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Indications for vaccination "Measles"

Planned and emergency prevention of measles:

Routine vaccinations are carried out twice at the ages of 12 months and 6 years for children who have not had measles. Children born from mothers seronegative for the measles virus are vaccinated at the age of 8 months and then at 14-15 months and 6 years. The interval between vaccination and re-vaccination must be at least 6 months.

Children aged 1 year to 18 years inclusive and adults up to 35 years old inclusive, who have not been vaccinated previously, who do not have information about vaccinations against measles, who have not previously had measles, are vaccinated in accordance with the instructions for use twice with an interval of at least 3 months between vaccinations.

Persons previously vaccinated once are subject to a single immunization with an interval of at least 3 months between vaccinations.

INSTRUCTIONS FOR USE

Registration Certificate Holder:

MERCK SHARP & DOHME, BV (Netherlands)

Representation:

MERK SHARP & DOUM IDEA, INC. (Switzerland)

ATX code: J07BD52 (Measles, combinations with mumps & rubella, live attenuated)

Active substance: live measles, mumps and rubella virus vaccine (measles, mumps and rubella virus vaccine live)

Ph.Eur. European Pharmacopoeia

Dosage form

reg. No.: P N013153/01 dated 06/24/08 - Valid

Release form, composition and packaging

Excipients: neomycin (25 mcg per dose), sorbitol, sucrose, human albumin, fetal calf serum, hydrolyzed gelatin, sodium chloride, sodium phosphate.

The drug does not contain preservatives.

1 dose - vials (1) complete with solvent (syringes or vials) - cardboard packs.

1 dose - vials (10) complete with solvent (syringes or vials) - cardboard packs.

The viruses contained in the vaccine are identical to those used to produce Attenuvax (live measles vaccine, MSD), Mumpsvax (live mumps vaccine, MSD), Meruvax II (live rubella vaccine, MSD).

Attenuvax (live measles vaccine, MSD), a more attenuated line of measles virus, derived from the attenuated (Enders) Edmonston strain and grown in chicken embryo cell culture.

Mumpsvax (live mumps vaccine, MSD), Jeryl Lynn strain (Level B) of mumps virus grown in chick embryo cell culture;

Meruvax II (live rubella vaccine, MSD), Wistar RA 27/3 strain of live attenuated rubella virus grown in culture of diploid human pulmonary fibroblast cells (WI-38).

* — TID50 — dose that infects 50% of cell cultures.

Clinical and pharmacological group: Vaccine for the prevention of measles, mumps and rubella

Pharmacotherapeutic group: MIBP vaccine

pharmachologic effect

Vaccine for the prevention of rubella, measles and mumps. MMP II has high immunogenic properties.

A single dose of the vaccine produces measles hemagglutination-inhibiting antibodies in 95% of susceptible patients, mumps neutralizing antibodies in 96%, and hemagglutination-inhibiting rubella virus antibodies in 99% of susceptible patients.

The rubella virus strain RA 27/3, which is part of MM-P II, detects immediately after vaccination higher titers of hemagglutination-inhibiting, complement-fixing and neutralizing antibodies than other strains of the rubella vaccine. It has been shown to induce a wider range of circulating antibodies, including anti-theta and anti-iota precipitating antibodies. Rubella virus strain RA 27/3 immunologically mimics natural infection to a greater extent than other rubella vaccine viruses. Increased levels and a wider range of antibodies, the appearance of which is induced by the vaccine strain of rubella virus RA 27/3, correlate with greater resistance to subclinical reinfection with the natural virus, and more reliably provide long-term immunity.

Vaccination with the MM-P II vaccine ensures that the level of antibodies in the patient’s blood is maintained for more than 11 years.

Immunization of women of childbearing age who are not immune to rubella protects them from rubella during pregnancy, which in turn prevents infection of the fetus and the development of lesions due to congenital rubella.

Indications

• carrying out simultaneous vaccination of children aged 1 year and older against measles, mumps and rubella;
• immunization of children over 1 year of age who are not immunized against rubella and who have not had rubella, whose pregnant mothers are susceptible to rubella;
• immunization of women of childbearing age who do not have immunity against rubella;
• vaccination of persons from high-risk groups (including students, medical workers, military personnel).

ICD-10 codes

Dosage regimen

The vaccine is administered subcutaneously, preferably into the area of ​​the outer surface of the upper third of the shoulder in a dose of 0.5 ml. The vaccine dose is the same for patients of any age.

Children less than 15 months of age may not respond to the measles component of the vaccine due to the presence of residual circulating measles antibodies from the mother, and the younger the child, the lower the likelihood of seroconversion. In geographically isolated or otherwise inaccessible populations for which implementation of immunization programs is difficult, as well as in population groups in which the risk of natural measles virus infection in children under 15 months of age is high, it is possible to introduce the vaccine earlier. If vaccination was carried out before the age of 12 months, then revaccination should be carried out at the age of 15 months.

Rules for the preparation and administration of vaccine solutions

To inject and/or dissolve the vaccine, use a sterile syringe that does not contain preservatives, antiseptics or detergents, as these may inactivate the live viral vaccine. Only the diluent supplied with the vaccine (sterile water for injection) should be used, as it does not contain preservatives or antiviral substances that could inactivate the vaccine.

Before administration, the drug should be carefully inspected for the presence of suspended particles and discoloration. The dissolved M-M-P II vaccine should be clear and yellow in color.

Separate sterile syringes and needles must be used for each patient. Compliance with aseptic rules and proper storage of the vaccine before and after its dissolution and subsequent use are important.

To use M-M-P II in a vial containing 1 dose, completely draw up the solvent into a sterile syringe, inject the entire solvent into the vial with the lyophilized vaccine and mix thoroughly. Draw up the entire contents of the bottle into a syringe and completely inject it subcutaneously.

The vaccine and diluent do not contain preservatives, so potential contamination must be avoided and special precautions must be taken to ensure sterility of the product. It is recommended to use the vaccine as soon as possible after dissolution.

Side effect

When using the MM-P II vaccine, the same adverse reactions were observed as when administering monovalent or combination vaccines.

Local reactions: often - quickly passing burning sensation and/or pain at the injection site; rarely - erythema, thickening and sensitivity of the skin.

Dermatological reactions: rarely - rash (usually minor, but sometimes generalized; appears between 5 and 12 days).

From the digestive system: rarely - mumps, nausea, vomiting, diarrhea.

From the hematopoietic system: rarely - thrombocytopenia, thrombocytopenic purpura.

From the lymphatic system: rarely - regional lymphadenopathy.

Allergic reactions: rarely - skin reaction such as blisters or hyperemia at the injection site, anaphylactic and anaphylactoid reactions, angioedema (including peripheral edema and facial edema), bronchospasm, urticaria.

From the musculoskeletal system: rarely - arthralgia and/or arthritis (usually transient, in some cases chronic), myalgia.

When children are vaccinated, joint reactions are not typical and are usually short-lived. The incidence of arthritis in women is usually higher than in children and is 12-20% and 0-3%, respectively, and the reactions are usually more pronounced and lasting.

Joint syndrome in women tends to be more severe and prolonged; symptoms can persist for several months, and in rare cases, even years. In teenage girls, the frequency of joint reactions is higher than in children, but lower than in adult women. Even in older women (35-45 years), these reactions are usually well tolerated and do not affect normal functioning.

From the central nervous system and peripheral nervous system: rarely - febrile convulsions in children, convulsions not associated with fever, headache, dizziness, irritability, paresthesia, polyneuritis, polyneuropathy, Guillain-Barré syndrome, ataxia, subacute sclerosing encephalitis, various types of optic neuritis nerve, including retrobulbar rhinitis, papillitis; palsy of the optic nerves, deafness associated with neuritis.

Isolated cases of encephalitis/encephalopathy have been described with a frequency of 1 in 3 million doses. In no case has a real connection between these reactions and vaccination been proven. The risk of developing such serious neurological disorders after administration of live measles vaccine remains significantly lower than the risk of encephalitis and encephalopathies associated with measles (1 in 2000 reported cases).

From the senses: rarely - otitis media, conjunctivitis.

From the respiratory system: rarely - pneumonia, cough, rhinitis.

From the reproductive system: rarely - orchitis.

Other: rarely - fever (38.8°C or more; usually appears between 5 and 12 days), sore throat, malaise, mild measles, syncope.

There have been very rare reports of deaths from various and in some cases unknown causes following administration of the measles, mumps and rubella vaccine, but no relationship to vaccination has been established. In a study of widespread clinical use involving 1.5 million children and adults vaccinated with M-M-P II during 1982-1993, there were no reports of deaths or long-term complications.

Contraindications for use

• history of anaphylactic or anaphylactoid reactions to neomycin;
• history of anaphylactic or anaphylactoid reactions to eggs;
• diseases of the respiratory system accompanied by fever;
• acute infections accompanied by fever;
• untreated tuberculosis in the active phase;
• malignant diseases of the blood and lymphatic system, other malignant neoplasms affecting the bone marrow;
• primary and secondary immunodeficiencies (including AIDS or other clinical manifestations of HIV infection); violation of cellular immunity; hypogammaglobulinemia or dysgammaglobulinemia;
• carrying out immunosuppressive therapy (with the exception of corticosteroid replacement therapy, for example, for Addison's disease);
• the presence of congenital or hereditary immunodeficiency in the family history (until the state of the patient’s immune system is established);
• pregnancy;
• hypersensitivity to any component of the vaccine, including gelatin.

According to the Merck Sharp & Dohme Physician Brochure for this drug, persons with a history of anaphylactic, anaphylactoid, or other immediate hypersensitivity reactions (eg, urticaria, swelling of the oral and pharyngeal mucosa, difficulty breathing, hypotension, or shock) associated with egg consumption have an increased risk of developing an immediate hypersensitivity reaction after administration of a vaccine containing traces of chick embryo antigens. In such cases, the balance of potential risk and benefit must be carefully assessed before vaccination. Such patients should be vaccinated in exceptional cases and in the presence of all medications necessary in case of an allergic reaction.

Use during pregnancy and breastfeeding

The MM-P II vaccine is contraindicated for use during pregnancy.

It is not known whether MM-P II vaccine can cause fetal harm if vaccinated in a pregnant woman.

However, in case of unintentional vaccination during pregnancy or pregnancy occurring within 3 months after vaccination, it should be taken into account that in a 10-year study of more than 700 pregnant women vaccinated against rubella within 3 months before or after conception (189 of them received the Wistar RA strain 27/3), none of the newborns had congenital defects characteristic of congenital rubella syndrome. With mumps infection in the first trimester of pregnancy, the risk of spontaneous abortion may increase. Mumps vaccine virus has been shown to infect the placenta and fetus, but there is no evidence that it can cause birth defects in humans. There are reports that natural exposure to measles during pregnancy increases the risk to the fetus. Increased rates of spontaneous abortion, stillbirth, birth defects, and preterm birth have been observed in cases of measles during pregnancy. Adequate studies of the effect of an attenuated vaccine strain of measles virus in pregnant women have not been conducted. However, the assumption that the vaccine strain of the virus is also capable of causing damage to the fetus is justified.

MM-P II should be administered with caution to a nursing mother during lactation. It is not known whether measles and mumps vaccine viruses are excreted in breast milk. Recent studies have shown that when women are immunized during lactation with a live attenuated rubella vaccine, the virus can be detected in breast milk and transmitted to newborns. There were no cases of severe disease in newborns with serological signs of rubella virus infection, but one child developed typical mild acquired rubella.

Women of childbearing age are advised to protect themselves from pregnancy for 3 months after vaccination. They should be informed of the frequent occurrence of transient arthralgias and/or arthritis 2-4 weeks after vaccination. Conducting serological studies to determine susceptibility to rubella followed by vaccination of seronegative patients is desirable, but not mandatory.

It is believed that in many cases it is justified to vaccinate women susceptible to rubella immediately after childbirth.

Use in children

Children less than 15 months of age may not respond to the measles component of the vaccine due to the presence of residual circulating measles antibodies from the mother, and the younger the child, the lower the likelihood of seroconversion. In geographically isolated or otherwise inaccessible populations for which implementation of immunization programs is difficult, as well as in population groups in which the risk of natural measles virus infection in children under 15 months of age is high, it is possible to introduce the vaccine earlier. If vaccination was carried out before the age of 12 months, then revaccination should be carried out at the age of 15 months.

special instructions

The vaccine is not administered intravenously.

Given the possibility of anaphylactic and anaphylactoid reactions, the necessary treatment should be prepared before administering the vaccine, including adrenaline for injection (1:1000).

There is evidence that in children immunized before 1 year of age, later booster vaccination does not always result in long-term antibody retention, so the benefits of early immunization must be weighed against the possibility of an inadequate response to booster vaccination.

Vaccination of contacts of someone with measles may provide some protection if the vaccine is administered within 72 hours of exposure. If the vaccine was administered several days before infection, then in this case a high preventive effect will be achieved. There is no convincing data on the preventive effect of vaccination of people in contact with people with mumps and rubella.

Encephalitis, pneumonia and death have been reported in patients with severe immunocompromise after accidental administration of measles vaccine due to disseminated vaccine virus infection.

Particular caution should be exercised when vaccinating patients with a history of seizures (including in relatives), damage to brain tissue, or any other conditions in which an increase in body temperature must be avoided.

Patients with thrombocytopenia may develop more severe thrombocytopenia after vaccination. In addition, in persons with thrombocytopenia after the first vaccination with M-M-P II (or a vaccine included in its composition), thrombocytopenia may develop with subsequent doses. In the latter case, specific immunity should be assessed to determine the need for re-vaccination. In such cases, the balance of potential risk and benefit must be carefully assessed before vaccination.

Children and adolescents who are infected with human immunodeficiency virus but without obvious clinical signs of immunosuppression can be vaccinated. In such cases, vaccination may be less effective than in uninfected individuals.

M-M-P II should be prescribed 1 month before or 1 month after the administration of other vaccines.

Most patients experienced shedding of small amounts of live, attenuated rubella virus from the nose and throat within 7 to 28 days after vaccination. The possibility of transmitting the virus in this way from a vaccinated person to other people has not been proven. In close personal contact, this possibility should theoretically be taken into account, but the risk is negligible.

There are no reports of transmission of live attenuated measles or mumps virus from vaccinated individuals to susceptible individuals.

There are reports that live measles, mumps and rubella vaccines, administered separately, may temporarily reduce skin sensitivity to tuberculin. Therefore, if necessary, tuberculin tests should be performed before or simultaneously with the administration of the MM-P II vaccine.

In children receiving anti-tuberculosis therapy, there was no exacerbation of the disease after the administration of live measles vaccine. There are no reported studies on the effect of live measles vaccine on untreated tuberculosis in children.

Arthralgia and/or arthritis (usually transient and rarely chronic) and polyneuritis are characteristic of natural rubella and may vary in frequency and severity depending on age and sex, being most severe in adult women and least in prepubertal children. With natural rubella, chronic arthritis may occur due to the persistence of the virus and/or viral antigen released from body tissues. Vaccinated individuals rarely develop chronic joint symptoms.

A study of the widespread clinical use of more than 200 million doses of M-M-P and M-M-P II worldwide over a 25-year period (1971-1996) suggests that reports of serious adverse events such as encephalitis and encephalopathy , remain rare. Cases of subacute sclerosing panencephalitis (SSPE) have been described in children who have not had measles but received measles vaccine. In some of them, the cause of the disease may have been unrecognized measles during the first year of life or vaccination against measles. Considering the estimated prevalence of measles vaccination, the possible risk of developing SSPE during vaccination is about 1 case per 1 million vaccine doses. This is significantly less than for measles - 6-22 cases of SSPE per million cases of measles. It is believed that measles vaccination generally prevents SSPE by reducing the incidence of measles, in which the risk of this complication is high.

There are rare reports of panniculitis following administration of measles vaccine.

Vaccination should be carried out 2 weeks before or 3 months after the administration of human immunoglobulin, as well as blood or plasma transfusion.

Like any other vaccine, MM-P II does not provide protection against disease in 100% of those vaccinated.

It should be noted that each dose of the dissolved MM-P II vaccine contains about 25 mcg of neomycin.

Use in pediatrics

The safety and effectiveness of measles vaccine in children under 6 months of age have not been established. The safety and effectiveness of mumps and rubella vaccines in children under 1 year of age have not been established.

Overdose

Rare cases of overdose have not been accompanied by serious adverse reactions.

Drug interactions

With the simultaneous administration of M-M-P II and immunoglobulins, the expected immune response may be disrupted.

M-M-P II was used simultaneously with vaccinations against chickenpox and Haemophilus influenzae B infection, administered with different syringes to different parts of the body. At the same time, no disturbances in the immune response to the administered antigens were found, and the nature, frequency and severity of adverse reactions were similar to those with the introduction of single drugs.

Mass use of DTP and/or live polio vaccines simultaneously with measles, mumps and rubella vaccines is not recommended due to limited data on the results of the combined use of these antigens.

However, data from published studies regarding co-administration of commercial multivalent vaccines (eg, DTP, OPV, M-M-P, Haemophilus influenzae B vaccine and hepatitis B vaccine) do not indicate any interaction between them.

Storage conditions and periods

Before dissolution, the M-M-P II vaccine should be stored at a temperature of 2° to 8°C in a dark place. It is necessary to protect the vaccine from light, because Virus inactivation is possible. The solvent can be stored in the refrigerator along with the lyophilized vaccine or separately at room temperature. The shelf life of the vaccine is 3 years, the solvent is 5 years. Do not use after expiration date.

It is recommended to use the vaccine as soon as possible after dissolution; Storage is allowed in a dark place at a temperature of 2-8°C for no more than 8 hours.

To ensure the safety of the vaccine during transportation, it is necessary that the vaccine is kept at a temperature of 10°C or lower. Freezing during transportation does not affect the quality of the drug.

Compatibility with other vaccines

Vaccination against measles can be carried out simultaneously (on the same day) with other vaccinations of the National Preventive Vaccination Calendar (against mumps, rubella, polio, hepatitis B, whooping cough, diphtheria, tetanus) or no earlier than 1 month after the previous vaccination. After the administration of human immunoglobulin preparations, vaccinations against measles are carried out no earlier than 3 months later. After the administration of measles vaccine, immunoglobulin preparations can be administered no earlier than 2 weeks later. If it is necessary to use immunoglobulin earlier than this period, measles vaccination should be repeated.

After immunosuppressive therapy, measles vaccination can be carried out 3-6 months after the end of treatment.

COMPOUND

1 dose contains (0.5 ml):

Active ingredients:

• Measles virus with low virulence, obtained from an attenuated (Endegs') Edmonston strain and grown in a chicken embryo cell culture, not less than 1000 TCD50;
• Mumps virus obtained from the Jeryl Lynn strain (level B) and grown in a chicken embryo cell culture, not less than 12500 TCD50;
• Rubella virus obtained from a live attenuated strain Wistar RA 27/Z and grown in a culture of diploid human pulmonary fibroblast cells (WI-38), not less than 1000 TCD50

Excipients:

• Sodium hydrogen phosphate 2.2 mg;
• Sodium dihydrogen phosphate monohydrate 3.l mg;
• Sodium bicarbonate 0.5 mg;
• Medium 199 with Hanks salts 3.3 mg;
• Medium MEM Needle 0.1 mg;
• Neomycin sulfate 25 mcg;
• Phenol red 304 mcg;
• Sorbitol 14.5 mg;
• Potassium hydrogen phosphate 30 mcg;
• Potassium dihydrogen phosphate 20 mcg;
• Hydrolyzed gelatin 14.5 mg;
• Sucrose 1.9 mg;
• Sodium L-glutamate monohydrate 20 mcg.

Note: the drug contains trace amounts of recombinant human albumin (no more than 0.3 mg), bovine serum albumin (no more than 50 ng).

Sterile solvent:

Water for injection: 0.7 ml.

Note: the primary package contains 0.7 ~ l of solvent to dissolve the lyophilisate to the required volume (0.7 ml). An excess of 0.2 ml is necessary to compensate for losses and ensure the administration of 1 dose of vaccine in a volume of 0.5 ml.

Contraindications

Only a doctor can decide whether Measles is suitable for vaccination

The Measles vaccine is contraindicated if there is a history of an allergic reaction to any component of the vaccine, and in the following cases:

• Severe forms of allergic reactions to aminoglycosides (gentamicin sulfate, etc.), chicken and/or quail eggs.
• Primary immunodeficiency conditions, malignant blood diseases and neoplasms.
• Severe reaction (temperature rise above 40 C, swelling, hyperemia more than 8 cm in diameter at the injection site) or complication to a previous administration of measles or mumps-measles vaccines.
• Pregnancy.

MANUFACTURER

Legal person to whom the marketing authorization was issued: Merck Sharp and Dome B.V., the Netherlands

Manufactured by: Merck Sharp and Dome Corp., USA.

Merck Sharp & Dohme Co., 770 Sumneytown Pike, West Point, RA 19486, USA or Merck Sharp & Dohme Corp., USA.

Merck Sharp & Dohme Cogr., 5325 Old Oxford Road, Duham, NC 27712, USA.

Quality control: Merck Sharp & Dohme B.V., The NetherlandsMerck Sharp & Dohme B.V., Waarderweg 39, 2031 BN Haarlem, The Netherlands.

Possible side effects

• In most vaccinated people, the post-vaccination period is asymptomatic.
• In the period from 6 to 18 days after vaccination, temperature reactions, mild hyperemia of the pharynx, and rhinitis may be observed.
• Rarely, coughing and conjunctivitis are observed, lasting for 1-3 days, minor skin hyperemia and mild swelling, which disappear after 1-3 days without treatment.
• Very rarely, 6-10 days after vaccination, mild malaise and a measles-like rash and convulsive reactions occur, most often occurring against a background of high fever.
• In the first two days, allergic reactions may be observed in children with allergic altered reactivity.
• A history of febrile convulsions, as well as an increase in temperature above 38.5 ºC in the post-vaccination period, are an indication for the prescription of antipyretics.
• Considering the possibility of developing immediate allergic reactions (anaphylactic shock, Quincke's edema, urticaria) in particularly sensitive individuals, vaccinated persons must be provided with medical supervision for 30 minutes.

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