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 NeisVac-C?
NeisVac-C is a vaccine used to help prevent invasive meningococcal disease caused
by bacteria called Neisseria meningitidis group C for people from 8 weeks of age.
2. What should I know before I use NeisVac-C?
Do not use if you have ever had an allergic reaction to any vaccination or any of
the ingredients listed at the end of the CMI.
Talk to your doctor 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 NeisVac-C and affect how it works.
4. How do I use NeisVac-C?
NeisVac-C will be injected into a muscle. It is usually injected into the thigh for
infants and into the arm for older children, adolescents, and adults.
5. What should I know while using NeisVac-C?
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Things you should do
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Tell your doctor or nurse if you or your child have been given other vaccines.
Tell your doctor or nurse if you are pregnant or plan to become pregnant or are breast-feeding.
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Things you should not do
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Vaccination should not be given to an infant under 8 weeks of age.
Do not withhold any information from your treating health professional.
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Looking after your medicine
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If you are required to store Neisvac-C:
Keep NeisVac-C stored at 2°C to 8°C (in a refrigerator). Do not freeze.
Store it in a cool, dry place away from moisture, heat or sunlight.
NeisVac-C can be stored out of the refrigerator, at room temperature up to 25°C, for
up to 9 months before the expiry date shown on the pack.
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6. Are there any side effects?
Common side effects may include pain, redness or swelling at the injection site, nausea,
vomiting, diarrhoea, stomach pains or fatigue. More serious side effects may be a
severe allergic reaction known as anaphylaxis, neck stiffness or easy bruising and
blistering.
Active ingredient(s):
Meningococcal group C polysaccharide conjugate vaccine (tetanus toxoid protein conjugate)
Full Consumer Medicine Information (CMI)
This leaflet provides important information about using NeisVac-C. 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 NeisVac-C.
Where to find information in this leaflet:
1. Why am I using NeisVac-C?
NeisVac-C is a vaccine, a type of medicine used to help protect against infectious
diseases
Neis
Vac-C is used to prevent invasive disease caused by bacteria called
Neisseria meningitidis
group C.
The Neisseria meningitidis bacteria can cause serious and sometimes life-threatening infections such as meningitis
and septicaemia (blood poisoning). NeisVac-C will only protect against invasive disease
(commonly called meningococcal) caused by meningococci group C bacteria. It will not
protect against other groups of meningococci or other organisms that cause meningitis
and blood poisoning.
When a person is given NeisVac-C, the immune system (the body's natural defence system)
will produce its own protection (antibodies) against disease.
Your body usually takes several weeks after vaccination to develop protection against
invasive meningococcal disease. Most people will produce enough antibodies to protect
them against invasive meningococcal disease. However, as with all vaccines, 100% protection
cannot be guaranteed.
NeisVac-C will not give you or your child meningococcal disease.
The chance of a severe reaction from NeisVac-C is very small, but the risks from not
being vaccinated against invasive meningococcal disease may be very serious.
NeisVac-C is given to children from 8 weeks of age, adolescents and adults.
2. What should I know before I use NeisVac-C?
Warnings
Your or your child should not be given NeisVac-C if:
1. You are allergic to any of the ingredients listed at the end of this leaflet including
tetanus toxoid (TT) or if you or your child have shown an allergic reaction to NeisVac-C
when given it previously.Some of the 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.
Always check the ingredients to make sure you can use this medicine.
2. It has passed the expiry date printed on the pack or if the packaging is torn or shows
signs of tampering.It has expired or is damaged - return it to your pharmacist.
3. Vaccination should not be given to an infant under 8 weeks of age.
Vaccination should be delayed if you or your child has a moderate or severe fever,
or a current or recent medical concern.
If you are not sure whether you or your child should be given NeisVac-C, talk to your
doctor or nurse. A minor illness, such as a cold, is not usually a reason to delay
vaccination.
Check with your doctor if you or your child have any other medical conditions, including
any of the following:
blood clotting disorder
if you or your child are taking anti-coagulation medicine or undergoing anti-coagulation
therapy (as there is a risk of bleeding at the injection site following vaccination)
any condition affecting the immune system, such as HIV infection, or if you or your
child are undergoing treatment which can alter the effectiveness of your immune system,
such as cancer therapy.
Tell your doctor:
if you are pregnant or plan to become pregnant or are breastfeeding – see Pregnancy
and breastfeeding below.
if your baby was born prematurely. There is a higher risk of apnoea (temporarily stopping
breathing) for 2-3 days after vaccination of a premature baby. Your doctor may decide
if your baby requires monitoring during this time.
NeisVac-C will not cause meningococcal group C infection but some people could already
have the disease or have meningitis caused by other organisms, prior to vaccination.
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.
The vaccine should not be used during pregnancy unless there is a defined risk of
meningococcal C disease. If there is a need to consider vaccination during pregnancy
or breast-feeding, your doctor can discuss with you the risks and benefits involved.
Talk to your doctor if you are breastfeeding or intend to breastfeed.
Your doctor will advise regarding this vaccine and pregnancy.
3. What if I am taking other medicines?
Tell your doctor or pharmacist if you are taking any other medicines, vitamins or
supplements that you buy without a prescription from your pharmacy, supermarket or
health food shop.
Tell your doctor or nurse if you or your child have been given other vaccines.
Your doctor will advise you if you or your child need to have NeisVac-C at the same
time as other injected vaccines.
NeisVac-C must not be mixed with other vaccines in the same syringe.
NeisVac-C may be given at the same time as other vaccines as long as they are given
at different places on your body and using separate syringes.
Other vaccines that can be given at the same time can protect against:
polio
measles, mumps, and rubella (German measles) (MMR)
diphtheria, tetanus and pertussis (whooping cough)
infections caused by Haemophilus influenzae (Hib)
Pneumococcal infections.
NeisVac-C can be given to infants at the same time as certain types of vaccines that
protect against hepatitis B infection. Your doctor will advise you if this is necessary
and which vaccine might be suitable.
Immunisation with NeisVac-C is not a substitute for routine tetanus immunisation.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect NeisVac-C.
4. How do I use NeisVac-C?
How much to be given
The dosage for infants under the age of 12 months is two separate doses, the first
dose given not earlier than 8 weeks of age and with an interval of at least two months
between doses.
After the infant course of two doses is completed, children should be given a single
booster dose in the second year of life. This should help maintain protection. Your
doctor will advise you when your child should receive this.
For children 12 months of age and older, and for adolescents and adults, a single
dose of the vaccine is recommended.
How NeisVac-C is given
NeisVac-C will be injected into a muscle. It is usually injected into the thigh for
infants and into the arm for older children, adolescents, and adults.
The vaccine must not be injected under the skin or into a blood vessel and your doctor
or nurse will take care to avoid doing this when administering the vaccine.
If you miss a dose of NeisVac-C vaccination
Your doctor or nurse will inform you about the vaccination schedule to follow. If
you or your child miss a recommended dose or stop the vaccination course, this may
result in incomplete protection.
If you take too much NeisVac-C
An overdose is highly unlikely, as it is given as a single-dose syringe by a doctor
or nurse. If the doses are given closer together than recommended or more doses than
required are given, side effects are more likely to occur.
If you think that you have been given too much NeisVac-C, you may need urgent medical
attention.
You should immediately:
phone the Poisons Information Centre
(by calling
13 11 26), or
contact your doctor, or
go to the Emergency Department at your nearest hospital.
You should do this even if there are no signs of discomfort or poisoning.
5. What should I know while using NeisVac-C?
Things you should do
Ensure you and your child stay up to date with required vaccinations.
Call your doctor straightaway if you:
Notice any symptoms that worry you or may be severe.
Develop signs of an allergic reaction such as skin rash, swelling of the lips or tongue,
or difficulty breathing.
Things you should not do
Do not withhold any information from your treating health professional.
Looking after your medicine
If you are required to store NeisVac-C:
Keep NeisVac-C stored at 2°C to 8°C (in a refrigerator). Do not freeze.
NeisVac-C can be stored out of the refrigerator, at room temperature up to 25°C, for
up to 9 months before the expiry date shown on the pack. Store it in a cool dry place
away from moisture, heat or sunlight; for example, do not store it:
in the bathroom or near a sink, or
in the car or on window sills.
When NeisVac-C is stored at room temperature, the initial date i was taken out of
the refrigerator must be recorded and the product must not be returned to the refrigerator.
At the end of this period, NeisVac-C should be used or returned to a pharmacy.
Do not use this medicine after the expiry date.
Keep it where young children cannot reach it.
Getting rid of any unwanted medicine
If you no longer need to use this medicine or it is out of date, take it to any pharmacy
for safe disposal.
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.
Side effects
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Side effects
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What to do
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Injection site symptoms
redness, swelling, tenderness and pain at the site of injection
Aches and pains
pain in the arms and legs or muscle aching or weakness
Gastrointestinal symptoms
nausea or vomiting
diarrhoea
stomach pain
loss of appetite
indigestion or reflux
Tiredness, alertness, and sleep related symptoms
fatigue
tiredness or sleepiness
generally feeling unwell
agitation or restlessness
irritability or crying
poor sleep
Skin symptoms
itchy skin, dermatitis, rash or skin discolouration that resembles bruising
Cold and flu symptoms:
fever
coughing
inflamed throat or a runny or blocked nose
chills, swollen glands or flu-like symptoms.
Other side effects
increased sweating
dizziness
headache
flushing
burning sensation/pins and needles
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Speak to your doctor if you have any of these common side effects and they worry you.
Seek appropriate medical treatment if any of these symptoms worsen.
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Serious side effects
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Serious side effects
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What to do
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Severe allergy (anaphylaxis)
swelling of the lips, mouth and throat which may cause difficulty swallowing or breathing
Breathing symptoms in very premature infants
interruption in breathing or longer gaps between breaths in premature infants
rapid, shallow breathing
shortness of breath
Muscle, blood and skin symptoms
loss of muscle tone or floppiness in infants
neck and/or joint stiffness
easy bruising or bleeding
severe blisters and bleeding in the lips, eyes, mouth, nose and genitals.
red or purple bruise-like spots that do not fade under pressure welling of the eyelids
or face resulting from fluid retention
Other
a seizure or convulsion which may be accompanied by a very high temperature
intolerance or sensitivity of bright light (photophobia)
recurrence of nephrotic syndrome in children - a condition of the kidney - which results
in swelling around the face or eyes and frothy urine
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Call your doctor straightaway, or go straight to the Emergency Department at your
nearest hospital if you notice any of these serious side effects.
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Tell your doctor or pharmacist if you notice anything else that may be making you
or your child 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 NeisVac-C contains
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Active ingredient
(main ingredient)
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Each dose of NeisVac-C contains the following active ingredients:
10 micrograms of meningococcal group C polysaccharide
10 to 20 micrograms of tetanus toxoid protein
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Other ingredients
(inactive ingredients)
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aluminium hydroxide
sodium chloride
water for injection
NeisVac-C does not contain preservatives.
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Do not take this medicine if you are allergic to any of these ingredients.
What NeisVac-C looks like
NeisVac-C is supplied in a pre-filled syringe without a needle, containing one dose
of 0.5 mL (AUST R 83093).
The product is supplied in a pack containing a single syringe.
NeisVac-C is a white to off-white suspension in a single dose glass syringe. All parts
of the syringe are latex-free.
Who distributes NeisVac-C
Pfizer Australia Pty Ltd
Sydney NSW
This leaflet was prepared in March 2023.
® = Registered Trademark