate measured in children aged 13 years after two doses of vaccination was 100% and was maintained for at least 1 year.

Clinical studies have shown that the majority of vaccinated people who were subsequently in contact with sick people are either not susceptible to infection or experience a much milder form of the disease (fewer rashes, no fever).

To ensure that the seroconversion rate is as high as possible, since the end of 2012, the Varilrix® vaccine has been used with booster vaccination at all ages, which prevents the occurrence of so-called “breakthrough chickenpox” (an outbreak of chickenpox in vaccinated children).

Varilrix® (varicella zoster vaccine, live attenuated) (Varilrix®)

Method of administration

Varilrix® vaccine is intended for subcutaneous or intramuscular administration. The vaccine should be injected into the deltoid muscle or anterolateral thigh area.

Varilrix® should be administered subcutaneously to patients with bleeding disorders (eg, thrombocytopenia or any other coagulation disorder).

Varilrix® vaccine should not be administered intravascularly or intradermally.

Before reconstitution or administration, the solvent and reconstituted vaccine must be visually inspected for the absence of mechanical inclusions and/or changes in appearance (see section “Description”). If they are detected, you should stop using the solvent or reconstituted vaccine.

Varilrix® vaccine cannot be mixed in the same syringe with other vaccines.

Preparation of the vaccine before administration

Varilrix® vaccine must be reconstituted by adding the full volume of diluent from the prefilled syringe to the vial containing the lyophilisate.

Attention!

The packaging of the Varilrix® vaccine can be presented in two types of syringes, differing in the way the needle is connected to the syringe nozzle.

Syringe type 1

To ensure proper connection of the needle and syringe, please read the instructions below carefully. The syringe included in the package with the Varilrix® vaccine may differ slightly from the image in the pictures.

Always hold the syringe by the barrel (do not hold the syringe by the plunger or luer lock) and position the needle in the same plane as the syringe, as shown in Figure 2. Failure to do this will result in deformation of the luer lock and syringe leakage. .

If the Luer-lock fastener becomes detached when assembling the syringe, you should take a new dose of vaccine (a new syringe and vial).

1. Unscrew the protective cap of the syringe by turning it counterclockwise (see Figure 1).

2. Attach the needle to the syringe. To do this, carefully place the needle head on the luer lock and rotate clockwise 90° until you feel the needle is secured to the syringe (see Figure 2).

3. Remove the protective cap from the needle (in some cases it may be tightly attached to the needle).

4. Add solvent to the lyophilisate. Shake the resulting mixture well until the lyophilisate is completely dissolved in the solvent. After recovery, the vaccine must be administered immediately.

5. Remove all contents from the reconstituted vaccine vial.

6. A new needle should be used to administer the vaccine. Unscrew the needle from the syringe and attach the injection needle as described in step 2.

Syringe type 2

If the package contains a syringe that differs from the one shown in Figures 1-2, after removing the protective cap from the syringe nozzle, insert the needle onto the syringe until it stops without additional twisting. The solvent should be transferred from the syringe to the vial with the lyophilisate. After adding the solvent to the lyophilisate, shake the resulting suspension well until the lyophilisate is completely dissolved in the solvent (approximately 3 minutes).

After treating the injection site with alcohol or another substance used for disinfection, you should wait until this substance evaporates, since contact with such compounds may inactivate the vaccine virus. Unused drug and waste from its use must be destroyed in accordance with the requirements adopted in the Russian Federation.

Vaccination schedules

Planned prevention

1 dose of vaccine (0.5 ml) twice.

For children aged 9 to 12 months, the second dose should be given at a minimum interval of 3 months after the first dose.

For children 12 months of age and older, adolescents and adults, the recommended minimum interval between vaccinations is 6 weeks.

Emergency prevention

Vaccination is carried out once with 1 dose of vaccine (0.5 ml) during the first 96 hours after contact (preferably within the first 72 hours).

Vaccination of high-risk groups

Patients with acute leukemia, patients with severe chronic diseases and patients receiving immunosuppressant therapy and radiation therapy

Immunization is carried out in a state of complete hematological remission. In this case, it is necessary to make sure that the total number of lymphocytes is at least 1200/mm3, and that there are no symptoms indicating a deficiency of cellular immunity. If vaccination is planned to be carried out in the acute phase of leukemia, it is necessary to interrupt chemotherapy for a period of one week before and one week after vaccination. Vaccination should not be carried out during periods of radiation therapy.

Patients scheduled for organ transplantation

If patients are undergoing organ transplantation, the vaccination course should be completed several weeks before starting immunosuppressant therapy.

High-risk patients may require additional doses of the vaccine. The decision on the need to administer additional doses of the Varilrix® vaccine is made by the attending physician (immunohematologist, oncologist, transplantologist).

Interchangeability of vaccines

Varilrix® vaccine can be given to people who have already been vaccinated with another vaccine that contains a component to prevent chickenpox. A course of varicella vaccination started with Varilrix® can be continued with another vaccine containing a component for the prevention of varicella.

Using Varilrix in combination with other vaccines

The Varilrix® vaccine can be administered simultaneously with all drugs from the national preventive vaccination calendar on the same day, in different parts of the body, with the exception of the BCG vaccine and the rabies vaccine (rabies vaccination).

The use of the Varilrix® vaccine in combination with other vaccinations does not affect their immunogenicity (ability to develop immunity). Tolerability of vaccines does not deteriorate, and the number of adverse reactions does not increase.

Administering several vaccines on the same day does not place an excessive burden on the immune system.

Administration of the Varilrix® vaccine is possible no earlier than 3 months after the administration of immunoglobulins or after blood transfusion.

Immunological efficacy Healthy subjects Seroconversion rates in healthy children aged 9 months to 12 years inclusive, measured 6 weeks after vaccination, exceeded 98% and persisted for at least 7 years after vaccination.

The seroconversion rate measured in children aged 13 years after two doses of vaccination was 100% and was maintained for at least 1 year.

Clinical studies have shown that the majority of vaccinated people who were subsequently in contact with sick people are either not susceptible to infection or experience a much milder form of the disease (fewer rashes, no fever). One study also demonstrated 100% protection against standard clinical manifestations of chickenpox and 88% protection against all manifestations of Varicella virus infection (measured as at least one rash).

Patients from high-risk groups Chickenpox is an important risk factor that worsens the course and prognosis of the existing severe disease in the following groups of patients: - patients with acute leukemia; - patients receiving immunosuppressant therapy, including the use of corticosteroids; — patients who are planning to undergo a transplant operation; - patients suffering from severe chronic diseases, such as metabolic and endocrine disorders, chronic lung and cardiovascular diseases, cystic fibrosis and neuromuscular disorders can also be factors that worsen the prognosis for chickenpox; - healthy people who are in close contact with sick people or high-risk groups, who have not had chickenpox and have not been previously vaccinated.

Patients from the above groups receiving immunosuppressant therapy (including the use of corticosteroids) for malignant solid tumors or for severe chronic diseases (renal failure, autoimmune diseases, collagen diseases, severe bronchial asthma) are predisposed to severe chickenpox.

In high-risk patients, the seroconversion rate is 80%, and in patients with leukemia the rate is approximately 90%.

In high-risk patients, periodic determination of antibody titers to the varicella zoster virus is recommended to decide on the need for revaccination.

One study found that the incidence of chickenpox among patients with leukemia was lower in vaccinated patients than in unvaccinated patients who were naturally infected.

Transmission of vaccinia virus between immunocompromised siblings has been reported, but skin manifestations in infected children were mild.

Indications Prevention of chickenpox from 12 months, primarily in persons classified as high-risk groups who have not had chickenpox and have not been previously vaccinated; Emergency prevention of chickenpox in persons who have not had chickenpox and were not previously vaccinated, who were in close contact with patients with chickenpox (family members, doctors, nursing and junior medical personnel, as well as other persons).

Method of administration and dosage Varilrix vaccine is intended for subcutaneous administration.

To prepare the solution for injection, transfer the contents of the ampoule or syringe with the solvent into a bottle with lyophilisate, shake the resulting suspension well until the lyophilisate is completely dissolved (approximately 3 minutes), then draw it back into the syringe.

The prepared solution is transparent from yellow-pink to pink, without sediment and visible foreign inclusions.

The vaccine should be administered immediately after diluting it with a solvent.

Vaccination regimen Children from 12 months to 13 years – 1 dose of vaccine (0.5 ml) once.

Persons over 13 years of age (including those in contact with high-risk groups and sick people) - 1 dose (0.5 ml) twice with an interval between doses of 6-10 weeks.

Vaccination of high-risk groups: Patients with acute leukemia, patients with severe chronic diseases and patients receiving immunosuppressant therapy and radiation therapy.

Immunization of such patients is carried out in a state of complete hematological remission of the underlying disease. In this case, it is necessary to make sure that the total number of lymphocytes is at least 1200/μl, and there are no symptoms indicating a deficiency of cellular immunity.

If vaccination is planned for patients in the acute phase of leukemia, it is necessary to interrupt chemotherapy for a period of one week before and one week after vaccination. Vaccination should not be carried out during periods of radiation therapy.

Patients scheduled for organ transplantation

If patients are undergoing organ transplantation (eg, kidney), vaccination should be given several weeks before starting immunosuppressant therapy.

Emergency prophylaxisVaccination is carried out once with 1 dose of vaccine (0.5 ml) during the first 96 hours after contact (preferably within the first 72 hours).

Side effects Healthy individuals The safety profile of the vaccine is based on data obtained from 5369 doses of the vaccine administered to children, adolescents and adults. Reactions were recorded for 42 days after vaccination.

From the side of the central nervous system: sometimes – headache, drowsiness, irritability. From the organ of vision: rarely – conjunctivitis. From the respiratory system: sometimes – rhinitis, cough, upper respiratory tract infections, pharyngitis. From the digestive system: sometimes – diarrhea, vomiting; rarely – abdominal pain. Dermatological reactions: often - rash; sometimes - a rash similar to the rash of chicken pox, pruritis; rarely – urticaria. From the musculoskeletal system: sometimes – arthralgia, myalgia. From the body as a whole: sometimes – lymphadenopathy, often – increased temperature (rectal above 38°C, axillary cavity/oral cavity above 37.5°C); sometimes - increased temperature (rectal temperature above 39.5°C, axillary cavity/oral cavity above 39°C), weakness, malaise. Local reactions: very often - pain and redness at the injection site; often - swelling at the injection site. During surveillance of the widespread use of the vaccine, there were reports of reactions and symptoms considered to be temporarily associated (not necessarily related) to vaccination. From the side of the central nervous system: convulsions, ataxia. Possible: infections caused by the Herpes zoster virus, hypersensitivity reactions, allergic reactions (including anaphylactic and anaphylactoid reactions). On average, the reactogenicity of the vaccine upon administration of the second dose (re-vaccination) does not exceed the reactogenicity of the first dose. There were also no differences in the safety profile of the vaccine between seronegative and seropositive subjects.

High-risk patients Reactions at the vaccine site are usually mild. A papular-vesicular rash, rarely accompanied by mild to moderate fever, may appear several days to several weeks after vaccination.

Contraindications Primary or acquired immunodeficiency (developed as a result of leukemia, lymphoma, blood dyscrasia, clinical manifestations of HIV infection, use of immunosuppressants, including high-dose corticosteroid therapy), determined by the number of lymphocytes (<1200/μl), as well as in the presence of other signs of cellular immunodeficiency;

Acute infectious and non-infectious diseases, exacerbation of chronic diseases are temporary contraindications for vaccinations; for mild ARVI and acute intestinal diseases, vaccinations are carried out immediately after the temperature has normalized;

Pregnancy or planned pregnancy within 3 months; lactation period (breastfeeding);

Hypersensitivity to any component of the vaccine (including neomycin); Symptoms of hypersensitivity to previous administration of the Varilrix vaccine.

Special instructions When administering the Varilrix vaccine, you must have all the necessary drugs and means to relieve a possible anaphylactic reaction. The vaccinated person must be under medical supervision for 30 minutes after immunization.

Adequate contraceptive measures should be taken for 3 months after vaccination with Varilrix.

In the presence of primary or acquired immunodeficiency, it is necessary to determine the number of lymphocytes.

Varilrix vaccine should not be given intradermally and should not be given IV.

Patients receiving extensive immunosuppressant therapy may develop clinically symptomatic varicella after vaccination.

In extremely rare cases, vaccine virus transmission has been reported. Vaccinated persons should therefore avoid contact with pregnant women, as they are particularly susceptible to chickenpox (primarily in the first trimester), as well as with persons at high risk of severe chickenpox (for example, patients with leukemia or those receiving immunosuppressant treatment). . In cases where it is not possible to prevent exposure to the above individuals, the potential risk of transmission of the vaccine virus should be weighed against the risk of contracting and transmitting natural varicella zoster virus.

Vaccinated patients who develop a rash within 3 weeks after vaccination should avoid any contact with pregnant women (primarily in the first trimester) and immunocompromised women.

Drug interactions Administration of the Varilrix vaccine is possible no earlier than 3 months after the administration of immunoglobulins or after blood transfusion.

Salicylates should be avoided for 6 weeks after Varilrix vaccination, as there have been isolated reports of Reye's syndrome secondary to varicella zoster virus infection.

The vaccine can be administered simultaneously with inactivated vaccines of the national calendar of preventive vaccinations of the Russian Federation and the vaccination calendar for epidemic indications of the Russian Federation, with the exception of rabies vaccine.

Coadministration of Varilrix vaccine with measles-rubella-mumps vaccine or diphtheria-tetanus-pertussis vaccine does not reduce the immune response or increase the reactogenicity of Varilrix vaccine.

The combination measles-rubella-mumps vaccine and varicella vaccine can be given at the same time when given at different sites. However, if these vaccines were not prescribed at the same time, then the interval between their administration to achieve maximum antibody levels should be at least 30 days.

Between vaccinations with Varilrix and other vaccines, in addition to those mentioned above, the interval between administrations should be at least 1 month.

When carrying out simultaneous vaccination with several drugs, contraindications to each of the vaccines used must be taken into account.

All vaccines are administered with different syringes at different injection sites.

In high-risk patients, Varilrix should not be administered concomitantly with other live attenuated vaccines. However, other injectable vaccines must be administered at different sites.

Storage conditions Store and transport at temperatures from 2 to 8°C; do not freeze. Keep out of the reach of children.

The shelf life of the vaccine is 2 years, the solvent is 5 years.

Adverse reactions

Reactions to the Varilrix® vaccine are rare and most often easily tolerated. They are divided into local and general.

Local reactions: pain and redness at the injection site.

General reactions: increased body temperature to subfebrile levels, lymphadenopathy (swelling of the lymph nodes), weakness, malaise. A rash similar to chickenpox may appear. The rash is not abundant and rarely develops into blisters.

Most often, such reactions do not require special treatment; symptomatic therapy is carried out.

On average, the reactogenicity of the vaccine upon administration of the second dose (re-vaccination) does not exceed the reactogenicity of the first dose. There were also no differences in the safety profile of the vaccine between people with and without immunity to chickenpox.

Possible side effects

Local reactions occur rarely: pain and redness at the injection site.

General reactions occur extremely rarely: increased body temperature to low-grade levels (rectal ≥ 38°C, in the armpit or oral cavity: ≥ 37.5°C), lymphadenopathy, weakness, malaise. A rash similar to chickenpox may appear. The rash is not abundant and rarely develops into blisters. In isolated cases, absolutely extremely rarely, vaccinated people may develop fainting or clonic-tonic convulsions within 15 minutes after vaccination.

Varilrix should be used with caution in cases of thrombocytopenia or blood coagulation disorders, since bleeding may occur during intramuscular administration.

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Contraindications for use

• primary or acquired immunodeficiency (developed as a result of leukemia, lymphoma, clinical manifestations of HIV infection, use of immunosuppressants, including high-dose corticosteroid therapy), as well as in the presence of other signs of cellular immunodeficiency;
• acute infectious and non-infectious diseases, exacerbation of chronic diseases are temporary contraindications for vaccinations; for mild ARVI and acute intestinal diseases, vaccinations are carried out immediately after the temperature has normalized;
• pregnancy or planned pregnancy within 3 months;
• lactation period (breastfeeding);
• hypersensitivity to any component of the vaccine (including neomycin);
• symptoms of hypersensitivity to previous administration of the Varilrix® vaccine.

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

Varilrix

Trade name:

Varilrix® (Live attenuated chickenpox vaccine) / Varilrix®.

Group name:

vaccine to prevent chickenpox.

Dosage form:

lyophilisate for preparing a solution for subcutaneous administration.

Compound

1 vaccination dose (0.5 ml) contains 1.2:

Notes 1. The vaccine does not contain preservatives. 2. The vaccine contains trace amounts of neomycin sulfate (no more than 25 mcg/dose). 3. PFU - plaque-forming units. 4. The nominal titer of the virus corresponds to the minimum titer guaranteed by the manufacturer at the expiration date. The virus content in one vaccination dose at the time of release of the drug must be different and exceed the minimum titer specified in the composition.

Description

Amorphous mass or powder from cream to light yellow or light pink; the reconstituted drug is a clear yellow-pink to pink liquid. Solvent: transparent, colorless liquid without visible mechanical inclusions.

Characteristic

Varilrix® (Live attenuated chickenpox vaccine) (hereinafter referred to as Varilrix®) is a live attenuated vaccine for the prevention of chickenpox, which is a live attenuated Varicella Zoster virus (Oka strain), cultivated in a culture of human diploid MRC-5 cells. Varilrix® meets all the requirements of the World Health Organization for the production of medical immunobiological preparations.

Pharmacotherapeutic group:

MIBP vaccine.

ATX code:

J07BK01.

Immunological properties

Immunological and epidemiological efficacy The immunological effectiveness of Varilrix® vaccine for the prevention of varicella (cases confirmed by PCR or exposure to a clinically confirmed case of varicella) was assessed in a large international clinical trial with an active control group in children aged 12-22 months. received one dose of Varilrix® vaccine or two doses of a combination vaccine to prevent measles, mumps, rubella and varicella.

The immunological effectiveness of vaccination with the Varilrix® vaccine was:

Administration of 1 dose of Varilrix® vaccine reduced the number of hospitalizations for chickenpox and the number of outpatient visits among children by 81% and 87%, respectively. The epidemiological effectiveness of 1 dose of Varilrix® vaccine was assessed in various settings (outbreaks, case-control studies, study databases), the effectiveness value ranged from 20 to 92% against chickenpox of any severity and from 86 to 100% against chickenpox of moderate or severe severity.

Epidemiological efficacy data indicate an increase in protection and a decrease in the incidence of breakthrough episodes of varicella after 2 doses of the vaccine compared with 1 dose.

Immune response Healthy individuals In children aged 11 to 21 months inclusive, seroconversion measured by enzyme immunoassay (50 mIU/ml) 6 weeks after vaccination was 89.6% after 1 dose and 100% after 2 doses of vaccine.

In all children aged 9 months to 12 years inclusive, seroconversion, measured by immunofluorescence reaction 6 weeks after administration of 1 dose, reached 98%.

In children aged 9 months to 6 years, seroconversion, measured by immunofluorescence reaction 6 weeks after the second dose of the vaccine, was 100% (an increase in the geometric mean antibody titer by 5-26 times).

In children aged 13 years and older, seroconversion, as measured by immunofluorescence reaction 6 weeks after the second dose of the vaccine, was 100%. At control 1 year after the vaccination course, all individuals were seropositive.

Clinical studies have shown that the majority of vaccinated people who were subsequently in contact with sick people are either not susceptible to infection or experience a much milder form of the disease (fewer rashes, no fever).

There is insufficient data to assess the level of protection against the development of complications of chickenpox, such as encephalitis, hepatitis or pneumonia.

Data from clinical studies on the use of Varilrix® vaccine in patients at high risk of developing chickenpox are limited. The overall seroconversion rate in patients in this category was found to be ≥ 80%.

In patients at high risk, after vaccination, the titer of antibodies to the varicella zoster virus should be periodically determined to decide whether additional vaccination is necessary.

Indications for use

— Planned prevention of chickenpox from 12 months, primarily in persons classified as high-risk groups (see section “Special instructions”) who have not had chickenpox and have not been vaccinated previously. — Emergency prevention of chickenpox in persons who have not had chickenpox and have not been vaccinated previously, who were in close contact with patients with chickenpox (family members, doctors, paramedical and junior medical personnel, as well as other persons).

Contraindications

- Hypersensitivity to any component of the vaccine, including neomycin; symptoms of hypersensitivity to previous administration of chickenpox vaccine. - Severe humoral or cellular immunodeficiencies, such as: primary or acquired immunodeficiency (developed as a result of leukemia, lymphoma, blood dyscrasia, clinical manifestations of HIV infection, use of immunosuppressants, including high-dose corticosteroid therapy), defined by the number of lymphocytes - less than 1200 / mm3, and also in the presence of other signs of cellular immunodeficiency. — Acute infectious and non-infectious diseases, exacerbation of chronic diseases are temporary contraindications for vaccinations; for mild ARVI and acute intestinal diseases, vaccination is carried out immediately after the temperature has normalized. — Pregnancy or planned pregnancy within 1 month after vaccination. Breastfeeding period.

Use during pregnancy and breastfeeding

Fertility No data available.

Pregnancy Pregnant women should not be vaccinated with Varilrix®. Pregnancy should not occur within 1 month after vaccination. Women planning pregnancy should be advised to delay pregnancy. There are no adequate data on the use of Varilrix in humans during pregnancy, and reproductive toxicity studies have not been conducted in animals.

Breastfeeding period There are no data on use in women during breastfeeding.

Directions for use and doses

Method of administration Varilrix® vaccine is intended for subcutaneous administration. The vaccine should be injected into the deltoid muscle or anterolateral thigh area.

Varilrix® vaccine should not be administered intravascularly or intradermally. Before use, the solvent and reconstituted vaccine must be visually checked for the absence of mechanical inclusions and/or changes in appearance (see section “Description”). If they are detected, you should stop using the solvent or reconstituted vaccine. Varilrix® vaccine cannot be mixed in the same syringe with other vaccines.

Preparation of the vaccine before administration using a diluent in a syringe Varilrix® vaccine must be reconstituted by adding the full volume of diluent from a pre-filled syringe to the vial containing the lyophilisate.

Attention! The packaging of the Varilrix® vaccine can be presented in two types of syringes, differing in the way the needle is connected to the syringe nozzle.

To select the correct method for connecting the needle and syringe, follow the instructions below. The syringe included in the Varilrix® vaccine package may differ slightly from the syringe shown in Figure 1.

Type 1 syringe Instructions for preparing a type 1 syringe for use: 1. Unscrew the protective cap of the syringe by turning it counterclockwise (while holding the syringe by the barrel, avoiding contact with the syringe piston). 2. Using a clockwise twisting motion, connect the needle to the syringe until you feel them click into place. 3. Remove the protective cap from the needle (in some cases it may be tightly attached to the needle).

Syringe type 2 If the package contains a syringe other than type 1, then after removing the protective cap from the nose of the syringe, the needle is inserted onto the syringe until it stops without additional twisting.

Transfer the solvent from the syringe into the vial with the lyophilisate. After adding the solvent to the lyophilisate, shake the resulting suspension well until the lyophilisate is completely dissolved in the solvent (approximately 3 minutes). After recovery, the vaccine must be administered immediately. A new needle should be used to administer the vaccine. For administration, all its contents are removed from the vial with the reconstituted vaccine.

Preparation of the vaccine before administration using the solvent in the Varilrix® ampoule must be reconstituted by adding the full volume of the solvent from the ampoule to the vial containing the lyophilisate.

After adding the solvent to the lyophilisate, shake the resulting suspension well until the lyophilisate is completely dissolved in the solvent (approximately 3 minutes). After recovery, the vaccine must be administered immediately. A new needle should be used to administer the vaccine. For administration, all its contents are removed from the vial with the reconstituted vaccine.

After treating the injection site with alcohol or another substance used for disinfection, you should wait until this substance evaporates, since contact with such compounds may inactivate the vaccine virus.

The vaccine should be administered immediately after diluting it with a solvent.

Unused drug and waste from its use must be destroyed in accordance with the requirements adopted in the Russian Federation.

Vaccination regimens Planned prevention 1 dose of vaccine (0.5 ml) twice. The recommended minimum interval between vaccinations is 6 weeks.

Emergency prophylaxis Vaccination is carried out once with 1 dose of vaccine (0.5 ml) within the first 96 hours after contact (preferably within the first 72 hours).

Vaccination of high-risk groups Patients with acute leukemia, patients with severe chronic diseases and patients receiving immunosuppressant therapy and radiation therapy Immunization is carried out in a state of complete hematological remission. In this case, it is necessary to make sure that the total number of lymphocytes is at least 1200/mm3, and that there are no symptoms indicating a deficiency of cellular immunity.

If vaccination is planned to be carried out in the acute phase of leukemia, it is necessary to interrupt chemotherapy for a period of one week before and one week after vaccination. Vaccination should not be carried out during periods of radiation therapy.

Patients scheduled for organ transplantation If patients are scheduled for organ transplantation, the vaccination course should be completed several weeks before starting immunosuppressant therapy.

High-risk patients may require additional doses of the vaccine. The decision on the need to administer additional doses of the Varilrix® vaccine is made by the attending physician (immunohematologist, oncologist, transplantologist).

Interchangeability of Vaccines Varilrix® Vaccine can be given to those who have already been vaccinated with another vaccine containing a component to prevent chickenpox. A course of varicella vaccination started with Varilrix® can be continued with another vaccine containing a component for the prevention of varicella.

Side effect

Clinical Study Data Healthy Subjects The vaccine safety profile shown below is based on data obtained from 5,369 vaccine doses administered to children, adolescents and adults.

The adverse reactions presented below are listed according to the damage to organs and organ systems and the frequency of occurrence. The frequency of occurrence is defined as follows: very common (≥ 1/10), common (≥ 1/100 and < 1/10), uncommon (≥ 1/1,000 and < 1/100), rare (≥ 1/10,000 and <1/1,000), very rare (<1/10,000, including isolated cases).

Frequency of occurrence of adverse reactions Infectious and parasitic diseases Uncommon: upper respiratory tract infections, pharyngitis.

Blood and lymphatic system disorders Uncommon: lymphadenopathy.

Mental disorders Uncommon: irritability.

Nervous system disorders Uncommon: headache, drowsiness.

Visual disorders Rare: conjunctivitis.

Respiratory, thoracic and mediastinal disorders Uncommon: cough, rhinitis.

Gastrointestinal disorders Uncommon: nausea, vomiting. Rarely: abdominal pain, diarrhea.

Skin and subcutaneous tissue disorders Common: rash. Uncommon: rash similar to chickenpox, pruritis. Rarely: urticaria.

Musculoskeletal and connective tissue disorders Uncommon: arthralgia, myalgia.

General disorders and disorders at the injection site Very common: pain and redness at the injection site. Common: swelling at the injection site, increased body temperature (rectal ≥ 38 °C, axillary or oral ≥ 37.5 °C).

Swelling at the injection site and increased body temperature were very common in studies conducted in adolescents and adults. Swelling is also very common after the second dose in children under 13 years of age. The trend for increased incidence of pain, redness and swelling at the injection site after the second dose was comparable to the incidence of these adverse reactions observed after the first dose. Uncommon: increased body temperature (rectal ≥ 39.5°C; axillary or oral > 39°C), weakness, malaise.

There were no differences between the reactogenicity profile of initially seropositive and seronegative individuals.

High-risk patients There are only limited data from clinical studies among patients at increased risk of complications from varicella. Vaccine-associated reactions (mainly papulovesicular rash and fever) are usually mild. As in healthy individuals, redness, swelling and pain at the injection site are mild and transient.

Data from post-registration surveillance During post-registration surveillance, the following adverse reactions after vaccination were additionally registered.

Infectious and parasitic diseases Rare: infection caused by Herpes Zoster.

Blood and lymphatic system disorders Rare: thrombocytopenia.

Immune system disorders Rare: hypersensitivity reactions, anaphylactic reactions.

Nervous system disorders Rare: encephalitis, acute cerebrovascular accident, cerebellitis, symptoms resembling cerebellitis (including transient gait disturbance and transient ataxia), convulsions.

Vascular disorders Rare: vasculitis (including Henoch-Schönlein purpura and Kawasaki syndrome).

Skin and subcutaneous tissue disorders Rare: erythema multiforme.

When observing the mass use of the vaccine, cases of anaphylactoid reactions were recorded.

Overdose

There have been isolated reports of accidental vaccine overdose. Some of them reported the development of symptoms such as lethargy and convulsions. In other cases, an overdose did not lead to the development of adverse events.

Interaction with other drugs

If a tuberculin test is necessary, it should be performed before vaccination, since according to available data, live viral vaccines can cause a temporary decrease in skin sensitivity to tuberculin. Due to the fact that such a decrease in sensitivity can persist for up to 6 weeks, tuberculin testing should not be performed within the specified period of time after vaccination to avoid obtaining false negative results.

Vaccination with Varilrix® is possible no earlier than 3 months after the administration of immunoglobulins or after blood transfusion.

Salicylates should be avoided for 6 weeks after vaccination with Varilrix, as there have been reports of Reye's syndrome secondary to naturally occurring varicella-zoster virus infection.

Simultaneous administration with other vaccines Varilrix® vaccine can be administered simultaneously with inactivated vaccines of the national preventive vaccination schedule and the vaccination schedule for epidemic indications, with the exception of rabies vaccine.

Varilrix® vaccine can be given on the same day as vaccines to prevent measles, rubella and mumps.

In this case, different vaccines are administered to different parts of the body.

Healthy individuals Varilrix® can be used simultaneously with any other vaccines. When used with measles vaccine, if the vaccinations were not given on the same day, it is recommended to maintain an interval of 30 days.

High-Risk Patients Varilrix® should not be administered concomitantly with other live attenuated vaccines, with the exception of the combination measles, rubella and mumps vaccine. However, if these vaccines were not prescribed at the same time, then the interval between their administration to achieve maximum antibody levels should be at least 30 days.

special instructions

As with any vaccination, not everyone vaccinated may develop an immune response.

As with the use of other vaccines to prevent chickenpox, cases of chickenpox have been reported in individuals vaccinated with the Varilrix® vaccine. However, such cases of chickenpox are usually mild, with few rashes and less fever than cases of chickenpox in unvaccinated individuals. There have been rare cases of transmission of the vaccine strain of the virus from vaccinated individuals with rash to contact seronegative individuals. Transmission of the vaccine strain of the virus to contact seronegative persons from vaccinated persons cannot be ruled out if the latter do not have a rash.

If vaccinated within the first 72 hours of exposure to naturally occurring varicella-zoster virus infection, protection against chickenpox may not be fully achieved.

Vaccinated individuals who develop a rash within 3 weeks of vaccination should avoid any contact with pregnant women (especially during the first trimester of pregnancy) and immunocompromised individuals for 14 days after the last rash appeared.

As with the parenteral administration of any other vaccine, everything necessary should be ready to stop a possible anaphylactic reaction to the Varilrix® vaccine. The vaccinated person must be under medical supervision for 30 minutes after immunization.

After vaccination or sometimes before it, fainting (loss of consciousness) is possible as a psychological reaction to the injection. Before vaccination, it is important to ensure that the patient will not be harmed if they faint.

Adequate contraceptive measures should be taken for 1 month after administration of the Varilrix® vaccine.

Data on the use of Varilrix® vaccine in people with immunocompromised conditions are limited, so vaccination should be used with caution and only when, in the opinion of a physician, the benefit outweighs the risk.

In persons with immunodeficiency conditions who do not have contraindications to vaccination (section “Contraindications”), as well as in immunocompetent patients, an immune protective reaction may not be detected; accordingly, some vaccinated people may become infected with chickenpox, despite proper vaccination. Persons with immunocompromised conditions should be closely monitored for signs of chickenpox.

Isolated cases of dissemination of the varicella zoster virus involving internal organs after vaccination with a drug containing the Oka strain have been reported, mainly in patients with immunodeficiency.

In the presence of primary or acquired immunodeficiency, vaccination is carried out after determining the number of lymphocytes. Patients receiving extensive immunosuppressant therapy may develop clinical signs of varicella after vaccination.

High-Risk Patients The following groups of people are predisposed to developing severe chickenpox:

— patients with acute leukemia; - patients receiving immunosuppressant therapy, including the use of corticosteroids for malignant solid tumors or severe chronic diseases (renal failure, autoimmune diseases, collagenosis, severe bronchial asthma); — patients who are planning to undergo a transplant operation; - patients with severe chronic diseases, such as metabolic and endocrine disorders, chronic lung and cardiovascular diseases, cystic fibrosis and neuromuscular disorders.

Immunizing people at high risk against chickenpox with Varilrix® vaccine can reduce the risk of developing complications caused by chickenpox.

To further reduce the risk of infection in high-risk patients, it is also recommended that persons in close contact with chickenpox patients or high-risk patients be vaccinated. This category includes parents, siblings of high-risk patients, senior and nursing staff and other persons who were in close contact with persons with chickenpox.

Impact on the ability to drive vehicles and machinery

Not installed.

Release form

Lyophilisate for preparing a solution for subcutaneous administration.

Lyophilisate 1 dose of vaccine in a transparent glass bottle of type I (Eur.F.) with a capacity of 3 ml, sealed with a rubber stopper and an aluminum cap for rolling, equipped with a protective plastic cap.

Solvent 0.5 ml in a clear glass ampoule type I (Eur.F.) with a capacity of 1 ml. 0.5 ml in a syringe made of transparent glass type I (Eur.F.) with a capacity of 1.25 ml. The syringe nozzle is hermetically sealed with a protective rubber cap or a sealed rubber stopper with a protective screw-on plastic cap.

Contents: 1 bottle with lyophilisate, 1 ampoule with solvent in a polyvinyl chloride blister covered with polyethylene terephthalate film. 1 blister with instructions for use in a cardboard box. 1 bottle with lyophilisate, 1 syringe with solvent in a polyvinyl chloride blister covered with polyethylene terephthalate film. 1 blister with instructions for use in a cardboard box. 1 bottle with lyophilisate, 1 syringe with solvent complete with 1 needle in a separate plastic container with a cannula closed with a plastic cap, in a polyvinyl chloride blister covered with polyethylene terephthalate film. 1 blister with instructions for use in a cardboard box. 1 bottle with lyophilisate, 1 syringe with solvent complete with 2 needles in separate plastic containers with cannulas closed with plastic caps, in a polyvinyl chloride blister covered with polyethylene terephthalate film. 1 blister with instructions for use in a cardboard box. 100 bottles of lyophilisate with 1 or 10 instructions for use in a cardboard box. 25 ampoules with solvent in a blister made of polyvinyl chloride or polyethylene, covered with film, or without film. 4 blisters in a cardboard box.

Best before date

Lyophilisate: 2 years. Solvent: 5 years. The expiration date of the kit is indicated by the shortest expiration date of one of the components. Do not use after the expiration date stated on the package. The expiration date is the last day of the month indicated on the packaging.

Storage conditions

Lyophilisate Store at a temperature of 2 to 8°C. Store in a place protected from light.

Solvent Store at temperatures from 2 to 25°C. Do not freeze.

Kit (lyophilisate, solvent, with or without needles) Store at a temperature of 2 to 8°C. Do not freeze. Store in a place protected from light. Keep out of the reach of children.

Transportation conditions

Lyophilisate Transport at a temperature of 2 to 8°C.

Solvent Transport at temperatures from 2 to 25°C. Do not freeze.

Kit (lyophilisate, solvent, with or without needles) Transport at a temperature of 2 to 8°C. Do not freeze.

Vacation conditions

A package containing 1 bottle of lyophilisate and 1 ampoule or syringe with a solvent is available with a prescription. A package containing 100 vials of vaccine, a package containing 100 ampoules with a solvent - for medical institutions.

Manufacturer

Manufacturer of the finished dosage form Lyophilisate GlaxoSmithKline Biologicals SA, Belgium Corixa Corporation, USA Solvent Aspen Notre Dame de Bondeville, France Delpharm Tour, France Catalent Belgium SA, Belgium

Packer (primary packaging) Lyophilisate GlaxoSmithKline Biologicals SA, Belgium Corixa Corporation, USA Solvent Aspen Notre Dame de Bondeville, France Delpharm Tour, France Catalent Belgium SA, Belgium

Packer (secondary (consumer) packaging) GlaxoSmithKline Biologicals SA, Belgium Delpharm Tour, France (for solvent release form of 100 ampoules) SmithKline Beecham-Biomed LLC, Russia

Release quality control "GlaxoSmithKline Biologicals S.A." / GlaxoSmithKline Biologicals sa Rue de l'Enstitut, 89, 1330 Rixensart, Belgium / Rue de l'Institut, 89, 1330 Rixensart, Belgium SmithKline Beecham-Biomed LLC Russia, Moscow region, Krasnogorsk district, p. Petrovo-Dalnee

Name and address of the holder or holder of the registration certificate for the medicinal product

JSC GlaxoSmithKline Trading, Russia 125167, Moscow, Leningradsky Prospekt, 37A, building 4, floor 3, room XV, room 1

Complaints regarding the quality of the drug and the development of post-vaccination complications should be sent to: Federal Service for Surveillance in Healthcare (Roszdravnadzor) 109074, Russia, Moscow, Slavyanskaya Square, 4, bldg. 1 and JSC GlaxoSmithKline Trading, Russia 125167, g Moscow, Leningradsky Prospekt, 37A, building 4, floor 3, room XV, room 1

additional information

For emergency prevention, the vaccine can be used in the first 96 hours. Time is counted not from the moment the patient is diagnosed, but from the moment of last contact with the patient with chickenpox.

The Varilrix® vaccine protects only against chickenpox and does not protect against other diseases accompanied by skin lesions and other diseases caused by viruses of the herpes family.

Women of childbearing age are advised to protect themselves from pregnancy for 1 month before vaccination and 2 months after vaccination.

How is vaccination carried out?

Vaccination is carried out in a vaccination room, in compliance with all sanitary requirements. All drugs are certified. A certificate for the drug is provided upon request.

Without reminders, before vaccination, the medical worker must show the drug and the expiration date of the vaccine.

Only sterile and disposable instruments are used. The vaccination must be carried out using disposable medical gloves.

On the day of vaccination, the child is examined by a pediatrician and the temperature is measured. In the absence of contraindications, vaccination is carried out. Information about the vaccination performed is entered into the card, vaccination certificate, and detailed recommendations for caring for the child in the post-vaccination period are given.

Before vaccination, the doctor will answer all your questions. Be sure to bring information about previous vaccinations to your appointment!

Please note that vaccination of a child, Mantoux test, Diaskintest can only be carried out in the presence of parents or legal representatives of the child (guardians), or if the accompanying person has a NOTARIZED power of attorney to carry out the manipulation (indicating the drug planned for administration) . Otherwise, vaccination will be denied. We comply with the laws of the Russian Federation.

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