InfoCons Consumer Protection informs you – MenQuadfi – Package Leaflet

Before anything else

Read all of this leaflet carefully before you or your child are given this vaccine because it contains important information for you or your child .

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, pharmacist or nurse.
• This vaccine has been prescribed for you or your child only. Do not pass it on to others
• If you or your child get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4 .

ℹ️ 1. What MenQuadfi is and what it is used for

MenQuadfi (MenACWY) is a vaccine that can be given to individuals from 6 weeks of age and older .

MenQuadfi helps to protect against infections caused by a type of bacteria (germs) called “ Neisseria meningitidis ”, specifically against types A, C, W and Y.

Neisseria meningitidis bacteria (also called meningococci) can be passed from person to person and can cause serious and sometimes life -threatening infections , such as:

• Meningitis – an inflammation of the tissues that surround the brain and spinal cord ;
• Septic aemia – an infection of the blood.

Both infections can result in serious disease with long lasting effects or possibly death.

MenQuadfi should be used in accordance with official national guidelines .

How the vaccine works

MenQuadfi works by stimulating the vaccinated person natural defen ce (immune system), to produce protect ive antibodies against the bacteria.

MenQuadfi only help s to protect against illnesses caused by Neisseria meningitidis types A, C, W and Y.

• It does not protect against infections caused by other types of Neisseria meningitidis.
• It does not protect against meningitis or septicaemia caused by other bacteria or viruses.

⚠️ 2. What you need to know before you are given MenQuadfi

Do not have MenQuadfi if you or your child

• are allergic to any of the active substances or any of the other ingredients of this vaccine (listed in section 6) or have experienced a previous allergic reaction to this vaccine.

If you are not sure, talk to your doctor, pharmacist or nurse before you or your child are given MenQuadfi.

Warnings and precautions

Talk to your doctor, pharmacist or nurse before vaccination with MenQuadfi if you or your child have:

• an infection with high temperature (over 38 °C). If this applies, the vaccination will be given after the infection is under control . There is no need to delay vaccination for a minor infection such as a cold. However, talk to your doctor, pharmacist or nurse first.
• a bleeding problem or bruise easily.
• ever fainted from an injection. Fainting, sometimes accompanied by falling, can occur (mostly in adolescents) after, or even before , any injection .
• a weak immune system (such as due to HIV infection , other disease , or use of a medicine that affect the immune system), as you or your child may not fully benefit from having MenQuadfi .

If any of the above apply to you or your child (or you are not sure whether they apply ), talk to your doctor, pharmacist or nurse before you or your child are given MenQuadfi.

As with any vaccine, MenQuadfi may not fully protect all the people who are vaccin ated.

Other medicines and MenQuadfi

Tell your doctor , pharmacist , or nurse if you or your child are taking, have recently taken or might take any other vaccines or medicines, including medicines obtained without a prescription.

In particular, tell your doctor , pharmacist , or nurse if you or your child are taking any medicines that affect your immune system , such as:

• high-dose corticosteroids
• chemotherapy MenQuadfi may be given at the same time as other vaccines at a separate injection site during the same visit.

In infants, MenQuadfi can be given with combined diphtheria – tetanus – acellular pertussis (DTaP) vaccines – inactivated poliovirus (IPV) – hepatitis B (HepB) – Haemophilus influenzae type b (Hib) vaccine (DTaP -IPV-HepB -Hib), rotavirus vaccine and with 10-valent pneumococcal conjugate d vaccine (PCV10 ).

In toddlers aged 12-23 months, MenQuadfi can be given with any of the following vaccines: measles – mumps -rubella vaccine (MMR) and varicella vaccine (V), DTaP vaccines (including combination DTaP vaccines with IPV, HepB , and HiB such as DTaP -IPV-HepB -HiB vaccine ), PCV10, and PCV13.

In individuals 12 months of age and older , there was no impact on the immune response to MenQuadfi when given with a meningococcal serogroup B vaccine.

In children and adolescents 10-17 years of age, MenQuadfi can be given with diphtheria, tetanus, acellular pertussis vaccine (Tdap ) or Tdap and inactivated polio virus vaccine (Tdap -IPV) , 4-valent human papillomavirus vaccine (4vHPV) or 9 -valent HPV vaccine (9vHPV).

Pregnancy and breast -feeding If you are pregnant, breast -feeding, think you may be pregnant , or are planning to have a baby, ask your doctor , pharmacist, or nurse for advice before receiving MenQuadfi.

Driving and using machines

MenQuadfi is not likely to affect you r ability to drive , cycle or use machines. However, do not drive , cycle or use any machines if you are not feeling well.

MenQuadfi contains sodium

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

💊 3. How MenQuadfi is given

MenQuadfi is given by a doctor , pharmacist or nurse as a 0.5 mL injection in the muscle . It is given in the upper arm or in the thigh depending on the age and how much muscle you or your child have.

❗ 4. Possible side effects

Like all vaccines , MenQuadfi can cause side effects, although not everybody gets them.

If you or your child get any of th ese symptoms after the vaccination :

• itchy skin rash
• difficulty breathing, shortness of breath
• swelling of the face, lips, throat, or tongue Contact your doctor or other healthcare professional immediately or go to the nearest hospital emergency room right away. These could be signs of an allergic reaction.

Side effects in children (2 years of age and older), adolescents and adults

Very common (may affect more than 1 in 10 vaccinated )

• pain where the injection was given
• muscle pain
• headache
• generally feeling unwell

Common (may affect up to 1 in 10 vaccinated )

• redness or swelling where the injection was given
• fever

Uncommon (may affect up to 1 in 100 vaccinated )

• itching, warmth, bruising or rash where the injection was given
• vomiting
• feeling dizzy
• nausea
• fatigue (feeling tired)

Rare (may affect up to 1 in 1 000 vaccinated )

• enlarged lymph nodes
• diarrhoea
• stomach pain
• hives
• itching
• rash
• pain in the arms or legs
• chills
• pain in the armpit
• injection site firmness

Very rare (may affect less than 1 in 10 000 vaccinated )

• sudden, severe allergic reactions with difficulty breathing, hives, swelling of the face and throat, a fast heartbeat, dizziness, weakness, sweating and loss of consciousness

Not known (frequency cannot be estimated from the available data)

• allergic reaction
• fits (convulsions) with or without fever
• inflammation of the deep skin tissue at injection site Contact your doctor or healthcare professional immediately or go to the nearest hospital emergency room right away. This could be signs of an allergic reaction.

Side effects in infants and toddlers from 6 weeks through 23 months

Very common (may affect more than 1 in 10 vaccinated)

• feeling irritable
• crying
• tenderness where the injection was given
• feeling drowsy
• loss of appetite
• redness where the injection was given
• fever
• swelling where the injection was given
• vomiting (happens less often in toddlers 12 through 23 months of age)

Common (may affect up to 1 in 10 vaccinated)

• bruising
• diarrhoea (happens less often in infants initiating vaccination 6 weeks t hrough 11 months of age)

Uncommon (may affect up to 1 in 100 vaccinated )

• bleeding where the injection was given
• firmness or rash where the injection was given
• warmth where the injection was given
• rash
• itching where the injection was given ( happens less often in infants initiating 6 weeks t hrough 11 months of age)
• hives (happens less often in infants initiating vaccination 6 weeks t hrough 11 months of age)
• difficulty sleeping (happens less often in infants initiating 6 weeks through 11 months of age)

Rare (may affect up to 1 in 1 000 vaccinated )

• tiny blood spots under the skin
• skin redness
• flushing

Very rare (may affect less than 1 in 10 000 vaccinated)

• sudden, severe allergic reactions with difficulty breathing, hives, swelling of the face and throat, a fast heartbeat, dizziness, weakness, sweating and loss of consciousness

Not known (frequency cannot be estimated from the available data)

• allergic reaction
• fits (convulsions) with or without fever
• inflammation of the deep skin tissue at injection site

Reporting of side effects

If you or your child get any side effects, talk to your doctor, pharmacist, or nurse. 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 MenQuadfi

Keep this va ccine out of the sight and reach of children.

Do not use this va ccine after the expiry date which is stated on the carton after EXP. The expiry date refers to the last day of that month.

Store in a refrigerator (2 C to 8 C).

Do not freeze.

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 MenQuadfi contains

One dose (0.5 mL) contains:

• The active substances are :
• Neisseria meningitidis group A polysaccharide1 10 micrograms
• Neisseria meningitidis group C polysaccharide1 10 micrograms
• Neisseria meningitidis group Y polysaccharide1 10 micrograms
• Neisseria meningitidis group W polysaccharide1 10 micrograms
• 1Conjugated to tetanus toxoid carrier protein 55 micrograms
• The other ingredients are
• sodium chloride
• sodium acetate (E 262)
• water for injection s

What MenQuadfi looks like and contents of the pack

MenQuadfi is a clear colourless solution for injection.

MenQuadfi is available in packs of 1 , 5 or 10 single dose (0.5 mL) vials and pack of 1 single dose vial (0.5 mL) co-packaged with 1 single use empty syringe and 2 needles .

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Sanofi Winthrop Industrie 82 Avenue Raspail 94250 Gentilly France

Manufacturer

Sanofi Winthrop Industrie Voie de l’Institut Parc Industriel d’Incarville BP 101 27100 Val de Reuil France Sanofi -Aventis Zrt.

Building DC5 Campona utca 1 .

Budapest, 1225 Hungary For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

België/ Belgique /Belgien Sanofi Belgium Tél/Tel : +32 2 710.54.00 Lietuva Swixx Biopharma UAB Tel: +370 5 236 91 40 България Swixx Biopharma EOOD Teл.: +359 (0)2 4942 480 Luxembourg/Luxemburg Sanofi Belgium Tél/Tel : +32 2 710.54.00 Česká republika Sanofi s.r.o.

Tel: +420 233 086 111 Magyarország sanofi -aventis zrt Tel.: +36 1 505 0055 Danmark Sanofi A/S Tlf.: +45 4516 7000 Malta Sanofi S.r.l.

Tel: +39 02 39394 275 Deutschland Sanofi -Aventis Deutschland GmbH Tel: 0800 54 54 010 Tel aus dem Ausland: +49 69 305 21 130 Nederland Sanofi B.V.

Tel: +31 20 245 4000 Eesti Swixx Biopharma OÜ Tel: +372 640 10 30 Norge Sanofi -aventis Norge AS Tlf: + 47 67 10 71 00 Ελλάδα ΒΙΑΝΕΞ Α.Ε.

Τηλ: +30.210.8009111 Österreich Sanofi -Aventis GmbH Tel: +43 (1) 80185 -0.

España sanofi -aventis, S.A.

Tel: +34 93 485 94 00 Polska Sanofi Sp. z o.o.

Tel.: + 48 22 280 0 0 00 France Sanofi Winthrop Industrie Tél: 0800 222 555 Appel depuis l’étranger : +33 1 57 63 23 23 Portugal Sanofi – Produtos Farmacêuticos, Lda.

Tel: + 351 21 35 89 400 Hrvatska Swixx Biopharma d.o.o Tel: +385 1 2078 500 Ireland sanofi -aventis Ireland T/A SANOFI Tel: + 353 (0) 1 4035 600 România Sanofi Romania SRL Tel: +40(21) 317 31 36 Slovenija Swixx Biopharma d.o.o.

Tel: +386 1 235 51 00 Ísland Vistor ehf.

Sími : +354 535 7000 Slovenská republika Swixx Biopharma s.r.o.

Tel: +421 2 208 33 600 Italia Sanofi S.r.l.

Tel: 800536389 Suomi/Finland Sanofi Oy Puh/Tel: +358 (0) 201 200 300 Κύπρος C.A. Papaellinas Ltd.

Τηλ: +357 22 741741 Sverige Sanofi AB Tel: +46 8 -634 50 00 Latvija Swixx Biopharma SIA Tel: +371 6 616 4750

This leaflet was last revised in

Other sources of information Detailed information on this medicine is available on the European Medicines Agency web site: https://www.ema.europa.eu

📄 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 MenQuadfi (PDF, ec.europa.eu).

You can check this medicine at any time in the Union Register of medicinal products (EU number EU/1/20/1483).

⚠️ 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.