VARILRIKS

Active material: live attenuated varicella vaccine.
When ATH: J07BK01
CCF: A vaccine for the prevention of chickenpox
ICD-10 codes (testimony): Z 25.8
When CSF: 14.03.01.22
Manufacturer: GlaxoSmithKline Trading Company (Russia)

Pharmaceutical form, composition and packaging

Valium for drug of a solution for s / c administration as an amorphous mass or powder from cream-yellow to light yellow in colour.

Excipients: human serum albumin, neomycin sulfate, lactose, sorbitol, mannitol, amino acids.

Solvent: water d / and – 0.5 ml.

1 dose (0.5 ml) – glass bottles with capacity 3 ml (1) together with the solvent (amp. 1 PC.) – blisters: polyethylene (1) – packs cardboard.
1 dose (0.5 ml) – glass bottles with capacity 3 ml (1) together with the solvent (syringe 1 PC.) – blisters: polyethylene (1) – packs cardboard.
1 dose (0.5 ml) – glass bottles with capacity 3 ml (1) together with the solvent (syringe 1 PC. from 1 or 2 needles) – blisters: polyethylene (1) – packs cardboard.

Pharmacological action

Live attenuated varicella vaccine.

Varilriks vaccine^® causes the production of antibodies to varicella-zoster virus, providing specific protection against infection.

Immunological efficiency

Healthy subjects

Level of seroconversion in healthy children from 9 Months before 12 years inclusive, defined through 6 weeks after vaccination, exceeded 98% and stored, at least, during 7 years after vaccination.

Level of seroconversion, defined in children 13 years, After double vaccination, was 100% and maintained for at least 1 year.

Clinical studies have shown, that the majority of vaccinees, were subsequently in contact with sick people, either they are not susceptible to infection, or carry disease in much more mild form (fewer lesions, absence of fever). In one of the studies was also demonstrated 100% protection against standard clinical manifestations of varicella and 88% protection against all manifestations of infection, a virus called Varicella (ocenivavshejsja least one precipitation).

High risk patients

Chickenpox is an important risk factor, which current and forecast available serious disease in the following groups of patients:

-patients with acute leukemia;

- Patients, receiving the therapy immunodepressantami, including corticosteroids;

- Patients, that you want to perform the transplant operation;

- Patients, suffering from severe chronic diseases, such as metabolic and endocrine disorders, chronic lung disease and cardiovascular system, Cystic Fibrosis and neuromuscular disturbances also may be factors, the demand forecast at disease chicken pox;

-healthy people, being in close contact with sick people or high risk groups, bolevshie not chicken pox and not previously vaccinated.

Patients from the above groups, receiving the therapy immunodepressantami (including corticosteroids) for malignant solid tumors or chronic diseases (renal failure, autoimmune diseases, collagenoses, severe bronchial asthma), predisposed to the disease chicken pox in severe form.

In patients of high risk level of seroconversion is 80%, and in patients with leukemia – about 90%.

In patients in high-risk groups recommended periodical determination of the titers of antibodies to varicella-zoster virus to decide whether revaccination.

In one study, it was found, the incidence of chicken pox among patients with leukemia was lower in vaccinated patients, than patients, which was not carried out vaccination and who were infected naturally.

Vaccine virus was registered among brothers and sisters with immune deficiency, However, infected children skin manifestations were weakly expressed.

Pharmacokinetics

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Testimony

Prevention of varicella with 12 Months, primarily of persons, classified as high-risk groups, not exclude chickenpox and not previously vaccinated;

— emergency prevention of varicella in persons, not exclude chickenpox and not previously vaccinated, staying in close contact with sick chicken pox (family members, doctors, Middle and junior medical staff, as well as other persons).

Dosage regimen

Varilriks Vaccine^® designed for p/to the introduction.

For the preparation of injection solution should shift the contents of sealed or syringe with diluent into the vial with liofilizatom, shake well the formed slurry before full dissolution liofilizata (about 3 m), then dial in the syringe.

Cooked solution transparent yellow-pink to pink, no sediment and visible inclusions.

Before the introduction of the vaccine, please inspect contents of bottle to detect foreign particles and changing the appearance of. If the vaccine discovered any abnormalities, such packaging shall be destroyed. After processing, the venue for the injection of alcohol or another substance, applied for disinfection, should wait, While this substance will evaporate, Since when in contact with these compounds can occur inactivation vaccine virus.

The vaccine should be injected immediately after its dilution solvent.

Vaccination scheme

Children 12 Months before 13 years – 1 dose of vaccine (0.5 ml) single.

Persons over the age of 13 years (including contact with high-risk groups and the ill) – by 1 dose (0.5 ml) investigated at intervals between wvedeniami 6-10 weeks.

Vaccination of high-risk groups

Patients with acute leukemia, patients with severe chronic illness and patients, receiving the therapy immunodepressantami and radiation therapy.

Immunization such patients in a State of complete hematological remission of the disease. It is necessary to ensure, the total number of lymphocytes is not less than 1200/µl, and there are no symptoms, pointing to the lack of cellular immunity.

If vaccination of patients is scheduled to take place in the acute phase of leukemia, you need to stop chemotherapy for a period, equal one week before and one week after vaccination. Vaccination should not be conducted during periods of radiation therapy.

Patients, which organ transplantation is scheduled

If patients have to organ transplantation (eg, kidneys), the vaccination should be a few weeks before the start of the therapy immunodepressantami.

Emergency prevention

Vaccines hold momentarily 1 dose of vaccine (0.5 ml) during the first 96 h after contact (preferably within the first 72 no).

Side effect

Healthy persons

The safety profile of the vaccine is based on the data, received for 5369 vaccine doses, administered to children, adolescents and adults. Reactions were recorded during 42 days after vaccination.

The frequency of reactions were determined as follows:: Often (≥10%), often (≥1%, but <10%), sometimes (≥0.1%, but <1%), rarely (≥0.01%, but <0.1%), rarely (<0.01%).

CNS: sometimes – headache, drowsiness.

On the part of the organ of vision: rarely – conjunctivitis.

The respiratory system: sometimes – rhinitis, cough, infections of the upper respiratory tract, pharyngitis.

From the digestive system: sometimes – diarrhea, vomiting; rarely – stomach ache.

Dermatological reactions: often – rash; sometimes – rash, similar to a rash with chicken pox, prurit; rarely – hives.

On the part of the musculoskeletal system: sometimes – arthralgia, myalgia.

From the body as a whole: sometimes – lymphadenopathy, often – temperature rise (rectal ≥ 38° c, Axilla/oral cavity ≥ 37.5° c); sometimes – temperature rise (rectal ≥ 39.5° c, Axilla/oral cavity ≥ 39° c), weakness, malaise.

Local reactions: Often – pain and redness at the injection site; often – swelling at the injection site.

When monitoring the massive use of vaccines, there were reports of reactions and symptoms, considered as temporarily associated (not necessarily associated) with vaccination.

CNS: convulsions, ataxia.

There are: infection, caused by the virus Herpes zoster, hypersensitivity reactions, allergic reactions (including anaphylacticskie and anaphylactoidnye reaction).

An average of reactogennosti vaccine when administered a second dose (revaccination) does not exceed reactogennosti of the first dose. Also not noted differences in the profile of the vaccine safety from seronegative and seropositive subjects.

High-risk patients

Reactions at the injection of the vaccine are usually mild.

Delayed-vezikuleznaja rash, in rare cases, accompanied by non-severe or moderate fever, can appear in a period from several days to several weeks after vaccination.

Contraindications

is the primary or acquired immune deficiency (developed as a result of leukemia, lymphoma, blood diskrazii, clinical manifestations of HIV infection, application of immunosuppressants, including high-dose corticosteroid therapy), defined by the number of lymphocytes (<1200/l), and also if there are other signs of cellular immunodeficiency;

-acute infectious and non-infectious diseases, exacerbation of chronic diseases are temporary contraindications for conducting vaccination; in netagelah VIRAL RESPIRATORY INFECTIONS, acute intestinal diseases vaccinations are immediately after the normalization of the temperature;

-pregnancy or planned pregnancy during 3 Months;

- Lactation (breast-feeding);

-hypersensitivity to any component of the vaccine (incl. to neomitino);

-symptoms of hypersensitivity to the previous vaccine Varilriks^® .

Pregnancy and lactation

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

Cautions

With the introduction of vaccine Varilriks^® must be all the necessary preparations and remedies for edema possible anaphylactic reaction. Vaccinated should be under medical supervision during 30 min after immunization.

Should take appropriate measures of contraception during 3 months after vaccination Varilriksom^® .

If there is a primary immunodeficiency or should be carried out to determine the number of lymphocytes.

Varilriks Vaccine^® should not be injected intracutaneously and/386/1989.

Patients, who receive massive therapy immunodepressantami, after vaccination may develop chicken pox with clinical signs.

In extremely rare cases, the vaccine virus transmission was registered. Therefore, vaccinated individuals should avoid contact with pregnant women, because they are particularly susceptible to chicken pox (mainly in the first trimester), as well as with persons from high-risk diseases chicken pox in severe form (eg, with patients with leukaemia or receiving treatment immunodepressantami). In cases, When there is no possibility to prevent contact with the above persons, You should weigh the potential risk of transmission of the virus vaccine and compare it with the risk of becoming infected and transmit natural chicken pox virus.

Vaccinated patients, which identifies the precipitation during the 3 weeks after vaccination, must exclude any contact with pregnant women (mainly in the first trimester) and immuno.

Effects on ability to drive vehicles and management mechanisms

Impact on the ability of concentration it is unlikely.

Overdose

Registered individual reports of accidental overdose of vaccine. Some messages have included a description of symptoms such as lethargy, convulsions.

Drug Interactions

Varilriks vaccine^® Perhaps no earlier, than 3 months after the introduction of immunoglobulins or after blood transfusion.

You should avoid salicylates for 6 weeks after vaccination Varilriksom^® , Since there were isolated reports of the development of the syndrome Rayee amid infection, caused by the varicella-zoster virus.

The vaccine may be administered concurrently with inactivated vaccines national calendar of preventive vaccination calendar and RF vaccination in case of RF, with the exception of rabies vaccine.

The simultaneous appointment Varilriks vaccine^® with a vaccine against measles-mumps-rubella vaccine or diphtheria-tetanus-pertussis does not diminish the immune response and does not increase the reactogennosti vaccine Varilriks^® .

A combined vaccine against measles-rubella vaccine-mumps and varicella vaccine can be administered at the same time when introducing them to different places. But, If these vaccines has not been assigned at the same time, the interval between their appointment to achieve the maximum level of antibodies must be at least 30 days.

Between the rounds Varilriksom^® and other vaccines, In addition to the above, the interval between wvedeniami must be not less than 1 Months.

When conducting simultaneous vaccination of multiple drugs must be taken into account contraindications for each of the vaccines.

All vaccines are administered different needles in different place of injection.

High-risk patients Varilriks^® You cannot enter simultaneously with other live attenuated viral vaccines. Other vaccine for introduction in the form of injections should be introduced in different places.

Conditions of supply of pharmacies

The drug is released under the prescription.

Conditions and terms

The vaccine should be stored and transported at a temperature of 2 ° to 8 ° C; Do not freeze.

Solvent (in packages of 100 ampoules) should be stored at a temperature between 2° to 25° c.

Keep out of the reach of children.

The shelf-life of vaccines – 2 year, Solvent – 5 years.