Menquadfi solution for injection

Patient Information Leaflet

Introduction

Patient Information Leaflet

MenQuadfi, injectable solution

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

Read the entire leaflet carefully before you or your child receives this medicine, because it contains important information for you or your child.

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

Leaflet Contents

1. What MenQuadfi is and what it is used for
2. What you need to know before you or your child are given 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 a type of bacterium (germ) called "Neisseria meningitidis", specifically types A, C, W, and Y.

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

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

Both infections can lead to 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 vaccinated person's natural defense (immune system) to produce protective antibodies against the bacterium.

MenQuadfi only helps protect against diseases 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 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 to any of the other ingredients of this vaccine (listed in section 6), or have previously experienced an 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

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

• a current infection with high fever (over 38 °C). If this is the case, vaccination will be postponed until the infection is under control. It is not necessary to delay vaccination for a minor infection such as a cold. However, consult your doctor, pharmacist, or nurse first.
• a bleeding disorder or bruise easily.
• have ever fainted after an injection. Fainting may occur after or even before any injection, sometimes accompanied by falls (particularly in adolescents).
• a weakened immune system (for example, due to HIV infection, other illness, or use of a medication affecting 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 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 individuals who receive it.

Other medicines and MenQuadfi

Consult your doctor, pharmacist, or nurse if you or your child are taking, have recently taken, or might need to take any other vaccine or medicine, including medicines obtained without a prescription.

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

• high-dose corticosteroids
• chemotherapy

MenQuadfi can be administered at the same time as other vaccines, using 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 are planning to become pregnant, consult your doctor, pharmacist, or nurse before receiving MenQuadfi.

Driving and using machines

MenQuadfi is unlikely to affect your ability to drive, ride a bicycle, or operate machinery. However, do not drive, ride a bicycle, 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; 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 given in the upper arm or thigh, depending on your age or the age and muscle mass of your child.

4. Possible side effects

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

If you or your child develop 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 generally 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 rash 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
• pain in arms or legs
• chills
• pain in the armpit
• 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 available data)

• allergic reactions
• seizures with or without fever

Side effects in children 12 to 23 months of age

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 face and throat, rapid heartbeat, dizziness, weakness, sweating, and loss of consciousness

Frequency not known (cannot be estimated from available data)

• allergic reactions
• seizures with or without fever

Reporting of side effects

If you or your child experience any type of side effect, talk to your doctor, pharmacist, or nurse, even if it is a possible side effect not listed in this leaflet. You can also report them 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 stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

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 packaging and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of MenQuadfi

One dose (0.5 ml) contains:

• The active substances are:

• Polysaccharide from Neisseria meningitidis group A1 10 micrograms

• Polysaccharide from Neisseria meningitidis group C1 10 micrograms

• Polysaccharide from Neisseria meningitidis group Y1 10 micrograms

• Polysaccharide from Neisseria meningitidis group W1 10 micrograms

• 1 Conjugated to tetanus toxoid carrier protein 55 micrograms

• The other excipients are:

• Sodium chloride

• Sodium acetate (E 262)

• Water for injections

Appearance of the product 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) co-packaged with 1 single-use empty syringe and 2 needles.

Only certain 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 more information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

Date of the most recent review 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