Prospect: information for the user

M-M-RvaxPro

Powder and solvent for injectable suspension in pre-filled syringe

Measles, mumps, and rubella vaccine (live virus)

Read this prospect carefully before you or your child is vaccinatedbecause it contains important information for you or your child.

• Keep this prospect, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• If you experience any adverse effects, consult your doctor or pharmacist,even if they are not listed in this prospect. See section 4.

1.What is M-M-RvaxProand how it is used

2.Things you need to knowbefore receiving M-M-RvaxPro

3.How to use M-M-RvaxPro

4.Possible adverse effects

5.Storage of M-M-RvaxPro

6.Contents of the package and additional information

M-M-RvaxProis a vaccine of attenuated virus of measles, mumps, and rubella. When the vaccine is administered to a person, the immune system (the body's natural defenses) will create antibodies against the measles, mumps, and rubella viruses. The antibodies help to protect against infections caused by these viruses.

M-M-RvaxProis administered as a means to protect you or your child against measles, mumps, and rubella. The vaccine can be administered to individuals 12months of age or older.

M-M-RvaxProcan be administered, in special circumstances, to children 9 to 12 months of age.

M-M-RvaxPromay also be used in measles epidemics, for post-exposure vaccination, or for use in individuals 9months of age or older who have not been previously vaccinated and are in contact with susceptible pregnant women, and individuals who are likely to be susceptible to mumps and rubella.

Although M-M-RvaxProcontains live viruses, they are too weak to cause measles, mumps, or rubella in healthy individuals.

No use M-M-RvaxPro

• If the person receiving the vaccine is allergic to any measles, mumps or rubella vaccine or to any of the other components of this vaccine (including neomycin) (see section 6).
• If the person receiving the vaccine is pregnant (in addition, pregnancy should be avoided for 1 month after vaccination, see Pregnancy and breastfeeding).
• If the person receiving the vaccine has any illness with a fever above 38.5°C; however, a mild fever is not in itself a reason to delay vaccination.
• If the person receiving the vaccine has active untreated tuberculosis.
• If the person receiving the vaccine has a blood disorder or any type of cancer that affects the immune system.
• If the person receiving the vaccine is receiving treatment or taking medications that may weaken the immune system (except low-dose corticosteroid therapy for asthma or hormone replacement therapy).
• If the person receiving the vaccine has a weakened immune system due to any disease (including AIDS).
• If the person receiving the vaccine has a family history of congenital or hereditary immunodeficiency, unless the person's immune capacity has been demonstrated.

Warnings and precautions

Consult your doctor or pharmacist before the person receiving the vaccine receives M-M-RvaxPro if they have experienced any of the following situations:

• An allergic reaction to egg or any product containing egg.
• Personal or family history of allergies or seizures (attacks).
• An adverse effect after vaccination with measles, mumps and/or rubella vaccine that involves bruising or prolonged bleeding.
• Human Immunodeficiency Virus (HIV) infection but no symptoms of HIV disease. The person receiving the vaccine should be closely monitored for measles, mumps and rubella vaccination, which may be less effective than for non-infected individuals (see section No use M-M-RvaxPro).

Like other vaccines, M-M-RvaxPro may not protect all people vaccinated. In addition, if the person to be vaccinated has already been exposed to measles, mumps or rubella viruses but has not yet contracted the disease, M-M-RvaxPro may not be able to prevent the onset of the disease.

M-M-RvaxPro may be administered to people who have recently (within the last 3 days) been in contact with a case of measles and may be incubating the disease. However, in these cases, M-M-RvaxPro may not be able to prevent the development of measles.

Use of M-M-RvaxPro with other medications

Inform your doctor or pharmacist if the person receiving the vaccine is using or has recently used other medications (or other vaccines).

The doctor may delay vaccination at least 3 months after a blood or plasma transfusion or after administration of immunoglobulin (known as Ig).After vaccination with M-M-RvaxPro, Ig should not be administered for 1 month, unless your doctor tells you otherwise.

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

M-M-RvaxPro may be administered with a conjugated pneumococcal vaccine and/or a hepatitis A vaccine at the same time in different injection sites (for example, the other arm or leg).

M-M-RvaxPro may be administered with some routine childhood vaccines as they may need to be administered at the same time. For vaccines that cannot be administered at the same time, M-M-RvaxPro should be administered 1 month before or after administration of these vaccines.

Pregnancy and breastfeeding

M-M-RvaxPro should not be administered to pregnant women. Women of childbearing age, after being vaccinated, should take the necessary precautions to avoid pregnancy for 1 month, or as recommended by their doctor.

Inform your doctor if you are breastfeeding or plan to be. Your doctor will decide if you should receive M-M-RvaxPro.

If you are pregnant or breastfeeding, or think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this vaccine.

Driving and operating machinery

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

M-M-RvaxPro contains sodium

This medicine contains less than 1 mmol of sodium (23 milligrams) per dose; this is essentially "sodium-free".

M-M-RvaxPro contains potassium

This medicine contains potassium, less than 1 mmol (39 milligrams) per dose; this is essentially "potassium-free".

M-M-RvaxPro contains sorbitol (E-420)

This medicine contains 14.5 milligrams of sorbitol per dose. The additive effect of concomitantly administered medications containing sorbitol (or fructose) and dietary sorbitol (or fructose) should be taken into account.

M-M-RvaxPromust be injected into the muscle or under the skin in the outer region of the thigh or upper arm. For muscle injections in young children, the thigh region is usually recommended, while for adults, the upper arm region is recommended. M-M-RvaxPromust not be injected intoany blood vessel.

M-M-RvaxProshould be administered as follows:

A dose on the chosen date, typically from 12 months of age. In special circumstances, it may be administered from 9 months of age. Additional doses should be administered according to your doctor's recommendations. The interval between 2 doses should be at least 4 weeks.

The instructions for reconstitution intended for doctors or healthcare professionals are included at the end of the prospectus.

Like all medicines, this vaccine may cause side effects, although not everyone will experience them.

The following side effects were reported with the use of M-M-RvaxPro:

* These side effects were reported with the administration of both M-M-RvaxPro and the measles, mumps, and rubella vaccine manufactured by MSD, as well as its monovalent (individual) components during post-marketing use and/or clinical trials.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this prospectus.You can also report them directly through the national notification system included in theAppendix V. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep out of sight and reach of children.

Do not use this vaccine after the expiration date that appears on the outer packaging after CAD.The expiration date is the last day of the month indicated.

Store and transport refrigerated (between 2°C and 8°C).

Store the powder vial in the outer packaging to protect it from light.

Do not freeze the vaccine.

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of containers and medicines that you no longer need. This will help protect the environment.

Composition of M-M-RvaxPro

The active ingredients are:

After reconstitution, one dose (0.5ml) contains:

Measles virus1strain Enders’ Edmonston(live, attenuated) no less than 1 x 103TCID50*

Mumps virus1strain Jeryl Lynn [Level B] (live, attenuated) no less than 12.5 x 103TCID50*

Rubella virus2strain Wistar RA 27/3(live, attenuated) no less than 1 x 103TCID50*

* Dose that infects 50% of the histocultures.

1produced in chicken embryo cells.

2produced in diploid human lung fibroblasts (WI-38).

The other components are:

Dry Powder:

Sorbitol (E‑420), sodium phosphate(NaH2PO4/Na2HPO4), potassium phosphate(KH2PO4/K2HPO4), sucrose, hydrolyzed gelatin,Medium 199 with Hanks’ salts, MEM, L-glutamic acid monosodium, neomycin, phenol red, sodium bicarbonate(NaHCO3), hydrochloric acid(HCl)(to adjust pH) and sodium hydroxide(NaOH)(to adjust pH).

Vehicle:

Water for injection.

Appearance of M-M-RvaxPro and contents of the container

The vaccine is a powder for suspension for injection contained in a single-dose vial, which must be mixed with the vehicle supplied.

The vehicle is a transparent and colorless liquid. The powder is a compact, pale yellow crystalline mass.

M-M-RvaxProis available in containers of 1, 10 and 20, with or without needles. Not all container sizes may be marketed.

Marketing Authorization Holder and Responsible Person

Merck Sharp & Dohme B.V., Waarderweg 39, 2031 BN Haarlem, Netherlands

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

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Other sources of information

The detailed information on this medicinal product is available on the website of the European Medicines Agencyhttps://www.ema.europa.eu.

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This information is intended only for healthcare professionals:

Before mixing with the vehicle, the vaccine powder isa compact, pale yellow crystalline mass. The vehicle is a transparent and colorless liquid.When fully reconstituted, the vaccine is a pale yellow clear liquid.

To reconstitute the vaccine, use the vehicle supplied.

It is essential to use a new sterile syringe and needle for each patient to prevent the transmission of infectious agents from one person to another.

A separate needle should be used for reconstitution and injection.

Instructions for reconstitution

To attach the needle, firmly push it into the end of the syringe and secure it with a twist.

Inject the entire contents of the vehicle from the syringe into the vial containing the powder. Gently agitate to mix thoroughly.

The reconstituted vaccine should not be used if any foreign particles are observedor if the appearance of the vehicle or powder or reconstituted vaccine differs from that described above.

After reconstitution, the vaccine should be administered immediately to minimize loss of potency or within 8hours if stored in the refrigerator.

Do not freeze the reconstituted vaccine.

Withdraw the entire contents of the reconstituted vaccine from the vial into a syringe, change the needle and inject the entire contents subcutaneously or intramuscularly.

Unused products or waste materials should be disposed of in accordance with local requirements.

See also section3. How to use M-M-RvaxPro.