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M-M-RVaxPro (measles virus Enders Edmonston strain...) – Package leaflet - J07BD52

Updated on site: 08-Oct-2017

Medication nameM-M-RVaxPro
ATC CodeJ07BD52
Substancemeasles virus Enders Edmonston strain (live, attenuated) / mumps virus Jeryl Lynn (level B) strain (live, attenuated) / rubella virus Wistar RA 27/3 strain (live, attenuated)
ManufacturerMSD VACCINS

Package leaflet: Information for the user

M-M-RVAXPRO

Powder and solvent for suspension for injection

Measles, mumps and rubella vaccine (live)

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

-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 of pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

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.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 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.

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

Do not use M-M-RVAXPRO:

-If you or your child are allergic to any of the components of this vaccine (including neomycin or any of the other ingredients listed in section 6)

-If you or your child are pregnant (in addition, pregnancy should be avoided for 1 month after vaccination, see Pregnancy)

-If you or your child have any illness with fever higher than 38.5°C; however, low-grade fever itself is not a reason to delay vaccination

-If you or your child have active untreated tuberculosis

-If you or your child have a blood disorder or any type of cancer that affects the immune system

-If you or your child are receiving treatment or taking medicines that may weaken the immune system (except low-dose corticosteroid therapy for asthma or replacement therapy)

-If you or your child have a weakened immune system because of a disease (including AIDS)

-If you or your child have a family history of congenital or hereditary immunodeficiency, unless the immune competence of you or your child is demonstrated.

Warnings and precautions

Talk to the doctor or pharmacist before you or your child receive M-M-RVAXPRO if you have experienced any of the following:

-If you or your child have an allergic reaction to eggs or anything that contained egg

-If you or your child have a history or family history of allergies or of convulsions (fits)

-If you or your child have a side effect after vaccination with measles, mumps, or rubella vaccine (in a single component vaccine or a combined vaccine, such as the measles, mumps, and rubella vaccine manufactured by Merck & Co., Inc., or M-M-RVAXPRO) that involved easy bruising or bleeding for longer than usual

-If you or your child have infection with Human Immunodeficiency Virus (HIV) but do not show symptoms of HIV disease. You or your child 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.

Other medicines and M-M-RVAXPRO

Tell your doctor or pharmacist if you or your child are taking or have recently taken any other medicines (or other vaccines).

The doctor may delay vaccination for at least 3 months following blood or plasma transfusions, or 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.

Pregnancy and breast-feeding

M-M-RVAXPRO should not be given to pregnant females. Females of child-bearing 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.

Driving and using machines

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

M-M-RVAXPRO contains sorbitol.

If you have been told by your doctor that you or your child have an intolerance to some sugars, inform your doctor before you or your child receive this vaccine.

3.How to use M-M-RVAXPRO

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.

4.Possible side effects

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 effect

 

 

 

Very common (may

 

Fever (38.5°C or higher).

affect more than 1 in

 

Injection-site redness; injection-site pain; injection-site swelling.

10 vaccinees)

 

 

Common (may affect

 

Rash (including measles-like rash).

1 to 10 in 100

 

Injection-site bruising.

vaccinees)

 

 

Uncommon (may

 

Nasal congestion and sore throat; upper respiratory tract infection

affect 1 to 10 in 1000

 

or viral infection; runny nose.

vaccinees)

 

Diarrhoea, vomiting.

 

 

Hives.

 

Injection-site rash.

 

 

 

Not known

 

Aseptic meningitis (fever, feeling sick, vomiting, headache, stiff

(Frequency cannot be

 

neck, and sensitivity to light); swollen testicles; infection of the

estimated from the

 

middle ear; inflamed salivary glands; atypical measles (described in

available data)*

 

patients who received a killed measles virus vaccine, usually given

 

 

before 1975).

 

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 syndrome).

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, eyes, and/or genitals (Stevens-Johnson syndrome).

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.

Reporting of side effects

If you get 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 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.How to store M-M-RVAXPRO

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.

Once the vaccine has been mixed with the solvent supplied, it should be either used immediately or stored in the refrigerator and used within 8 hours.

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.

6. Contents of the pack and other information

What M-M-RVAXPRO contains

The active substances are:

After reconstitution, one dose (0.5 ml) contains:

Measles virus1 Enders’ Edmonston strain (live, attenuated) ………...…….not less than 1x103 CCID50* Mumps virus1 Jeryl Lynn™ [Level B] strain (live, attenuated)……………not less than

12.5x103 CCID50*

Rubella virus2 Wistar RA 27/3 strain (live, attenuated) ……………….….not less than 1x103 CCID50*

* 50% cell culture infectious dose

1produced in chick embryo cells.

2produced in WI-38 human diploid lung fibroblasts.

The other ingredients are:

Powder:

sorbitol, sodium phosphate, potassium phosphate, sucrose, hydrolysed gelatin, medium 199 with Hanks’ salts, MEM, monosodium L-glutamate, neomycin, phenol red, sodium bicarbonate, hydrochloric acid (to adjust pH), and sodium hydroxide (to adjust pH)

Solvent:

water for injections

What M-M-RVAXPRO looks like and contents of the pack

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 and 10. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder: MSD VACCINS, 162 avenue Jean Jaurès, 69007 Lyon, France

Manufacturer Responsible for Batch Release: Merck Sharp and 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.

België/Belgique/Belgien

Lietuva

MSD Belgium BVBA/SPRL

UAB Merck Sharp & Dohme

Tél/Tel: 0800 38 693

Tel.: +370.5.2780.247

(+32(0)27766211)

msd_lietuva@merck.com

dpoc_belux@merck.com

 

България

Luxembourg/Luxemburg

Мерк Шарп и Доум България ЕООД,

MSD Belgium BVBA/SPRL

тел.: + 359 2 819 3737

Tél/Tel: +32(0)27766211

info-msdbg@merck.com

dpoc_belux@merck.com

Česká republika

Merck Sharp & Dohme s.r.o. Tel.: +420 233 010 111 dpoc_czechslovak@merck.com

Danmark

MSD Danmark ApS Tlf: + 45 4482 4000 dkmail@merck.com

Deutschland

MSD SHARP & DOHME GMBH

Tel: 0800 673 673 673 (+49 (0) 89 4561 2612) e-mail@msd.de

Eesti

Merck Sharp & Dohme OÜ Tel.: +372 6144 200 msdeesti@merck.com

Ελλάδα

MSD Α.Φ.Β.Ε.Ε.

Τηλ: +30 210 98 97 300 dpoc_greece@merck.com

España

Merck Sharp & Dohme de España, S.A. Tel: +34 91 321 06 00 msd_info@merck.com

France

MSD VACCINS

Tel:+ 33 (0)1 80 46 40 40

Hrvatska

Merck Sharp & Dohme d.o.o. Tel: +385 1 66 11 333 croatia_info@merck.com

Ireland

Merck Sharp & Dohme Ireland (Human Health) Limited

Tel: +353 (0)1 2998700 medinfo_ireland@merck.com

Ísland

Vistor hf.

Sími: + 354 535 7000

Italia

MSD Italia S.r.l. Tel: +39 06 361911

medicalinformation.it@merck.com

Magyarország

MSD Pharma Hungary Kft. Tel.: + 36.1.888.5300 hungary_msd@merck.com

Malta

Merck Sharp & Dohme Cyprus Limited. Tel: 8007 4433 (+356 99917558) malta_info@merck.com

Nederland

Merck Sharp & Dohme BV Tel: 0800 9999000

(+31 23 5153153) medicalinfo.nl@merck.com

Norge

MSD (Norge) AS Tlf: +47 32 20 73 00 msdnorge@msd.no

Österreich

Merck Sharp & Dohme Ges.m.b.H. Tel: +43 (0) 1 26 044 msd-medizin@merck.com

Polska

MSD Polska Sp. z o.o. Tel.: +48.22.549.51.00 msdpolska@merck.com

Portugal

Merck Sharp & Dohme, Lda Tel: +351 21 4465700 clic@merck.com

România

Merck Sharp & Dohme Romania S.R.L Tel: + 4021 529 29 00 msdromania@merck.com

Slovenija

Merck Sharp & Dohme, inovativna zdravila d.o.o. Tel: +386.1.520.4201

msd.slovenia@merck.com

Slovenská republika

Merck Sharp & Dohme, s. r. o Tel: +421 2 58282010 dpoc_czechslovak@merck.com

Suomi/Finland

MSD Finland Oy

Puh/Tel: +358 (0)9 804 650 info@msd.fi

Κύπρος

Merck Sharp & Dohme Cyprus Limited Τηλ: 800 00 673 (+357 22866700) cyprus_info@merck.com

Latvija

SIA Merck Sharp & Dohme Latvija Tel: +371.67364.224 msd_lv@merck.com

This leaflet was last revised in:

Other source of information

Sverige

Merck Sharp & Dohme (Sweden) AB Tel: +46 77 5700488 medicinskinfo@merck.com

United Kingdom

Merck Sharp & Dohme Limited Tel: +44 (0) 1992 467272 medicalinformationuk@merck.com

Detailed information on this vaccine is available on the European Medicines Agency website: http://www.ema.europa.eu.

-----------------------------------------------------------------------------------------------------------------------

The following information is intended for healthcare professionals only:

Reconstitution instructions

The solvent is a clear colourless liquid. Before mixing with the solvent, the powder is a light yellow compact crystalline cake. When completely reconstituted, the vaccine is a clear yellow liquid.

Do not use the reconstituted vaccine if you notice any particulate matter or if the appearance of the solvent or powder or of the reconstituted vaccine differs from that described above.

Withdraw the entire volume of solvent into a syringe. Inject the entire content of the syringe into the vial containing the powder. Gently agitate to dissolve completely. Withdraw the entire content of the reconstituted vaccine vial into the same syringe and inject the entire volume.

If two needles are provided: use one needle to reconstitute the vaccine and the other for its administration to the person to be vaccinated.

It is recommended that the vaccine be administered immediately after reconstitution or stored in the refrigerator and used within 8 hours to minimize loss of potency. Discard if reconstituted vaccine is not used within 8 hours.

Do not freeze the reconstituted vaccine.

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.

Package leaflet: information for the user

M-M-RVAXPRO

Powder and solvent for suspension for injection in pre-filled syringe

Measles, mumps and rubella vaccine (live)

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

-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 of pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

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.How to store M-M-RVAXPRO

6.Content 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 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.

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

Do not use M-M-RVAXPRO:

-If you or your child are allergic to any of the components of this vaccine (including neomycin or any of the other ingredients listed in section 6)

-If you or your child are pregnant (in addition, pregnancy should be avoided for 1 month after vaccination, see Pregnancy)

-If you or your child have any illness with fever higher than 38.5°C; however, low-grade fever itself is not a reason to delay vaccination

-If you or your child have active untreated tuberculosis

-If you or your child have a blood disorder or any type of cancer that affects the immune system

-If you or your child are receiving treatment or taking medicines that may weaken the immune system (except low-dose corticosteroid therapy for asthma or replacement therapy)

-If you or your child have a weakened immune system because of a disease (including AIDS)

-If you or your child have a family history of congenital or hereditary immunodeficiency, unless the immune competence of your or your child is demonstrated.

Warnings and precautions

Talk to the doctor or pharmacist before you or your child receive M-M-RVAXPRO if you have experienced any of the following:

-If you or your child have an allergic reaction to eggs or anything that contained egg

-If you or your child have a history or family history of allergies or of convulsions (fits)

-If you or your child have a side effect after vaccination with measles, mumps, or rubella vaccine (in a single component vaccine or a combined vaccine, such as the measles, mumps, and rubella vaccine manufactured by Merck & Co., Inc., or M-M-RVAXPRO) that involved easy bruising or bleeding for longer than usual

-If you or your child have infection with Human Immunodeficiency Virus (HIV) but do not show symptoms of HIV disease. You or your child 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.

Other medicines and M-M-RVAXPRO

Tell your doctor or pharmacist if you or your child are taking or have recently taken any other medicines (or other vaccines).

The doctor may delay vaccination for at least 3 months following blood or plasma transfusions, or 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.

Pregnancy and breast-feeding

M-M-RVAXPRO should not be given to pregnant females. Females of child-bearing 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.

Driving and using machines

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

M-M-RVAXPRO contains sorbitol.

If you have been told by your doctor that you or your child have an intolerance to some sugars, inform your doctor before you or your child receive this vaccine.

3. How to use M-M-RVAXPRO

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.

4. Possible side effects

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 effect

 

 

 

Very common (may

 

Fever (38.5°C or higher).

affect more than 1 in

 

Injection-site redness; injection-site pain; injection-site swelling.

10 vaccinees)

 

 

Common (may affect

 

Rash (including measles-like rash).

1 to 10 in 100

 

Injection-site bruising.

vaccinees)

 

 

Uncommon (may

 

Nasal congestion and sore throat; upper respiratory tract infection

affect 1 to 10 in 1000

 

or viral infection; runny nose.

vaccinees)

 

Diarrhoea, vomiting.

 

 

Hives.

 

Injection-site rash.

 

 

 

Not known

 

Aseptic meningitis (fever, feeling sick, vomiting, headache, stiff

(Frequency cannot be

 

neck, and sensitivity to light); swollen testicles; infection of the

estimated from the

 

middle ear; inflamed salivary glands; atypical measles (described

available data)*

 

in patients who received a killed measles virus vaccine, usually

 

 

given before 1975).

 

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 syndrome).

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, eyes, and/or genitals (Stevens-Johnson syndrome).

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.

Reporting of side effects

If you get 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 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. How to store M-M-RVAXPRO

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 dates 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.

Once the vaccine has been mixed with the solvent supplied, it should be either used immediately or stored in the refrigerator and used within 8 hours.

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.

6. Contents of the pack and other information

What M-M-RVAXPRO contains

The active substances are:

After reconstitution, one dose (0.5 ml) contains:

Measles virus1 Enders’ Edmonston strain (live, attenuated) …………...….not less than 1x103 CCID50* Mumps virus1 Jeryl Lynn™ [Level B] strain (live, attenuated)……………not less than

12.5x103 CCID50*

Rubella virus2 Wistar RA 27/3 strain (live, attenuated) ………………..….not less than 1x103 CCID50*

* 50% cell culture infectious dose

1produced in chick embryo cells.

2produced in WI-38 human diploid lung fibroblasts.

The other ingredients are:

Powder:

sorbitol, sodium phosphate, potassium phosphate, sucrose, hydrolysed gelatin, medium 199 with Hanks’ salts, MEM, monosodium L-glutamate, neomycin, phenol red, sodium bicarbonate, hydrochloric acid (to adjust pH), and sodium hydroxide (to adjust pH)

Solvent:

water for injections

What M-M-RVAXPRO looks like and contents of the pack

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, 10 and 20, with or without needles. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder: MSD VACCINS, 162 avenue Jean Jaurès, 69007 Lyon, France

Manufacturer Responsible for Batch Release: Merck Sharp and 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.

België/Belgique/Belgien

Lietuva

MSD Belgium BVBA/SPRL

UAB Merck Sharp & Dohme

Tél/Tel: 0800 38 693

Tel.: +370.5.2780.247

(+32(0)27766211)

msd_lietuva@merck.com

dpoc_belux@merck.com

 

България

Luxembourg/Luxemburg

Мерк Шарп и Доум България ЕООД,

MSD Belgium BVBA/SPRL

тел.: + 359 2 819 3737

Tél/Tel: +32(0)27766211

info-msdbg@merck.com

dpoc_belux@merck.com

Česká republika

Magyarország

Merck Sharp & Dohme s.r.o.

MSD Pharma Hungary Kft.

Tel.: +420 233 010 111

Tel.: + 36.1.888.5300

dpoc_czechslovak@merck.com

hungary_msd@merck.com

Danmark

MSD Danmark ApS Tlf: + 45 4482 4000 dkmail@merck.com

Deutschland

MSD SHARP & DOHME GMBH

Tel: 0800 673 673 673 (+49 (0) 89 4561 2612) e-mail@msd.de

Eesti

Merck Sharp & Dohme OÜ Tel.: +372 6144 200 msdeesti@merck.com

Ελλάδα

MSD Α.Φ.Β.Ε.Ε.

Τηλ: +30 210 98 97 300 dpoc_greece@merck.com

España

Merck Sharp & Dohme de España, S.A. Tel: +34 91 321 06 00 msd_info@merck.com

France

MSD VACCINS

Tel:+ 33 (0)1 80 46 40 40

Hrvatska

Merck Sharp & Dohme d.o.o. Tel: +385 1 66 11 333 croatia_info@merck.com

Ireland

Merck Sharp & Dohme Ireland (Human Health) Limited

Tel: +353 (0)1 2998700 medinfo_ireland@merck.com

Ísland

Vistor hf.

Sími: + 354 535 7000

Italia

MSD Italia S.r.l. Tel: +39 06 361911

medicalinformation.it@merck.com

Κύπρος

Merck Sharp & Dohme Cyprus Limited Τηλ: 800 00 673 (+357 22866700) cyprus_info@merck.com

Malta

Merck Sharp & Dohme Cyprus Limited. Tel: 8007 4433 (+356 99917558) malta_info@merck.com

Nederland

Merck Sharp & Dohme BV Tel: 0800 9999000

(+31 23 5153153) medicalinfo.nl@merck.com

Norge

MSD (Norge) AS Tlf: +47 32 20 73 00 msdnorge@msd.no

Österreich

Merck Sharp & Dohme Ges.m.b.H. Tel: +43 (0) 1 26 044 msd-medizin@merck.com

Polska

MSD Polska Sp. z o.o. Tel.: +48.22.549.51.00 msdpolska@merck.com

Portugal

Merck Sharp & Dohme, Lda Tel: +351 21 4465700 clic@merck.com

România

Merck Sharp & Dohme Romania S.R.L Tel: + 4021 529 29 00 msdromania@merck.com

Slovenija

Merck Sharp & Dohme, inovativna zdravila d.o.o. Tel: +386.1.520.4201

msd.slovenia@merck.com

Slovenská republika

Merck Sharp & Dohme, s. r. o Tel: +421 2 58282010 dpoc_czechslovak@merck.com

Suomi/Finland

MSD Finland Oy

Puh/Tel: +358 (0)9 804 650 info@msd.fi

Sverige

Merck Sharp & Dohme (Sweden) AB Tel: +46 77 5700488 medicinskinfo@merck.com

Latvija

SIA Merck Sharp & Dohme Latvija Tel: +371.67364.224 msd_lv@merck.com

This leaflet was last revised in:

Other sources of information

United Kingdom

Merck Sharp & Dohme Limited Tel: +44 (0) 1992 467272 medicalinformationuk@merck.com

Detailed information on this vaccine is available on the European Agency website: http://www.ema.europa.eu.

-----------------------------------------------------------------------------------------------------------------------

The following information is intended for healthcare professionals only:

Reconstitution instructions

The solvent is a clear colourless liquid. Before mixing with the solvent, the powder is a light yellow compact crystalline cake. When completely reconstituted, the vaccine is a clear yellow liquid.

Do not use the reconstituted vaccine if you notice any particulate matter or if the appearance of the solvent or powder or of the reconstituted vaccine differs from that described above.

Inject the entire content of the pre-filled syringe into the vial containing the powder. Gently agitate to dissolve completely. Withdraw the entire content of the reconstituted vaccine vial into the same syringe and inject the entire volume.

If two needles are provided: use one needle to reconstitute the vaccine and the other for its administration to the person to be vaccinated.

It is recommended that the vaccine be administered immediately after reconstitution or stored in the refrigerator and used within 8 hours to minimize loss of potency. Discard if reconstituted vaccine is not used within 8 hours.

Do not freeze the reconstituted vaccine.

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.

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