NeisVac-C

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

Meningococcal polysaccharide - Group C; Tetanus toxoid; Aluminium hydroxide; Meningococcal group C polysaccharide; meningococcal group C polysaccharide

Available from:

Baxter Healthcare Pty Ltd

Class:

Medicine Registered

Patient Information leaflet

NEISVAC-C  
Consumer 
Medicine 
Information 

NEISVAC-C CMI 130723 

Page 1 of 6 
Baxter 

NEISVAC-C 

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 W
135
) 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 agains

Summary of Product characteristics

NEISVAC-C  
Product 
Information 

NEISVAC-C PI Approved 130919 
Page 1 of 13 
Baxter 

NEISVAC-C 

NAME OF THE MEDICINE 

NEISVAC-C

VACCINE 
Meningococcal group C polysaccharide conjugate
vaccine (tetanus toxoid protein 
conjugate). 

COMPOSITION  
_ _
_Active ingredient_: each 0.5 mL dose contains 10 micrograms
of meningococcal 
polysaccharide group C conjugated with 10 to 20 micrograms
of tetanus toxoid protein, 
adsorbed to aluminium hydroxide (adjuvant). 
_ _
_Inactive ingredient_:
aluminium hydroxide (1.4 mg, equivalent to 0.5 mg aluminium), 
sodium chloride (4.1 mg) and water for injection to
0.5 mL. No preservative is added to 
the formulation. 

CHEMICAL NAME   

The capsular polysaccharide, referred to as GCMP
(group C meningococcal 
polysaccharide) in NeisVac-C vaccine, is a linear polymer
of repeated unit of [(2---9)-α-
N-acetyl neuraminic acid; (C
11
H
19
NO
9
)
_n_
], with a defined molecular size. It is covalently 
bonded to a carrier protein, tetanus toxoid (TT).  

DESCRIPTION 

NeisVac-C vaccine is a sterile, homogenous semi-opaque white
to off-white suspension 
filled in single dose syringes. It is supplied in a
1.0 mL pre-filled syringe (without an 
integrated needle), containing one deliverable 0.5
mL dose. Contains no antibacterial 
agent. Product is for single use in one
patient only. Discard any residue. 

The capsular polysaccharide is isolated from the
fermentation of _Neisseria meningitidis_ 
serogroup C (strain C11) The GCMP-TT
Conjugate is devoid of an acetyl group at either 
C-7 or C-8 of the sialic acid (de-_O_-acetylated derivative). The
oxidised GCMP 
intermediate is covalently bonded to TT
protein by a reductive amination reaction, 
yielding the active ingredient, GCMP-TT conjugate. 

The manufacturer of this product includes
exposure to bovine derived ma