ProQuad powder and solvent for suspension for injection in a pre-filled syringe

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or your pharmacist.
• This vaccine has been prescribed for you or your child only. Do not pass it on to others.
• 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.

1. What ProQuad is and what it is used for
2. What you need to know before you receive ProQuad
3. How to use ProQuad
4. Possible side effects
5. How to store ProQuad
6. Contents of the pack and other information

• If the person to be vaccinated is allergic to any varicella vaccine or 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 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 medications 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 this person is demonstrated.
• If the person to be vaccinated has active untreated tuberculosis.
• 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 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 experienced any of the following, talk to the doctor or pharmacist before ProQuad is given:

• 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-containing vaccines that involved easy bruising or bleeding for longer than usual.
• An infection with Human Immunodeficiency Virus (HIV) without showing symptoms of HIV disease. However, vaccination may be less effective than for uninfected persons (see Do not use ProQuad).

If you have a blood clotting disorder or low levels of platelets in your blood, the injection will be given under the skin.

In rare circumstances, it is possible to catch chickenpox, including severe chickenpox, from a person who has been vaccinated with ProQuad. This may occur in persons who have not previously been vaccinated against chickenpox or had chickenpox, as well as persons who fall into one of the following categories:

• 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.

Whenever possible, individuals who have been vaccinated with ProQuad should attempt to avoid close contact, for up to 6 weeks following the vaccination, with anyone who falls into one of the categories above. Tell your doctor if there is anyone who falls into one of the categories above and is expected to be in close contact with the person being vaccinated.

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.

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

ProQuad can be given at the same time as other childhood vaccines such as Prevenar, and/or hepatitis A vaccine, or with vaccines containing diphtheria, tetanus, acellular pertussis, Haemophilus influenzae type b, inactivated poliomyelitis, or hepatitis B. A different place for the injection will be used for each vaccine.

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 the person to be vaccinated 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.

ProQuad should not be given to pregnant women. Women of child-bearing age should take the necessary precautions to avoid pregnancy for 1 month following vaccination.

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

This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium-free’.

This medicine contains less than 1 mmol potassium (39 mg) per dose, that is to say essentially ‘potassium-free’.

This medicine contains 16 mg 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.

Your doctor will decide when to give the missed dose.

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 the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

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 TCID₅₀*

Mumps virus¹ Jeryl Lynn™ (Level B) strain (live, attenuated) ... not less than 4.30 log₁₀ TCID₅₀*

Rubella virus² Wistar RA 27/3 strain (live, attenuated) ............... not less than 3.00 log₁₀ TCID₅₀*

Varicella virus³ Oka/Merck strain (live, attenuated) .................... not less than 3.99 log₁₀ PFU**

*50% tissue culture infectious dose

**plaque-forming units

(¹) Produced in chick embryo cells.

(²) Produced in human diploid lung (WI-38) fibroblasts.

(³) Produced in human diploid cells (MRC-5).

The other ingredients are:

Powder

Sucrose, hydrolysed gelatin, urea, sodium chloride, sorbitol (E 420), 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.

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.

The powder is a white to pale yellow compact crystalline cake and the solvent is a clear colourless liquid.

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

Marketing Authorisation Holder:

Manufacturer Responsible for Batch Release:

For any information about this medicinal product, please contact the Marketing Authorisation Holder: