M-M-RVaxPro
measles, mumps and rubella vaccine (live)
Measles, mumps and rubella vaccine (live)
Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or your pharmacist.
If you get any of the side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
What M-M-RvaxPro is and what it is used for
What you need to know before you receive M-M-RvaxPro
How to use M-M-RvaxPro
Possible side effects
How to store M-M-RvaxPro
Contents 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.
if the person to be vaccinated is allergic to any measles, mumps or rubella vaccine or to any of the ingredients of this vaccine (listed in section 6) including neomycin
if the person to be vaccinated is pregnant (in addition, 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 higher than 38.5 °C; however, low-grade fever itself is not a reason to delay vaccination
if the person to be vaccinated has active untreated 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 low-dose corticosteroid therapy for asthma or replacement therapy)
if the person to be vaccinated has a weakened immune system because of a 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.
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:
an allergic reaction to eggs or anything that contained egg
a history or family history of allergies or of convulsions (fits)
a side effect after vaccination with measles, mumps and/or rubella vaccine that involved easy bruising or bleeding for longer than usual
an infection with Human Immunodeficiency Virus (HIV) but do not show symptoms of HIV disease. The vaccinated person 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.
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.
Side ef ect | |
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) |
Fever (38.5 °C or higher).
Injection site redness; injection site pain; injection site swelling.
Rash (including measles-like rash).
Injection site bruising.
Nasal congestion and sore throat; upper respiratory tract infection or viral infection; runny nose.
Crying.
Diarrhoea, vomiting.
Hives.
Injection site rash.
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 ef ect |
Not known (Frequency cannot be estimated from the available data)* | middle ear; inflamed salivary glands; atypical measles (described in patients who received a killed measles virus vaccine, usually given before 1975). syndrome). eyes, and/or genitals (Stevens-Johnson syndrome). |
Aseptic meningitis (fever, feeling sick, vomiting, headache, stiff neck, and sensitivity to light); swollen testicles; infection of the
Swollen lymph nodes.
Bruising or bleeding more easily than normal.
Severe allergic reaction that may include difficulty in breathing, facial swelling, localised swelling, and swelling of the limbs.
Irritability.
Seizures (fits) without fever; seizures (fits) with fever in children; walking unsteadily; dizziness; illnesses involving inflammation of the nervous system (brain and/or spinal cord).
An illness consisting of muscle weakness, abnormal sensations, tingling in the arms, legs, and upper body (Guillain-Barré
Headache; fainting; nerve disorders which can cause weakness, tingling, or numbness; eye nerve disturbances.
Discharge and itching of the eyes with crusting of eyelids (conjunctivitis).
Inflammation of the retina (in the eye) with changes in sight.
Deafness.
Cough; lung infection with or without fever.
Feeling sick (nausea).
Itching; inflammation of the fatty tissue under the skin; red or purple, flat, pinhead spots under the skin; hardened, raised area of the skin; serious illness with ulcers or blistering of the skin, mouth,
Joint pain and/or swelling (usually transient and rarely chronic); muscle pain.
Burning and/or stinging of short duration at the injection site; blisters and/or hives at the injection site.
Generally feeling unwell (malaise); swelling; soreness.
Inflammation of blood vessels.
*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 thenational reporting system listed in Appendix V. 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
produced in chick embryo cells.
produced in WI-38 human diploid lung fibroblasts. The other ingredients are:
Powder:
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)
Solvent:
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, 5 and 10. Not all pack sizes may be marketed. Marketing Authorisation Holder and Manufacturer
Merck Sharp & 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.
MSD Belgium
Tél/Tel: +32(0)27766211
UAB Merck Sharp & Dohme Tel.: +370.5.2780.247
Мерк Шарп и Доум България ЕООД, тел.: + 359 2 819 3737
MSD Belgium
Tél/Tel: +32(0)27766211
Merck Sharp & Dohme s.r.o. Tel.: +420 233 010 111
MSD Pharma Hungary Kft. Tel.: + 36.1.888.5300
MSD Danmark ApS Tlf: + 45 4482 4000
Merck Sharp & Dohme Cyprus Limited. Tel: 8007 4433 (+356 99917558)
MSD Sharp & Dohme GmbH
Tel: 0800 673 673 673 (+49 (0) 89 4561 0)
Merck Sharp & Dohme B.V.
Tel: 0800 9999000
(+31 23 5153153)
Merck Sharp & Dohme OÜ Tel.: +372 6144 200
MSD (Norge) AS Tlf: +47 32 20 73 00
MSD Α.Φ.Β.Ε.Ε.
Τηλ: +30 210 98 97 300
Merck Sharp & Dohme Ges.m.b.H. Tel: +43 (0) 1 26 044
Merck Sharp & Dohme de España, S.A. Tel: +34 91 321 06 00
MSD Polska Sp. z o.o. Tel.: +48.22.549.51.00
MSD France
Tél: + 33 (0)1 80 46 40 40
Merck Sharp & Dohme, Lda Tel: +351 21 4465700
Merck Sharp & Dohme d.o.o. Tel: +385 1 66 11 333
Merck Sharp & Dohme Romania S.R.L Tel: + 4021 529 29 00
Merck Sharp & Dohme Ireland (Human Health) Limited
Tel: +353 (0)1 2998700
Merck Sharp & Dohme, inovativna zdravila d.o.o.
Tel: +386.1.520.4201
Vistor hf.
Sími: + 354 535 7000
Merck Sharp & Dohme, s. r. o Tel: +421 2 58282010
MSD Italia S.r.l.
Tel: 800 23 99 89 (+39 06 361911)
MSD Finland Oy
Puh/Tel: +358 (0)9 804 650
Merck Sharp & Dohme Cyprus Limited
Τηλ: 800 00 673 (+357 22866700)
Merck Sharp & Dohme (Sweden) AB Tel: +46 77 5700488
SIA Merck Sharp & Dohme Latvija Tel: +371.67364.224
Merck Sharp & Dohme Ireland (Human Health) Limited
Tel: +353 (0)1 2998700
Detailed information on this vaccine is available on the European Medicines Agency website:
Before mixing with the solvent, the powder vaccine is a light yellow compact crystalline cake. The solvent is a clear colourless liquid. When completely reconstituted, the vaccine is a clear yellow liquid.
To reconstitute the vaccine, use the solvent supplied.
It is important to use a separate sterile syringe and needle for each patient to prevent transmission of infectious agents from one individual to another.
One needle should be used for reconstitution and a separate, new needle for injection. Reconstitution instructions
Withdraw the entire content of the solvent vial into a syringe to be used for reconstitution and injection. Inject the entire content of the syringe into the vial containing the powder. Gently agitate to mix thoroughly.
The reconstituted vaccine must not be used if any particulate matter is noted or if the appearance of the solvent or powder or of the reconstituted vaccine differs from that described above.
Withdraw the entire content of the reconstituted vaccine from the vial into a syringe, change the needle and inject the entire volume by subcutaneous or intramuscular route.
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.