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Powder and solvent for suspension for injection in pre-filled syringe
Measles, mumps and rubella vaccine (live)
1. What M-M-RvaxPro is and what it is used for
2. What you need to know before you receive M-M-RvaxPro
3. How to use M-M-RvaxPro
4. Possible side effects
5. How to store M-M-RvaxPro
6. Content of the pack and other information
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 of age or older.
M-M-RvaxPro can be administered to infants from 9 to 12 months of age under special circumstances.
M-M-RvaxPro can also be used in measles outbreaks, or for post-exposure vaccination, or for use in previously unvaccinated persons older than 9 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.
Talk to the doctor or pharmacist before the person to be vaccinated receives M-M-RvaxPro if he/she has experienced any of the following:
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.
Tell your doctor or pharmacist if the person to be vaccinated is taking or has recently taken any other medicines (or other vaccines).
The doctor may delay vaccination for at least 3 months following blood or plasma transfusions, or administration of 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.
M-M-RvaxPro should not be given to pregnant females. Females of childbearing age should take the necessary precautions to avoid pregnancy for 1 month, 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.
If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this vaccine.
There is no information to suggest that M-M-RvaxPro affects the ability to drive or operate machinery.
This medicine contains less than 1 mmol sodium (23 milligrams) per dose, that is to say essentially ‘sodium-free’.
This medicine contains less than 1 mmol potassium (39 milligrams) per dose, that is to say essentially ‘potassium-free’.
This medicine contains 14.5 milligrams of sorbitol per dose. The additive effect of concomitantly administered products containing sorbitol (or fructose) and dietary intake of sorbitol (or fructose) should be taken into account.
M-M-RvaxPro should be injected into the muscle or 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:
One dose is given at an elected date usually from 12 months of age. Under special circumstances, it can be given from 9 months of age. Further doses should be administered according to your doctor’s recommendation. The interval between 2 doses should be at least 4 weeks.
Reconstitution instructions intended for medical and healthcare professionals are included at the end of the package leaflet.
Like all vaccines and medicines, this vaccine can cause side effects, although not everybody gets them.
The following side effects were reported with the use of M-M-RvaxPro:
Frequency Side effect
Very common (may affect more than 1 in 10 vaccinees)
Common (may affect up to 1 in 10 vaccinees)
Uncommon (may affect up to 1 in 100 vaccinees)
Not known (Frequency cannot be estimated from the available data)*
*These side effects were reported with the use of M-M-RvaxPro or with the measles, mumps and rubella vaccine manufactured by Merck & Co., Inc., or with its monovalent (single) components, during post-marketing use and/or during clinical studies.
If the vaccinated person gets any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
Keep out of the sight and reach of children.
Do not use this vaccine after the expiry date which is stated on the outer carton after EXP. The expiry date refers to the last day of that month.
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 throw away any vaccines via wastewater or household waste. Ask your pharmacist how to throw away vaccines you no longer use. These measures will help to protect the environment.
The active substances are:
After reconstitution, one dose (0.5 mL) contains:
Measles virus1 Enders’ Edmonston strain (live, attenuated) not less than 1x103 TCID50*
Mumps virus1 Jeryl Lynn™ [Level B] strain (live, attenuated) not less than 12.5x103 TCID50*
Rubella virus2 Wistar RA 27/3 strain (live, attenuated) not less than 1x103 TCID50*
* 50% tissue culture infectious dose
1 produced in chick embryo cells.
2 produced in WI-38 human diploid lung fibroblasts.
The other ingredients are:
Sorbitol (E 420), sodium phosphate (NaH2PO4/Na2HPO4), potassium phosphate (KH2PO4/K2HPO4), sucrose, hydrolysed gelatine, medium 199 with Hanks’ salts, MEM, monosodium L-glutamate, neomycin, phenol red, sodium bicarbonate (NaHCO3), hydrochloric acid (HCl) (to adjust pH), and sodium hydroxide (NaOH) (to adjust pH)
Water for injections
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:
Manufacturer Responsible for Batch Release:
For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
This leaflet was last revised in September 2022.
© 2022 Merck & Co., Inc., Rahway, NJ, USA and its affiliates. All rights reserved.