MenQuadfi solution for injection

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.

What is in this leaflet

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 MenQuadfi is given
4. Possible side effects
5. How to store MenQuadfi
6. Contents of the pack and other information

What MenQuadfi is used for

MenQuadfi is a vaccine that can be given 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.

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;
• Septicaemia – 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 defense (immune system), to produce protective antibodies against the bacteria.

MenQuadfi only helps 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.

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

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 of those who get the vaccine.

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 separate injection site during the same visit. These include the vaccines that protect against measles, mumps, rubella, varicella, diphtheria, tetanus, pertussis, polio, Haemophilus influenzae type b, hepatitis B, pneumococcal and human papillomavirus infections.

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 your 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, this means that it is essentially ‘sodium-free’.

Possible side effects in children aged 12 to 23 months:

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

• tenderness, redness, or swelling where the injection was given
• feeling irritable
• crying
• loss of appetite
• feeling drowsy

Common (may affect up to 1 in 10 children)

• fever
• vomiting
• diarrhoea

Uncommon (may affect up to 1 in 100 people):

• difficulty sleeping
• hives
• itching, bruising, firmness, or rash where the injection was given

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

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

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

Common (may affect up to 1 in 10 people)

• redness or swelling where the injection was given
• fever

Uncommon (may affect up to 1 in 100 people)

• 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 people)

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

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 (see details below). By reporting side effects, you can help provide more information on the safety of this medicine.

United Kingdom

Medicines and Healthcare products Regulatory Agency (MHRA):

Yellow Card Scheme at https://yellowcard.mhra.gov.uk or search for MHRA Yellow Card in the Google Play or Apple App Store.

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
  • water for injections

What MenQuadfi looks like and contents of the pack

MenQuadfi is a clear colourless solution for injection.

MenQuadfi is available in packs of 1 or 5 single dose (0.5 ml) vials. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Manufacturer