Prospect: information for the user

MenQuadfi, injectable solution

Conjugated vaccine against meningococcal groups A, C, W and Y

This medicine is subject to additional monitoring, which will facilitate the detection of new information about its safety. You can contribute by reporting any adverse effects you may experience. The final part of section 4 includes information on how to report these adverse effects.

Read this prospect carefully before you or your child receive this medicine, because it contains important information for you or your child.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor, pharmacist or nurse.
• This medicine has been prescribed only for you or your child and should not be given to other people.
• If you experience adverse effects, consult your doctor, pharmacist or nurse, even if they are not listed in this prospect. See section 4.

MenQuadfi (MenACWY) is a vaccine that can be administered to children from 1 year of age, adolescents, and adults.

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

The bacteriaNeisseria meningitidis(also known as meningococcus) can be transmitted from person to person and can cause severe and sometimes potentially fatal infections, such as:

• Meningitis– aninflammation of the tissues surrounding the brain and spinal cord;
• Septicemia–a blood infection.

Both infections can cause severe disease with lasting effects or possibly death.

MenQuadfi should be used in accordance with official national recommendations.

How the vaccine works

MenQuadfi works by stimulating the natural defense (immune system) of the vaccinated person to produce protective antibodies against the bacteria.

MenQuadfi only helps to protect against diseases caused byNeisseria meningitidistypes A, C, W, and Y.

• It does not protect against infections caused by other types ofNeisseria meningitidis.
• It does not protect against meningitis or septicemia caused by other bacteria or viruses.

Do not use MenQuadfi if you or your child

• is allergic to any of the active ingredients or to any of the other components of this vaccine (listed in section 6) or has had a previous allergic reaction to this vaccine.

If you are unsure, consult your doctor, pharmacist or nurse before you or your child receive MenQuadfi.

Warnings and precautions

Consult your doctor, pharmacist or nurse before vaccination with MenQuadfi if you or your child have any of the following conditions:

• an infection with high fever (above 38 °C). If this occurs, the vaccine will be administered after the infection is under control. It is not necessary to delay vaccination in case of a minor infection such as a cold. However, consult your doctor, pharmacist or nurse first.
• a bleeding disorder or bruising easily.
• have fainted at any time due to an injection. Fainting can occur before or after any injection, sometimes accompanied by falls (mainly in adolescents).
• a weakened immune system (for example, due to HIV infection, another disease or the use of a medication that affects the immune system), as it is possible that you or your child may not benefit fully from receiving MenQuadfi.

If any of the above applies to you or your child (or if you are unsure whether it applies), consult your doctor, pharmacist or nurse before you or your child receive MenQuadfi.

As with any vaccine, vaccination with MenQuadfi may not protect all vaccinated individuals.

Other medicines and MenQuadfi

Consult your doctor, pharmacist or nurse if you or your child are using, have used recently or may need to use another vaccine or medication, including over-the-counter medications.

Particularly, consult your doctor, pharmacist or nurse if you or your child are taking any medication that affects your immune system, such as:

• high doses of corticosteroids
• chemotherapy

MenQuadfi can be administered at the same time as other vaccines in separate injection sites during the same visit. These include vaccines against measles, mumps, rubella, varicella, diphtheria, tetanus, pertussis, polio, Haemophilus influenzae type b, hepatitis B, pneumococcal infections, human papillomavirus, and Neisseria meningitidis type B.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant or intend to become pregnant, consult your doctor, pharmacist or nurse before receiving MenQuadfi.

Driving and operating machinery

It is unlikely that MenQuadfi will affect your ability to drive, ride a bicycle or use machines. However, do not drive, ride a bicycle or use machines if you do not feel well.

MenQuadfi contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per dose, which is essentially "sodium-free".

MenQuadfi is administered by a doctor or nurse as a 0.5 ml injection into the muscle. It is given in the upper arm or thigh, depending on the age and amount of muscle mass of the patient.

Like all vaccines, MenQuadfi may cause side effects, although not everyone will experience them.

If you or your child experience any of these symptoms after vaccination:

• skin rash with itching
• difficulty breathing, shortness of breath
• swelling of the face, lips, throat, or tongue

Immediately contact your doctor or healthcare professional or go to the nearest hospital emergency department immediately. These may be signs of an allergic reaction.

Possible side effects in children aged 12 to 23 months:

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

• sensitivity, redness, or swelling at the injection site
• irritability
• crying
• loss of appetite
• drowsiness

Common(may affect up to 1 in 10 people)

• fever
• vomiting
• diarrhea

Uncommon(may affect up to 1 in 100 people)

• difficulty sleeping
• urticarial rash
• itching, bruising, induration, or rash at the injection site

Rare(may affect fewer than 1 in 10,000 people)

• severe and sudden allergic reactions with difficulty breathing, urticaria, swelling of the face and throat, tachycardia, dizziness, weakness, sweating, and loss of consciousness

Frequency not known(cannot be estimated from available data)

• allergic reactions
• convulsions with or without fever

Possible side effects in children (2 years of age and older), adolescents, and adults:

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

• painat the injection site
• muscle pain
• headache
• general feeling of discomfort

Common(may affect up to 1 in 10 children)

• redness or swelling at the administration site
• fever

Uncommon(may affect up to 1 in 100 people)

• itching, heat, bruises, or rashat the injection site
• vomiting
• dizziness
• nausea
• fatigue (feeling tired)

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

• enlarged lymph nodes
• diarrhea, stomach pain
• urticarial rash, itching, skin rash
• pain in the arms or legs
• chills, axillary pain
• induration at the injection site

Rare(may affect fewer than 1 in 10,000 people)

• severe and sudden allergic reactions with difficulty breathing, urticaria, swelling of the face and throat, tachycardia, dizziness, weakness, sweating, and loss of consciousness

Frequency not known(cannot be estimated from available data)

• allergic reactions
• convulsions with or without fever

Reporting of side effects

If you or your child experience any type of side effect, consult your doctor,pharmacistor nurse, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through thenational reporting system included in theAppendix V. By reporting side effects, you can contribute to providing more information on the safety of this medication.

Keep this vaccine out of sight and reach of children.

Do not use this vaccine after the expiration date that appears on the packaging after CAD.

Store in refrigerator (between 2°C and 8°C).

Do not freeze.

Medicines should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of the containers and medicines that you no longer need. This will help protect the environment.

Composition of MenQuadfi

One dose (0.5 ml) contains:

• The active principles are:
• Polysaccharide ofNeisseria meningitidisgroup A1 10 micrograms
• Polysaccharide ofNeisseria meningitidisgroup C1 10 micrograms
• Polysaccharide ofNeisseria meningitidisgroup Y110 micrograms
• Polysaccharide ofNeisseria meningitidisgroup W110 micrograms
• 1Conjugated with tetanus toxoid carrier protein 55 micrograms

• The other excipients are:
• Sodium chloride
• Sodium acetate
• Injectable water for preparation

Appearance of the product and contents of the package

MenQuadfi is a transparent and colorless injectable solution.

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

Only some package sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Sanofi Winthrop Industrie

82 Avenue Raspail

94250 Gentilly

France

Manufacturer

SanofiWinthrop Industrie

Voie de l’Institut

Parc Industriel d’Incarville

BP 101

27100 Val de Reuil

France

Sanofi-Aventis Zrt.

Edificio DC5

Campona utca 1.

Budapest, 1225

Hungary

You can request more information about this medicine by contacting the local representative of the marketing authorization holder:

Last review date of this leaflet:

Other sources of information

Detailed information about this medicine is available on the website of the European Medicines Agency:http://www.ema.europa.eu