Vaccine against measles, mumps and rubella, live attenuated (lyophilized), Lyophilisate for preparing a solution for subcutaneous administration. Live attenuated vaccine against measles, mumps and rubella Instructions for use of mumps-measles vaccine

This combination drug is used to create stable immunity in the human body and prevent the above diseases. Let's find out everything about this vaccine in this article.

Description of the Priorix vaccine

"Priorix" is a powder from which a solution is made for intramuscular or subcutaneous administration. The bottle contains a white or pinkish powder with a slightly porous consistency. It comes with a solvent: 0.5 ml of water for injection. The diluted liquid has no odor, suspension or visible impurities.

When a drug is administered, the human body produces antibodies in response to foreign agents. Clinical studies were conducted on the Priorix vaccine, which showed quite high effectiveness. They have proven the detection of protective bodies against measles in 98% of those vaccinated, against mumps - in 96%, and against rubella - in 99%. A year later, a test for antibodies was taken again. Seropositivity (active antibodies) against measles and rubella was established in the same individuals, and against mumps - in 88% of those examined.

The manufacturer of Priorix is ​​the British company GlaxoSmithKline. It has been used in Russia since 2001.

Composition of the Priorix vaccine

The viruses in Priorix are attenuated, that is, they are contained in a weakened form. This means that they are not capable of causing disease, but they have all the necessary antigenic properties and cause a good immune response that can last for many years.

Viral bodies are propagated in chicken embryos (measles, mumps) and diploid human cells (rubella). Upon reaching the required quantity, they are weakened and made into a lyophilisate - dried in a special way while maintaining structural integrity and biological activity. The viruses are not inactivated, but only attenuated, that is, they cause a full response of the immune system, but no clinical manifestations are observed.

The Priorix vaccine contains the following strains of viruses:

• measles (Schwarz strain);
• mumps (Jeryl Lynn-strain);
• rubella (Wistar RA 27/3-strain).

In addition to weakened viruses, 1 dose of the vaccine contains:

• neomycin;
• lactose;
• mannitol;
• sorbitol;
• egg whites.

Indications and dosing

The vaccine is administered to prevent mumps, measles and rubella. The dose of one injection is 0.5 ml. Where do you get vaccinated against measles, rubella, mumps? The vaccine is administered subcutaneously or intramuscularly, but in no case intravenously.

The instructions for the Priorix vaccine say that the drug is administered:

• for the first time - to children in one year;
• for revaccination - for children aged 6 years;
• for the second revaccination, only for girls who have not been vaccinated or who have received only 1 vaccination - at 13 years of age.

According to the national Russian vaccination calendar "Priorix" the following is introduced:

• at 12 months;
• at 6 years old;
• at 15–17 years old;
• in 22–29 and each subsequent decade.

This vaccine can be used if there is no immunity to the above diseases within 72 hours of contact with a person with measles. It will provide some protection against this disease.

The solution is prepared immediately before administration. To do this, mix the solvent with the lyophilisate and shake, but not more than 1 minute. The solution has a light orange or reddish color. If it has a different color or contains impurities, particles or suspension, then such a vaccine cannot be administered. A sterile needle is used for insertion. You can wet the injection site. If the package is designed for several doses, then for each new dose of the drug you need to take a new needle and syringe. The prepared solution can be stored for 8 hours in the refrigerator.

Contraindications to the use of measles, rubella, mumps vaccination

Priorix should not be used if the immune system is weakened. But its use in people with HIV infection and AIDS has been proven to be safe if they are asymptomatic.

A caveat should be made that in cases of non-anaphylactic reactions to chicken eggs or contact dermatitis caused by neomycin, the vaccine can be administered.

Non-pregnant women of childbearing age can receive Priorix with the condition of birth control for about 3 months after the injection.

Persons with a family or personal history of allergic or convulsive reactions should be given the Priorix vaccine with caution. All vaccinated people with seizures or allergies are advised to be monitored after vaccination. Treatment rooms in which vaccinations are carried out must be equipped with an anti-shock first aid kit.

When performing an injection and treating the area with alcohol solutions, you need to make sure that all the alcohol from the surface of the skin evaporates, otherwise this may lead to the death of viruses. In this case, the vaccine will become useless.

Side effects of Priorix

Like any vaccine, Priorix has side effects.

Often appearing:

• rash;
• redness, swelling, pain at the injection site;
• fever.

Rarely occurring:

• hypertrophy of the parotid salivary glands;
• convulsive syndrome due to fever.

Very rare:

• manifestations from the respiratory system (rhinitis, bronchitis, cough);
• nausea and vomiting;
• loose stools;
• lack of appetite and weight loss;
• excessive excitability of the nervous system;
• sleep disorders (insomnia or drowsiness);
• acute otitis media;
• pathology of the lymphatic system.

Cases of Priorix overdose have not been described in clinical practice.

How is the measles, rubella, mumps vaccine tolerated?

How is Priorix tolerated? 60% of vaccinated people report the absence of any side effects, but in 40% they still occur. The most common reaction to the Priorix vaccine is an increase in body temperature. The maximum increase is observed up to 39–40 °C. She is considered normal. This indicates that the child’s immunity is working. The temperature after vaccination against measles, rubella and mumps is the body’s protective reaction to the introduction of foreign proteins. It will go away in a few days. After vaccination, for prevention, you can give the child a single dose of an antipyretic drug. The rash may appear all over the body or on specific parts of the body, such as the face or buttocks.

How is the vaccine against measles, rubella and mumps tolerated at 1 year of age? At this age, children are more likely to experience adverse reactions than at older ages. These are mainly fever and hives, runny nose, cough. These reactions may also occur delayed, after 9 days. This is the nature of vaccination. This phenomenon is explained by the fact that the composition contains not a killed, but a weakened virus, and the immune bodies for the response accumulate only after 5–10 days.

How is the measles, rubella and mumps vaccine tolerated at 6 years of age? At this age, the immune system is almost fully formed. Children tolerate vaccination well. A good immune response may not be accompanied by side effects at all.

Priorix combines well with other vaccines. It can be done on the same day as them, but use different syringes.

In isolated cases, complications may occur after vaccination with Priorix:

• encephalitis;
• serous meningitis;
• pneumonia;
• lymphopenia (low number of lymphocytes in the blood count);
• myocarditis;
• toxic shock caused by a “dirty” vaccine with microorganisms.

In adults, the most common complication is arthritis. And the older the age, the stronger it manifests itself.

Features of Priorix

According to its pharmacological action, Priorix is ​​classified as an immunomodulatory drug. As a result of its introduction, active acquired immunity is formed. With the help of revaccination, lifelong circulation of antibodies is achieved.

The vaccine against measles, rubella, mumps "Priorix" meets WHO standards and all requirements for vaccinations.

Many mothers ask the question: which is better - Priorix or the domestic vaccine? In Russia, only two-component vaccines against rubella and mumps are produced, which means that the measles vaccine will have to be vaccinated separately. Two injections involve more parts of the body, which means there is a higher risk of unwanted effects. In addition, Priorix is ​​rarely available in municipal clinics; most likely, you need to buy the vaccine yourself. And that's a lot of money.

Mumps and rubella vaccines are the most important in the vaccination schedule. After all, they protect against diseases that affect the reproductive system. Mumps is dangerous for boys due to infertility (one in 20 boys who have had mumps develops orchitis), and rubella during pregnancy in mature women is highly likely to lead to malformations and death of the fetus. Therefore, in no case should you refuse vaccination.

Last update of the description by the manufacturer 31.07.2003

Filterable list

Active substance:

ATX

Pharmacological group

Nosological classification (ICD-10)

Composition and release form

1 dose of lyophilized powder for preparing a solution for subcutaneous administration contains measles virus not less than 1000 TCD 50, mumps virus not less than 20,000 TCD 50 and gentamicin sulfate not more than 25 mcg; in ampoules for 1 dose, in a cardboard box 10 ampoules.

Characteristic

Homogeneous porous mass of pink color, hygroscopic.

pharmachologic effect

pharmachologic effect- immunostimulating.

Stimulates the production of antibodies to measles and mumps viruses, reaching maximum levels 3-4 weeks and 6-7 weeks after vaccination, respectively.

Indications of the drug Mumps-measles cultural live vaccine

Planned and emergency prevention of measles and mumps.

Contraindications

Hypersensitivity (including to aminoglycosides, quail egg white), severe reaction or complication to the previous dose, primary immunodeficiency conditions, malignant blood diseases, neoplasms, pregnancy.

Use during pregnancy and breastfeeding

Contraindicated during pregnancy.

Dosage and administration

S.C., immediately before use, mix the vaccine with the solvent (0.5 ml of solvent per 1 vaccination dose of the vaccine), inject 0.5 ml under the shoulder blade or into the shoulder area (at the border between the lower and middle third of the shoulder, on the outside). Routine vaccinations are carried out twice at the ages of 12 months and 6 years for children who have not had measles and mumps.

Emergency prophylaxis is carried out for children aged 12 months, adolescents and adults who have had contact with a patient with measles or mumps, who have not had these infections and have not been vaccinated against them in accordance with the vaccination calendar (the vaccine is administered no later than 72 hours after contact with the patient) .

Precautionary measures

Vaccination can be carried out after the end of acute manifestations of infectious and non-infectious diseases, exacerbations of chronic diseases; after normalization of body temperature in mild forms of ARVI or acute intestinal diseases; 3-6 months after immunosuppressive therapy. After the administration of human immunoglobulin preparations, vaccinations against measles and mumps are carried out no earlier than 2 months later. After the administration of the mumps-measles vaccine, immunoglobulin preparations are administered no earlier than 2 weeks later. If it is necessary to use immunoglobulin earlier than this period, vaccination against measles and mumps should be repeated.

Measles, mumps, and rubella are three typical childhood infections that are viral in nature and therefore extremely contagious. Vaccination against these diseases, done in a timely manner and in compliance with sanitary rules, provides a guarantee against infection in 99 out of 100 cases. If infection occurs after immunization, the disease will be mild, with mild symptoms and without complications.

The pharmaceutical industry offers a large selection of vaccines. Some doctors recommend a domestic vaccine (against 2 viruses: measles and mumps), others recommend an imported one made from three components (MMR). Each has its own advantages and disadvantages. Regardless of which vaccine is preferred, the first MMR immunization is given at 1 year of age. Then follow the national calendar.

The epidemiology of these diseases suggests that only humans can be the source of infection, so mass immunization is the only effective way to prevent the spread of infection. And possible reactions to protection against these viruses should not be a reason for refusing immunization.

At what age should a child be vaccinated?

In order to know at what age a child needs to receive certain vaccinations, parents should familiarize themselves with the vaccination calendar. In accordance with it, vaccination against measles, rubella and mumps is done three times: at 1 year, then at 6 and at 16-17 years. There are no differences in the timing of the vaccination schedule for girls and boys.

The need for repeated administration of the MMR vaccine (measles, rubella, mumps) is due to the fact that sometimes after the first vaccination children do not develop stable immunity to these infections.

Another reason for revaccination is the duration of acquired immunity. Over time it weakens. Therefore, adults need to follow the vaccination calendar so as not to miss the next vaccination.

In adolescence, there are reasons for revaccination:

• for women who are expected to give birth to children in the next 10 years, vaccination is necessary due to the fact that intrauterine infection with rubella or mumps during pregnancy poses a threat to the life of the fetus;
• For young men, revaccination in adolescence is necessary due to the fact that infertility can be a complication of mumps.

If a child, for various reasons, has not been vaccinated, he is given the measles, rubella, and mumps vaccine at the age of 13. Then, after 10 years, revaccination is carried out.

Doctors do not recommend combining vaccinations against tetanus, diphtheria, whooping cough, and polio with the MMR vaccine. It is better that a month has passed since the vaccination. The second vaccination can be carried out after this period has passed. In the video, conversations with the doctor about vaccination:

How to prepare for vaccination

To be vaccinated with the MMR vaccine (measles, rubella, mumps), healthy children or adults do not require any special preparation. The main thing is that the person is healthy for two weeks before and on the day of vaccination. It is recommended to do tests before vaccination. A general blood test will provide information about whether there is any inflammatory process in the body.

Preparing for vaccination of special groups of patients requires special measures. Children with a history of allergic reactions are prescribed antihistamines 3 days before vaccination.

For the duration of possible vaccine reactions (2 weeks), children with various lesions of the nervous system or chronic diseases are given therapy to prevent the exacerbation of these pathologies.

For children with frequent respiratory infections, general strengthening therapy is recommended 3 days before vaccination and for two weeks after it.

During the vaccination period and after it, contact with people who have signs of infections and look contagious should be avoided. You can walk, but for this you need to choose uncrowded places. You should not start visiting preschool institutions for the first time after vaccination for at least a week. If any signs of a respiratory infection appear on the eve of vaccination, it will have to be abandoned.

Contraindications

Speaking about the measles + rubella + mumps vaccine, doctor E. O. Komarovsky advises not to ignore contraindications to immunization. They are divided into temporary and permanent. Temporary ones include the following:

1. Periods of exacerbation of somatic diseases before their transition into stable remission.
2. Pregnancy, this is especially important for those women who have never had rubella; they should be vaccinated against mumps, measles and rubella at the stage of pregnancy planning.
3. Blood transfusion or administration of blood products.
4. Vaccination is delayed for 5-6 weeks if a tuberculosis vaccine has been administered or a mantoux test has been done.
5. A sick child should not be vaccinated with measles+rubella+mumps; the reaction to it can be unpredictable. If there are signs, symptoms of illness or blood test results indicating that an inflammatory process is developing in the body, the vaccination should be rescheduled. During periods of illness, neither adults nor children should be vaccinated.

Permanent contraindications to MMR vaccination include:

• allergy to antibiotics Gentamicin, Neomycin, Kanamycin;
• allergy to egg white (chicken and quail);
• a history of anaphylactic reactions in the form of shock or Quincke's edema;
• oncological diseases;
• severe reaction to a previously administered vaccine;
• decreased platelet level in blood test;
• HIV infection;
• undergone organ transplantation.

Which vaccine is better

Parents who are planning to vaccinate their children often ask the question which vaccine is better: domestic (the name of the vaccine is divaccine) or imported.

The Priorix vaccine is widely used. This is an imported vaccine (manufactured in Belgium), multicomponent, containing strains of the measles, rubella and mumps virus. Priorix fully complies with WHO standards and requirements for vaccines and has proven itself well in Europe, where this drug has been used for childhood vaccinations for a long time.

According to the instructions, after vaccination against measles, rubella, mumps, immunity to these viruses is formed in 96-98% of cases.

The significant difference between the domestic measles vaccine and Priorix is ​​that the imported vaccine is based on chicken eggs, while the domestic one is based on quail eggs. Priorix is ​​contraindicated for children who are allergic to chicken protein; the domestic vaccine is suitable for them.

When vaccinated with Priorix, you can give an injection in different parts of the body (under the shoulder blade, in the thigh, in the arm). Many people prefer the imported vaccine, since only one injection is required to be vaccinated against three viruses at once. When it comes to one-year-old children, doctors often recommend it. And when vaccinated with a domestic drug, the injection is given twice.

Both domestic and imported vaccines contain live viruses and are therefore equally tolerated. Both of them have instructions that reactions from different body systems can be observed within 42 days from the date of vaccination.

There are many types and varieties of vaccines; the types of virus strains in the drug determine its characteristics. When choosing a vaccine, parents and their doctor should choose the one that is most suitable for the child, taking into account the characteristics of his health.

What not to do after vaccination

Parents of children who have received the measles+mumps+rubella vaccine should refrain for a week from introducing into the diet foods that the child has not tried before. The mother also needs to do the same if the baby is breastfed. Because if allergic reactions occur, it will be difficult to figure out whether the reaction is to the vaccine or to the product.

If there is redness or swelling at the vaccine injection site, it is not recommended to heat the affected area. On the day the vaccination was given, you should not swim or wet the injection site.

The social circle of a child who has been vaccinated with MMR should be limited, especially during seasonal epidemiological outbreaks. The child is not allowed to communicate or have contact with people who have visual signs of infection with a respiratory disease. It is better to spend a few days at home after vaccination. If there is no temperature, then you can walk, while avoiding crowded places.

These rules must be followed regardless of whether the multicomponent MMR vaccine was given or a divaccine (measles and mumps): these vaccinations are tolerated equally.

How is the measles, rubella and mumps vaccine tolerated?

Parents who are about to vaccinate their child are interested in how their children tolerate the measles+rubella+mumps vaccine. In most children, neither multicomponent nor single vaccines cause post-vaccination reactions.

In 10% of children, a local reaction may develop at the site of vaccine administration in the form of slight swelling or redness, which disappears in 1-2 days.

The most difficult to carry is the measles virus, and a reaction to it occurs in 10-15% of children. Starting from 4-5 days until 13-14 days after vaccination, reactions may occur that are manifested by high temperature (up to 40 degrees) and runny nose. A slight cough may occur.

A reaction to the rubella virus may appear 10-14 days after vaccination. It is expressed in the form of skin rashes (most often the rash is localized on the back).

Regardless of whether a divaccine or a multicomponent vaccine was used, mumps rarely causes post-vaccination reactions. They manifest themselves as fever, redness of the throat, runny nose, and inflammation of the place where the vaccine was given. Even less commonly, enlargement of the parotid salivary glands may occur.

In adults, the consequences of revaccination can manifest themselves in joint pain.

The occurrence of these reactions is not a pathology, but you should definitely consult a doctor if these symptoms appear on the 4-5th day and persist after two weeks (for example, the temperature regularly rises), as well as if they first appeared after two weeks. Since this may mean that the child is sick and these symptoms have nothing to do with the vaccine.

Possible complications and side effects

Severe complications after vaccination with measles + rubella + mumps are quite rare. They can be like this:

• anaphylactic shock;
• serous aseptic meningitis;
• pneumonia;
• encephalitis;
• toxic shock syndrome;
• glomerulonephritis.

Vaccine-associated diseases (resulting from the introduction of live viruses) are the most severe and at the same time the most rare complications of vaccination. Post-vaccination measles encephalitis (a reaction to a measles vaccine) occurs in 1 case per million. The vaccine-associated disease caused by mumps vaccination is serous meningitis, which occurs at a rate of 1 case per 100,000 vaccinated.

Having analyzed reviews of reactions after vaccination with measles + rubella + mumps, you can see that such severe consequences of vaccination develop extremely rarely. Much more often we are talking about side effects, such as allergic reactions, the appearance of skin rashes, redness and discomfort at the site of vaccine administration, fever after vaccination with measles + rubella + mumps.

Some believe that in addition to side effects, MMR vaccination can provoke disturbances in the psycho-emotional development of the child, delayed speech development, etc. But these statements have not been proven from a scientific and medical point of view.

pharmachologic effect

The imported vaccine (Priorix) is created from live strains of pathogens of these viruses. The strains are grown on chicken embryo cells. After vaccination, the formation of immunity against measles occurs in 98% of cases, to the mumps virus - in 96% of cases, to the rubella pathogen - in 99%.

The domestic vaccine (against mumps and measles) also contains live, weakened measles and mumps viruses; the vaccine remains effective for 10-11 years.

The measles + rubella + mumps vaccine can provide some degree of protection to non-immune individuals from these diseases; the vaccine must be given within 72 hours of their contact with the patient.

When are mumps vaccinations given - calendar

The measles + rubella + mumps vaccination is included in the list of mandatory preventive vaccinations, in accordance with the National Immunization Schedule. Immunization within the framework of this calendar is carried out with vaccines of domestic and imported production, registered in accordance with the law and approved for use.

The first vaccination against measles, rubella and mumps is given at 12 months. The second vaccination (first revaccination) should be given at 6-7 years of age. The second revaccination is done at the age of 15-17, while mumps vaccinations are important for boys, and girls, as expectant mothers, need to acquire immunity to rubella.

The vaccination schedule is followed regardless of whether immunization is carried out with a multicomponent vaccine or a monovaccine. If a measles and mumps vaccine is given without rubella, the rubella single vaccine can be given on the same day.

Priorix™

International non-proprietary name

Dosage form

Lyophilisate for solution for injection complete with solvent, 0.5 ml/dose

Compound

1 dose (0.5 ml) contains

Lyophilisate

active substances: live attenuated measles virus (strain

Schwarz) - no less than 103.0 TsPD501;

live attenuated mumps virus (strain RIT 4385) - no less than 103.7 CPD501;

live attenuated rubella virus (strain Wistar RA 27/3) - not less than 103.0 CPD501

1 CPP - cytopathogenic effect

Excipients: lactose, sorbitol, mannitol, amino acids.

Contains residual neomycin sulfate (not more than 25 mcg).

Solvent

Water for injection 0.5 ml

Description

Lyophilisate: homogeneous porous mass from whitish to slightly pink.

Solvent: transparent, colorless liquid, odorless, free from visible impurities.

After dilution with a solvent: the solution is light peach to reddish pink in color.

Pharmacotherapeutic group

Measles vaccines. Measles virus in combination with mumps and rubella viruses - live weakened.

ATX code J07BD52

Pharmacological properties

Pharmacokinetics

Vaccines do not require pharmacokinetic evaluation.

Pharmacodynamics

Live combined attenuated vaccine against measles, mumps and rubella. Attenuated vaccine strains of measles virus (Schwarz), mumps (RIT4385, Jeryl Lynn derivatives) and rubella (Wistar RA 27/3) are cultivated separately in chicken embryo cell culture (mumps and measles viruses) and human diploid MRC5 cells (rubella virus).

Priorix™ meets the World Health Organization's requirements for the production of biological products, the requirements for vaccines against measles, mumps, rubella and live combination vaccines.

Immunogenicity

In clinical trials, Priorix™ showed high immunogenicity. Antibodies to the measles virus were detected in 98%, to the mumps virus - in 96.1%, and to the rubella virus - in 99.3% of previously seronegative vaccinated individuals.

A year after vaccination, all seropositive individuals retained a protective titer of antibodies to measles and rubella and 88.4% to the mumps virus, while all vaccinated individuals had previously seronegative reactions. For 12 months after vaccination, all individuals followed remained seropositive for measles and rubella antibodies. For mumps antibodies, 88.4% of vaccine recipients were seropositive at 12 months.

Indications for use

Active immunization against measles, mumps and rubella for ages 12 months and older

Dosage and administration

Priorix™ is administered subcutaneously in a dose of 0.5 ml, but can also be used as an intramuscular injection.

Official recommendations must be followed during immunization with Priorix™. The vaccination schedule is approved in accordance with the National Vaccination Calendar of the Republic of Kazakhstan, according to which children are vaccinated as follows: primary vaccination - at the age of 12-15 months and revaccination - at 6 years.

In countries where measles incidence and mortality during the first year of life are high, immunization with the vaccine is recommended at or soon after 9 months of age (270 days).

Instructions for use

Before use, the solvent and dissolved lyophilisate must be visually assessed for the presence of foreign particles, if detected, the vaccine cannot be used.

The lyophilized powder must be dissolved with the solvent included in the kit by introducing the solvent into the bottle with the lyophilisate.

The resulting mixture is shaken until the lyophilized powder is completely dissolved.

Due to slight changes in pH, the color of the reconstituted vaccine may vary from light peach to reddish pink, which does not affect the quality of the vaccine.

A new needle should be used to administer the vaccine.

The resulting solution should be administered completely.

Priorix™ is not administered intravenously under any circumstances!

The prepared vaccine should be used, if possible, immediately after dilution; the maximum shelf life of the reconstituted vaccine is 8 hours if stored in the refrigerator (at a temperature of +2 ° C to +8 ° C).

Any unused vaccine or waste must be disposed of in accordance with local biohazardous materials requirements.

Side effects

Controlled clinical studies conducted on more than 12,000 vaccine recipients actively examined objective and subjective symptoms up to 42 days after vaccination.

Determination of the frequency of side effects: very often (≥1/10), often (≥1/100, but<1/10), нечасто (≥ 1/1,000, но <1/100), редко (≥1/10,000, но <1/1,000), очень редко (< 1/10,000), единичные сообщения < 1/10000000).

Often

Redness at the injection site

Increase in temperature to ≥ 37.5 °C (or ≥ 38 °C when measured rectally)

Often

Upper respiratory tract infection

- rash

Pain and swelling at the injection site

Increase in temperature to > 39.0 °C (or > 39.5 °C when measured rectally)

Infrequently

Otitis media

Lymphadenopathy

Nervousness, unusual crying, insomnia

Conjunctivitis

Bronchitis, cough

Vomiting, loss of appetite, diarrhea

Enlarged parotid glands

Rarely

Allergic reactions (urticaria, itching)

Febrile seizures

According to post-marketing studies, there were additional isolated reports of transient reactions, the presence of which was associated with vaccination with a frequency< 1 случая на 10000000 доз:

Meningitis, morbilliform syndrome, mumps syndrome (including orchitis, epididymitis and mumps)

Thrombocytopenia, thrombocytopenic purpura

Anaphylactic reactions

Encephalitis, cerebellitis, cerebellitis-like syndrome (including intermittent claudication and transient ataxia), Guillain-Barré syndrome, transverse myelitis, peripheral neuritis

Vasculitis (including Henoch-Schönlein purpura and Kawasaki syndrome)

Erythema multiforme

Arthralgia, arthritis.

Accidental intravascular administration can lead to severe reactions, including the development of shock. Depending on the severity of the condition, emergency measures are required.

Contraindications

Hypersensitivity to neomycin or to any other component of the vaccine and chicken protein. Contact dermatitis to neomycin is not a contraindication.

Hypersensitivity reactions to previous administration of vaccines containing measles, mumps and/or rubella components

Severe humoral or cellular immunodeficiency (primary or secondary), incl. manifest HIV infection.

Pregnancy, women should be protected from pregnancy for 1 month after vaccination.

Acute infectious diseases, exacerbation of chronic diseases.

Increased body temperature above 37 oC.

Drug interactions

The tuberculin test should be performed either before vaccination or at the same time as the vaccine, since it has been shown that live measles vaccine (and possibly mumps) can cause a temporary weakening of general immunity for a period of 4 to 6 weeks. Therefore, in order to avoid false-positive results, a tuberculin test is not performed within 6 weeks after vaccination.

Priorix™ can be given at the same time as live attenuated chickenpox vaccine (Varilrix™), using different syringes to inject different areas of the body.

Priorix™ can be administered simultaneously with live (OPV) and inactivated polio vaccine (IPV), with DTaP and DTaP vaccines, Haemophilus influenzae type b subject to injections with different syringes in different parts of the body.

If Priorix™ is not administered simultaneously with other live attenuated vaccines, the interval between vaccinations should be at least one month.

In persons who have received human gamma immunoglobulin or blood transfusion, vaccination should be delayed for three months due to possible ineffectiveness resulting from exposure to passively administered antibodies to measles, mumps and rubella vaccine viruses.

Priorix™ may be used as a booster dose in patients previously vaccinated with another combination measles, mumps and rubella vaccine.

Priorix™ cannot be mixed with other vaccines in the same syringe.

special instructions

Priorix™ vaccination should be delayed in persons suffering from acute febrile illness. Mild infection is not a contraindication for vaccination.

It is possible to develop a fainting state as a psychological reaction to the injection route of administration of the drug, and therefore it is necessary to prevent possible bruises and injuries if the patient falls.

It is necessary to wait until alcohol or other disinfectants have completely evaporated from the surface of the skin before injection, as they may inactivate the viruses in this vaccine.

Limited protection against measles can be achieved by vaccination within 72 hours of exposure to someone with measles.

Vaccination of children under 12 months of age may not be effective enough for the measles component due to the possible retention of maternal antibodies. However, this situation is not a contraindication for the use of the vaccine in infants (<12месяцев) в ситуациях со степенью высокого риска заражения. При таких обстоятельствах показана повторная вакцинация после достижения возраста 12 месяцев.

As with other injectable vaccines, appropriate medical care and monitoring should be in place for rare anaphylactic reactions following vaccine administration. Vaccination sites must be provided with anti-shock therapy.

The measles and mumps components of the vaccine, isolated from tissue cultures of chicken embryos, contain egg white. Patients with a history of anaphylactic, anaphylactoid or other reactions (for example, generalized urticaria, swelling of the larynx and oral area, difficulty breathing, hypotension, shock) to chicken protein are at risk of experiencing an immediate hypersensitivity reaction after vaccination. In this regard, in patients with known hypersensitivity to chicken protein, vaccination should be carried out with extreme caution, with a full set of anti-shock therapy available in case of an allergic reaction.

Priorix™ should be used with caution in persons with a history of allergic and convulsive reactions in themselves or family members.

Transmission of measles and mumps viruses from vaccinated individuals has not been documented. There are known cases of pharyngeal isolation of the rubella virus on days 7-28 after vaccination with a peak of isolation approximately on the 11th day. However, there is no evidence of transmission of this virus through contact.

Priorix™ should never be administered intravenously.

As with other vaccines, an adequate response to vaccination may not be achieved in all vaccine recipients.

In patients with thrombocytopenia, symptoms may worsen or reactions associated with thrombocytopenia may return after the first dose of the vaccine. In such cases, before immunization with the Priorix™ vaccine, a careful assessment of the benefit versus risk of vaccination should be carried out.

There is limited data on the use of Priorix™ in immunocompromised individuals, so vaccination should be considered with caution and only when, in the opinion of a physician, the benefit outweighs the risk (including persons with asymptomatic HIV infection).

The immunological response of immunocompromised individuals who do not have contraindications to vaccination (see Contraindications) may differ from that of immunocompetent subjects, so some immunocompromised individuals may develop measles, mumps, or rubella despite appropriate vaccination. Immunocompromised subjects should be closely monitored for symptoms of measles, mumps, and rubella.

A history of contact dermatitis to neomycin is not a contraindication for vaccination.

Fertility

No data.

Pregnancy

The use of the Priorix™ vaccine is contraindicated in pregnant women.

However, there have been no reports of fetal harm when MMR vaccination was given during pregnancy.

Even if a theoretical risk cannot be excluded, no cases of congenital rubella syndrome have been reported in more than 3,500 vaccinated women who were early pregnant and unaware at the time of rubella vaccination. Thus, accidental vaccination against measles, mumps and rubella in women who were unaware of their pregnancy at the time of vaccination should not be a reason to terminate the pregnancy.

Contraceptive methods must be used to avoid pregnancy for 1 month after vaccination.

Lactation

There is currently insufficient information regarding the use of the vaccine in breastfeeding women. A woman can be vaccinated if the benefits of vaccination outweigh the risks.

Features of the influence on the ability to drive vehicles and other mechanisms and other potentially dangerous mechanisms

The effect of the vaccine on the ability to drive a car and use machinery is unlikely.

Overdose

There were no side effects associated with overdose (administration of 2 doses).

Release form and packaging

Lyophilisate for the preparation of solution for injection complete with solvent, 0.5 ml/dose.

Lyophilisate: Type I clear glass bottle, hermetically sealed with a rubber butyl stopper.

Solvent: sealed clear glass ampoule with a white opening ring on the neck of the ampoule.

100 bottles of lyophilisate in a cardboard box along with instructions for use in the state and Russian languages.

100 ampoules with solvent in a separate cardboard box.

Storage conditions

Lyophilisate: store at temperatures from 2°C to 8°C in the original packaging to protect from light. Do not freeze.

Solvent: store at a temperature from 2 С to 25 С. Do not freeze.

Reconstituted vaccine: can be stored for 8 hours at a temperature of 2°C to 8°C.

Keep out of the reach of children!

Transportation conditions

At temperatures from 2°C to 8°C. Do not freeze.

Shelf life

Lyophilisate: 2 years

Solvent: 5 years

Do not use after the expiration date

Conditions for dispensing from pharmacies

By prescription (only for specialized institutions)

Manufacturer

Packer

GlaxoSmithKline Biologicals s.a., Belgium

(Rue Flemming 20, 1300 Wavre, Belgium)

Registration Certificate Holder

GlaxoSmithKline Biologicals s.a., Belgium

(Rue de I'Institut 89, 1330 Rixensart, Belgium)

Priorix is ​​a trademark of the GlaxoSmithKline group of companies

Address of the organization that accepts claims from consumers regarding the quality of products (products) on the territory of the Republic of Kazakhstan

Representative office of GlaxoSmithKline Export Ltd in Kazakhstan

050059, Almaty, Furmanov st., 273

Phone number: +7 7019908566, +7 727 258 28 92, +7 727 259 09 96

Fax number: + 7 727 258 28 90

E-mail address: [email protected]

Diseases such as measles, rubella and mumps are included in the list of “classical” childhood infections. These diseases are caused by viruses, are highly contagious (infectious) and have an airborne transmission mechanism, therefore they are included in the group of childhood droplet infections. Mostly young children suffer from measles, rubella and mumps. However, at the moment there is an increase in the incidence of childhood infections among adolescents and adults.

According to the NKPP (national calendar of preventive vaccinations), MMR (measles, mumps, rubella vaccination) is done at twelve months and at six years (revaccination).

Many parents are wary of this vaccination because it is a live vaccine. It is known that in young children these infections are usually mild. Because of this, there is an opinion that one should not load a child with vaccines and “interfere” with his natural immunity.

At the moment, the anti-vaccination movement has gained wide popularity and parents are increasingly categorically refusing to vaccinate their children.

Of course, the risk of complications always exists when using any medicine, vaccine, etc. There are no absolutely and 100% safe medications. However, with strict adherence to the methodology for preparing for vaccination and the rules for administering the vaccine, as well as the use of a high-quality vaccine (not expired and properly preserved) and following the doctor’s recommendations in the post-vaccination period, the risk of developing complications from vaccination is minimal.

Why is MMR vaccination necessary?

In this case, you need to understand the main feature of childhood droplet infections - in children, they usually occur in mild or moderate forms. However, in adults, these infections can be extremely severe and lead to serious complications.

When refusing vaccination at a young age, fearing complications from the vaccine or considering it an unreasonable burden on the immune system, the parent must be aware of the full range of risks for the child in the future.

The danger of rubella for pregnant women

Rubella, which is usually mild in young children (complications such as rubella encephalitis occur in approximately 1 child out of 1000), poses a serious danger for a pregnant woman who has not been vaccinated and has not had rubella.

The rubella virus has a high affinity for fetal tissues and can lead to the development of congenital rubella syndrome (CRS). A baby with CRS is born with congenital heart defects, blindness and deafness. Also, the rubella virus can infect the fetal brain tissue (severe mental retardation is possible in the future), its liver, spleen, etc. Rubella in the first trimester of pregnancy can cause miscarriage or miscarriage.

The main danger of rubella for women bearing a child is that a woman can suffer from the disease in an erased form. With this course of the disease, only isolated rashes may be observed over several days. The pregnant woman’s well-being is not affected, and the woman can attribute a minor rash to an allergic one. However, even erased forms of rubella have a severe teratogenic and mutagenic effect on the fetus.

In this regard, at the slightest suspicion of rubella, a pregnant woman should be examined for the presence of anti-rubella antibodies. If infected with rubella, termination of pregnancy may be recommended in the early stages. The final decision is made only by the mother. She must be notified of all the risks to the unborn child and the high likelihood of severe birth defects.

In this regard, all women who have not been sick and have not been vaccinated are recommended to be vaccinated against rubella when planning pregnancy. It is not recommended to become pregnant within 3 months after vaccination. However, the onset of pregnancy before three months after vaccination is not an indication for termination of pregnancy, since significantly weakened viruses are used during vaccination.

Features of preparation for vaccination

Measles, rubella, mumps vaccination is on the list of mandatory ones. However, the issue of vaccination is considered strictly individually for each child. This is due to the fact that MMR vaccination, like any other, has a number of general and specific contraindications or time restrictions for implementation. Therefore, before vaccination, the child must be examined by a pediatrician and pass general tests (general blood and urine tests).

Without a preliminary examination, tests and obtaining permission from a pediatrician for vaccination, vaccination cannot be given.

Compliance with these safety measures will minimize the risk of complications after vaccination.

Which vaccine against measles, rubella, mumps is better?

Since MCP, according to the national calendar of state vaccinations, is included in the list of mandatory ones, vaccines are purchased by the state. The vaccination is given free of charge.

Most often, the domestic vaccine against measles and mumps and the Indian vaccine against rubella are used.

If necessary, the Priorix ® vaccine containing all three viruses is used.

All vaccines undergo preliminary studies for effectiveness and safety.

Domestic vaccines measles rubella mumps

• L-16 ® (anti-measles).

There is no Russian anti-rubella vaccine.

Imported vaccines measles rubella mumps

Trivaccines include:

• MMR-II®;
• Priorix®.

Antirubella:

• Rudivax®;
• Ervevax®.

Contraindications to vaccination against measles, rubella and mumps

Vaccination is carried out only after the child has been examined by a doctor and tested. The vaccine is administered in a clinic by qualified personnel. At home, on your own, etc. no vaccination is given.

Due to the fact that a live (weakened) vaccine is used, mumps, measles, rubella vaccination is not given when:

• the patient has allergic reactions to chicken (quail) eggs and aminoglycoside antibiotics;
• individual hypersensitivity to vaccine components;
• allergies to the vaccine during the first administration (contraindication for revaccination);
• confirmed or suspected pregnancy;
• the presence of acute diseases or exacerbation of chronic pathologies;
• severe cellular immunodeficiency and the presence of clinical manifestations of HPV infection;
• the presence of malignant neoplasms, leading to a violation of the reactions of cellular immunity (leukemia, lymphoma, etc.).

With caution, the vaccine is used if the patient has a history of severe allergic reactions (of any origin) and convulsive seizures.

The peculiarities of drug interactions are also taken into account. Vaccination of mumps, measles, rubella is not given to patients who received immunoglobulin preparations or blood plasma components. In this case, the interval between the introduction of these drugs and the vaccine should be three months.

Considering that mumps, measles, rubella vaccination is done with live, attenuated vaccines, it is strictly forbidden to combine it with the introduction of other live vaccines.

If the child managed to get measles, rubella or mumps, this is not a contraindication to revaccination at 6 years of age.

Vaccination of children born to HIV-positive mothers

The greatest difficulty is vaccinating children born to HIV-infected mothers. For this category of patients, preventive vaccinations are extremely important, since due to severe immunodeficiency they are more difficult to tolerate any infections, and, therefore, they have a significantly higher risk of death and the development of complications from the disease. Timely vaccination can improve the prognosis and reduce the risk for such patients.

Previously, MMR vaccination was not given to children with HIV. However, recent studies have confirmed that HIV-infected children are capable of developing a cellular and humoral immune response (despite a decrease in antibody levels).

Vaccination is carried out only after a final diagnosis has been made and testing for CD4+ cells has been carried out. Mumps, measles, and rubella vaccinations are performed for children without clinical and pronounced cellular manifestations of immunodeficiency.

For patients with contraindications, after contact with patients with measles or mumps, prophylaxis with immunoglobulins is indicated.

Side effects of the measles, rubella, mumps vaccine, how to avoid?

It is necessary to understand that the appearance of a runny nose, slight weakness, fever (37-38 degrees), slight redness of the throat and a mild rash is a normal reaction of a child to the vaccine. There may also be slight swelling of the parotid glands and redness at the injection site.

Photo of the rash after MMR vaccination (measles, mumps, rubella):

Rash after PDA

This reaction is not a reason to panic. When a rash appears, children are advised to take antihistamines. It should be noted that to reduce the risk of developing a rash after vaccination, taking antihistamines should be started two days before vaccination and continued for at least three days after it.

Additionally, a course of sorbents (Enterosgel ®) may be recommended. However, it should be remembered that the time interval between taking sorbents and other medications should be at least two hours. Drinking plenty of fluids is also recommended.

To reduce the risk of developing undesirable effects, it is also recommended to refrain from going out and inviting guests on the first day after vaccination. In the future, in the absence of contraindications, walks are allowed.

When the temperature rises above 37.5-38 degrees, antipyretics (paracetamol, ibuprofen ®) are used. Aspirin ® is contraindicated.

Antiviral drugs, antibiotics, immunoglobulins, etc. If the temperature rises and a runny nose appears after vaccination, it is not prescribed.

Most often, MMR vaccination is tolerated easily or with a slight increase in temperature, runny nose and mild rash. Severe reactions of allergic origin and other complications from the administration of the vaccine occur extremely rarely, as a rule, when the rules of preparation for vaccination are not followed and the drug is administered to patients with contraindications.

True side effects from the vaccine that require immediate medical attention are:

• high fever resistant to antipyretics;
• profuse draining rash;
• convulsions;
• multiform;
• otitis;
• bronchitis and pneumonia, etc.

Is it possible to go for a walk after getting the measles, rubella, mumps vaccine?

A contraindication to walking is if the baby has a fever reaction to the vaccine. After the temperature has stabilized, or if the vaccination is well tolerated, walks are allowed.

Where is the measles, rubella, mumps vaccine given?

The vaccine is administered subcutaneously (under the shoulder blade or in the shoulder). Some vaccines (Priorix) can be administered intramuscularly.

Intravenous administration is strictly prohibited for any vaccine.

Is it possible to get mumps, measles or rubella if you have been vaccinated?

According to statistics, about 15% of children after the first vaccination can suffer from measles, rubella or mumps. However, in vaccinated children these diseases often occur in an erased form and do not lead to the development of severe complications.