M-M-RVaxPro powder and solvent for injectable suspension in pre-filled syringe

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

M-M-RvaxPro

Powder and solvent for injectable suspension in pre-filled syringe

Measles, mumps and rubella vaccine (live viruses)

Read all of this leaflet carefully before you or your child is vaccinated because it contains important information for you or your child.

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

Contents of this leaflet

1. What M-M-RvaxPro is and what it is used for
2. What you need to know before receiving M-M-RvaxPro
3. How to use M-M-RvaxPro
4. Possible side effects
5. How to store M-M-RvaxPro
6. Contents of the pack and other information

1. What M-M-RvaxPro is and what it is used for

M-M-RvaxPro is a vaccine containing attenuated measles, mumps, and rubella viruses. When the vaccine is administered to a person, the immune system (the body's natural defenses) will produce antibodies against the measles, mumps, and rubella viruses. These 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 individuals 12 months of age or older.

M-M-RvaxPro may also be administered, under special circumstances, to children between 9 and 12 months of age.

M-M-RvaxPro may also be used during measles outbreaks, for vaccination following exposure, or for use in individuals over 9 months of age who have not been previously vaccinated and who are in contact with susceptible pregnant women, as well as in individuals who are likely susceptible to mumps and rubella.

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

2. What you need to know before receiving M-M-RvaxPro

Do not use M-M-RvaxPro

• if the person to be vaccinated is allergic to any measles, mumps, or rubella vaccine or to any of the other components of this vaccine (listed in section 6), including neomycin.
• if the person to be vaccinated is pregnant (also, pregnancy should be avoided for 1 month after vaccination; see Pregnancy and breastfeeding).
• if the person to be vaccinated 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 to be vaccinated has untreated active tuberculosis.
• if the person to be vaccinated has a blood disorder or any type of cancer affecting the immune system.
• if the person to be vaccinated is receiving treatment or taking medications that may weaken the immune system (except low-dose corticosteroid therapy for asthma or replacement therapy).
• if the person to be vaccinated has a weakened immune system due to disease (including HIV/AIDS).
• if the person to be vaccinated has a family history of congenital or hereditary immunodeficiency, unless their immune competence has been demonstrated.

Warnings and precautions

Consult your doctor or pharmacist before the person to be vaccinated receives M-M-RvaxPro if they have experienced any of the following:

• an allergic reaction to egg or to any product containing egg.
• personal or family history of allergies or seizures (fits).
• an adverse reaction after vaccination with a measles, mumps, and/or rubella vaccine involving bruising or prolonged bleeding.
• human immunodeficiency virus (HIV) infection without symptoms of HIV disease. The person to be vaccinated should be closely monitored when receiving measles, mumps, and rubella vaccination, which may be less effective than in non-infected individuals (see section Do not use M-M-RvaxPro).

As with other vaccines, M-M-RvaxPro may not fully protect all vaccinated individuals. In addition, if the person to be vaccinated has already been exposed to measles, mumps, or rubella viruses but has not yet developed the disease, M-M-RvaxPro may not prevent the disease from occurring.

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

Use of M-M-RvaxPro with other medicines

Inform your doctor or pharmacist if the person to be vaccinated is using or has recently used other medicines (or other vaccines).

The doctor may delay vaccination for 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 within 1 month, unless otherwise directed by your doctor.

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

M-M-RvaxPro may be administered concomitantly with a pneumococcal conjugate vaccine and/or a hepatitis A vaccine, given at separate injection sites (e.g., the other arm or leg).

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

Pregnancy and breastfeeding

M-M-RvaxPro must not be given to pregnant women. Women of childbearing age should take appropriate precautions to avoid pregnancy for 1 month after vaccination, or as advised by their doctor.

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

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

Driving and use of machines

There is no information suggesting 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; i.e., essentially “sodium-free”.

M-M-RvaxPro contains potassium

This medicine contains potassium, less than 1 mmol (39 milligrams) per dose; i.e., essentially “potassium-free”.

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

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

3. How to use M-M-RvaxPro

M-M-RvaxPro should be injected into the muscle or under the skin in the outer aspect of the thigh or the upper arm. For intramuscular injections, the thigh area is normally recommended in young children, whereas for older individuals the recommended injection site is the upper arm. M-M-RvaxPro must not be injected into any blood vessel.

M-M-RvaxPro should be administered as described below:

One dose on the scheduled date, normally starting at 12 months of age. Under special circumstances, it may be administered starting at 9 months of age. Additional doses should be given according to your doctor's recommendations. The interval between any 2 doses should be at least 4 weeks.

Reconstitution instructions intended for physicians or healthcare professionals are included at the end of the leaflet.

4. Possible adverse reactions

Like all medicines, this vaccine may cause adverse reactions, although not everyone will experience them.

The following adverse reactions have been reported with the use of M-M-RvaxPro:

• These adverse reactions were reported during post-marketing use and/or clinical trials with both M-M-RvaxPro and the measles, mumps, and rubella vaccine manufactured by MSD, as well as with their monovalent (individual) components.

Reporting of adverse reactions

If you experience any type of adverse reaction, consult your doctor or pharmacist, even if it is a possible adverse reaction not listed in this leaflet. You can also report them directly through the national reporting system listed in Appendix V. By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. Storage of M-M-RvaxPro

Keep out of the sight and reach of children.

Do not use this vaccine after the expiry date stated on the outer packaging after EXP. The expiry date refers to the last day of the month indicated.

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

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

Do not freeze the vaccine.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging that you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of M-M-RvaxPro

The active substances are:

After reconstitution, one dose (0.5 ml) contains:

Measles virus1 Enders' Edmonston strain (live, attenuated) not less than 1 x 103 TCID50*

Mumps virus1 Jeryl Lynn strain [Level B] (live, attenuated) not less than 12.5 x 103 TCID50*

Rubella virus2 Wistar RA 27/3 strain (live, attenuated) not less than 1 x 103 TCID50*

• Tissue culture infectious dose required to infect 50% of cell cultures.

1 Produced in chicken embryo cells.

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

The other components are:

Powder:

Sorbitol (E-420), sodium phosphate (NaH2PO4/Na2HPO4), potassium phosphate (KH2PO4/K2HPO4), sucrose, hydrolyzed gelatin, Hanks' salts medium 199, MEM, monosodium L-glutamate, neomycin, phenol red, sodium bicarbonate (NaHCO3), hydrochloric acid (HCl) (for pH adjustment), and sodium hydroxide (NaOH) (for pH adjustment).

Solvent:

Water for injections.

Presentation of M-M-RvaxPro and contents of the pack

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

The solvent is a clear, colourless liquid. The powder is a compact, crystalline mass of pale yellow colour.

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

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

Further information on this medicinal product is available upon request to the local representative of the Marketing Authorisation Holder.

Date of the most recent review of this leaflet: <{MM/YYYY}><{month YYYY}>.

Other sources of information

Detailed information on this medicinal product is available on the website of the European Medicines Agency: https://www.ema.europa.eu.

This information is intended for healthcare professionals only:

Before mixing with the solvent, the vaccine powder is a compact crystalline mass of pale yellow colour. The solvent is a clear, colourless liquid. When fully reconstituted, the vaccine is a clear yellow liquid.

For reconstitution of the vaccine, use only the solvent supplied.

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

A separate needle should be used for reconstitution and a different needle for injection.

Instructions for reconstitution

Withdraw the entire contents of the solvent vial into a syringe intended for reconstitution and injection. Inject the full contents of the syringe into the vial containing the powder. Gently shake to ensure complete mixing.

Do not use the reconstituted vaccine if any foreign particles are observed or if the appearance of the solvent, powder, or reconstituted vaccine differs from that described above.

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

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 full dose subcutaneously or intramuscularly.

Any unused product or waste materials must be disposed of in accordance with local requirements.

See also section 3. How to use M-M-RvaxPro.