Powder and solvent for suspension for injection Live vaccine against measles,
mumps and rubella
What MM-RVAXPRO is and what it is used for
MM-RVAXPRO is a vaccine containing measles, mumps, and rubella viruses that have been weakened. When the vaccine is given to a person, the immune system (the body’s natural defense system) will produce antibodies against measles, mumps, and rubella viruses. The antibodies help to defend against infection caused by these viruses.
MM-RVAXPRO is given to protect you or your child against measles, mumps, and rubella. The vaccine can be given to people who are 12 months or older.
MM-RVAXPRO can in special circumstances be administered to children from 9 to 12 months of age
MM-RVAXPRO can also be given for measles outbreaks or post-exposure vaccinations, or to previously unvaccinated people older than 9 months who are in contact with susceptible pregnant women, and to people who may be susceptible to mumps and rubella.
Although MM-RVAXPRO contains live viruses, they are too weak to cause measles, mumps, or rubella in healthy people.
What you need to know before you get MM-RVAXPRO
Do not use MM-RVAXPRO
- if the person to be vaccinated is allergic to any measles, mumps or rubella vaccine or any of the other ingredients of this vaccine including neomycin (listed in section 6).
- if the person to be vaccinated is pregnant (in addition, pregnancy should be avoided 1 month after vaccination, see Pregnancy and breast-feeding).
- if the person to be vaccinated has a disease with a fever exceeding 38.5 ºC. In case of low fever, however, the vaccination does not need to be postponed.
- if the person to be vaccinated has active untreated tuberculosis .
- if the person to be vaccinated has a blood disease or some type of cancer that affects the immune system.
- if the person to be vaccinated is receiving treatment or taking any medication that may weaken the immune system (except low-dose corticosteroid therapy for asthma or as a replacement therapy).
- if the person to be vaccinated has a weakened immune system due to illness (including AIDS ).
- if there is a congenital or hereditary immune deficiency in the person to be vaccinated, unless the immune competence of the person to be vaccinated can be demonstrated.
Warnings and cautions
Talk to a doctor or pharmacist before getting the person to be vaccinated M ‑ M ‑ RVAXPRO if he/she has had any of the following:
- an allergic reaction to eggs or anything that contains eggs.
- he / she or someone in the family has had allergies or seizures.
- a side effect , such as bruising or bleeding that has lasted longer than usual, after previous vaccination against measles, mumps and / or rubella.
- HIV – infection without showing symptoms of HIV disease. The vaccinated person should then be closely monitored for measles, mumps and rubella as the vaccination may be less effective than for non- HIV -infected persons (see section Do not use M ‑ M ‑ RVAXPRO ).
As with other vaccines, MM-RVAXPRO may not result in complete protection in all vaccines. In addition, if the person to be vaccinated has already been exposed to the measles, mumps, or rubella virus without having already become ill, MM-RVAXPRO may not be able to prevent the disease from breaking out.
MM-RVAXPRO can be given to people who have recently (within 3 days) been in contact with a measles case and who are in the incubation period for the disease. However, MM-RVAXPRO can not always prevent the disease from breaking out in these cases.
Other medicines and MM-RVAXPRO
Tell your doctor or pharmacist if the person to be vaccinated is taking or has recently taken any other medicines (or other vaccines).
Vaccination with MM-RVAXPRO should be postponed for at least 3 months after a blood or plasma transfusion or after administration of immunoglobulin (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 before, at the same time, or 4 to 6 weeks after vaccination with MM-RVAXPRO.
MM-RVAXPRO can be given at the same time as Prevenar and/or hepatitis A vaccine, but at a different injection site (eg in the other arm or leg).
MM-RVAXPRO can be given with some routine vaccinations to children that may be suitable to be given at the same time. For vaccines that cannot be given concomitantly, MM-RVAXPRO should be given 1 month before or after administration of these vaccines.
Pregnancy and breastfeeding
MM-RVAXPRO should not be given to pregnant women. Women of childbearing potential should take the necessary precautions to avoid pregnancy for 1 month, or according to the doctor’s recommendation, after receiving the vaccine.
Tell your doctor if you are breastfeeding or intend to breastfeed. Your doctor will decide if you should receive MM-RVAXPRO.
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this vaccine.
Driving and using machines
There is no evidence that MM-RVAXPRO affects the ability to drive or use machines.
MM-RVAXPRO contains sodium, potassium and sorbitol (E 420)
MM-RVAXPRO contains sodium
This medicine contains less than 1 mmol (23 mg) sodium per dose, ie essentially ‘sodium-free’. is next to “sodium-free”.
MM-RVAXPRO contains potassium
This medicine contains less than 1 mmol (39 mg) potassium per dose, ie essentially ‘potassium’. is next to “potassium free”
MM-RVAXPRO contains sorbitol (E 420)
This medicine contains 14.5 mg sorbitol per dose. The additive effect of concomitantly administered drugs containing sorbitol (or fructose) and pre-administration of sorbitol (or fructose) should be considered.
How to use MM-RVAXPRO
MM-RVAXPRO should be injected into the muscle or under the skin either on the outside of the thigh or on the upper arm. In young children, the thigh is usually recommended for intramuscular injection, while the upper arm is recommended as an injection site in older people. MM-RVAXPRO should not be injected into the bloodstream.
MM-RVAXPRO is given as follows:
- A dose is given on a given date, usually from 12 months of age. In special circumstances it can be given from the age of 9 months. Additional doses should be administered according to a doctor’s recommendation. The interval between 2 doses should be at least 4 weeks.
Preparation instructions intended for healthcare professionals can be found at the end of the package leaflet.
Possible side effects
Like all vaccines and medicines, this vaccine can cause side effects, although not everybody gets them.
The following side effects have been reported with the use of M ‑ M ‑ RVAXPRO:
| Presence | Side effect |
| Very common (may affect more than 1 in 10 people vaccinated) | fever (38.5 ° C or higher). Redness at the injection site; injection site pain; swelling at the injection site. |
| Common (may affect up to 1 in 10 people vaccinated) | rash (including measles-like rash). Bruising at the injection site. |
| Uncommon (may affect up to 1 in 100 people vaccinated) | stuffy nose and sore throat; upper respiratory tract infection or viral infection; Runny nose. crying.diarrhea, vomiting.hives.rash at the injection site. |
| No known frequency (The occurrence can not be calculated from the available data) * | aseptic meningitis (fever, nausea, vomiting, headache, stiff neck, and sensitivity to light); swollen testicles; middle ear infection; inflamed salivary glands; atypical measles (described in patients who have received a vaccine with inactivated measles virus, usually given before 1975). swollen lymph nodes .more easily affected by bruising or bleeding .severe allergic reaction which may include difficulty breathing, swollen face, local swelling, swelling of the arms and legs. irritability.Seizures (attacks) without fever; seizures (attacks) with fever in children; unsteady gait; dizziness; diseases including inflammation of the nervous system (brain and/or spinal cord).a disease consisting of muscle weakness, abnormal sensations, tingling in the arms, legs, and upper body ( Guillain-Barré syndrome ).headache; fainting; nerve problems that can cause weakness, tingling, or numbness; disorders of the optic nerve. secretion and itching of the eyes with crusting on the eyelids ( conjunctivitis ).retinitis (in the eyes) with vision changes.deafness.cough; lung infection with or without fever. nausea.itching; inflammation of the adipose tissue under the skin; red or purple, flat, pinhead-sized dots under the skin; hard elevations of the skin; severe disease with sores or blisters on the skin, mouth, eyes, and/or genitals (Stevens-Johnson syndrome).pain and/or swelling in joints (usually transient and rarely chronic ); muscle aches.short-term burning and/or stabbing pain at the injection site; blisters and/or hives at the injection site .general malaise (feeling sick); swelling; tenderness. inflammation of the blood vessels. |
* These side effects have been reported with the use of MM-RVAXPRO or the measles, mumps, and rubella vaccine manufactured by Merck & Co., Inc., or its monovalent (individual) components, when used in the market and/or in clinical trials.
How to store MM-RVAXPRO
Keep this vaccine out of the reach and sight of children.
Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiration date is the last day of the specified month.
Store and transport cold (2 ° C ‑ 8 ºC).
Store the vial of powder in the outer carton. Sensitive to light.
Do not freeze.
Vaccines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of vaccines that are no longer in use. These measures will help to protect the environment.
Contents of the pack and other information
Content declaration
The active substances are:
After reconstitution , one dose (0.5 ml) contains:
Measles virus 1 Enders Edmonston strain (live, attenuated) not less than 1×10 3 TCID 50 *
Parotitic virus 1 Jeryl Lynn TM strain (B level) (live, attenuated) not less than 12.5×10 3 TCID 50 *
Rubella virus 2 Wistar RA 27/3 strain (live attenuated) not less than 1×10 3 TCID 50 *
* 50% infectious dose in tissue culture.
1 produced in cell culture from the chicken embryo.
2 produced in WI-38 human diploid lung fibroblasts.
Other ingredients are:
Powder:
Sorbitol (E 420), sodium phosphate (NaH 2 PO 4 / Na 2 HPO 4 ), potassium phosphate (KH 2 PO 4 / K 2 HPO 4 ), sucrose, hydrolyzed gelatin, medium 199 with Hanks salt, MEM, sodium -L- glutamate, neomycin, phenol red, sodium bicarbonate (NaHCO 3 ), hydrochloric acid ( HCl ) (to regulate pH ) and sodium hydroxide (NaOH) (to regulate pH ).
Diluent:
Water for injections.
What the medicine looks like and contents of the pack
The vaccine is a powder for solution for injection, suspended in single-dose vials, which should be mixed with the diluent provided.
The diluent is clear and colorless. The powder is a light yellow compact cake of powder crystals.
MM-RVAXPRO is available in packs of 1, 5 and 10. Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder: MSD VACCINS, 162 avenue Jean Jaurès, 69007 Lyon, France
Manufacturer responsible for batch release: Merck Sharp and Dohme, BV, Waarderweg, 39, 2031 BN Haarlem, The Netherlands
Contact the representative of the marketing authorization holder to find out more about this medicine:
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