Meningococcal polysaccharide groups A, C, W-135 and Y conjugate vaccine powder and
solvent for solution for injection in pre-filled syringe
Consumer Medicine Information
What is in this leaflet
Please read this leaflet carefully before you or your child are given NIMENRIX.
This leaflet answers some common questions about NIMENRIX. It does not contain all
the available information. It does not take the place of talking to your doctor or
All vaccines and medicines have risks and benefits. Your doctor has weighed the expected
benefits of you or your child having NIMENRIX against the possible risks.
If you have any questions about NIMENRIX, ask your doctor, nurse or pharmacist.
Keep this leaflet. You may need to read it again.
What NIMENRIX is used for
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
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
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
NIMENRIX may also be prescribed for other people or situations.
If you are not sure whether you or your child should be given this vaccine, talk to
Before you or your child is given NIMENRIX
When NIMENRIX should not be given:
You or your child have had an allergic reaction to NIMENRIX, or any ingredient contained
in this vaccine. The ingredients are 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.
If you or your child have been given NIMENRIX before and become unwell, tell your
doctor or nurse before the vaccine is given.
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.
The expiry date printed on the NIMENRIX pack has passed
The NIMENRIX packaging is torn or shows signs of tampering.
Before being given NIMENRIX, tell your doctor or nurse if:
You or your child have had a serious reaction to any vaccine, including
an allergic reaction
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 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
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 are pregnant, plan to become pregnant or are breastfeeding.
Your doctor will discuss the possible risks and benefits of having NIMENRIX during
pregnancy or breastfeeding.
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.
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
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 diptheria toxoid and acellular pertussis
vaccine (Tdap) in individuals aged 9 to 25 years.
If you have not told your doctor or nurse about any of the above, tell him or her
before you or your child is given NIMENRIX.
How NIMENRIX is given
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 to 12 weeks 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.
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 have any questions about how this vaccine is to be given, talk to your doctor,
nurse or pharmacist.
IF YOU TAKE TOO MUCH (overdose)
For information on the management of overdose, contact the Poison Information Centre
When you or your child are given NIMENRIX
THINGS YOU MUST 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.
If required, it is important for you or your child to have follow-up doses of NIMENRIX
to make sure the vaccine has the best chance of providing protection against meningococcal
THINGS TO BE CAREFUL OF
Be careful driving or operating machinery until you know how NIMENRIX affects you.
In some people, vaccination can cause dizziness or lightheadedness.
Tell your doctor, nurse or pharmacist as soon as possible if you or your child does
not feel well after receiving NIMENRIX.
NIMENRIX, like all medicines and vaccines, may cause unwanted side effects in some
people. Most of the time side effects are not serious; however, sometimes they may
need medical treatment.
Do not be alarmed by the following lists of side effects. You or your child may not
experience any of them.
Ask your doctor, nurse or pharmacist to answer any questions you may have.
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.
Tell your doctor or nurse if you notice any of the following side effects and they
Very common (may occur in more than 1 in 10 people)
pain, redness or swelling around the injection site
loss of appetite
drowsiness or feeling tired
irritability/fussiness in a child
Common (may occur in up to 1 in 10 people)
diarrhoea, vomiting or nausea
bruising at the injection site
rash (in infants)
Uncommon (may occur in up to 1 in 100 people)
warmth, itchiness, lack of sensation, or a hard lump around the injection site
decreased sensation or itchiness of the skin; rash
pain in a muscle, arm or leg
crying in a child
large swelling of the vaccinated limb associated with redness may occur
As with all vaccines given by injection, there is a very small risk of a serious allergic
reaction. This usually happens within hours, but may occur days to weeks after vaccination.
If any of the following happen, tell your doctor or nurse immediately, or go to the
Accident and Emergency Department at your nearest hospital:
swelling of limbs, face, eyes, inside of nose, mouth or throat
shortness of breath, breathing or swallowing difficulties
hives, itching (especially of the hands or feet), reddening of skin (especially around
the ears), or severe skin reactions
unusual tiredness or weakness that is sudden and severe.
Tell your doctor, nurse or pharmacist if you notice anything else that is making you
or your child feel unwell.
Other side effects not listed above may also occur in some people.
There may also be some side effects not yet known.
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.
WHAT IT LOOKS LIKE
NIMENRIX comes as a white powder in a vial, together with a pre-filled syringe or
glass container of clear liquid (solvent). The powder is dissolved in the solvent
by the doctor or nurse, just before injection.
NIMENRIX contains agents that stimulate an immune response to Neisseria meningitidis
types A, C, W and Y.
The vaccine also contains sucrose and trometamol.
The solvent contains sodium chloride (salt) and water for injection.
NIMENRIX vaccine does not contain lactose, gluten, tartrazine or any other azo dyes.
NIMENRIX is only available if prescribed by a doctor.
Pharmaceutical companies are not in the position to give people medical advice. Your
doctor or pharmacist is the best person to give you advice on vaccination.
NIMENRIX is supplied in Australia by:
Pfizer Australia Pty Ltd
Sydney, NSW Toll Free Number 1800 675 229
Australian Registration Number:
AUST R 199742
This leaflet was prepared in
® = Registered Trademark
NIMENRIX® is a registered trademark of GlaxoSmithKline Biologicals SA, licensed to Pfizer Inc.