ProQuad powder and solvent for suspension for injection in apre-filled syringe.Measles, mumps, rubella and varicella vaccine (live)

ProQuad is a vaccine containing measles, mumps, rubella, and varicella (chickenpox) 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, rubella, and varicella viruses. The antibodies help protect against diseases caused by these viruses.

ProQuad is given to help protect your child against measles, mumps, rubella, and varicella (chickenpox). The vaccine may be administered to persons from 12 months of age.

Although ProQuad contains live viruses, they are too weak to cause measles, mumps, rubella, or varicella (chickenpox) in healthy people.

Do not use ProQuad

• If your child is allergic (hypersensitive) to any of the components of ProQuad (including neomycin or any of the ingredients listed under?other ingredients?-see section 6, Further information).
• If your child has a blood disorder or any type of cancer that affects the immune system.
• If your child is receiving treatment or taking medications that may weaken the immune system (except low-dose corticosteroid therapy for asthma or replacement therapy).
• If your child has a weakened immune system because of a disease (including AIDS).
• If your child has a family history of congenital or hereditary immunodeficiency, unless the immune competence of your child is demonstrated.
• If your child has active untreated tuberculosis.
• If your child has any illness with fever higher than 38.5°C; however, low-grade fever itself is not a reason to delay vaccination.
• If your child is pregnant (in addition, pregnancy should be avoided for 3 months after vaccination, see Pregnancy and breast-feeding).

Take special care with ProQuad

If the person to be vaccinated has experienced any of the following, talk to the doctor or pharmacist before ProQuad is given:

• If your child has had an allergic reaction to eggs or anything that contained egg.
• If your child has a history or family history of allergies or of convulsions (fits).
• If your child has had a side effect after vaccination with measles, mumps, or rubella (in a single vaccine or combined vaccine, such as the measles, mumps, and rubella vaccine manufactured by Merck & Co., Inc. or ProQuad) that involved easy bruising or bleeding for longer than usual.
• If your child has infection with Human Immunodeficiency Virus (HIV) but does not show symptoms of HIV disease. However, vaccination may be less effective than for uninfected persons (see Do not use ProQuad).

Once vaccinated, your child should attempt to avoid for up to 6 weeks following vaccination, whenever possible, close association with the following individuals:

• Individuals with a lowered resistance to diseases.
• Pregnant women who have either not had chickenpox or have not been vaccinated against chickenpox.
• Newborn infants of mothers who have either not had chickenpox or have not been vaccinated against chickenpox.

Tell your doctor if there is anyone who falls into one of the categories above and is expected to be in contact with your vaccinated child.

As with other vaccines, ProQuad may not completely protect all persons who are vaccinated. Also, if the person to be vaccinated has already been exposed to the measles, mumps, rubella, or varicella virus but is not yet ill, ProQuad may not be able to prevent the illness from appearing.

Using other medicines and other vaccines

ProQuad 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).

The doctor may delay vaccination for at least 3 months following blood or plasma transfusions, or administration of immune globulin (IG), or varicella zoster immune globulin (VZIG). After vaccination with ProQuad, IG or VZIG 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 ProQuad.

Tell the doctor if your child has recently received a vaccine or if one is scheduled to be given in the near future. The doctor will determine when ProQuad may be given.

The use of salicylates (for example, acetylsalicylic acid, a substance present in many medicines used to relieve pain and lower fever) should be avoided for 6 weeks following vaccination with ProQuad.

Please tell your doctor or pharmacist if your child is taking or has recently taken any other medicines (or other vaccines) including medicines obtained without a prescription.

Pregnancy and breast-feeding

ProQuad should not be given to pregnant females. Females of child-bearing age should take the necessary precautions to avoid pregnancy for 3 months, or according to doctor?s recommendation, after they have been given the vaccine.

Persons who are breast-feeding or who intend to breast-feed should tell the doctor. The doctor will decide if ProQuad should be given.

Ask your doctor or pharmacist for advice before taking any medicine.

Important information about some of the ingredients of ProQuad

ProQuad contains sorbitol. If you have been told by your doctor that you or your child has an intolerance to some sugars, inform your doctor before you or your child takes this vaccine.

ProQuad should be injected under the skin in the upper arm or in the outer thigh.

ProQuad is not to be injected directly into any blood vessel.

ProQuad is given by injection to persons from 12 months of age. The appropriate time and number of injections will be determined by your doctor using appropriate official recommendations.

Reconstitution instructions intended for medical and healthcare professionals are included at the end of the leaflet

If you forget to take ProQuad

Your doctor will decide when to give the missed dose.

Like all medicines, ProQuad can cause side effects, although not everybody gets them.

The most common side effects reported with the use of ProQuad were: injection site complaints including pain/tenderness/soreness, redness, swelling or bruising; fever (38.9°C or higher); irritability; rash (including measles-like rash, varicella-like rash, viral exanthema, and injection site rash); upper respiratory infection; vomiting and diarrhoea.

Other less common side effects have been reported following administration of ProQuad and some of these were serious. These included: allergic reactions (hives); seizures with a fever; cough and bronchiolitis (difficulty breathing with or without cough); and unsteadiness with walking.

Other side effects have been reported with the use of either measles, mumps, and rubella vaccine manufactured by Merck & Co., Inc., the monovalent components of the measles, mumps, and rubella vaccine produced by Merck & Co., Inc., or Varicella Vaccine live (Oka/Merck): unusual bleeding or bruising under the skin, swelling of the testicles; tingling of the skin, herpes zoster (shingles); inflammation of the brain (encephalitis); severe skin disorders; skin infection; stroke; seizures without a fever; joint pain and/or swelling (which could be transient or chronic); and inflammation of the lung (pneumonia/pneumonitis).

The doctor has a more complete list of side effects for ProQuad and for the vaccine components for ProQuad (the measles, mumps, and rubella vaccine manufactured by Merck & Co., Inc. and Varicella Vaccine live (Oka/Merck)).

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. If the condition persists or worsens, seek medical attention.

Keep out of the reach and sight of children.

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

Keep the vial in the outer carton in order to protect from light.

Do not use ProQuad after the expiry date which is stated on the outer carton after EXP.

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.

What ProQuad contains

After reconstitution, one dose (0.5 ml) contains:
The active substances are:

Measles virus1 Enders Edmonston strain live, attenuated........not less than 3.00 log10 CCID50 CCID50Mumps virus1 Jeryl Lynn Level B strain live, attenuated...not less than 4.30 log10Rubella virus2 Wistar RA 273 strain live, attenuated...............not less than 3.00 log10 CCID50 Varicella virus3 OkaMerck strain live, attenuated ...................not less than 3.99 log10 PFU

*50% cell culture infectious dose
**plaque-forming units

123 Produced in chick embryo cells. Produced in human diploid lung WI-38 fibroblasts. Produced in human diploid cells MRC-5.

The other ingredients are:

Powder
Sucrose, hydrolysed gelatin, urea, sodium chloride, sorbitol, monosodium glutamate, sodium phosphate, sodium bicarbonate, potassium phosphate, potassium chloride, medium 199 with Hanks? Salts, MEM, neomycin, phenol red, hydrochloric acid and sodium hydroxide.

Solvent
Water for injections.

What ProQuad 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 with the vial of powder.

ProQuad is available in pack of 1, 10 and 20. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder: Sanofi Pasteur MSD SNC, 8 rue Jonas Salk, F-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: Sanofi Pasteur MSD, Tél/Tel: +32.2.726.95.84
--------: ---- ---- - ---- -------- ---- ---. + 359 2 819 3740
-eská republika: Merck Sharp & Dohme IDEA, Inc., org. sl.,Tel.: +420.233.010.111 Danmark: Sanofi Pasteur MSD, Tlf: +45 23 32 69 29
Deutschland: Sanofi Pasteur MSD GmbH, Tel: +49.6224.5940
Eesti: Merck Sharp & Dohme OÜ, Tel: +372.613.9750
???-??: ?????? ?.?., ???: +30.210.8009111
España: Sanofi Pasteur MSD S.A., Tel: +34.91.371.78.00
France: Sanofi Pasteur MSD SNC, Tél: +33.4.37.28.40.00
Ireland: Sanofi Pasteur MSD Ltd, Tel: +3531. 468.5600
Ísland: Sanofi Pasteur MSD, Sími: +32.2.726.95.84
Italia: Sanofi Pasteur MSD Spa, Tel: +39.06.664.092.11
K-????: Merck Sharp & Dohme (Middle East) Limited., ???: +357 22866700
Latvija: SIA Merck Sharp & Dohme Latvija, Tel: +371.67364.224
Lietuva: UAB Merck Sharp & Dohme, Tel.: +370.5.2780.247
Luxembourg/Luxemburg: Sanofi Pasteur MSD, Tél: +32.2.726.95.84
Magyarország: MSD Magyarország Kft, Tel.: + 36.1.888.5300
Malta: Merck Sharp & Dohme (Middle East) Limited., Tel: +357 22866700
Nederland: Sanofi Pasteur MSD, Tel: +31. 23.567.96.00
Norge: Sanofi Pasteur MSD, Tlf: +47. 67.50.50.20
Österreich: Sanofi Pasteur MSD GmbH, Tel: +43.1.866.70.22.202
Polska: MSD Polska Sp. z o.o., Tel.: +48.22.549.51.00
Portugal: Sanofi Pasteur MSD, SA, Tel: +351.21.470.45.50
România: Merck Sharp & Dohme Romania S.R.L. Tel: + 4021 529 29 00
Slovenija: Merck Sharp & Dohme, inovativna zdravila d.o.o., Tel: +386.1.520.4201 Slovenská republika: Merck Sharp & Dohme IDEA, Inc., Tel: +421.2.58282010 Suomi/Finland: Sanofi Pasteur MSD, Puh/Tel: +358.9.565.88.30
Sverige: Sanofi Pasteur MSD, Tel: +46.8.564.888.60
United Kingdom: Sanofi Pasteur MSD Ltd, Tel: +44.1.628.785.291

This leaflet was last approved in:

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The following information is intended for medical or healthcare professionals only:

Reconstitution instructions

Before mixing with the solvent, the powder vaccine is a white to pale yellow compact crystalline cake. When completely mixed, the vaccine is a clear pale yellow to light pink liquid.

.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 from the vial into the same syringe and inject the entire volume.

It is recommended that the vaccine be administered immediately after reconstitution to minimize loss of potency. Discard if reconstituted vaccine is not used within 30 minutes.

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

Any unused product or waste material should be disposed of in accordance with local requirements.

See also section 3 HOW TO USE ProQuad.