M-M-RVAXPROPowder and solvent for suspension for injection in pre-filledsyringe.Measles, mumps, and rubella vaccine (live)

M-M-RVAXPRO is a vaccine containing measles, mumps, and rubella viruses that have been weakened. When a person is given the vaccine, the immune system (the body's natural defences) will make antibodies against the measles, mumps, and rubella viruses. The antibodies help protect against infections caused by these viruses.

M-M-RVAXPRO is given to help protect you or your child against measles, mumps, and rubella. The vaccine may be administered to persons 12 months or older.

M-M-RVAXPRO can also be used in measles outbreaks, or for post-exposure vaccination, or for use in previously unvaccinated children older than 12 months who are in contact with susceptible pregnant women, and persons likely to be susceptible to mumps and rubella.

Although M-M-RVAXPRO contains live viruses, they are too weak to cause measles, mumps, or rubella in healthy people.

Do not use M-M-RVAXPRO:

• If you or your child are allergic (hypersensitive) to any of the components of M-M-RVAXPRO(including neomycin or any of the ingredients listed under ?other ingredients?. See section 6. Further information)
• If you or your child are pregnant (in addition, pregnancy should be avoided for 3 months aftervaccination, see Pregnancy)
• If you or your child have active untreated tuberculosis
• If you or your child are receiving treatment or taking medicines that may weaken the immune system(except low-dose corticosteroid therapy for asthma or replacement therapy)
• If you or your child have a weakened immune system because of a disease (including AIDS)
• If you or your child have a blood disorder or any type of cancer that affects the immune system
• If you or your child have a family history of congenital or hereditary immunodeficiency, unless theimmune competence of your or your child is demonstrated.
• If you or your child have any illness with fever higher than 38.5°C; however, low-grade fever itself is not a reason to delay vaccination

Take special care with M-M-RVAXPRO:
If the person to be vaccinated has experienced any of the following, talk to the doctor or pharmacist before M-M-RVAXPRO is given :

• If you or your child have an allergic reaction to eggs or anything that contained egg
• If you or your child have a history or family history of allergies or of convulsions (fits)
• If you or your child have a side effect after vaccination with measles, mumps, or rubella vaccine (in a single component vaccine or a combination vaccine, such as the measles, mumps, and rubella vaccine manufactured by Merck & Co., Inc.) that involved easy bruising or bleeding for longer than usual
• If you or your child have infection with Human Immunodeficiency Virus (HIV) but do not show symptoms of HIV disease. You or your child should be monitored closely for measles, mumps, and rubella because vaccination may be less effective than for uninfected persons (see section Do not use M-M-RVAXPRO).

As with other vaccines, M-M-RVAXPRO may not completely protect all persons who are vaccinated. Also, if the person who is to be vaccinated has already been exposed to the measles, mumps, or rubella virus but is not yet ill, M-M-RVAXPRO may not be able to prevent the illness from appearing.

M-M-RVAXPRO can be given to persons who have been in recent (within 3 days) contact with a case of measles and may be incubating the disease. However, M-M-RVAXPRO may not always be able to prevent measles developing in these cases.

Using other medicines and other vaccines:

The doctor may delay your or your child?s vaccination for at least 3 months following blood or plasma transfusions, or immune globulin (known as IG). After vaccination with M-M-RVAXPRO, IG should not be given for 1 month, unless your doctor tells you otherwise.

If a tuberculin test is to be performed, it should be done either any time before, simultaneously with, or 4 to 6 weeks after vaccination with M-M-RVAXPRO.

M-M-RVAXPRO may be given with Prevenar and/or hepatitis A vaccine at the same visit at a separate injection site (e.g. the other arm or leg).M-M-RVAXPRO may be given with some routine childhood vaccines that may be due to be given at the same time. For vaccines that cannot be given at the same time, M-M-RVAXPRO should be given 1 month before or after administration of those vaccines.

Please tell your doctor or pharmacist if you or your child are taking or have recently taken any other medicines (or other vaccines), including medicines obtained without a prescription.

Pregnancy and breast-feeding

M-M-RVAXPRO must not be given to pregnant females. Females of child-bearing age should take the necessary precautions to avoid pregnancy for 3 months, or according to doctor?s recommendation, after they have been given the vaccine.

Persons who are breast-feeding or intend to breast-feed should tell the doctor. The doctor will decide if M-M-RVAXPRO should be given.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines:

There is no information to suggest that M-M-RVAXPRO affects the ability to drive or operate machinery.

M-M-RVAXPRO should be injected into the muscle under the skin either in the area of the outer thigh or of the upper arm. Usually for injections into the muscle the thigh area is preferred in young children whereas for older individuals the upper arm area is the preferred injection site. M-M-RVAXPRO is not to be injected directly into any blood vessel.

M-M-RVAXPRO is given as follows:

• To persons 12 months or older. One dose is given at an elected date.
• For persons vaccinated at 12 months or older, an additional dose is usually recommended at least 4 weeks after the first dose according to your doctor?s recommendation.
• Children first vaccinated between 6 months and less than 12 months should be revaccinated at 12 to 15 months followed by an additional dose according to your doctor?s recommendation.

Reconstitution instructions intended for medical and healthcare professionals are included at the end of the leaflet

Like all medicines, M-M-RVAXPRO can cause side effects, although not everybody gets them.

Approximately 1 out of 10 patients reported the following side effects with the use of M-M-RVAXPRO: fever (38.5°C or higher), injection site redness, and injection site pain and swelling. Injection site bruising was reported in approximately 1 out of 100 patients.

Other side effects have been reported with the use of either the measles, mumps, and rubella vaccine manufactured by Merck & Co., Inc. or of its monovalent (single) components: burning and/or stinging of short duration at the injection site, joint pain and/or swelling (which could be transient or chronic), rash, unusual bleeding or bruising under the skin, and swelling of the testicles.

Other less common side effects have been reported and some of these were serious. These included: allergic reactions, seizures (fits), and inflammation of the brain (encephalitis).

The doctor has a more complete list of side effects for M-M-RVAXPRO. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please inform your doctor or pharmacist. If the condition persists or worsens, seek medical attention.

Keep out of the reach and sight of children.
Store and transport refrigerated (2°C- 8°C).
Keep the vial of powder in the outer carton in order to protect from light.
Do not freeze the vaccine.
Do not use M-M-RVAXPRO after the expiry date which is stated on the outer carton after EXP.

Once the vaccine has been mixed with the solvent supplied, it should be either used immediately or stored in the refrigerator and used within eight hours.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

What M-M-RVAXPRO contains

The active substances are:

After reconstitution, one dose (0.5 ml) contains:

Measles virus1 Enders Edmonston strainlive, attenuated.not less than 1x103 CCID50 Mumps virus1 Jeryl Lynn Level B strainlive, attenuatednot less than 12.5x103 CCID50 Rubella virus2 Wistar RA 273 strain live, attenuated .not less than 1x103 CCID50

* 50% cell culture infectious dose

12 produced in chick embryo cells. produced in WI-38 human diploid lung fibroblasts.

The other ingredients are:

Powder:
sorbitol, sodium phosphate, potassium phosphate, sucrose, hydrolysed gelatin, medium 199 with Hanks? salts, MEM, monosodium L-glutamate, neomycin, phenol red, sodium bicarbonate, hydrochloric acid (to adjust pH), and sodium hydroxide (to adjust pH)

Solvent:
water for injections

What M-M-RVAXPRO looks like and contents of the pack

The vaccine is a powder for suspension for injection contained in a single-dose vial, which should be mixed with solvent provided.

The solvent is a clear and colourless liquid. The powder is a light yellow compact crystalline cake.

M-M-RVAXPRO is available in packs of 1, 10 and 20, with or without needles. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder: Sanofi Pasteur MSD SNC, 8 rue Jonas Salk, F-69007 Lyon, France

Manufacturer Responsible for Batch Release: Merck Sharp and Dohme, B.V., Waarderweg 39, 2031 BN Haarlem, The Netherlands

For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder.

België/Belgique/Belgien: Sanofi Pasteur MSD, Tél/Tel: +32.2.726.95.84
--------: ---- ---- - ---- -------- ---- ---. + 359 2 8193740
-eská republika: Merck Sharp & Dohme, IDEA, Inc., org. sl., Tel.: +420.233.010.111 Danmark: Sanofi Pasteur MSD, +45 23 32 69 29
Deutschland: Sanofi Pasteur MSD GmbH, Tel: +49.6224.5940
Eesti: Merck Sharp & Dohme OÜ, Tel: +372.613.9750
???-??: ?????? ?.?., ???: +30.210.8009111
España: Sanofi Pasteur MSD S.A., Tel: +34.91.371.78.00
France: Sanofi Pasteur MSD SNC, Tél: +33.4.37.28.40.00
Ireland: Sanofi Pasteur MSD Ltd, Tel: +3531.468.5600
Ísland: Sanofi Pasteur MSD, Sími: +32.2.726.95.84

Italia: Sanofi Pasteur MSD Spa, Tel: +39.06.664.092.11
K-????: Merck Sharp & Dohme (Middle East) Limited., ???: +357 22866700
Latvija: SIA Merck Sharp & Dohme Latvija, Tel: +371.67364.224
Lietuva: UAB Merck Sharp & Dohme, Tel.: +370.5.2780.247
Luxembourg/Luxemburg: Sanofi Pasteur MSD, Tél: +32.2.726.95.84
Magyarország: MSD Magyarország Kft, Tel.: + 36.1.888.5300
Malta: Merck Sharp & Dohme (Middle East) Limited, Tel: +357 22866700
Nederland: Sanofi Pasteur MSD, Tel: +31.23.567.96.00
Norge: Sanofi Pasteur MSD, Tlf: +47.67.50.50.20
Österreich: Sanofi Pasteur MSD GmbH, Tel: +43.1.866.70.22.202
Polska: MSD Polska Sp. z o.o., Tel.: +48.22.549.51.00
Portugal: Sanofi Pasteur MSD, SA, Tel: +351 21 470 45 50
România: Merck Sharp & Dohme Romania S.R.L. Tel: + 4021 529 29 00
Slovenija: Merck Sharp & Dohme, inovativna zdravila d.o.o. Tel: +386.1.520.4201 Slovenská republika: Merck Sharp & Dohme IDEA, Inc., Tel: +421.2.58282010 Suomi/Finland: Sanofi Pasteur MSD, Puh/Tel: +358.9.565.88.30
Sverige: Sanofi Pasteur MSD, Tel: +46.8.564.888.60
United Kingdom: Sanofi Pasteur MSD Ltd, Tel: +44.1.628.785.291

This leaflet was last approved in:

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The following information is intended for medical or healthcare professionals only:

Reconstitution instructions

The solvent is a clear colourless liquid. Before mixing with the solvent, the powder is a light yellow compact crystalline cake. When completely reconstituted, the vaccine is a clear yellow liquid.

Inject the entire content of the pre-filled syringe into the vial containing the powder. Gently agitate to dissolve completely. Withdraw the entire content of the reconstituted vaccine vial into the same syringe and inject the entire volume.

If two needles are provided: use one needle to reconstitute the vaccine and the other for its administration to the person to be vaccinated.

It is recommended that the vaccine be administered immediately after reconstitution or stored in the refrigerator and used within 8 hours to minimize loss of potency. Discard if reconstituted vaccine is not used within 8 hours.

Do not freeze the reconstituted vaccine.

Do not use the reconstituted vaccine if you notice any particulate matter or if the appearance of the solvent or powder or of the reconstituted vaccine differs from that described above.

Any unused product or waste material should be disposed of in accordance with local requirements.

See also section 3 HOW TO USE M-M-RVAXPRO.