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    Active Ingredient *

    Status in Israel
    RX

    Presentation and Status in Health Basket

    Presentation Basket Yarpa Pharmasoft

    Vial

    1 X 0.5 ml

    partial basket chart 9768 16093

    Related information


    Dosage

    The use of this vaccine should be based on official recommendations.
    Individuals 12 months of age or older: The dose is 0.5 ml. A second dose should be given according to official recommendations. this vaccine  may be used in individuals who have previously been vaccinated with another monovalent or combined measles, mumps and rubella vaccine.
    Infants between 9 and 12 months of age: Infants in their first year of life may not respond sufficiently to the components of the vaccines. In case an epidemiological situation requires vaccinating infants in their first year of life (e.g. outbreak or travel to endemic regions), a second dose should be given in the second year of life, preferably within three months after the first dose. Under no circumstances should the interval between doses be less than four weeks.
    Infants less than 9 months of age: The safety and efficacy in infants under 9 months of age has not been established.
    Method of administration: Subcutaneous  injection, although it can also be given by intramuscular injection. The vaccine should preferably be administered subcutaneously in patients with thrombocytopenia or any coagulation disorder. For instructions on reconstitution of the medicinal product before administration.


    Indications

    Active immunisation of children from the age of 9 months or older, adolescents and adults against measles, mumps and rubella. For use in children between 9 to 12 months of age.


    Contra-Indications

    Hypersensitivity to the active substances or to any of the excipients listed in or neomycin. A history of contact dermatitis to neomycin is not a contraindication. For hypersensitivity reactions to egg proteins. 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%. Pregnancy. Furthermore, pregnancy should be avoided for 1 month following vaccination. As with other vaccines, the administration of this vaccine should be postponed in subjects suffering from acute severe febrile illness. The presence of a minor infection, such as a cold, should not result in the deferral of vaccination.


    Special Precautions

    As with all injectable vaccines, appropriate medical treatment and supervision should always be readily available in case of a rare anaphylactic event following the administration of the vaccine. Alcohol and other disinfecting agents must be allowed to evaporate from the skin before injection of the vaccine since they can inactivate the attenuated viruses in the vaccine.
    Infants in their first year of life may not respond sufficiently to the components of the vaccine, due to the possible interference with maternal antibodies.
    Due caution should be employed in administration of this vaccine  to individuals with Central Nervous System (CNS) disorder, susceptibility to febrile convulsions or family history of convulsions. Vaccinees with a history of febrile convulsions should be closely followed-up.
    The measles and mumps components of the vaccine are produced in chick embryo cell culture and may therefore contain traces of egg protein. Persons with a history of anaphylactic, anaphylactoid, or other immediate reactions (e.g. generalised urticaria, swelling of the mouth and throat, difficulty in breathing, hypotension, or shock) subsequent to egg ingestion may be at an enhanced risk of immediate-type hypersensitivity reactions after vaccination, although these types of reactions have been shown to be very rare. Individuals who have experienced anaphylaxis after egg ingestion should be vaccinated with extreme caution, with adequate treatment for anaphylaxis on hand should such a reaction occur.
    Patients with rare hereditary problems of fructose intolerance should not be vaccinated with this vaccine since it contains sorbitol.
    Limited protection against measles may be obtained by vaccination up to 72 hours after exposure to natural measles.
    Syncope (fainting) can occur following, or even before, any vaccination especially in adolescents as a psychogenic response to the needle injection. This can be accompanied by several neurological signs such as transient visual disturbance, paraesthesia and tonic-clonic limb movements during recovery. It is important that procedures are in place to avoid injury from faints.
    As with any vaccine, a protective immune response may not be elicited in all vaccinees.
    THIS VACCINE SHOULD UNDER NO CIRCUMSTANCES BE ADMINISTERED INTRAVASCULARLY.
    Thrombocytopenia: Cases of worsening of thrombocytopenia and cases of recurrence of thrombocytopenia in subjects who suffered thrombocytopenia after the first dose have been reported following vaccination with live measles, mumps and rubella vaccines. MMR-associated thrombocytopenia is rare and generally self-limited. In patients with existing thrombocytopenia or a history of thrombocytopenia after measles, mumps or rubella vaccination the risk-benefit of administering the vaccine  should be carefully evaluated. These patients should be vaccinated with caution and preferably using subcutaneous route.
    Immunocompromised patients: Vaccination may be considered in patients with selected immune deficiencies where the benefits outweigh the risks (e.g. asymptomatic HIV subjects, IgG subclass deficiencies, congenital neutropenia, chronic granulomatous disease and complement deficiency diseases).
    Immunocompromised patients who have no contraindication for this vaccination  may not respond as well as immunocompetent subjects, therefore some of these patients may acquire measles, mumps or rubella in case of contact, despite appropriate vaccine administration. These patients should be monitored carefully for signs of measles, parotitis and rubella.
    Transmission: Transmission of measles and mumps virus from vaccinees to susceptible contacts has never been documented. Pharyngeal excretion of the rubella and measles virus is known to occur about 7 to 28 days after vaccination with peak excretion around the 11th day. However there is no evidence of transmission of these excreted vaccine viruses to susceptible contacts. Transmission of the rubella vaccine virus to infants via breast milk as well as transplacental transmission has been documented without any evidence of clinical disease.


    Side Effects

    Redness at the injection site, fever ≥38°C (rectal) or ≥37.5°C (axillary/oral) pain and swelling at the injection site, fever >39.5°C (rectal) or >39°C (axillary/oral) upper respiratory tract infection.
    See prescribing information for full details.


    Drug interactions

    Thia vaccine can be given simultaneously (but at separate injection sites) with any of the following monovalent or combination vaccines [including hexavalent vaccines (DTPa-HBV-IPV/Hib)]: diphtheria-tetanus-acellular pertussis vaccine (DTPa), Haemophilus influenzae type b vaccine (Hib), inactivated polio vaccine (IPV), hepatitis B vaccine (HBV), hepatitis A vaccine (HAV), meningococcal serotype C conjugated vaccine (MenC), varicella zoster vaccine (VZV), oral polio vaccine (OPV) and 10-valent pneumococcal conjugate vaccine in accordance with local recommendations.
    If not given at the same time, an interval of at least one month is recommended between administration of this vaccine and other live attenuated vaccines. There are no data to support the use of this vaccine  with any other vaccines. If tuberculin testing has to be done it should be carried out before or simultaneously with vaccination since it has been reported that combined measles, mumps and rubella vaccines may cause a temporary depression of tuberculin skin sensitivity. As this anergy may last up to a maximum of 6 weeks, tuberculin testing should not be performed within that period after vaccination to avoid false negative results. In subjects who have received human gammaglobulins or a blood transfusion, vaccination should be delayed for three months or longer (up to 11 months) depending on the dose of human globulins administered because of the likelihood of vaccine failure due to passively acquired measles, mumps and rubella antibodies.


    Pregnancy and Lactation

    Pregnancy: Pregnancy should be avoided for 1 month following vaccination. Women who intend to become pregnant should be advised to delay.
    See prescribing information for full details.
    Lactation: There is limited experience with this vaccine during breast-feeding.


    Overdose

    Cases of overdose (up to 2 times the recommended dose) have been reported during post-marketing surveillance. No adverse reactions have been associated to the overdose.


    Important notes

    Storage: Store and transport refrigerated (2°C – 8°C). Do not freeze.


    Manufacturer
    GlaxoSmithKline Biologicals S.A., Rixensart, Belgium
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