Menquadfi

Package leaflet: Information for the user

MenQuadfi solution for injection

Meningococcal conjugate vaccine group A, C, W and Y
Read all of this leaflet carefully before this vaccine is administered to you or your child
because it contains important information for you and your child.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you or your child only. Do not give it to other people.
• If you experience any side effects, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

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

1. What MenQuadfi is and what it is used for

MenQuadfi (MenACWY) is a vaccine that can be administered to children from 1 year of age,
adolescents, and adults.
MenQuadfi helps protect against infections caused by bacteria (germs) called "Neisseria
meningitidis", specifically against types A, C, W, and Y.
The bacteria "Neisseria meningitidis" (also known as meningococci) can be transmitted from person to
person and can cause serious, and sometimes life-threatening, infectious diseases such as:

• meningitis – an inflammation of the membranes surrounding the brain and spinal cord
• septicemia – a blood infection. Both infections can lead to severe complications with long-term effects and can be fatal.

MenQuadfi should be used in accordance with official national guidelines.
How MenQuadfi works
MenQuadfi helps the body produce its own protection (antibodies) against the bacteria.
Antibodies help protect against disease.
MenQuadfi helps protect only against diseases caused by Neisseria meningitidis of 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 septicemia caused by other bacteria or viruses.

2. What you should know before receiving MenQuadfi

MenQuadfi must not be administered if:

• you are allergic to the active substance or to any of the other ingredients of this vaccine (listed in section 6), or if you have previously had an allergic reaction to this vaccine.

If you are unsure, consult your doctor, pharmacist, or nurse before receiving MenQuadfi.
Warnings and precautions
Consult your doctor, pharmacist, or nurse before receiving MenQuadfi if you or your child:

• have an infection with high fever (above 38°C). If this applies to you, vaccination should be postponed until you feel better. Vaccination does not need to be delayed in case of a minor infection such as a cold. However, consult your doctor, pharmacist, or nurse first;
• have bleeding disorders or are prone to bruising easily;
• have previously fainted after an injection. Fainting, sometimes followed by falling (especially in adolescents), may occur after or even before an injection;
• have a weakened immune system (due to HIV infection, other illnesses, or taking medications that affect the immune system), as you may not achieve full protection from MenQuadfi. If any of the above conditions apply (or if you have any doubts), consult your doctor, pharmacist, or nurse before you or your child receive MenQuadfi.

As with any vaccine, MenQuadfi may not protect all vaccinated individuals.
Other medicines and MenQuadfi
Inform your doctor, pharmacist, or nurse if you or your child are taking, have recently taken, or might take any other medicines, including other vaccines and over-the-counter medicines.
In particular, inform your doctor, pharmacist, or nurse if you or your child are taking medicines that affect the immune system, such as:

• high-dose corticosteroids
• chemotherapeutic agents.

MenQuadfi can be administered simultaneously with other vaccines, using a different injection site. These vaccines include: measles, mumps, rubella, varicella, diphtheria, tetanus, pertussis, poliomyelitis, Haemophilus influenzae type b, hepatitis B, pneumococcus, human papillomavirus, and Neisseria meningitidis type b.
Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, planning to become pregnant, or are breastfeeding, consult your doctor, pharmacist, or nurse before receiving MenQuadfi.
Driving and using machines
It is unlikely that MenQuadfi affects the ability to drive or operate machinery.
However, do not drive or operate machinery if you do not feel well.
MenQuadfi contains sodium
This medicine contains less than 1 mmol of sodium (23 mg) per dose, i.e. essentially “sodium-free”.

3. How to use MenQuadfi

MenQuadfi will be administered by a doctor or a nurse as a 0.5 mL injection into the muscle.
MenQuadfi is injected into the upper arm or thigh, depending on age and muscle mass.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
Contact your doctor or a healthcare professional immediately, or go straight to the nearest hospital emergency department if you or your child experience any of the following symptoms after vaccination:

• itchy rash
• difficulty breathing, shortness of breath
• swelling of the face, lips, throat or tongue
  These could be signs of an allergic reaction.

Side effects in children (aged 2 years and older), adolescents and adults
Very common (may affect more than 1 in 10 people)

• pain at the injection site
• muscle pain
• headache
• general feeling of malaise

Common (may affect up to 1 in 10 people)

• redness or swelling at the injection site
• fever

Uncommon (may affect up to 1 in 100 people)

• itching, warmth, bruising or rash at the injection site
• vomiting
• dizziness
• nausea
• fatigue (feeling tired)

Rare (may affect up to 1 in 1,000 people)

• swollen lymph nodes
• diarrhoea
• stomach ache
• hives
• itching sensation
• rash
• pain in arms or legs
• chills
• pain in armpits
• stiffness at the injection site

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

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

Not known (frequency cannot be estimated from available data)

• allergic reaction
• seizures (convulsions) with or without fever

Side effects in children aged between 12 and 23 months
Very common (may affect more than 1 in 10 people)

• tenderness/pain, redness or swelling at the injection site
• irritability
• crying
• loss of appetite
• drowsiness

Common (may affect up to 1 in 10 people)

• fever
• vomiting
• diarrhoea

Uncommon (may affect up to 1 in 100 people)

• sleep disturbances
• hives
• itching, bruising, stiffness or rash at the injection site

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

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

Not known (frequency cannot be estimated from available data)

• allergic reaction
• seizures (convulsions) with or without fever

Reporting of side effects
If you or your child experience any side effect, including those not listed in this leaflet, please inform your doctor, pharmacist or nurse. You can also report side effects directly via the national reporting system detailed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store MenQuadfi

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the packaging after Exp. The expiry date refers to the last day of the month.
Store in a refrigerator (2 °C – 8 °C).
Do not freeze.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What MenQuadfi contains
One dose (0.5 mL) contains:

• Active substances
  • Neisseria meningitidis group A polysaccharide 10 micrograms
  • Neisseria meningitidis group C polysaccharide 10 micrograms
  • Neisseria meningitidis group Y polysaccharide 10 micrograms
  • Neisseria meningitidis group W polysaccharide 10 micrograms

conjugated to tetanus toxoid carrier protein 55 micrograms

• Other components
  • Sodium chloride
  • Sodium acetate (E 262)
  • Water for injections

Description of the appearance of MenQuadfi and contents of the pack
MenQuadfi is a clear, colourless injectable solution.
MenQuadfi is available in packs of 1, 5 or 10 single-dose vials (0.5 mL) and in a pack containing 1 single-dose vial (0.5 mL) with 1 pre-filled syringe and 2 needles. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
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 further information on this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien Lietuva
Sanofi Belgium Swixx Biopharma, UAB
Tél/Tel: +32 2 710.54.00 Tel: +370 5 2369140

България Luxembourg/Luxemburg
Swixx Biopharma EOOD Sanofi Belgium
Tel: +359 (0)2 4942 480 Tél/Tel: +32 2 710.54.00

Česká republika Magyarország
Sanofi s.r.o. sanofi-aventis zrt
Tel: +420 233 086 111 Tel: +36 1 505 0055

Danmark Malta
Sanofi A/S Sanofi S.r.l.
Tlf: +45 4516 7000 Tel: +39 02 39394275

Deutschland Nederland
Sanofi-Aventis Deutschland GmbH Sanofi B.V.
Tel: 0800 54 54 010 Tel: +31 20 245 4000
From abroad: +49 69 305 21 130

Eesti Norge
Swixx Biopharma OÜ Sanofi-aventis Norge AS
Tel: +372 640 10 30 Tlf: +47 67 10 71 00

Ελλάδα Österreich
VIANEX S.A. Sanofi-Aventis GmbH
Tel: +30.210.8009111 Tel: +43 (1) 80185-0

España Polska
sanofi-aventis, S.A. Sanofi Sp. z o.o.
Tel: +34 93 485 94 00 Tel: +48 22 280 00 00

France Portugal
Sanofi Winthrop Industrie Sanofi – Produtos Farmacêuticos, Lda.
Tél: 0800 222 555 Tel: +351 21 35 89 400
From abroad: +33 1 57 63 23 23

Hrvatska România
Swixx Biopharma d.o.o. Sanofi Romania SRL
Tel: +385 1 2078 500 Tel: +40(21) 317 31 36

Ireland Slovenija
sanofi-aventis Ireland T/A SANOFI Swixx Biopharma d.o.o.
Tel: +353 (0) 1 4035 600 Tel: +386 1 235 51 00

Ísland Slovenská republika
Vistor Swixx Biopharma s.r.o.
Sími: +354 535 7000 Tel: +421 2 208 33 600

Italia Suomi/Finland
Sanofi S.r.l. Sanofi Oy
Tel: 800536389 Puh/Tel: +358 (0) 201 200 300

Κύπρος Sverige
C.A. Papaellinas Ltd. Sanofi AB
Tel: +357 22 741 741 Tel: +46 8-634 50 00

Latvija
Swixx Biopharma SIA
Tel: +371 6 616 47 50

Other sources of information
More detailed information on this medicinal product is available on the European Medicines Agency website: https://www.ema.europa.eu