NeisVac-C Vaccine Suspension for injection
NeisVac-C Vaccine Suspension for injection is a brand of medicine containing the active ingredient neisseria meningitidis vaccine.
Find out more about active ingredients.
Consumer medicine information (CMI) leaflet
Developed by the pharmaceutical company responsible for this medicine in Australia, according to TGA regulations.
[meningococcal group C polysaccharide conjugate vaccine (tetanus toxoid protein conjugate)]
Consumer Medicine Information
What is in this leaflet
This leaflet answers some common questions about NeisVac-C (meningococcal group C polysaccharide chemically bonded to tetanus toxoid protein). It does not contain all of the available information. All medicines have risks and benefits. Your doctor has weighed the risks of using NeisVac-C against the benefits that it will have for you or your child.
It does not take the place of talking to your doctor or pharmacist. If you have any concerns about having this medicine, ask your doctor, nurse or pharmacist. Please read this leaflet carefully before receiving NeisVac-C as it contains information about your vaccine. It may be useful to keep this leaflet in case you need to read it again after vaccination.
What NeisVac-C is used for
NeisVac-C is one of a general group of medicines called vaccines, which are used to protect against infectious diseases. NeisVac-C is used to prevent disease caused by bacteria called Neisseria meningitidis group C. The vaccine works by causing the body to produce its own protection (antibodies) against the group C bacteria.
The Neisseria meningitidis family (A, B, C, Y and W135) can cause serious and sometimes life-threatening infections such as meningitis and septicaemia (blood poisoning). NeisVac-C will only protect against disease caused by the meningococci group C bacteria. It will not protect against other groups of meningococci or other organisms that cause meningitis and blood poisoning.
How NeisVac-C works
When a person is given NeisVac-C, the immune system (the body’s natural defense system) will produce its own protection (antibodies) against disease. Levels of antibody will continue to increase with each booster injection.
Your body usually takes several weeks after vaccination to develop protection against meningococcal disease. Most people will produce enough antibodies against meningococcal disease. However, as with all vaccines, 100% protection cannot be guaranteed. The vaccine 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 meningococcal disease may be very serious.
Before you or your child are given NeisVac-C
NeisVac-C should not be given to you or your child or baby if:
- you are hypersensitive to any component of the vaccine or have had an allergic reaction to any other type of vaccine previously received. Some of the symptoms of an allergic reaction may include skin rash, peeling of the skin, swelling of the face, lips or tongue which may cause difficulty swallowing or shortness of breath
- have an infectious illness (e.g. high temperature, sore throat, cough, cold or flu)
- the expiry date printed on the pack is overdue
- If your child was born very prematurely (born ≤ 28 weeks of gestation), he/she may have short episodes of breathing difficulties (longer gaps between breaths than normal) for 2 to 3 days after vaccination. Your doctor will decide if your child requires monitoring during this time
You must tell your doctor if you, or your child:
- have any other illness, in particular if it is a blood clotting disorder
- are taking any prescription medicine or even non-prescription medicines
- have a medical condition which affects the immune system and/or are undergoing treatment which can alter your immune system such as steroids, cyclosporin or cancer treatment (including radiation). If you or your child has a weak immune system, the immune response may be lower than in other individuals with normal immune systems
- are pregnant, planning to become pregnant or breast-feeding. Vaccination with NeisVac-C is not recommended if you are pregnant. If there is a need to consider vaccination during pregnancy, your doctor will discuss the risks and benefits with you
Using other medicines
Your doctor will advise you if you need to have NeisVac-C at the same time as other injected vaccines.
NeisVac-C may be given at the same time as, but as separate injections at different injection sites, to vaccines that protect against:
- measles, mumps, and 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.
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Driving and using machines
The vaccine is unlikely to affect a person’s ability to drive or operate machinery.
How NeisVac-C is given
One dose of NeisVac-C is 0.5 ml (half a millilitre - a very small amount of liquid).
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.
For infants from 2 to 12 months of age, two doses of NeisVac-C should be given at least two months apart.
After the infant course of two doses has been completed, a booster dose should be given. This will maintain protection. Your doctor will advise you when your child should receive this.
For children of 12 months and older, adolescents, and adults, a single dose (0.5 ml) of the vaccine is recommended.
If you are given more NeisVac-C than you should be given
There is no experience with overdose of NeisVac-C vaccine. However, an overdose is highly unlikely to happen because the injection is given from a single-dose syringe by a doctor.
If you miss a dose of NeisVac-C or stop the vaccination course
Your doctor will inform you about the vaccination schedule to follow. If you miss a recommended dose or stop the recommended vaccination course, this may result in incomplete protection.
While you or your child are having NeisVac-C
As with all injectable vaccines, NeisVac-C may cause unwanted reactions in some individuals. Unwanted reactions may occur immediately after the injection, but recovery is usually rapid with proper treatment.
Possible side effects with NeisVac-C
Like all medicines, NeisVac-C can cause side effects although not everybody gets them. If any side effects worry you, or you have any unusual symptoms, please contact your doctor, nurse or pharmacist.
As with all injectable vaccines, allergic reactions can happen. Although they are very rare, they can be serious. To cover this possibility, effective medical treatment and supervision should always be readily available for the appropriate length of time after vaccination.
Signs and symptoms of serious allergic reactions include:
- swelling of the lips, mouth, and throat, which may cause difficulty in swallowing or breathing
- a rash and swelling of the hands, feet, and ankles
- loss of consciousness due to a drop in blood pressure.
These signs or symptoms usually develop quickly after the injection is given, while the person affected is still in the clinic or doctor’s surgery. If any of these symptoms occur after leaving the place where the injection was given, you must consult a doctor IMMEDIATELY.
The following side effects have been reported:
Very common side effects (affect more than 1 in 10 people)
- In all age groups:
- Redness, swelling, tenderness, and pain at the site of injection
- In infants and / or toddlers:
- Loss of appetite
- Feeling or being sick
- Poor sleep
- In older children:
- Pain in the arms or legs
Common side effects (affect less than 1 in 10 people)
- In all age groups:
- In children:
- Loss of appetite
- Feeling or being sick
- Pain in the arms or legs
- In adults and older children:
- Muscle pain
The following side effects have also been reported:
- Skin rashes that can cover much of the body and lead to blistering and peeling. The inside of the mouth and the eyes can also be affected.
- Other rashes
- Swollen lymph glands
- Abnormal or reduced sensation
- Loss of muscle tone or floppiness in infants
- Purple spots or blotches under the skin, which may be caused by a drop in special blood cells responsible for clotting - This may look like bruising.
- Fits (seizures) - These include reports of some fits in people who already suffered occasional fits. In teenagers and adults, some of the reports of fits may actually have been fainting attacks. In infants and young children, fits were usually associated with fever and were likely to be febrile convulsions. Most people recovered rapidly after the fit.
If you have previously been told by your doctor that you suffer from nephrotic syndrome there may be an increased chance that this condition will reoccur within a few months after vaccination. Nephrotic syndrome is a kidney disease which may result in swelling, particularly around the face or eyes, protein in the urine, making it appear frothy, and/or weight gain. You should tell your doctor if you notice similar symptoms after vaccination.
If you notice any of these side effects and they persist or become more serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In babies born very prematurely (at or before 28 weeks of gestation) longer gaps than normal between breaths may occur for 2-3 days after vaccination.
This vaccine cannot cause meningococcal group C disease. If you or your child experiences any of the following symptoms of meningococcal infection, i.e.
- neck pain
- neck stiffness
- a dislike of light (photophobia)
- red or purple bruise-like spots that do not fade under pressure
you should contact your doctor or local Accident and Emergency Department immediately.
What NeisVac-C looks like
NeisVac-C is presented as a semi-opaque white to off-white suspension in a single dose glass syringe with grey, isoprene bromobutyl tip cap and grey, bromobutyl rubber plunger stopper. The stopper and tip cap are latex free.
What is in NeisVac-C
The vaccine is supplied in a 1.0 mL pre-filled syringe (without an integrated needle), containing one deliverable of 0.5 mL dose. Each 0.5 mL dose of NeisVac-C contains 10 micrograms of meningococcal group C polysaccharide conjugated with 10 to 20 micrograms of tetanus toxoid protein, absorbed to 0.5 mg of aluminium adjuvant (as aluminium hydroxide). It does not contain a preservative.
How to store NeisVac-C
Keep out of the reach and sight of children.
Do not use NeisVac-C after the expiry date which is stated on the carton. Unless the day is indicated, the expiry date refers to the last day of that month.
This medicine should be stored in the refrigerator at +2°C to +8°C. Do not freeze. Keep the syringe in the outer carton.
The product may be stored at room temperature (up to +25°C) for nine months within the total shelf life. The starting date for storage at room temperature and the revised expiry date should be stated on the product package. Under no circumstances must the revised expiry date for storage at room temperature exceed the expiry date set in accordance with the total shelf life of the product. At the end of this period, the product should be used or discarded.
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 protect the environment.
Where can you get more information?
You can get more information from your doctor or pharmacist.
Name and address of the sponsor
Baxter Healthcare Pty Ltd
ABN 43 000 392 781
1 Baxter Drive
Toongabbie NSW 2146, Sydney
The last CMI revision: 23 July 2013
AUST R 83093
CMI provided by MIMS Australia, February 2016