Solution for injection,
conjugate vaccine against meningococcal group A, CW, and Y
What MenQuadfi is and what it is used for
What MenQuadfi is used for
MenQuadfi is a vaccine that can be given to children from 1 year of age, adolescents, and adults.
MenQuadfi protects against infection caused by a type of bacteria called Neisseria meningitides , specifically against types A, C, W, and Y.
The Neisseria meningitidis bacteria (also known as meningococci ) can be transmitted from one person to another and cause serious and sometimes life-threatening infections, such as
- meningitis – inflammation of the tissues surrounding the brain and spinal cord
- sepsis – infection of the blood.
Both of these infections can lead to serious illnesses with long-term effects or possibly be life-threatening.
MenQuadfi should be used by official, national guidelines.
This is how the vaccine works
MenQuadfi works by stimulating the vaccinated person’s natural defenses (immune system) so that it produces protective antibodies against the bacteria.
MenQuadfi only protects against diseases caused by Neisseria meningitidis – types A, C, W, and Y.
- It does not protect against infection caused by other types of Neisseria meningitidis .
- It does not protect against meningitis or sepsis caused by other bacteria or viruses .
Like all vaccines, MenQuadfi may not provide complete protection for everyone who is vaccinated.
What you need to know before you get MenQuadfi
Do not take MenQuadfi
- if you are allergic to the active substances or any of the other ingredients of this medicine (listed in section 6) or if you have previously had an 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 cautions
Talk to MenQuadfi if you or your child has: Talk to your doctor, pharmacist, or nurse before getting vaccinated.
- an infection with high body temperature (above 38 ° C). Then the vaccination is given when the infection is under control. There is no need to postpone vaccination in the event of a minor infection such as a cold. But talk to a doctor, pharmacist or nurse first.
- problems with bleeding or easy bruising.
- fainted at some point in connection with an injection . Fainting, sometimes accompanied by falls, can occur (usually in adolescents) after, or even before, an injection .
- a weak immune system (for example due to HIV infection, other disease or drugs that affect the immune system). In these cases, you or your child may not be able to get the full effect of MenQuadfi.
Talk to your doctor, pharmacist, or nurse before you or your child receive MenQuadfi if any of the above apply to you or your child (or if you are not sure).
Like all vaccines, MenQuadfi may not provide complete protection for everyone who is vaccinated.
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 medicines, including medicines obtained without a prescription.
In particular, tell your doctor, pharmacist, or nurse if you or your child are taking medicines that affect the immune system, such as
- corticosteroids are in high doses
- chemotherapy .
MenQuadfi can be given at the same time as other vaccines at separate injection sites during the same visit. These can be vaccines that protect against measles, mumps, rubella, chickenpox, diphtheria, tetanus, pertussis, polio, Haemophilus influenzae type b, hepatitis B, pneumococcal infections, and infection with human papillomavirus.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor, pharmacist, or nurse for advice before taking MenQuadfi.
Driving and using machines
MenQuadfi is unlikely to affect your ability to drive, cycle or use machines. But if you do not feel well, do not drive, cycle or use machines.
MenQuadfi contains sodium
This medicine contains less than 1 mmol (23 mg) sodium per dose, ie essentially ‘sodium-free’.
How MenQuadfi is given
MenQuadfi is given 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 how much muscle you or your child has.
Possible side effects
Like all medicines, MenQuadfi can cause side effects, although not everybody gets them.
If you or your child get any of the following allergic reactions after vaccination:
- itchy skin rash
- shortness of breath
- facial swelling or swelling of the tongue.
Contact a doctor immediately. It may be a sign of an allergic reaction.
Possible side effects in children from 12 to 23 months of age:
Very common (may affect more than 1 in 10 children)
- tenderness, redness or swelling at the site of injection
- irritation
- crying
- reduced appetite
- drowsiness.
Common (may affect up to 1 in 10 children)
- fever.
- vomiting
- diarrhea.
Uncommon (may affect up to 1 in 100 people):
- difficulty sleeping
- hives
- itching , bruising, calluses or rash at the site of injection
Possible side effects in children (from 2 years of age), adolescents, and adults:
Very common (may affect more than 1 user in 10)
- pain at the site of injection
- muscle pain
- headache
- general malaise.
Common (may affect up to 1 in 10 people)
- redness or swelling at the site of injection
- fever.
Uncommon (may affect up to 1 in 100 people)
- itching , heat, bruising or rash on the site of injection
- vomiting
- dizziness
- nausea
- fatigue.
Rare (may affect up to 1 in 1,000 people)
- enlarged lymph nodes
- diarrhea abdominal pain
- hives, itching , rash
- pain in the arms or legs
- chills, pain in the armpit
- hardening at the injection site.
How to store MenQuadfi
Keep out of sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton after EXP.
Store in a refrigerator (2-8 ° 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. These measures will help to protect the environment.
Contents of the pack and other information
What MenQuadfi contains
One dose (0.5 ml) contains:
- The active substances are
| – Neisseria meningitides, group A, polysaccharide 1 | 10 micrograms |
| – Neisseria meningitides, group C, polysaccharide 1 | 10 micrograms |
| – Neisseria meningitides, group Y, polysaccharide 1 | 10 micrograms |
| – Neisseria meningitides, group W, polysaccharide 1 | 10 micrograms |
| – 1 Conjugated to carrier protein from tetanus toxoid | 55 micrograms |
- The other ingredients are
- sodium chloride
- sodium acetate
- water for injections.
What the medicine looks like and contents of the pack
MenQuadfi is a clear and colorless solution for injection.
MenQuadfi is available in 1- or 5-packs with 0.5 ml single-dose bottles. Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder
Sanofi Pasteur
14 Henry Vallée Space
69007 Lyon
France
Manufacturer
Sanofi Pasteur
One Discovery Drive
Swiftwater PA 18370
United States
Sanofi Pasteur
Incarville Industrial Park
27100 Val de Reuil
France