M-M-RVAXPRO powder and solvent for injectable suspension

Introduction

Package Leaflet: Information for the User

M-M-RvaxPro

Powder and solvent for suspension for injection

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, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• If you experience any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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. Storage of 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 weakened viruses of measles, mumps and rubella. When the vaccine is given to a person, the immune system (the body's natural defenses) will create 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 can be given to people aged 12 months or older. M-M-RvaxPro can be given, in special circumstances, to children aged 9 to 12 months.

M-M-RvaxPro may also be used during measles outbreaks, for post-exposure vaccination, or for use in people over 9 months who have not been previously vaccinated and are in contact with susceptible pregnant women, and people who are 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 individuals.

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

Do not useM-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 breast-feeding).
• if the person to be vaccinated has any illness with fever over 38.5 °C; however, a slight 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 that affects the immune system.
• if the person to be vaccinated is receiving treatment or taking medicines that may weaken the immune system (except for low-dose corticosteroid therapy for asthma or replacement therapy).
• if the person to be vaccinated has an immune system weakened by any disease (including AIDS).
• if the person to be vaccinated has a family history of congenital or hereditary immunodeficiency, unless the immune competence of the person to be vaccinated is demonstrated.

Warnings and precautions

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

• a severe allergic reaction to egg or any egg-containing product.
• personal or family history of allergies or convulsions (fits).
• a side effect after vaccination with measles, mumps and/or rubella vaccine that involves bruising or bleeding more than usual.
• HIV infection without symptoms of HIV disease. The person to be vaccinated should be closely monitored during vaccination against measles, mumps and rubella, which may be less effective than for uninfected individuals (see section Do not use M-M-RvaxPro).

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

M-M-RvaxPro can be given 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.

Using M-M-RvaxPro with other medicines

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

Your doctor may delay vaccination for at least 3 months after a blood or plasma transfusion or after the administration of immunoglobulin (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 done, it should be done at any time before, at the same time as, or 4 to 6 weeks after vaccination with M-M-RvaxPro.

M-M-RvaxPro can be given at the same time as Prevenar and/or hepatitis A vaccine in a different injection site (e.g. the other arm or leg).

M-M-RvaxPro can be given with some routine infant vaccines as they may need 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 the administration of these vaccines.

Pregnancy and breast-feeding

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

Tell your doctor if you are breast-feeding or are planning to breast-feed. Your doctor will decide whether you should receive M-M-RvaxPro.

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 using this vaccine.

Driving and using machines

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

M-M-RvaxPro contains sodium

This medicine contains less than 1 mmol of sodium (23 milligrams) per dose, i.e. it is essentially “sodium-free”.

M-M-RvaxPro contains potassium

This medicine contains potassium, less than 1 mmol (39 milligrams) per dose; it 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 medicines containing sorbitol (or fructose) administered concomitantly and the intake of sorbitol (or fructose) in the diet 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 upper arm. For intramuscular injections, the thigh is the recommended site in young children, while the upper arm is the recommended site in older individuals. M-M-RvaxPro should not be injected into any blood vessel.

M-M-RvaxPro should be administered as follows:

A single dose on the selected date, usually from 12 months of age. In special circumstances, it can be given from 9 months of age. Additional doses should be given according to the doctor's recommendations. The interval between 2 doses should be at least 4 weeks.

Instructions for reconstitution intended for medical or healthcare professionals are included at the end of the leaflet.

4. Possible side effects

Like all 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:

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

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of M-M-RvaxPro

Keep out of sight and reach of children.

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

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 via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Container contents and additional information

M-M-RvaxPro composition

The active ingredients are:

After reconstitution, one dose (0.5 ml) contains:

• Dose that infects 50% of tissue 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, 199 medium with Hanks' salts, 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.

Appearance of M-M-RvaxPro and container contents

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, colorless liquid. The powder is a compact, crystalline mass of pale yellow color.

M-M-RvaxPro is available in packs of 1, 5, and 10. Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

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.

Date of last revision of this leaflet: <{MM/AAAA}><{month AAAA}>.

Other sources of information

Detailed information on this medicinal product is available on the European Medicines Agency website http://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 color. The solvent is a clear, colorless liquid. When fully reconstituted, the vaccine is a clear yellow liquid.

For reconstitution of the vaccine, use the supplied solvent.

It is important 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 a different needle for injection.

Reconstitution instructions

Withdraw the entire contents of the solvent vial into a syringe that will be used for reconstitution and injection. Inject the entire contents of the syringe into the vial containing the powder. Gently shake to mix completely.

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

After reconstitution, it is recommended to administer the vaccine immediately to minimize loss of potency or within 8 hours 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 section 3. How to use M-M-RvaxPro.