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

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

Description of the vaccine "Priorix"

"Priorix" is a powder from which a solution for intramuscular or subcutaneous administration is made. The vial contains a powder of white or pinkish color, slightly porous consistency. A solvent is attached to it: 0.5 ml of water for injection. The diluted liquid has no smell, suspension and visible impurities.

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

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

The composition of the vaccine "Priorix"

Viruses in Priorix are attenuated, that is, they are contained in a weakened form. This means that they are unable to cause 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 amount, they are weakened and a lyophilizate is made - dried in a special way while maintaining the structural integrity and biological activity. 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 virus strains:

• 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 they get vaccinated against measles, rubella, mumps? The vaccine is administered subcutaneously or intramuscularly, but never 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 at the age of 6;
• for the second revaccination, only unvaccinated or only 1 vaccinated girls - at 13 years old.

According to the national Russian vaccination calendar, Priorix is ​​administered:

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

This vaccine can be used in people who are not immune to the above diseases within 72 hours of exposure to a person with measles. It will give some protection against this disease.

The solution is prepared immediately before administration. To do this, mix the solvent with the lyophilisate, 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 collection 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 with a decrease in immunity. But it has been proven safe to use in people with HIV infection and AIDS, if they are asymptomatic.

It should be noted that non-anaphylactic reactions to chicken eggs or neomycin-induced contact dermatitis may be treated with the vaccine.

Non-pregnant women of childbearing age can do "Priorix" with the condition of protection from conception for about 3 months after the injection.

Caution should be given to the Priorix vaccine in persons with a family or personal history of allergic or convulsive reactions. All vaccinated patients with seizures or allergies should be monitored post-vaccination. Treatment rooms where vaccination is carried out should be equipped with an anti-shock first aid kit.

When performing an injection and treating the area with alcohol solutions, make sure that all the alcohol evaporates from the surface of the skin, otherwise this can 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 shown:

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

Rarely seen:

• hypertrophy of the parotid salivary glands;
• convulsive syndrome on the background of fever.

Very rare:

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

Cases of an overdose of "Priorix" in clinical practice are not described.

How is the measles, rubella, mumps vaccine tolerated?

How is Priorix tolerated? 60% of those vaccinated note the absence of any side effects, but in 40% they still happen. 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 a protective reaction of the body to the introduction of foreign proteins. It will pass in a few days. After vaccination, for prevention, you can give the child a single dose of an antipyretic. The rash can appear all over the body or on specific parts of the body, such as the face or buttocks.

How is the measles, rubella and mumps vaccine tolerated at 1 year? At this age, adverse reactions are more often observed in children than in older ones. Basically it is fever and urticaria, runny nose, cough. These reactions may occur and be 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 immune bodies for a response accumulate only after 5-10 days.

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

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

In isolated cases, complications may occur after the "Priorix" vaccination:

• encephalitis;
• serous meningitis;
• pneumonia;
• lymphopenia (low number of lymphocytes in the blood formula);
• 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 the pharmacological action, "Priorix" refers to immunomodulatory drugs. As a result of its introduction, active acquired immunity is formed. With the help of revaccination, lifelong circulation of antibodies is achieved.

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

Many mothers are wondering: 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 that the risk of unwanted effects is higher. In addition, Priorix is ​​rarely available in municipal clinics, most likely, the vaccine needs to be bought on its own. And that's a lot of money.

The mumps and rubella vaccines are the most important in the immunization schedule. After all, they protect against diseases that affect the reproductive system. Mumps is dangerous for boys with infertility (one in 20 boys who have had mumps has orchitis), and rubella during pregnancy in mature women is highly likely to lead to malformations and fetal death. 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 form of release

1 dose of lyophilized powder for preparation of solution for s/c administration contains measles virus not less than 1000 TCD 50, mumps virus not less than 20000 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 a maximum level 3-4 weeks and 6-7 weeks after vaccination, respectively.

Indications for the preparation

Planned and emergency prevention of measles and mumps.

Contraindications

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

Use during pregnancy and lactation

Contraindicated in pregnancy.

Dosage and administration

P / c, immediately before use, mix the vaccine with a 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 (on the border between the lower and middle third of the shoulder, from the outside). Scheduled vaccinations are carried out twice at the age 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 schedule (the vaccine is administered no later than 72 hours after contact with the patient) .

Precautionary measures

Vaccination can be carried out at the end of acute manifestations of infectious and non-infectious diseases, exacerbations of chronic diseases; after normalization of body temperature in non-severe forms of acute respiratory viral infections or acute intestinal diseases; 3-6 months after immunosuppressive therapy. After the introduction of human immunoglobulin preparations, vaccinations against measles and mumps are carried out no earlier than 2 months later. After the introduction 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, rubella are three typical childhood infections that are viral in nature, which means they are extremely contagious. Vaccination against these diseases, made in a timely manner and in compliance with sanitary rules, guarantees against infection in 99 out of 100 cases. If, after immunization, infection occurs, then the disease will proceed in a mild form, with erased symptoms and without complications.

The pharmaceutical industry offers a wide range of vaccines. Some doctors recommend a domestic divaccine (against 2 viruses: measles and mumps), others - an imported one, from three components (MMR). Each has its own merits and demerits. Regardless of which vaccine is preferred, the first MMR immunization is given at 1 year of age. Further - following the national calendar.

The epidemiology of these diseases suggests that only a person 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 not immunizing.

At what age should a child be vaccinated

In order to know at what age a child needs to be given 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 a strong immunity to these infections.

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

In adolescence, there are reasons for revaccination:

• women who will have children in the next 10 years should be vaccinated due to the fact that intrauterine infection with rubella or mumps during pregnancy poses a threat to the life of the fetus;
• Revaccination in adolescence is necessary for young men due to the fact that infertility can be a complication of mumps.

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

Doctors do not recommend combining vaccinations against tetanus, diphtheria, whooping cough, polio with MMR vaccination. 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 need 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.

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

Children with various lesions of the nervous system or chronic diseases for the period of possible vaccine reactions (2 weeks) 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 sparsely populated 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 vaccination, doctor E. O. Komarovsky advises not to disregard contraindications for immunization. They are divided into temporary and permanent. Temporary ones include:

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 planning stage of pregnancy.
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 taken.
5. A sick baby should not be vaccinated with measles + rubella + mumps, the reaction to it can be unpredictable. If there are signs, symptoms of an illness, or blood test results that indicate that an inflammatory process is developing in the body, the vaccination should be rescheduled. During periods of illness, neither adults nor children can be vaccinated.

Permanent contraindications for MMR vaccination include:

• allergy to antibiotics Gentamicin, Neomycin, Kanamycin;
• allergy to egg protein (chicken and quail);
• the presence in the anamnesis of anaphylactic reactions in the form of shock or Quincke's edema;
• oncological diseases;
• severe reaction to a previously administered vaccine;
• decreased level of platelets in the blood test;
• HIV infection;
• transferred organ transplant.

Which vaccine is best

Parents who are about to vaccinate their children often ask 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 (manufacturer - Belgium), multicomponent, contains strains of the measles, rubella and mumps virus. Priorix fully complies with the standards and requirements for WHO vaccines, has proven itself well in Europe, where this drug has been used for vaccinations for children 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 essential difference between the domestic measles vaccine and Priorix is ​​that the imported vaccine is based on chicken eggs, while the domestic vaccine is based on quail eggs. For children who are allergic to chicken protein, Priorix is ​​contraindicated, the domestic vaccine is suitable for them.

When vaccinated with Priorix, you can make an injection in different parts of the body (under the shoulder blade, in the thigh, in the arm). Many prefer an imported vaccine, since only one injection is required in order to get 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 done twice.

Both domestic and imported vaccines contain live viruses, so they are equally tolerated. For both, the instructions say that reactions from different body systems can be observed within 42 days from the moment of vaccination.

Vaccines have many types and varieties, the types of virus strains in the preparation determine its characteristics. When choosing a vaccine, parents, together with the doctor, should decide on 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 from introducing foods that the child has not tried before into the diet for a week. The same should be done for the mother if the child is breastfed. Since in case of allergic reactions it will be difficult to figure out what the reaction is to the vaccine or to the product.

If redness or swelling occurs at the injection site, it is not recommended to warm the affected area. On the day when the vaccination was given, you can not swim and wet the injection site.

The social circle of a child who has been vaccinated with MMR should be limited, especially during seasonal epidemiological outbreaks. It is impossible for a child to communicate, 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 observed regardless of whether a multicomponent MMR vaccine has been given or a divaccine (for measles and mumps): these vaccinations are equally tolerated.

How is the measles, rubella and mumps vaccine tolerated?

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

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

The most severely tolerated is the measles virus, and the reaction to it occurs in 10-15% of children. Starting from 4-5 days and 13-14 days after vaccination, reactions may occur, which are manifested by high fever (up to 40 degrees), runny nose. There may be a slight cough.

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 gives post-vaccination reactions. They are manifested by fever, redness of the throat, runny nose, inflammation of the place where they were vaccinated. Rarely, there may be an increase in the parotid salivary glands.

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

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

Possible complications and side effects

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

• 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.

After analyzing the 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 injection site, fever after measles + rubella + mumps vaccination.

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 scientifically and medically.

pharmachologic effect

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

Domestic vaccination (against mumps and measles) also contains live attenuated measles and mumps viruses, the vaccine retains its effect for 10-11 years.

Some degree of protection against these diseases can be given to non-immune persons by vaccination with measles + rubella + mumps, and the vaccine must be given within 72 hours after their contact with the patient.

When are mumps vaccinations given?

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, mumps is done at 12 months. The second vaccination (the first revaccination) should be done 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

Schwarz) - not less than 103.0 TsPD501;

live attenuated mumps virus (strain RIT 4385) - not less than 103.7 TsPD501;

live attenuated rubella virus (strain Wistar RA 27/3) - not less than 103.0 TsPD501

1 CPD - cytopathogenic effect

Excipients: lactose, sorbitol, mannitol, amino acids.

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

Solvent

Water for injection 0.5 ml

Description

Lyophilizate: homogeneous porous mass from whitish to slightly pink.

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

After dilution with solvent: light peach to reddish-pink solution.

Pharmacotherapeutic group

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

ATX code J07BD52

Pharmacological properties

Pharmacokinetics

Vaccines do not require evaluation of pharmacokinetic properties.

Pharmacodynamics

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

Priorix™ complies with the World Health Organization's requirements for the production of biologicals, requirements for measles, mumps, rubella and live combination vaccines.

Immunogenicity

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

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 had previously had seronegative reactions. Within 12 months after vaccination, all subjects who were followed up remained seropositive for antibodies against measles and rubella. For mumps antibodies, 88.4% of those vaccinated within 12 months were seropositive.

Indications for use

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

Dosage and administration

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

It is necessary to follow official recommendations during immunization with Priorix™. The vaccination schedule is approved in accordance with the National Immunization Schedule 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 of age.

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

Instructions for use

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

The lyophilized powder must be dissolved with the solvent supplied in the kit by introducing the solvent into the vial 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 entered completely.

Priorix™ is not administered intravenously under any circumstances!

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

Any unused vaccine or waste must be disposed of in accordance with local biohazard regulations.

Side effects

In controlled clinical studies conducted on more than 12,000 vaccinated patients, objective and subjective symptoms were actively investigated within 42 days after vaccination.

Determining 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

Temperature rise to ≥ 37.5°C (or ≥ 38°C when measured rectally)

Often

Upper respiratory tract infection

- rash

Soreness and swelling at the injection site

Temperature rise 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

Enlargement of the parotid glands

Rarely

Allergic reactions (urticaria, itching)

Febrile convulsions

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 hemorrhagic purpura of Shenlein-Genoch and Kawasaki syndrome)

Erythema multiforme

Arthralgia, arthritis.

Accidental intravascular administration can lead to severe reactions up to the development of shock. Depending on the severity of the condition, immediate action is required.

Contraindications

Hypersensitivity to neomycin or 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 components of measles, mumps and/or rubella

Humoral or cellular immunodeficiency of severe degree (primary or secondary), incl. overt HIV infection.

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

Acute infectious diseases, exacerbation of chronic diseases.

An increase in body temperature above 37 ° C.

Drug Interactions

A tuberculin test should be performed either before vaccination or at the same time as the vaccine is given, as it has been found 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, the tuberculin test is not carried out within 6 weeks after vaccination.

Priorix™ can be given at the same time as the live attenuated varicella vaccine (Varylrix™) by injecting different syringes into different parts of the body.

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

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

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

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

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

special instructions

Priorix™ vaccination should be deferred in persons suffering from acute febrile illnesses. A mild infection is not a contraindication for vaccination.

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

You must wait until the alcohol or other disinfectants have completely evaporated from the skin before injecting, as they can inactivate the viruses of this vaccine.

Limited protection against measles can be achieved by vaccination up to 72 hours after exposure to measles.

Vaccination of children under the age of 12 months may not be effective enough for the measles component due to the possible retention of maternal antibodies in them. 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 established for rare anaphylactic reactions following vaccine administration. Vaccination sites should be provided with anti-shock therapy.

The measles and mumps components of the vaccine, isolated from tissue cultures of chick embryos, contain egg protein. Patients with a history of anaphylactic, anaphylactoid, and other reactions (eg, generalized urticaria, laryngeal and oral edema, shortness of breath, hypotension, shock) to chicken protein are at risk of developing an immediate-type hypersensitivity reaction after vaccination. In this regard, in patients with known hypersensitivity to chicken protein, vaccination should be carried out with extreme caution, in the presence of a full set of anti-shock therapy in case of an allergic reaction.

Priorix should be used with caution in individuals 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 reported. Cases of pharyngeal shedding of rubella virus have been reported on days 7-28 post-vaccination, with peak shedding around day 11. However, there is no evidence of transmission of this virus through contact.

Priorix should not be given intravenously under any circumstances.

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

In patients with thrombocytopenia, after the first dose of the vaccine, symptoms may worsen or reactions associated with thrombocytopenia may resume. In such cases, prior to immunization with the Priorix™ vaccine, a careful assessment of the benefit-risk ratio 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 the benefit outweighs the risk in the judgment of the clinician (including those with asymptomatic HIV infection).

The immunological response in immunocompromised individuals who have no contraindications for vaccination (see Contraindications) may differ from that of immunocompetent individuals, 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 neomycin contact dermatitis 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 injury in cases where measles, mumps and rubella vaccination was given during pregnancy.

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

It is necessary to use contraceptive methods to avoid pregnancy within 1 month after vaccination.

Lactation

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

Features of 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 and use machines is unlikely.

Overdose

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

Release form and packaging

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

Lyophilisate: type I clear glass vial, hermetically sealed with a rubber butyl stopper.

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

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

100 ampoules with solvent in a separate carton.

Storage conditions

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

Solvent: Store between 2°C and 25°C. Do not freeze.

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

Keep out of the reach of children!

Transport conditions

At temperatures from 2 С to 8 С. Do not freeze.

Shelf life

Lyophilizate: 2 years

Solvent: 5 years

Do not use after the expiration date

Terms of 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 accepting claims from consumers on the quality of products (goods) on the territory of the Republic of Kazakhstan

Representation of GlaxoSmithKline Export Ltd in Kazakhstan

050059, Almaty, Furmanov street, 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 "classic" childhood infections. These diseases are caused by viruses, have a high contagiousness (contagiousness) and an airborne transmission mechanism, therefore they are included in the group of childhood droplet infections. Measles, rubella and mumps are mainly affected by young children. However, at the moment there is an increase in the frequency of childhood infections among adolescents and adults.

According to the National Immunization Schedule (NCV), MMR (measles, mumps and rubella), is done at twelve months and at six years (revaccination).

Many parents are wary of this vaccine because it is given as a live vaccine. At the same time, it is known that in young children, these infections are usually mild. Because of this, there is an opinion that one should not load the child with vaccines and "interfere" in his natural immunity.

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

Of course, the risk of complications always exists when using any drug, vaccine, etc. Absolutely and 100% safe drugs do not exist. However, with strict adherence to the methodology for preparing for vaccination and the rules for administering the vaccine, as well as using 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 drip 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 making a refusal to vaccinate at a young age, fearing complications from the introduction of 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 like rubella encephalitis occurs in about 1 out of 1000 children), is a serious danger for a pregnant woman who has not been vaccinated and has not been ill with rubella.

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 affect the brain tissue of the fetus (severe mental retardation is possible in the future), its liver, spleen, etc. Rubella in the first trimester of pregnancy can cause miscarriage or pregnancy failure.

The main danger of rubella for women carrying a child is that a woman can endure the disease in an erased form. With this course of the disease, only single rashes can be observed for several days. The well-being of a pregnant woman is not disturbed, and a woman can write off a small rash for 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. When infected with rubella, early termination of pregnancy may be recommended. The final decision is made only by the mother. She must be informed of all the risks to the unborn child and the high probability of having severe congenital malformations.

In this regard, all unill and unvaccinated women 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 the expiration of three months after vaccination is not an indication for termination of pregnancy, since significantly attenuated viruses are used for vaccination.

Features of preparation for vaccination

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

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

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

What is the best measles, rubella, mumps vaccine?

Since the MMR, according to the national calendar of state vaccinations, is included in the list of mandatory vaccines are purchased by the state. Vaccination is free.

Most often, they use the domestic vaccine against measles and mumps, and the Indian one against rubella.

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

All vaccines undergo preliminary studies for efficacy and safety.

Domestic vaccines measles rubella mumps

• L-16 ® (anti-measles).

There is no Russian rubella vaccine.

Imported vaccines measles rubella mumps

Trivaccines include:

• MMR-II®;
• Priorix®.

Rubella:

• 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 introduction of the vaccine is carried out in the clinic, by qualified personnel. At home, on your own, etc. vaccination is not 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 the components of the vaccine;
• allergies to the vaccine at the first injection (contraindication for revaccination);
• confirmed pregnancy or if it is suspected;
• 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 peculiarity of drug interactions is 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 the vaccination of children born to HIV-infected mothers. For this category of patients, preventive vaccinations are extremely important, because due to severe immunodeficiency, they are more difficult to tolerate any infections, and, consequently, they have a significantly higher risk of death and complications from the disease. Timely vaccination can improve the prognosis and reduce the risk for such patients.

Previously, children with HIV were not vaccinated with MMR. 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 the final diagnosis is made and the examination for CD4+ cells is carried out. Parotitis, measles, rubella vaccination is 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 must be understood that the appearance of a runny nose, slight weakness, fever (37-38 degrees), slight reddening of the throat and a slight rash is a normal reaction of the child to the vaccine. Also, there may be slight swelling of the parotid glands and redness at the injection site.

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

Rash after PDA

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

Additionally, a course of sorbents (Enterosgel®) may be recommended. However, it should be remembered that the time interval between taking sorbents and other drugs should be at least two hours. A plentiful drinking regimen is also recommended.

To reduce the risk of developing undesirable effects, it is also recommended that on the first day after vaccination, refuse to walk and invite guests. In the future, in the absence of contraindications, walks are allowed.

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

Antivirals, antibiotics, immunoglobulins, etc. with an increase in temperature and the appearance of a runny nose after vaccination is not prescribed.

Most often, the MMR vaccine is tolerated easily or with mild fever, runny nose, and mild rash. Severe reactions of allergic origin and other complications from the introduction of the vaccine occur extremely rarely, as a rule, if the rules for preparing for vaccination are not followed and the drug is administered to patients with contraindications.

The true side effects of the vaccine, which require immediate medical attention, are:

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

Can I walk after measles mumps rubella vaccination?

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

Where is the measles and mumps rubella 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.

Can you get mumps, measles, or rubella if you've been vaccinated?

According to statistics, about 15% of children after the first vaccination can suffer 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.