M-M-RVaxPro · 4.6 Fertility, pregnancy and lactation · 1

HOS-094022 · has-adverse-reaction-information · PDF-Seite 7

a. Summary of the safety profile In clinical trials, M-M-RvaxPro was administered to 1 965 children (see section 5.1), and the general safety profile was comparable to the previous formulation of the measles, mumps and rubella vaccine manufactured by MSD. In a clinical trial, 752 children received M-M-RvaxPro, either intramuscularly or subcutaneously. The general safety profile of either administration routes were comparable, although injection site reactions were less frequent in the IM group (15.8%) compared with the SC group (25.8%). All adverse reactions were evaluated in 1 940 children. Among these children, the vaccine-related adverse reactions, summarised in section b, were observed in individuals following vaccination with M-M-RvaxPro (excluding isolated reports with frequency < 0.2%). In comparison to the first dose, a second dose of M-M-RvaxPro is not associated with an increase in the incidence and severity of clinical symptoms including those suggestive of hypersensitivity reaction. Additionally, other adverse reactions reported with post-marketing use of M-M-RvaxPro and/or in clinical studies and post-marketing use of previous formulations of monovalent and of the combined measles, mumps and rubella vaccines manufactured by MSD without regard to causality or frequency are available and are summarised in section b. The frequency of these adverse events is qualified as "not known" when it cannot be estimated based on the available data. These data were reported based on more than 400 million doses distributed worldwide. The most common adverse reactions reported with the use of M-M-RvaxPro were: fever (38.5 °C or higher); injection site reactions including pain, swelling and erythema. b. Tabulated list of adverse reactions Adverse reactions are ranked under headings of frequency using the following convention: [Very common (≥ 1/10); Common (≥ 1/100 to < 1/10); Uncommon (≥ 1/1 000 to < 1/100); Not known (cannot be estimated from the available data)] Adverse reactions Frequency Infections and infestations Nasopharyngitis, Upper respiratory tract infection or Uncommon Viral infection Aseptic meningitis†, Atypical measles, Epididymitis, Orchitis, Otitis media, Parotitis, Rhinitis, Subacute Not known sclerosing panencephalitis† Blood and the lymphatic system disorders Regional lymphadenopathy, Thrombocytopenia

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HOS-094018 · has-contraindication-information · PDF-Seite 3

Hypersensitivity to any measles, mumps, or rubella vaccine, or to any of the excipients listed in section 6.1, including neomycin (see sections 2 and 4.4). Pregnancy. Furthermore, pregnancy should be avoided for 1 month following vaccination (see section 4.6). Vaccination should be postponed during any illness with fever > 38.5 °C. Active untreated tuberculosis. Children under treatment for tuberculosis have not experienced exacerbation of the disease when immunised with live measles virus vaccine. No studies have been reported to date on the effect of measles virus vaccines on children with untreated tuberculosis. Blood dyscrasias, leukaemia, lymphomas of any type, or other malignant neoplasms affecting the haematopoietic and lymphatic systems. Current immunosuppressive therapy (including high doses of corticosteroids). M-M-RvaxPro is not contraindicated in individuals who are receiving topical or low-dose parenteral corticosteroids (e.g., for asthma prophylaxis or replacement therapy). 3 Severe humoral or cellular (primary or acquired) immunodeficiency, e.g., severe combined immunodeficiency, agammaglobulinemia and AIDS or symptomatic HIV infection or an age-specific CD4+ T-lymphocyte percentage in children below 12 months: CD4+ < 25%; children between 12-35 months: CD4+ < 20%; children between 36-59 months: CD4+ < 15% (see section 4.4). In severely immunocompromised individuals inadvertently vaccinated with measles-containing vaccine, measles inclusion body encephalitis, pneumonitis, and fatal outcome as a direct consequence of disseminated measles vaccine virus infection have been reported. Family history of congenital or hereditary immunodeficiency, unless the immune competence of the potential vaccine recipient is demonstrated.

HOS-094017 · has-indication-information · PDF-Seite 2

M-M-RvaxPro is indicated for simultaneous vaccination against measles, mumps and rubella in individuals from 12 months of age (see section 4.2). M-M-RvaxPro can be administered to infants from 9 months of age under special circumstances (see sections 4.2, 4.4 and 5.1). For use in measles outbreaks, or for post-exposure vaccination, or, for use in previously unvaccinated individuals older than 9 months who are in contact with susceptible pregnant women, and persons likely to be susceptible to mumps and rubella, see section 5.1. M-M-RvaxPro is to be used on the basis of official recommendations. 2

HOS-094020 · has-interaction-information · PDF-Seite 5

Immune globulin Immune globulin (Ig) is not to be given concomitantly with M-M-RvaxPro. Administration of immune globulins concomitantly with M-M-RvaxPro may interfere with the expected immune response. Vaccination should be deferred for at least 3 months following blood or plasma transfusions, or administration of human immune serum globulin. Administration of measles, mumps, or rubella antibody-containing blood products, including immune globulin preparations, should be avoided within 1 month after a dose of M-M-RvaxPro unless considered to be essential. Laboratory tests It has been reported that live attenuated measles, mumps and rubella virus vaccines given individually may result in a temporary depression of tuberculin skin sensitivity. Therefore, if a tuberculin test is to be done, it should be administered either any time before, simultaneously with, or 4 to 6 weeks after vaccination with M-M-RvaxPro. Concomitant administration with other vaccines M-M-RvaxPro can be given concomitantly with a pneumococcal conjugate vaccine. Published clinical data support concomitant administration of the previous formulation of the measles, mumps and rubella vaccine manufactured by Merck Sharp & Dohme LLC, Rahway, NJ 07065, USA (herein after MSD) with other childhood vaccinations, including DTaP (or DTwP), IPV (or OPV), 5 HIB (Haemophilus influenzae type b), HIB-HBV (Haemophilus influenzae type b with Hepatitis B vaccine), and VAR (varicella). Based on clinical studies with the quadrivalent measles, mumps, rubella and varicella vaccine and with the previous formulation of the combined measles, mumps and rubella vaccine manufactured by MSD, M-M-RvaxPro can be given concomitantly with a hepatitis A vaccine. In these clinical studies, it was demonstrated that the immune responses were unaffected and that the overall safety profiles of the administered vaccines were similar. Since M-M-RvaxPro has been shown to have safety and immunogenicity profiles similar to the previous formulation of the combined measles, mumps and rubella vaccine manufactured by MSD, experience with this vaccine can be considered. M-M-RvaxPro should be given concomitantly at separate injection sites, or one month before or after administration of other live virus vaccines.

HOS-094021 · has-pregnancy-information · PDF-Seite 6

Pregnancy Pregnant women should not be vaccinated with M-M-RvaxPro. Studies have not been conducted with M-M-RvaxPro in pregnant women. In a review of more than 3 500 susceptible women who were unknowingly in early stages of pregnancy when vaccinated with a rubella-containing vaccine, no cases of congenital rubella syndrome were reported. Subsequent post-marketing surveillance identified congenital rubella syndrome associated with a rubella vaccine strain following inadvertent vaccination of a pregnant woman with a measles, mumps and rubella vaccine. Foetal damage has not been documented when measles or mumps vaccines have been given to pregnant women. Inadvertent vaccination of unknowingly pregnant women with measles-, mumps-, or rubella-containing vaccines should not be a reason for termination of pregnancy. Pregnancy should be avoided for 1 month following vaccination. Women who intend to become pregnant should be advised to delay. Breast-feeding Studies have shown that breast-feeding postpartum women vaccinated with live attenuated rubella vaccines may secrete the virus in breast milk and transmit it to breast-fed infants. In the infants with serological evidence of rubella infection, none had symptomatic disease. It is not known whether measles or mumps vaccine virus is secreted in human milk; therefore, caution should be exercised when M-M-RvaxPro is administered to a breast-feeding woman. Fertility M-M-RvaxPro has not been evaluated in fertility studies.

HOS-094019 · has-warning-information · PDF-Seite 4

Traceability In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded. As with all injectable vaccines, appropriate medical treatment should always be readily available in case of rare anaphylactic reactions following the administration of the vaccine (see section 4.8). Adults and adolescents with a history of allergies may potentially be at increased risk of anaphylaxis or anaphylactoid reactions. Close monitoring is recommended following vaccination for the early signs of such reactions. Since live measles vaccine and live mumps vaccine are produced in chick embryo cell culture, persons with a history of anaphylactic, anaphylactoid, or other immediate reactions (e.g., hives, swelling of the mouth and throat, difficulty breathing, hypotension, or shock) subsequent to egg ingestion may be at an enhanced risk of immediate type hypersensitivity reactions. The potential risk to benefit ratio should be carefully evaluated before considering vaccination in such cases. Due caution should be employed in administration of M-M-RvaxPro to persons with individual or family history of convulsions, or a history of cerebral injury. The physician should be alert to the temperature elevation that may occur following vaccination (see section 4.8). Infants from 9 to 12 months of age vaccinated with a measles-containing vaccine during measles outbreaks or for other reasons may fail to respond to the vaccine due to the presence of circulating antibodies of maternal origin and/or immaturity of the immune system (see sections 4.2 and 5.1). Thrombocytopenia This vaccine should be given subcutaneously to individuals with thrombocytopenia or any coagulation disorder because bleeding may occur following an intramuscular administration in these individuals. Individuals with current thrombocytopenia may develop more severe thrombocytopenia following vaccination. In addition, individuals who experienced thrombocytopenia with the first dose of M-M-RvaxPro (or its component vaccines) may develop thrombocytopenia with repeat doses. Serologic status may be evaluated to determine whether or not additional doses of vaccine are needed. The potential risk to benefit ratio should be carefully evaluated before considering vaccination in such cases (see section 4.8). Other Vaccination may be considered in patients with selected immune deficiencies where the benefits outweigh the risks (asymp

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