Index of drugs

For simultaneous vaccination against measles, mumps and rubella of people aged 12 months or older. To be used during measles epidemics or for vaccination after exposure to infection or for use in unvaccinated children over 12 months of age who are in contact with non-immune pregnant women, as well as in people who are not likely to be immunized against mumps and rubella.

1 dose (0.5 ml) contains live, attenuated viruses: measles (strain Enders - Edmonston) - not less than 1 × 10³ CCID₅₀, mumps (Jeryl Lynn strain) - not less than 12,5 × 10³ CCID₅₀, rubella (strain Wistar RA 27/3) - not less than 1 × 10³ CCID₅₀ . CCID₅₀ - infectious dose for 50% of the culture cells.

Combined, live vaccine containing attenuated measles, mumps and rubella viruses, obtained from breeding on hen embryos (measles, mumps) and human diploid pulmonary fibroblasts (rubella). The difference between the M-M-RVAXPRO and M-M-R II vaccine is that M-M-RVAXPRO is made using albumin produced by recombinant DNA, whereas M-M-R II is made of albumin, extracted from human plasma.

Hypersensitivity to any measles, mumps or rubella vaccine or to any of the excipients, including neomycin. Diseases with fever> 38.5 ° C (vaccination should be postponed). Active, untreated tuberculosis. Dyskrażja, leukemia, any type of lymphoma or other malignant neoplasms of the hematopoietic and lymphatic system. Current immunosuppressive treatment (including the use of high doses of corticosteroids); the vaccine is not contraindicated in people taking corticosteroids in low doses topically or parenterally (eg in the prevention of asthma or as part of a replacement therapy). Humoral or cellular immunodeficiency (primary or acquired), including hypogammaglobulinaemia and dysgammaglobulinaemia and AIDS or symptomatic HIV infection or CD4 + T cell count <25% of the normal value for age (due to the risk of encephalitis with the current measles virus inclusion bodies, pneumonia and fatal outcome as a direct consequence of the disseminated measles virus vaccine). People with a family history of congenital or hereditary immune disorder known for their family history, unless they have a normal immune system before vaccination. Pregnancy.

Special care should be taken in people who have anaphylactic, anaphylactoid or other early allergic reactions due to the consumption of egg - consider the potential risk to the benefits of administering the vaccine. Exercise caution in patients with hypersensitivity to human recombinant albumin (rHA). Use carefully in patients with a history of seizure or brain injury, as vaccine-induced fever may be a risk to these patients. Caution should be used in patients with thrombocytopenia or bleeding disorders (administered only under the skin, because they may bleed after intramuscular administration); in these patients, thrombocytopenia may get worse after the vaccine is given. The vaccine can be given to people who are infected with human immunodeficiency viruses but do not have impaired immunity; however, after vaccination, these people should be monitored for measles, mumps and rubella, because vaccination may be less effective. In children treated for tuberculosis no exacerbation of the disease was observed after vaccination with a live measles virus vaccine; no data on the effect of measles virus vaccines on children with untreated tuberculosis.

Administration of the vaccine in pregnancy is contraindicated, in addition, pregnancy should be avoided for 3 months after vaccination (increased risk of miscarriage as well as fetal defects or birth defects in the fetus).Caution should be exercised when administering the vaccine to breastfeeding women (the rubella virus may be transmitted to fed children, but without a clinically confirmed disease, no data on the excretion of measles and mumps virus with milk).

Safety profiles after intramuscular and subcutaneous administration were comparable, although reactions at the injection site were less frequent in the group them. compared to the groupa.s. Very common: fever (≥38.5st.C), erythema at the injection site, pain at the injection site, swelling at the injection site. Often: morbid rash or other type of rash, bruising at the injection site. Uncommon: nasopharyngeal inflammation, upper respiratory tract infection or viral infection, watery discharge from the nose, diarrhea, vomiting, urticaria, rash at the injection site. Frequency unknown: sterile meningitis, atypical measles, epididymitis, orchitis, otitis media, parotidisitis, rhinitis, subacute sclerosing encephalitis, regional lymphadenopathy, thrombocytopenia, anaphylactoid reaction, anaphylaxis and the like symptoms (such as angioedema, facial edema and peripheral edema), irritability, fits or fits, ataxia, dizziness, encephalitis, encephalitis, fever convulsions (in children), Guillain-Barré syndrome, headache, encephalitis with inclusion bodies of the measles virus (MIBE), ocular paralysis, optic neuritis, paraesthesia, polyneuropathy, retrobulbar optic neuritis, syncope, conjunctivitis, retinitis, nerve deafness, bronchospasm, cough, inflammation of the pulmonary parenchyma, inflammation lungs, soreness l of the throat, nausea, inflammation of the subcutaneous tissue, purpura, skin sclerosis, Stevens-Johnson syndrome, pruritus, arthritis and / or joint pain (usually transient and rarely chronic), muscle pain, short-term burning and / or stinging at the injection site, malaise, nephritis, peripheral edema, swelling, tenderness, blisters at the injection site, blister and redness of the skin at the injection site, vasculitis.

Subcutaneous or intramuscular (anterolateral thigh in younger children, deltoid muscle region in older children, adolescents and adults). The vaccination scheme used should be in accordance with official recommendations.Patients aged 12 months and older: one dose of vaccine on the selected date; the second dose can be given at least 4 weeks after the first dose (the second dose is intended for people who for any reason did not respond to the first dose).Patients under 12 monthsCurrently no data are available on the efficacy and safety of the vaccine in children under 12 months. Infants in 6-11 months. vaccinated during an epidemic of measles, or if vaccinated at this age in accordance with the official recommendations of a vaccine containing a measles virus, may not respond to the vaccine due to the presence of circulating antibodies from the mother. Such infants should be re-vaccinated at 12-15 months, followed by an additional dose of measles vaccine according to official recommendations.