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 or pharmacist.
1. Why am I using NIMENRIX?
NIMENRIX is a vaccine used to help prevent meningococcal disease, caused by four types
of Neisseria meningitidis bacteria (types A, C, W and Y). NIMENRIX works by causing
your body to produce its own protection (or antibodies), against these types of meningococcal
bacteria.
2. What should I know before I use NIMENRIX?
Do not use if you or your child have ever had an allergic reaction to NIMENRIX or
any of the ingredients listed at the end of the CMI.
Talk to your doctor if you or your child have had a serious reaction to any vaccine,
have fainted with a previous vaccine, have had a vaccine in the last 4 weeks, have
any other medical conditions, take any other medicines, or if you are pregnant or
plan to become pregnant or are breastfeeding.
3. What if I am taking other medicines?
Some vaccines or medicines may interfere with NIMENRIX and affect how it works.
4. How do I use NIMENRIX?
Your doctor or nurse will give NIMENRIX as an injection. The vaccine is injected into
muscle, usually in the thigh for babies from 6 to 12 weeks of age. In children from
12 months of age and adults, NIMENRIX can be injected into the thigh or arm muscle.
5. What should I know while using NIMENRIX?
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Things you should do
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Remind any doctor or dentist you visit that you are using NIMENRIX.
Keep a record of you or your child's vaccinations, and update this after each injection.
Keep any follow-up visits with your doctor or clinic.
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Things you should not do
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If required, ensure you or your child does not miss follow-up doses of NIMENRIX to
make sure the vaccine has the best chance of providing protection against meningococcal
disease.
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Driving or using machines
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Be careful driving or operating machinery until you know how NIMENRIX affects you.
In some people, vaccination can cause dizziness or lightheadedness.
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Drinking alcohol
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Be careful when drinking alcohol until you know how NIMENRIX affects you.
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Looking after your medicine
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NIMENRIX is usually stored in the doctor's surgery or clinic, or at the pharmacy.
However, if you need to store NIMENRIX, keep it in the fridge, stored between 2°C
and 8°C.
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6. Are there any side effects?
NIMENRIX, like all medicines and vaccines, may cause unwanted side effects in some
people. Most unwanted side effects with NIMENRIX are mild and clear up within a few
days. These effects, as with other vaccines, generally occur around the injection
site. Very common side effects include pain, redness or swelling around the injection
site, loss of appetite, fever, drowsiness or feeling tired, headache, irritability/fussiness
in a child. As with all vaccines given by injection, there is a very small risk of
a serious allergic reaction. For more information, including what to do if you have
any side effects, see Section
6. Are there any side effects? in the full CMI.
Active ingredient(s):
Meningococcal polysaccharide groups A, C, W-135 and Y conjugate vaccine powder and
solvent for solution for injection in pre-filled syringe
Full Consumer Medicine Information (CMI)
This leaflet provides important information about using NIMENRIX. You should also speak to your doctor or pharmacist if you would like further information
or if you have any concerns or questions about using NIMENRIX.
Where to find information in this leaflet:
1. Why am I using NIMENRIX?
NIMENRIX is a vaccine used to help prevent meningococcal disease, caused by four types
of Neisseria meningitidis bacteria (types A, C, W and Y).
NIMENRIX works by causing your body to produce its own protection (or antibodies),
against these types of meningococcal bacteria. NIMENRIX cannot cause meningococcal
disease.
The most common types of meningococcal disease are meningitis (infection of a lining
around the brain and spinal cord) and septicaemia (blood infection). Neisseria bacteria
can less commonly infect the joints, lungs or other organs.
Meningococcal disease is spread by small droplets from the nose, mouth or throat.
Meningococcal disease is generally serious and sometimes causes long-term effects
(eg deafness, memory problems, loss of fingers or toes), or death.
As with all vaccines, NIMENRIX may not protect all people who are vaccinated.
Also, NIMENRIX does not help to protect against meningococcal disease caused by other
types of Neisseria, or meningitis caused by other bacteria or viruses.
NIMENRIX can be used in infants from 6 weeks of age, children and adults and is particularly
recommended for:
Travellers to countries where meningococcal A, W or Y disease outbreaks may happen
(eg parts of Africa, annual Hajj)
Close contacts of people with meningococcal A, W or Y disease
People with medical conditions that make them more likely to get meningococcal disease
(eg. people without a functioning spleen or some people with a poor immune response
to infections).
NIMENRIX may also be prescribed for other people or situations.
2. What should I know before I use NIMENRIX?
Warnings
Do not use NIMENRIX if:
1. You or your child are allergic to NIMENRIX, or any of the ingredients listed at the
end of this leaflet. Symptoms of an allergic reaction may include:
shortness of breath
wheezing or difficulty breathing
swelling of the face, lips, tongue or other parts of the body
rash, itching or hives on the skin
2. If you or your child have been given NIMENRIX before and become unwell, tell your
doctor or nurse before the vaccine is given.
3. You or your child have a severe infection with a high temperature. A minor infection,
such as a cold, should not be a problem, but talk to your doctor or nurse before having
the vaccine.
Check with your doctor if you:
You or your child have had a serious reaction to any vaccine, including:
an allergic reaction
difficulty breathing
swelling of the throat
fainting or collapse
shock-like state or being unresponsive
fits or convulsions
high temperature (greater than 40°C)
severe skin reaction at the injection site
crying or screaming lasting for more than 3 hours, in a child.
You or your child have allergies to:
any medicines
any other substances, such as foods, preservatives or dyes.
You or your child fainted with a previous vaccine. Fainting can occur following, or
even before any needle injection.
You or your child have these medical conditions:
low platelets or a bleeding disorder, since bleeding can occur after injection of
NIMENRIX.
you or your child have any condition, treatment or medicines that affect the immune
response to infections. You or your child may still have NIMENRIX if your doctor or
nurse recommends it, but may not be protected as much as other people.
You or your child have had a vaccine in the last 4 weeks, or have recently taken any
medicines, including medicines that don't need a prescription.
Some vaccines may be affected by other vaccines or medicines. Your doctor, pharmacist
or nurse will be able to tell you what to do. See Section 3.What if I am taking other
medicines? for a list of vaccines that can be given at the same time as NIMENRIX.
During treatment, 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
Check with your doctor if you are pregnant or intend to become pregnant.
Talk to your doctor if you are breastfeeding or intend to breastfeed.
Your doctor will discuss the possible risks and benefits of having NIMENRIX during
pregnancy or breastfeeding.
3. What if I am taking other medicines?
Tell your doctor or pharmacist if you are taking any other medicines, including any
medicines, vitamins or supplements that you buy without a prescription from your pharmacy,
supermarket or health food shop.
Some vaccines may be affected by other vaccines or medicines. Your doctor, pharmacist
or nurse will be able to tell you what to do.
NIMENRIX can be given at the same time as the following vaccines.
Infants from 6 weeks up to 12 months of age:
Combined diphtheria, tetanus, acellular pertussis (DTaP), hepatitis B, inactivated
polio (IPV) and Haemophilus influenzae type b (Hib) vaccines and 10-valent pneumococcal
conjugate vaccine.
Children from 12 months of age and adults:
Hepatitis A and hepatitis B; DTaP vaccines, including combination DTaP vaccines with
hepatitis B, IPV or Hib; measles-mumps-rubella (MMR) vaccine, including in combination
with varicella (MMRV); seasonal flu and 10 or 13-valent pneumococcal conjugate vaccines;
human papillomavirus bivalent vaccine (HPV2) and diphtheria toxoid and acellular pertussis
vaccine (Tdap) in individuals aged 9 to 25 years.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect NIMENRIX.
4. How do I use NIMENRIX?
How is it given
Your doctor or nurse will give NIMENRIX as an injection. The vaccine is injected into
muscle, usually in the thigh for babies from 6 to 12 weeks of age.
In children from 12 months of age and adults, NIMENRIX can be injected into the thigh
or arm muscle.
When is it given
Infants 6 weeks to less than 6 months of age:
Your baby will receive two doses, normally given at 2 and 4 months old (2 months apart)
however the first dose may be given as early as 6 weeks of age. A booster dose is
recommended at 12 months of age.
Infants 6 months to less than 12 months of age:
Your baby will receive one dose given from 6 months of age. A booster dose is recommended
at 12 months of age, with an interval of at least 2 months after the initial dose.
Children from 12 months of age and adults:
Most people will be given one NIMENRIX injection.
Some people at increased or continued risk of meningococcal infection may be given
two initial NIMENRIX injections; NIMENRIX after another meningococcal vaccine; and/or
a booster dose of NIMENRIX.
Your doctor will advise if you or your child need more than one NIMENRIX injection.
If you or your child miss a dose
If a dose of NIMENRIX is missed, talk to your doctor or nurse and arrange another
visit as soon as possible.
If you use too much NIMENRIX
For information on the management of overdose, contact the Poison Information Centre
on 131126.
5. What should I know while using NIMENRIX?
Things you should do
Keep a record of you or your child's vaccinations, and update this after each injection.
Keep any follow-up visits with your doctor or clinic.
Things you should not do
If required, ensure you or your child does not miss follow-up doses of NIMENRIX to
make sure the vaccine has the best chance of providing protection against meningococcal
disease.
Driving or using machines
Be careful before you drive or use any machines or tools until you know how NIMENRIX
affects you.
In some people, vaccination can cause dizziness or lightheadedness.
Drinking alcohol
Tell your doctor if you drink alcohol.
Be careful when drinking alcohol until you know how NIMENRIX affects you.
Looking after your medicine
NIMENRIX is usually stored in the doctor's surgery or clinic, or at the pharmacy.
However, if you need to store NIMENRIX,
Keep it in the fridge, stored between 2°C and 8°C.
Do NOT freeze NIMENRIX, store it in the bathroom, or leave it in the car.
Store it in the original pack, to protect it from light.
Keep it out of reach of children.
Ask your pharmacist what to do with NIMENRIX that has expired or not been used.
6. Are there any side effects?
All medicines 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 or pharmacist if you
have any further questions about side effects.
Most unwanted side effects with NIMENRIX are mild and clear up within a few days.
These effects, as with other vaccines, generally occur around the injection site.
Very common side effects
Common side effects
Uncommon side effects
Serious side effects
Tell your doctor 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.
Reporting side effects
After you have received medical advice for any side effects you experience, you can
report side effects to the Therapeutic Goods Administration online at
www.tga.gov.au/reporting-problems . By reporting side effects, you can help provide more information on the safety of
this medicine.
Always make sure you speak to your doctor or pharmacist before you decide to stop
taking any of your medicines.
7. Product details
This medicine is only available with a doctor's prescription.
What NIMENRIX contains
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Active ingredient
(main ingredient)
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NIMENRIX contains agents that stimulate an immune response to Neisseria meningitidis
types A, C, W and Y.
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Other ingredients
(inactive ingredients)
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The vaccine also contains sucrose and trometamol.
The solvent contains sodium chloride (salt) and water for injection.
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Do not take this medicine if you are allergic to any of these ingredients.
What NIMENRIX looks like
NIMENRIX comes as a white powder in a vial, together with a pre-filled syringe of
diluent. The powder is dissolved in the solvent by the doctor or nurse, just before
injection.
Australian Registration Number:
AUST R 199742
Who distributes NIMENRIX
Pfizer Australia Pty Ltd
Sydney, NSW
Toll Free Number 1800 675 229
This leaflet was prepared in September 2021.
® = Registered Trademark
NIMENRIX® is a registered trademark of GlaxoSmithKline Biologicals SA, licensed to Pfizer Inc.