MENQUADFI Injectable Solution

Introduction

Package Leaflet: Information for the User

MenQuadfi, injectable solution

Meningococcal conjugate vaccine against groups A, C, W, and Y

Read all of this leaflet carefully before you or your child receive this medicine, 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 medicine has been prescribed for you or your child only. Do not pass it on to others.
• If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if they are not listed in this leaflet. See section 4.

Contents of the package leaflet

1. What is MenQuadfi and what is it used for
2. What you need to know before you or your child receive MenQuadfi
3. How to use MenQuadfi
4. Possible side effects
5. Storage of MenQuadfi
6. Contents of the pack and further information

1. What is MenQuadfi and what is it 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 a type of bacteria (germs) called Neisseria meningitidis, specifically against types A, C, W, and Y.

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

• Meningitis - an inflammation of the tissues that surround the brain and spinal cord;
• Septicemia - a blood infection.

Both infections can cause severe illness with long-lasting effects or possibly death.

MenQuadfi should be used in accordance with official national recommendations.

How the vaccine works

MenQuadfi works by stimulating the body's natural defense (immune system) to produce protective antibodies against the bacteria.

MenQuadfi only helps protect against diseases caused by Neisseria meningitidisof 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 need to know before receiving MenQuadfi

Do not use 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, 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:

• a high fever infection (over 38 °C). If this occurs, the vaccine will be administered after the infection is under control. There is no need to delay vaccination in the case of a minor infection such as a cold. However, consult your doctor, pharmacist, or nurse first.
• a bleeding problem or bruise easily.
• have fainted in the past due to an injection. Fainting can occur after or even before any injection, sometimes accompanied by falls (mainly in adolescents).
• a weakened immune system (e.g., due to HIV infection, another disease, or the use of a medicine that affects the immune system), as you or your child may not fully benefit from receiving MenQuadfi.

If any of the above applies to you or your child (or if you are not sure if 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 subjects.

Other medicines and MenQuadfi

Consult your doctor, pharmacist, or nurse if you or your child are using, have recently used, or might use another vaccine or medicine, including those bought without a prescription.

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

• high-dose 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 influenzaetype b, hepatitis B, pneumococcal infections, human papillomavirus, and Neisseria meningitidistype B.

Pregnancy and breast-feeding

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

Driving and using machines

MenQuadfi is unlikely to affect your ability to drive, ride a bike, or use machines. However, do not drive, ride a bike, 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; this is essentially "sodium-free".

3. How to use MenQuadfi

MenQuadfi is administered by a doctor or nurse as a 0.5 ml injection into the muscle. It is administered in the upper arm or thigh, depending on age and the amount of 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 experience any of the following symptoms after vaccination:

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

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

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

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

• pain at the injection site
• muscle pain
• headache
• feeling unwell

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 hardening at 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
• hives
• itching
• skin rash
• arm or leg pain
• chills
• armpit pain
• hardening at the injection site

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

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

Frequency not known(cannot be estimated from the available data)

• allergic reactions
• seizures with or without fever

Side effects in children from 12 to 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
• sleepiness

Common(may affect up to 1 in 10 people)

• fever
• vomiting
• diarrhea

Uncommon(may affect up to 1 in 100 people)

• difficulty sleeping
• hives
• itching, bruising, hardening, or rash at the injection site

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

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

Frequency not known(cannot be estimated from the available data)

• allergic reactions
• seizures with or without fever

Reporting of side effects

If you or your child experience any side effects, talk to your doctor, pharmacist, or nurse, even if they are not listed in this leaflet. You can also report side effects directly through 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. Storage of MenQuadfi

Keep this vaccine out of the sight and reach of children.

Do not use this vaccine after the expiry date which is stated on the carton after EXP. The expiry date is the last day of the month stated.

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

Do not freeze.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and further information

Composition of MenQuadfi

One dose (0.5 ml) contains:

• The active substances are:
• Neisseria meningitidisgroup A polysaccharide 10 micrograms
• Neisseria meningitidisgroup C polysaccharide 10 micrograms
• Neisseria meningitidisgroup Y polysaccharide 10 micrograms
• Neisseria meningitidisgroup W polysaccharide 10 micrograms
• Conjugated with tetanus toxoid carrier protein 55 micrograms

• The other excipients are:
• sodium chloride
• sodium acetate (E 262)
• water for injections

Appearance and pack contents

MenQuadfi is a clear and colorless injectable solution.

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

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization 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.

DC5 Building

Campona utca 1.

Budapest, 1225

Hungary

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

Date of last revision of this leaflet:

Other sources of information

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