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

Varilrix - Live attenuated chickenpox vaccine Registration number: LSR-001354/08 Trade name: Varilrix International nonproprietary or chemical name: Vaccine for the prevention of chickenpox Dosage form: lyophilisate for the preparation of a solution for subcutaneous administration. 1 dose / complete with solvent - water for injection Country of origin: GlaxoSmithKline Biologicals, Belgium Preliminary examination: not required Vaccine cost: 4500 rubles (examination before vaccination is additionally paid) Applicable: For children and adults Dispensing conditions from pharmacies: 1 bottle with lyophilisate and an ampoule or syringe with a solvent - according to a doctor’s prescription, 100 bottles of vaccine or 100 ampoules with a solvent - for medical institutions. Availability of vaccine: in stock Analogues of this vaccine: no.

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DESCRIPTION OF THE MEDICINE

Varilrix , a live attenuated vaccine for the prevention of chickenpox, 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 drugs.

Appearance: creamy yellow to light yellow amorphous mass or powder. Pharmacotherapeutic group: MIBP - vaccine. ATX code: J07BK01.

Immunological properties

Administration of the Varilrix vaccine causes the production of antibodies to the varicella zoster virus, providing specific protection against this infection. Some degree of protection can be achieved if immunized within 72 hours of exposure to Varicella Zoster virus. Antibody titer ≥1/4: determined by the NRIF method, is considered protective.

Effect on healthy people

Almost all healthy children aged 9 months to 12 years inclusive showed a level of protection six weeks after vaccination that persisted for at least 7 years after vaccination.

However, isolated cases of disease caused by the wild strain of Varicella Zoster have been reported in children who received 1 dose of Varilrix vaccine more than 42 days after vaccination. Administration of the 2nd dose effectively prevents cases of chickenpox infection. All children aged 13 years after two doses of vaccination had a significant level of protection that persisted for at least one year (during follow-up in the clinical trial). 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).

Impact on high-risk groups

Chickenpox is an important risk factor that worsens the course and prognosis of 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;
• 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 immunosuppressive therapy (including the use of corticosteroids) for malignant solid tumors or for severe chronic diseases (renal failure, autoimmune diseases, systemic connective tissue diseases, severe bronchial asthma) are predisposed to severe chickenpox.

In patients at high risk, antibody titers to the varicella zoster virus should be periodically determined to determine the need for additional vaccination.

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 side of 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.

INDICATIONS FOR USE

• Planned prophylaxis of chickenpox from 9 months in persons who have not had chickenpox and have not been vaccinated previously, as well as in persons classified as high-risk groups (see section “Special instructions”).
• Planned prevention of chickenpox in a healthy environment of people classified as risk groups who have not had chickenpox and have not been vaccinated previously (see section “Special instructions”).
• Emergency prevention of chickenpox in persons who have not had chickenpox and have not been vaccinated previously, and who have been in close contact with patients with chickenpox.

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.

CONTRAINDICATIONS

• Hypersensitivity to any component of the vaccine, including neomycin; symptoms of hypersensitivity to previous administration of the Varilrix vaccine;
• 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 - less than 1200 lymphocytes/mm3, 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 three months. Breastfeeding period.

PRECAUTIONARY MEASURES

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

Adequate contraception should be taken for three months after vaccination with Varilrix.

In the presence of primary or acquired immunodeficiency, vaccination is carried out after determining the number of lymphocytes. Varilrix* should not be administered intradermally and under no circumstances should it be administered intravenously.

Patients receiving extensive immunosuppressant therapy may develop clinical signs of varicella after vaccination.

Vacation conditions

The vaccine is available with a doctor's prescription. The cost of the drug in Moscow depends on the dosage. For medical institutions, special packages of 100 ampoules are produced for mass vaccination in the clinic. You can check the price by calling the center's contact number.

*Preliminary inspection is paid separately.

METHOD OF APPLICATION AND DOSAGE

The 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).

Method for preparing vaccine solution

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. To administer the prepared solution, you must use a new needle. The prepared solution is transparent from yellow-pink to pink, without sediment and visible foreign inclusions.

Before administering the vaccine, the contents should be inspected for foreign particles and changes in appearance. If any deviations from the norm are found in the vaccine, then such packaging must be destroyed.

The preferred site for administration of the Varilrix vaccine is the deltoid region of the shoulder or the anterolateral region of the thigh . 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.

VARILRIX VACCINATION

Routine prophylaxis: 1 dose of vaccine (0.5 ml) twice for children aged 9 to 12 months, the second dose should be administered 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.

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 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).

Emergency vaccination

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).

Interchangeability of vaccines:

Varilrix can be given to people who have already been vaccinated with another vaccine to prevent chickenpox.

A course of varicella vaccination started with Varilrix can be continued with another varicella vaccine.

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.

SIDE EFFECTS

The vaccine safety profile below is based on data obtained from 5,369 vaccine doses administered to children, adolescents and adults.

Possible side effects

• Upper respiratory tract infections, pharyngitis;
• Imphadenopathy, irritability;
• Headache, drowsiness;
• Conjunctivitis;
• Rhinitis, cough;
• Nausea, vomiting;
• Abdominal pain, diarrhea;
• Arthralgia, myalgia;
• Any exanthema that is not visually similar to vesiculosis caused by Varicella Zoster;
• A rash similar to that of chicken pox, pruritis;
• Hives;
• Pain and redness at the injection site;
• Swelling at the injection site, increased temperature (rectal t 38 C, axillary cavity/oral cavity: t 37.5 ° C). Swelling is also very common after the second dose in children under 13 years of age;
• Increased temperature (rectal t 39.5 °C; axillary cavity/oral cavity: t> 39 °C);
• Weakness, malaise.

Adverse reactions for high-risk groups

There are only limited data from clinical studies among patients at increased risk of complications from varicella. Vaccine-associated reactions were recorded, mainly papulovesicular rash and fever, which were mild .

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.

INTERACTIONS WITH OTHER MEDICINES

Vaccination with Varilrix is ​​possible no earlier than three 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 naturally occurring varicella-zoster virus infection.

Simultaneous administration with other vaccines

Varilrix 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.

Varilrix 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.

Varilrix can be used simultaneously with any other vaccines.

When used with measles vaccine, if the vaccinations were not given on the same day, an interval of 30 days is recommended.

Vaccination of patients from high-risk groups.

Varilrix should not be given concomitantly with other live attenuated vaccines, with the exception of the combined 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.

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

SPECIAL INSTRUCTIONS

Similar to other vaccines administered to prevent chickenpox, it has been shown to occur in individuals vaccinated with Varilrix.” There may be further cases of chickenpox. However, such cases of chickenpox are usually mild, with few rashes and coughing, compared to cases of chickenpox in unvaccinated individuals. It has been shown that in some cases transmission of the vaccine strain of the virus may occur among contacts of seronegative individuals. No transmission of the virus was observed from vaccinated individuals in the absence of skin lesions. Vaccinated patients 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 a period of 14 days from the last appearance of the rash.

When should the Varilrix vaccine not be given?

- if the test results do not comply with the standards

- at elevated temperature in a child

- in case of intolerance to the components contained in the Varilrix vaccine

- during exacerbation of chronic diseases

- in other cases mentioned by the pediatrician before vaccination

Additional Information

Is it possible to buy Varilrix from us or where to buy Varilrix in Moscow?

Medical and “Our Children” do not sell the Varilrix vaccine, we vaccinate.

Where to get the Varilrix vaccination in Moscow?

You can get the Varilrix vaccination in medical and “Our Children”, the Varilrix vaccine is available. Vaccination requires a mandatory examination before vaccination, the vaccination itself and observation after vaccination.

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RELEASE FORM

Lyophilisate: 0.5 ml (1 dose) in a transparent, colorless glass bottle, sealed with a rubber stopper and an aluminum cap for rolling in with a tear-off tab. Solvent:

• 0.5 ml per ampoule of transparent colorless glass;
• 0.5 ml in a 1 ml transparent colorless glass syringe with or without a needle. The needle cannulas are covered with a rubber cap. The syringe without a needle is closed with a rubber cap;
• 1 bottle of vaccine and 1 ampoule of solvent in a high-density polyethylene blister in a cardboard box with instructions for use;
• 1 bottle of vaccine, 1 syringe with solvent with 1 or 2 needles in a blister made of high-density polyethylene in a cardboard box with instructions for use;
• 1 bottle of vaccine, 1 syringe without a needle with a solvent in a blister of high-density polyethylene in a cardboard box with instructions for use;
• 100 vials of vaccine per cardboard pack with 10 instructions for use. Solvent, 25 ampoules in a polyethylene blister, 4 blisters in a separate cardboard pack.

CLAIMS

Complaints about the quality of the drug and the development of post-vaccination complications should be sent to:

1. National control body FSBI GISK named after. L.A. Tarasevich Ministry of Health and Social Development: 119002, Moscow, per. Sivtsev Vrazhek, 41. Tel.: +7 (499) 241-39-22, fax: +7 (499) 241-92-38;
2. CJSC GlaxoSmithKline Trading: 121614, Moscow, st. Krylatskaya, 17. bldg. 3, fl. 5 Business Park “Krylatsky Hills”. Tel.: +7 (495) 777-89-00, fax: (495) 777-89-04.