ProQuad – Package Leaflet: InfoCons – Consumer Protection presents, in an accessible format, the official package leaflet of the medicine ProQuad, as authorised in the European Union and published in the Union Register of medicinal products.
Before anything else
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 pharmacis t.
- 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 ef fects, talk to your doctor or pharmacist. This includes any possible side ef fects not listed in this leaf let.
See section 4.
What is in this leaflet 1.
What ProQuad is and what it is used for
2.
What you need to know bef ore 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 1.
What ProQuad is an d what it is used for ProQuad is a vaccine containing measles, mumps, rubella, and chickenpox (varicella ) viruses that have been weakened. When a person is given the vaccine, the immune system (the body’s natural def enses ) will make antibodies against th e 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 chickenpox (varicella ). The vaccine may be administere d to persons from 12 months of age.
ProQuad may also be administered to infants from 9 months of age under special circumstances (to conform with national vaccination schedules, outbreak situations, or travel to a region with high prevalence of measles).
Although ProQuad contains live viruses, they are too weak to cause measles, mumps, rubella, or chickenpox (varicella ) in healthy people.
2.
What you need to know before you receive ProQuad
Do not use ProQuad
- If the person to be vaccinated is allergic t o 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 aff ects the immune system.
- I f 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 f amily history of congenital or hereditary immunodef iciency, unless the immune competence of this person is demonstrated.
- If the person to be vaccinated has active untreated tuberculosis.
39• 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 vaccinat ion, see Pregnancy and breast -f eeding ).
Warnings and precautions
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 f amily history of allergies or of convulsions (f its).
- A side ef fect after vaccination with measles, mumps, and/or rubella – containing vaccines that involved easy bruising or bleeding for longer than usual.
- An inf ection with Human Immunodeficiency Virus (HIV) without showing symptoms of HIV disease. However, vaccination may be less ef fective 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 gi ven under the skin.
In rare circumstances, it is possible to catch chickenpox, including severe chickenpox, f rom a person who has been vaccinated with ProQuad. This may occur in persons who have not previously been vaccinated against chickenpox or have no t 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 moth ers 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 f ollowing the vaccination, with anyone who f alls into one of the categories above.
Tell your doctor if there is anyone who f alls 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 f rom appearing.
Other medicines and ProQuad
Te ll 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 va ccines containing diphtheria, tetanus, acellular pertussis, Haemophilus influenzae type b, inactivated poliomyelitis, or hepatitis B.
A dif f erent place f or the injection will be used for each vaccine.
The doctor may delay vaccination f or 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 tuber culin test is to be perf ormed, it should be done either any time before, simultaneously with, or 4 to 6 weeks af ter 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 (f or example, acetylsalicylic acid, a substance present in many medicines used to relieve pain and lower f ever) should be avoided for 6 weeks following vacci nation with ProQuad.
Pregnancy and breast -f eeding 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
- f eeding 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 f or advice before taking this vaccine.
Driving and using machines
There is no information to suggest that ProQuad af fects the ability to drive or operate machinery.
ProQuad contains sodium
This medicine contains less than 1
mmol sodium (23 mg) per dos e, that is to say essentially ‘so dium – free’.
ProQuad contains potassium
This medicine contains less than 1
mmol potassium (39 mg) per dos e , that is to say essentially ‘potassium -f ree’.
ProQuad contains sorbitol
This medicine contains 16 mg sorbitol per dose.
The additive ef fect of conco mitantly administered products containing sorbitol (or f ructose) and dietary intake of sorbitol (or fructose) should be taken into account.
3.
How to use ProQuad ProQuad should be injected into the muscle or under the skin either in the area of the o ute r thigh or of the upper arm.
Usually f or injections into the muscle the thigh area is pref erred in young children, whereas f or older individuals the upper arm area is the preferred injection site.
If the person to be vaccinated has a blood clotting disor der or low levels of platelets, the vaccine should be given under the skin because bleeding may occur following administration into the muscle.
ProQuad is not to be injected directly into any blood vessel.
ProQuad is given by injection as follows:
- Inf a nts between 9 and 12 months of age:
ProQuad may be administered f rom 9 months of age. To ensure optimal protection against chickenpox and measles, two doses of ProQuad should be given at least three months apart.
- Individuals 12 months of age and older:
To ensure optimal protection against chickenpox, two doses of ProQuad should be given at least one month apart.
The appropriate time and number of injections will be determined by your doctor in accordance with off icial recommendations.
Reconstitution in structions 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.
4.
Possible side effects Like all vaccines and medicines, this vacci ne can cause side ef fects, although not everybody gets them.
Allergic reactions (hives) may occur. Some of these reactions may be serious and may include dif ficulty in breathing or swall owing. If the vaccinated person has an allergic reaction, call your d octor right away.
Other side effects have been reported f ollowing administration of ProQuad and some of these were serious. These included:
Uncommon (may aff ect up to 1 in 100 people): seizures with a f ever
.
Rare (may affect up to 1 in
1 000 people): uns teadiness with walking.
The following other side ef fects reported with the use of ProQuad were:
Very common (may affect more than 1 in 10 people): injection site complaints including
pain/tenderness/soreness, redness, fever (38.9°C or higher);
Common (may
af fect up to 1 in 10 people): injection site complaints including swelling or bruising; irritability; rash (including measles -like rash , varicella – like rash, and injection -site rash); upper respiratory inf ection; vomiting and diarrhoea.
Other side effect s have been reported with the use of at least one of the following: ProQuad, previous formulations of monovalent and of the combined measles, mumps, and rubella vaccines manufactured by Merck Sharp & Dohme LLC, Rahway, NJ 07065 , USA (herein af ter MSD) , or Varicella Vaccine live (Oka/Merck). These adverse events include:
Uncommon (may aff ect up to 1 in 100 people)
cough.
- Rare (may affect up to 1 in 1 000 people) : skin infection; chickenpox (varicella).
Not known (f requency cannot be estimated from the avai
lable data): o infection or inf lammation of the brain (encephalitis) has been observed following vaccination with live attenuated measles, mumps, rubella and varicella vaccines . In a few cases, this condition has been fatal, especially in people with weaken ed immune systems (as noted in section 2, ProQuad must not be used in patients with weakened immune systems). Seek immediate medical attention if you or your child develop loss or reduced levels of consciousness, convulsions or loss of control of bodily mo vements, accom panied by fever and headache, as these might be a sign of inf ection or inflammation of the brain. Inform your doctor or pharmacist that you or your child received ProQuad. o unusual bleeding or bruising under the skin, swelling of the testicles ; tingling of the skin, herpes zoster (shingles); inflammation of the coverings of the brain and spinal cord not caused by bacterial infection (aseptic meningitis), severe skin disorders; skin granuloma (clumps of inflammatory cells) ; stroke; seizures with out 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 eff ects for ProQuad and f or the vaccine components for ProQuad (the measles, m umps, and rubella vaccine manufactured by MSD and Varicella Vaccine live (Oka/Merck)).
Reporting of side effects
If the vaccinated person gets any side ef fects, talk to your doctor or pharmacist. This includes any possible side eff ects not listed in this leaf let.
You can also report side ef fects directly via the national reporting system listed in Appendix V .
By reporting side ef f ects you can help provide more information on the safety of this medicine.
5.
How to store ProQuad Keep this vaccine out of the sight and reach of children.
Do not use this vaccine af ter the expiry date which is stated on the outer carton af ter EXP. Th e expiry date refers to the last day of that month.
Store and transport refrigerated (2°C -8°C).
Do not f reeze.
Keep the vial in th e outer carton in order to protect from light.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6.
Contents of the pack and other information
What ProQuad contains
After reconstitution, one dose ( approximately 0.5 mL ) contains:
The active s ubstances are:
Measles virus 1 Enders’ Edmonston strain (live, attenuated) …….. not less than 3.00 log 10 TCID50* Mumps virus Jeryl Lynn ( Level B) strain (live, attenuated) ……. not less than 4.30 log 10 TCID50* Rubella virus Wistar RA 27/3 strain (live, attenuated) …………… not less than 3.00 log 10 TCID50* Varicella virus Oka/Merck strain (live, attenuated) ……………….. not less than 3.99 log 10 PFU** *50% tissue culture inf ectious dose ** plaque – forming units (1 ) Produced in chick embryo cells. (2 ) Produced in human diploid lung (WI
- 38) f ibroblasts.
(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, potass ium chloride, medium 199 with Hanks’ Salts, MEM, neomycin, phenol red, hydrochloric acid (HCl) and sodium hydroxide (NaOH) .
Solvent Water for injections.
What ProQuad looks like and contents of the pack
The vaccine is a powder for suspension for injectio n contained in a single
- dose vial, which should be mixed with solvent provided with the vial of powder.
The powder is a white to pal e yellow compact crystalline cake and the solvent is a clear colourless liquid.
ProQuad is available in pack of 1 and pack of 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 produ ct, please contact the local representativ e of the Marketing Authorisation Holder.
België/Belgique/Belgien MSD Belgium Tél/Tel: +32(0)27766211 dpoc_belux@m sd.comLietuva UAB Merck Sharp & Dohme Tel. +370 5 2780 247 d [email protected] България Мерк Шарп и Доум България ЕООД, тел.: + 359 2 8 19 3737 inf o-msdbg @msd.com Luxembourg/Luxemburg MSD Belgium Tél/Tel: +32(0)27766211 dpoc_belux@m sd.com Česká republika Merck Sharp & Dohme s.r.o.
Tel.: +420 277 050 000 dpoc_czechslovak@ msd.com Magyarország MS D Pharma Hungary Kf t.
Tel.: + 36 1 888 5300 hungary_msd@ msd.com Danmark MSD Danmark ApS Tlf. : +45 4482 4000 dkmail@ msd.comMalta Merck Sharp & Dohme Cyprus Limited Tel: 8007 4433 (+356 99917558) malta_info@m sd.com Deutschland MSD Sharp & Dohme GmbH Tel.: +49 (0) 89 20 300 4500 [email protected] Nederland Merck Sharp & Dohme B .V.
Tel:
0800 9999000 (+31 23 5153153) medicalinfo.nl@ msd.com Eesti Merck Sharp & Dohme OÜ Tel: +372 614 4200 d [email protected] Norge MSD (Norge) AS Tlf : +47 32 20 73 m edinfo.norway@msd. com Ελλάδα MSD Α.Φ.Ε.Ε.
Τηλ : +30 210 98 97 300 dpoc .greece @msd.comÖsterreich Merck Sharp & Dohme Ges.m.b.H.
Tel: +43 (0) 1 26 044 dpoc_austria @msd.com España Merck Sharp & Dohme de España, S.A.
Tel: +34 91 321 06 00 msd_info@m sd.comPolska MSD Polska Sp. z o.o.
Tel.: +48 22 549 51 00 msdpolska@m sd.com France MSD France Tél: + 33 (0)1 80 46 40 40 Portugal Merck Sharp & Dohme, Lda Tel: +351 21 4465 inf orm_pt @msd.com 44Hrvatska Merck Sharp & Dohme d.o.o.
Tel: +385 1 66 11 333 dpoc . [email protected] România Merck Sharp & Dohme Romania S.R.L Tel: + 4021 529 29 00 msdromania@ msd.com Ireland Merck Sharp & Dohme Ireland (Human Health) Limited Tel: +353 (0)1 2998700 medinfo_ireland@m sd.comSlovenija Merck Sharp & Dohme , inovativna zdravila d.o.o.
Tel: +386 1 520 4201 msd.slovenia@ msd.com Ísland Vistor ehf .
Sími: + 354 535 7000 Slovenská republika Merck Sharp & Dohme, s. r. o .
Tel: +421 2 58282010 dpoc_czechslovak@ msd.com Italia MSD Italia S.r.l.
Tel:
800 23 99 89 (+39 06 361911) d [email protected] Suomi/Finland MSD Finland Oy Puh/Tel: +358 (0)9 804 650 [email protected] i Κύπρος Merck Sharp & Dohme Cyprus Limited Τηλ: 800 00 673 (+357 22866700) cyprus _inf [email protected] Sverige Merck Sharp & Dohme (Sweden) AB Tel: +46 77 5700488 medicinskinf o@ msd.com Latvija SIA Merck Sharp & Dohme Latvija Tel.: +371 67025300 dpoc.latvia@ msd.c om
This leaflet was last revised in
<{MM/YYYY}><{month YYYY}> .
Other source s of information Detailed information on this medicine is available on the European Medicines Agency website: https ://www.ema.europa.eu . ————————————- ——————————————————————————– The following information is intended for healthcare professionals only:
Before mixing with the solvent, the powder vaccine is a white to pale yellow compact crystallin e cak e.
The solvent is a clear colourless liquid. When completely reconstituted, the vaccine is a clear pale yellow to light pink liquid.
To reconstitute the vaccine, use only the solvent supplied, because it is free of preservatives or other antiviral substan ces, which might inactivate the vaccine.
It is important to use a separate sterile syringe and needle for each individual to prevent transmission of infectious agents from one individual to another.
One needle should be used for reconstitution and a sepa rate, new needle for injection.
ProQuad must not be mixed in a syringe with other vaccines.
Reconstitution instructions Withdraw the entire content of the solvent vial into a syringe. Inject the entire content of the syringe into the vial containing the powder. Gently agitate to dissolve completely.
The reconstituted vaccine should be inspected visually for any f oreign particulate matter and/or abnormal physical appearance prior to administration. In the event of either being observed, discard the vacci ne.
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 freeze the reconstituted vaccine.
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 als o sec tion 3 How to use ProQuad.
46Package l eaflet: Information for the User ProQuad Powder and solvent for suspension for injection in a pre
- filled syringe Measles, mumps, rubella and varicella vaccine (live) Read all of this leaflet carefully before you or y our 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.
- 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 ef fects talk to your doctor of pharmacist. This includes any possible side ef fects not listed in this leaf let.
See section 4.
ℹ️ 1. What ProQuad is and what it is used for
ProQuad is a vaccine containing measl es, mumps, rubella, and chickenpox (varicella) viruses that have been weakened. When a person is given the vaccine, the immune system (the body’s natural defenses) will make antibodies against the measles, mumps, rubella, and varicella viruses. The antibod ies help protect against diseases caused by these viruses.
ProQuad is given to help protect your child against measles, mumps, rubella, and chickenpox (varicella ). The vaccine may be administered to persons from 12 months of age.
ProQuad may also be admi nistered to infants from 9 months of age under special circumstances ( to conform with national vaccination schedules, outbreak situations, or travel to a region with high prevalence of measles).
Although ProQuad contains live viruses, they are too weak to
cause measles, mumps, rubella, or chickenpox (varicella ) in healthy people.
⚠️ 2. What you need to know before you receive ProQuad
Do not use ProQuad
- 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 aff ects the immune system.
- If the person to be vaccinated is receiving treatment or takin g 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 vaccinat ed ha s a f amily history of congenital or hereditary immunodef iciency, unless the immune competence of this person is demonstrated.
- If the person to be vaccinated has active untreated tuberculosis.
47• 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 -f eeding).
Warnings and pr ecaut ion 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 f amily history of allergies or of convulsions (f its ).
- A side ef fect after vaccination with measles, mumps, and/or rubella – containing vaccines that involved easy bruising or bleeding for longer than usual.
- An inf ection with Human Immunodeficiency Virus (HIV) without showing symptoms of HIV disease. How ever, vaccination may be less ef fective 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, f rom a person who has been vaccinated with ProQuad . This may occur in persons who have not previously been vaccinated against chickenpox or have not 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 vaccin ated against chickenpox.
Whenever possible, individuals who have been vaccinated with ProQuad should attempt to avoid close contact, for up to 6 weeks f ollowing the vaccination, with anyone who f alls into one of the categories above.
Tell your doctor if t here is anyone who f alls 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 vaccina ted 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 f rom appearing.
Other medicines and ProQuad
Tell your doctor or pharmacist if the person to be vaccinat ed 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, Ha emophilus influenzae type b, inactivated poliomyelitis, or hepatitis B.
A dif f erent place f or the injection will be used for each vaccine.
The doctor may delay vaccination f or at least 3 months following blood or plasma transfusions, or administratio n 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 perf ormed, it should be done either any ti me before, simultaneously with, or 4 to 6 weeks af ter 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 ProQu ad ma y be given.
The use of salicylates (f or example, acetylsalicylic acid, a substance present in many medicines used to relieve pain and lower f ever) should be avoided for 6 weeks following vaccination with ProQuad.
Pregnancy and breast -f eeding ProQuad sho uld 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
- f eeding 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 f or advice before taking this vaccine.
Driving and using machines
There is no information to suggest that ProQuad af fects the ability to drive or operate machinery.
ProQuad contains sodium
This medicine contains less than 1
mmol sodium (23 mg) per dos e, that is to say essentially ‘sodium – free’.
ProQuad contains potassium
This medicine co ntain s less than 1 mmol potassium (39 mg) per dos e , that is to say essentially ‘potassium -f ree’.
ProQuad contains sorbitol
This medicine contains 16 mg sorbitol per dose.
The additive ef fect of concomitantly administered products containing sorbitol (or f ructo se) and dietary intake of sorbitol (or fructose) should be taken into account.
💊 3. How to use ProQuad
ProQuad should be injected into the muscle or under the skin either in the area of the o uter thigh or of the upper arm.
Usually f or injections int o the muscle the thigh area is pref erred in young children, whereas f or older individuals the upper arm area is the preferred injection site.
If the person to be vaccinated has a blood clotting disorder or low levels of platelets, the vaccine should be given u nder the skin because bleeding may occur following administration into the muscle.
ProQuad is not to be injected directly into any blood vessel.
ProQuad is given by injection as follows:
- Infants between 9 and 12 months of age:
ProQuad may be admin ister ed f rom 9 months of age. To ensure optimal protection against chickenpox and measles, two doses of ProQuad should be given at least three months apart.
- Individuals 12 months of age and older:
To ensure optimal protection against chickenpox, two doses of P roQuad should be given at least one month apart.
The appropriate time and number of injections will be determined by your doctor in accordance with off icial recommendations.
Reconstitution instructions intended for medical and healthcare professiona ls ar e included at the end of the leaflet
If you forget to take ProQuad
Your doctor will decide when to give the missed dose.
❗ 4. Possible side effects
Like all vaccines and medicines, this vaccine can cause side ef fects, although not everybody gets them.
Allergic reactions (hives) may occur. Some of these reactions may be serious and may include dif ficulty in breathing or swallowing. If the vaccinated person has an allergic reaction, call your doctor right away.
Other side effects have been reported
f ollo wing administration of ProQuad and some of these were serious. These included:
Uncommon (may
aff ect up to 1 in 100 people): seizures with a f ever.
Rare (may affect up to 1 in
1 000 people ): unsteadiness with walking.
The following other side ef fects repo rted with the use of ProQuad were:
Very common (may affect more than 1 in 10 people)
injection site complaints including pain/tenderness/soreness, redness; f ever (38.9°C or higher);
Common (may af fect up to 1 in 10 people): injection site complaints
inclu ding swelling or bruising; irritability; rash (including measles -like rash , varicella -like rash, and injection -site rash); upper respiratory inf ection; vomiting and diarrhoea.
Other side effects have been reported with the use of at least one of the follo wing: ProQuad, previous formulations of monovalent and of the combined measles, mumps, and rubella vaccines manufactured by Merck Sharp & Dohme LLC, Rahway, NJ 07065 , USA (herein af ter MSD) , or Varicella Vaccine live (Oka/Merck).
These adverse events inclu de:
Uncommon (may aff ect up to 1 in 100 people)
cough.
- Rare (may affect up to 1 in 1 000 people) : skin infection; chickenpox (varicella).
Not known (f requency cannot be estimated from the available data)
o infection or inf lammation of the brain (encephali tis) has been observed following vaccination with live attenuated measles, mumps, rubella and varicella vaccines . In a few cases, this condition has been fatal, especially in people with weakened immune systems (as noted in section 2, ProQuad must not be u sed in patients with weakened immune systems). Seek immediate medical attention if you or your child develop loss or reduced levels of consciousness, convulsions or loss of control of bodily movements, acco mpanied by fever and headache, as these might be a sign of inf ection or inflammation of the brain. Inform your doctor or pharmacist that you or your child received ProQuad . o unusual bleeding or bruising under the skin, swelling of the testicles; tingling of the skin, herpes zoster (shingles); inflammation of the coverings of the brain and spinal cord not caused by bacterial infection (aseptic meningitis), severe skin disorders; skin granuloma ( clumps of inflammatory cells ); stroke; seizures without a fever; joint pain and/or swelling (which could be transie nt or chronic); and inflammation of the lung (pneumonia/pneumonitis) .
The doctor has a more complete list of side eff ects for ProQuad and f or the vaccine components for ProQuad (the measles, mumps, and rubella vaccine manufactured by MSD and Varicella Vac cine live (Oka/Merck)).
Reporting of side effects
If the vaccinated person gets any side ef fects, talk to your doctor or pharmacist. This includes any possible side eff ects not listed in this leaf let.
You can also report side ef fects directly via the nati onal reporting system listed in Appendix V .
By reporting side ef fects you can help provide more information on the safety of this medicine.
🌡️ 5. How to store ProQuad
Keep this vaccine out of the sight and reach of children.
Do not use this vaccine af ter the expiry date which is stated on the outer
carton af ter EXP. The expiry dates refers to the last day of that month.
Store and transport refrigerated (2°C -8°C).
Do not f reeze.
Keep the vial in the outer carton in order to protect from light.
Do not throw away any medicines via wastewater or hou sehold waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
📦 6. Contents of the pack and other information
What ProQuad contains
After reconstitution, one dose ( approximately 0.5 mL) contains:
The active substances are:
Measles virus 1 Enders’ Edmonston strain (live, attenuated) …….. not less than 3.00 log 10 TCID50* Mumps virus Jeryl Lynn (Level B) strain (live, attenuated) ……. not less than 4.30 log 10 TCID50* Rubella virus Wistar RA 27/3 str ain (live, attenuated) …………… not less than 3.00 log 10 TCID50* Varicella virus Oka/Merck strain (live, attenuated) ……………….. not less than 3.99 log 10 PFU** *50% tissue culture inf ectious dose **plaque – forming units (1 ) Produced in chick embryo cells. (2 ) Produced in hu man diploid lung (WI
- 38) f ibroblasts.
(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, potass ium phosphate, potassium chloride, medium 199 with Hanks’ Salts, MEM, neomycin, phenol red, hydrochloric acid (HCl) and sodium hydroxide (NaOH) .
Solvent Water for injections.
What ProQuad looks like and contents of the pack
The vaccine is a powder for su spension 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 and Manufacturer
Merck Sharp & Dohme B.V., Waarderweg 39, 2031 BN Haarlem, The Netherlands For any information about this medicinal product, please contact the lo cal representative of the Marketing Authorisation Holder.
België/Belgique/Belgien MSD Belgium Tél/Tel: +32(0)27766211 dpoc_belux@m sd.comLietuva UAB Merck Sharp & Dohme Tel. +370 5 2780 247 d [email protected] България Мерк Шарп и Доум България ЕООД, тел.: + 359 2 819 3737 inf o-msdbg @msd.com Luxembourg/Luxemburg MSD Belgium Tél/Tel: +32(0)27766211 dpoc_belux@m sd.com Česká republika Merck Sharp & Dohme s.r.o.
Tel.: +420 277 050 000 dpoc_czechslovak@ msd.com Magyarország MSD Pharma Hungary Kf t.
Tel.: + 36 1 888 5300 hungary_msd@ msd.com Danmark MSD Danmark ApS Tlf. : +45 4482 4000 dkmail@ msd.comMalta Merck Sharp & Dohme Cyprus Limited Tel: 8007 4433 (+356 99917558) malta_inf o@ msd.com Deutschland MSD S harp & Dohme GmbH Tel.: +49 (0) 89 20 300 4500 [email protected] Nederland Merck Sharp & Dohme B .V.
Tel:
0800 9999000 (+31 23 5153153) medicalinfo.nl@ msd.com Eesti Merck Sharp & Dohme OÜ Tel: +372 614 4200 d [email protected] Norge MSD (Norge) AS Tlf : +47 32 20 73 00 m edinfo.norway@msd. com Ελλάδα MSD Α.Φ.Ε.Ε.
Τηλ : +30 210 98 97 300 dpoc .greece @msd.comÖsterreich Merck Sharp & Dohme Ges.m.b.H.
Tel: +43 (0) 1 26 044 dpoc_austria @msd.com España Merck Sharp & Dohme de España, S.A.
Tel: +34 91 321 0 6 00 msd_in f o@m sd.comPolska MSD Polska Sp. z o.o.
Tel.: +48 22 549 51 00 msdpolska@ msd.com France MSD France Tél: + 33 (0)1 80 46 40 40 Portugal Merck Sharp & Dohme, Lda Tel: +351 21 4465 inf orm_pt @msd.com 52Hrvatska Merck Sharp & Dohme d.o.o.
Tel: +385 1 66 11 333 dpoc . [email protected] România Merck Sharp & Dohme Romania S.R.L Tel: + 4021 529 29 00 msdromania@ msd.com Ireland Merck Sharp & Dohme Ireland (Human Health) Limited Tel: +353 (0)1 2998700 medinfo_ireland@m sd.comSlovenija Merck Sharp & Dohme, inovativna zdravila d.o.o.
Tel: +386 1 520 4201 msd.slovenia@ msd.com Ísland Vistor ehf .
Sími: + 354 535 7000 Slovenská republika Merck Sharp & Dohme, s. r. o .
Tel: +421 2 58282010 dpoc_czechslovak@ msd.com Italia M SD Italia S.r.l.
Tel:
800 23 99 89 (+39 06 361911) d [email protected] Suomi/Finland MSD Finland Oy Puh/Tel: +358 (0)9 804 650 [email protected] i Κύπρος Merck Sharp & Dohme Cyprus Limited Τηλ: 800 00 673 (+357 22866700) cyprus _inf [email protected] Sverige Merck Sharp & Dohme (Sweden) AB Tel: +46 77 5700488 medicinskinf o@ msd.com Latvija SIA Merck Sharp & Dohme Latvija Tel.: +371 67025300 d poc.latvia@m sd.com
This leaflet was last revised in
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Other sources of information Detailed information on this medicine is available on the European Agency website: https ://www.ema.europa.eu . ———————————————– ———————————————————————-
🩺 Information intended for healthcare professionals only
Before mixing with the solvent, the powder vaccine is a white to pale yellow compact crystalline cake.
The sol vent is a clear colourless liquid. When completely reconstituted, the vaccine is a clear pale yellow to light pink liquid.
To reconstitute the vaccine, use only the solvent supplied, because it is free of preservatives or other antiviral substances, which might inactivate the vaccine.
It is important to use a separate sterile syringe and needle for each individual 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.
ProQuad must not be mixed in a syringe with other vaccines.
Reconstitution instructions To attach the needle, it should be firmly placed on the tip of the syringe and secured by rotating.
Inject the entire content of the solvent s yringe into the vial containing the powder. Gently agitate to dissolve completely.
The reconstituted vaccine should be inspected visually for any f oreign particulate matter and/or abnormal physical appearance prior to administration. In the event of e ither being observed, discard the vaccine.
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 freeze the reconstituted va ccine.
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 ProQuad.
📄 Package Leaflet – official source
This article reproduces the information in the official package leaflet, as authorised in the European Union. You can consult the original document here: Product information ProQuad (PDF, ec.europa.eu).
You can check this medicine at any time in the Union Register of medicinal products (EU number EU/1/05/323).
⚠️ Important: This article is for information purposes only and does not replace medical advice or the package leaflet inside the medicine box. Read the leaflet carefully before use. For any questions about your treatment, talk to your doctor or pharmacist. If you experience side effects, tell your doctor or pharmacist and report them through your national reporting system.