Consumer Medicine Information (CMI) summary
The
full CMI on the next page has more details. If you are worried about using this medicine,
speak to your doctor, nurse or pharmacist.
This medicine is new or being used differently. Please report side effects. See the
full CMI for further details
1. Why am I using MenQuadfi?
MenQuadfi is a vaccine. It is used to help protect you or your child against infections
caused by a bacteria (germs) called “Neisseria meningitides” types A, C, W and Y.
MenQuadfi can be given to children (12 months of age and above), adolescents, adults
and the elderly.
2. What should I know before I use MenQuadfi?
Do not use if you have ever had an allergic reaction to MenQuadfi or any of the ingredients
listed at the end of the CMI.
Talk to your doctor, nurse or pharmacist if you have any other medical conditions,
take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding.
3. What if I am taking other medicines?
Some medicines may interfere with MenQuadfi and may affect how it works. Tell your
doctor nurse or pharmacist if you are taking, have recently taken or might take any
other vaccines or medicines, including medicines obtained without a prescription.
4. How do I use MenQuadfi?
MenQuadfi is given by your doctor, nurse or pharmacist.
5. What should I know after using MenQuadfi?
Things you should do
|
Call your doctor, nurse or pharmacist straight away if you:
notice signs of allergic reaction which include rash, itching, difficulty breathing,
shortness of breath or swelling of the face, lips, throat or tongue.
Driving or using machines
MenQuadfi is not likely to affect your ability to drive or use machines. However,
do not drive or use any machines if you are feeling unwell.
|
Looking after your medicine
|
MenQuadfi is usually stored in the doctor's surgery or clinic, or at a pharmacy. However,
if you need to store MenQuadfi: keep in the fridge between 2-8°C. Do not freeze.
|
6. Are there any side effects?
Serious side effects can include allergic reactions. See your doctor immediately if
you notice this. Common side effects in children (2 years of age and older), adolescents,
adults and elderly include pain, redness, or swelling at the injection site, muscle
pain, headache, generally feeling unwell and fever. In children 12-23 months of age,
common side effects include tenderness, redness or swelling at the injection site,
feeling irritable, crying, loss of appetite, feeling drowsy, fever, vomiting and diarrhoea.
This medicine is subject to additional monitoring. This will allow quick identification
of new safety information.
You can help by reporting any side effects you may get. You can report side effects
to your doctor, or directly at www.tga.gov.au/reporting-problems .
Active ingredient(s): Meningococcal Polysaccharides Groups A, C, Y and W-135
Full Consumer Medicine Information (CMI)
This leaflet provides important information about using MenQuadfi. You should also speak to your doctor, nurse or pharmacist if you would like further
information or if you have any concerns or questions about using MenQuadfi.
This vaccine can be given to adults and children so you may be reading this leaflet
for you or for your child.
Where to find information in this leaflet:
1. Why am I using MenQuadfi
MenQuadfi contains the active ingredients meningococcal polysaccharide groups A, C,
W and Y.
MenQuadfi is a vaccine. It is used to help protect you or your child against infections
caused by a bacteria (germs) called “Neisseria meningitides” types A, C, W and Y.
Neisseria meningitidis is passed from person to person and can cause meningitis, an
inflammation of the tissues that surround the brain and spinal cord, or septicaemia,
an infection of the blood. Both can result in serious disease with lasting effects
and possibly death.
MenQuadfi can be given to children (12 months of age and above), adolescents, adults
and the elderly.
MenQuadfi stimulates the body’s natural defenses (immune system), to produce its own
protection (antibodies) against the bacteria (“Neisseria meningitidis" types A, C,
W and Y) that may cause the meningococcal disease. However, as with all vaccines,
100% protection cannot be guaranteed.
MenQuadfi will not prevent meningitis (an infection of the brain and spinal cord coverings)
caused by other groups of Neisseria meningitidis.
2. What should I know before I use MenQuadfi?
Warnings
Do not use MenQuadfi:
if you are allergic to the active ingredients or any of the ingredients listed at
the end of this leaflet. Symptoms of allergic reaction may include rash, itching,
difficulty breathing, shortness of breath or swelling of the face, lips, throat, or
tongue. If you are not sure if you are allergic, talk to your doctor, nurse or pharmacist
before you receive MenQuadfi.
Always check the ingredients to make sure you can receive this vaccine.
Tell your doctor, nurse or pharmacist if you 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 disease weakening your body’s natural defences (immune system). Your response to
vaccines may not be optimal.
ever fainted from an injection., Fainting sometimes with falling, can occur (mostly
in adolescents and young children) during, following, or even before, any injection
with a needle.
After vaccination, you may be at risk of developing certain side effects. It is important
you understand these risks and how to monitor for them. See additional information
under Section
6. Are there any side effects?
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, plan to become pregnant or are breast-feeding,
you must tell your doctor, nurse or pharmacist, before receiving MenQuadfi.
3. What if I am taking other medicines?
Some medicines may interfere with MenQuadfi and may affect how it works. Tell your
doctor, nurse or pharmacist if
You are taking, have recently taken or might take any other vaccines or medicines,
including any medicines, vitamins or supplements that you buy without a prescription
from your pharmacy, supermarket or health food shop.
You have been treated with medicines that may affect your body’s natural defenses
(immune system) such as high-dose corticosteroids or chemotherapy. Your response to
vaccines may not be optimal.
For age appropriate situations, MenQuadfi can be given at a separate injection site
during the same visit with other vaccines. Your doctor will advise you if MenQuadfi
is to be given at the same time as another vaccine.
Check with your doctor, nurse or pharmacist if you are not sure about what medicines,
vitamins or supplements you are taking and if these affect MenQuadfi.
4. How do I use MenQuadfi?
How much to use
MenQuadfi is given by your doctor, nurse or pharmacist as a 0.5 mL injection in the
muscle in the upper arm or in the thigh depending on your age and muscle mass.
5. What should I know after using MenQuadfi?
Things you should do
Call your doctor straight away if you:
Notice signs of allergic reaction which include rash, itching, difficulty breathing,
shortness of breath or swelling of the face, lips, throat or tongue.
Driving or using machines
MenQuadfi is not likely to affect your ability to drive or use machines. However,
do not drive or use any machines if you are feeling unwell.
Looking after your medicine
MenQuadfi is usually stored in the doctor's surgery or clinic, or at the pharmacy.
However, if you need to store MenQuadfi:
keep it where young children cannot reach it.
keep MenQuadfi in the original pack until it is time for it to be given.
keep it in the refrigerator, store at 2°C to 8°C. Do not freeze MenQuadfi.
Do not use MenQuadfi after the expiry date which is stated on the carton after EXP.
Do not use MenQuadfi if the packaging is torn or shows signs of tampering.
Getting rid of any unwanted medicine
Medicines including vaccines 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.
6. Are there any side effects?
All medicines including vaccines can have side effects. If you do experience any side
effects, most of them are minor and temporary. However, some side effects may need
medical attention.
See the information below and, if you need to, ask your doctor, nurse or pharmacist
if you have any further questions about side effects.
Less serious side effects
Less serious side effects
|
What to do
|
In children 12 – 23 months of age
tenderness, redness or swelling where the injection was given
feeling irritable
crying
loss of appetite
feeling drowsy
fever
vomiting
diarrhoea
In persons 2 years of age and older
pain, redness, swelling, itching, warmth, bruising or rash where the injection was
given
muscle pain
headache
feeling unwell
fever
vomiting
feeling dizzy
nausea
fatigue
|
Speak to your doctor if you have any of these less serious side effects and they worry
you.
|
Serious side effects
Serious side effects
|
What to do
|
Allergic reaction-related:
rash
itching
difficulty breathing,
shortness of breath
swelling of the face, lips, throat, or tongue
Fits (convulsions) with or without fever
|
Call your doctor straight away or go straight to the Emergency Department at your
nearest hospital if you notice any of these serious side effects.
|
Tell your doctor, nurse or pharmacist if you notice anything else that may be making
you feel unwell.
Other side effects not listed here may occur in some people.
7. Product details
This vaccine is only available with a doctor's prescription.
What MenQuadfi contains
Active ingredients
(main ingredients)
|
10 micrograms of each meningococcal polysaccharide groups A, C, Y and W-135 joined
to approximately 55 micrograms of tetanus toxoid
|
Other ingredients
(inactive ingredients)
|
Sodium chloride, sodium acetate and water for injections
|
Do not use this vaccine if you are allergic to any of these ingredients.
What MenQuadfi looks like
MenQuadfi is a clear, colourless solution for injection.
MenQuadfi is available in packs of 1 or 10 single dose (0.5 mL) vials. Not all pack
sizes may be marketed.
AUST R 325682
Who distributes MenQuadfi
Distributed in Australia by:
sanofi-aventis australia pty ltd
12-24 Talavera Road
Macquarie Park NSW 2113
Freecall: 1800 818 806
Distributed in New Zealand by:
Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics
PO Box 62027
Sylvia Park Auckland 1644
Freecall: 0800 283 684
This leaflet was prepared in July 2024.
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