NEISVAC-C Suspension for Injection

Nchi: Ayalandi

Lugha: Kiingereza

Chanzo: HPRA (Health Products Regulatory Authority)

Viambatanisho vya kazi:

NEISSERIA MENINGITIDIS C TETANUS TOXOID

Inapatikana kutoka:

Baxter Healthcare Limited

INN (Jina la Kimataifa):

NEISSERIA MENINGITIDIS C TETANUS TOXOID

Dawa fomu:

Suspension for Injection

Dawa ya aina:

Product subject to prescription which may not be renewed (A)

Idhini hali ya:

Authorised

Idhini ya tarehe:

0000-00-00

Taarifa za kipeperushi

b
0001471
PACKAGE LEAFLET: INFORMATION FOR THE USER
NeisVac-C 0.5 
ml
Suspension for injection in pre-filled syringe
Meningococcal Group C Polysaccharide Conjugate Vaccine 
Adsorbed
Read all of this leaflet carefully before you start receiving this
vaccine.
•  Keep this leaflet until you have finished the
complete vaccination course. 
You may need to read it again.
•  If you have further questions, ask your doctor or pharmacist.
•  This medicine has been prescribed for you or your child. Do not
pass it 
on to others. 
•  If you get any side effects, talk to your doctor or
pharmacist. This 
includes any possible side effects not listed in this leaflet. See
section 4 
In this leaflet:
1.  What NeisVac-C is and what it is used for
2. What you need to know before you take NeisVac-C
3. How to use NeisVac-C
4. Possible side effects
5. How to store NeisVac-C
6. Contents of the pack and other information
1. What NeisVac-C is and what it 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 your body to produce its own
protection 
(antibodies) against the group C bacteria.
The  _Neisseria meningitidis_ group C bacteria can cause serious
infections 
such as meningitis and septicaemia (blood poisoning). These infections
are 
sometimes life-threatening.
This vaccine will only protect against disease caused by the
meningococci 
group C bacteria. It will not protect against infections caused
by other 
groups of meningococci or other organisms that cause meningitis and
blood 
poisoning. As with other vaccines, NeisVac-C cannot completely
prevent 
meningococcal group C infections in all people who are vaccinated.
2. What you need to know before you use NeisVac-C 
Do not use NeisVac-C
•  if you have ever had an allergic reaction to a previous dose
of this 

Tabia za bidhaa

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
NeisVac-C

0.5 ml Suspension for injection in pre-filled syringe.
Meningococcal Group C Polysaccharide Conjugate Vaccine Adsorbed.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One dose (0.5 ml) contains:
_Neisseria meningitidis _group C (strain C11) polysaccharide (de-O-acetylated)...10 micrograms
conjugated to tetanus toxoid…………….............................................…....10-20 micrograms
adsorbed on aluminium hydroxide, hydrated.…………...……………………..…0.5 mg Al
3+
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Suspension for injection in pre-filled syringe.
A semi-opaque white to off-white suspension.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
NeisVac-C is indicated for active immunisation in children from 2 months of age, adolescents and adults, for the
prevention of invasive disease caused by Neisseria meningitidis serogroup C.
The use of NeisVac-C should be determined on the basis of official recommendations.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
There are no data on the use of different meningococcal group C conjugate vaccines within the primary series or for
boosting. Whenever possible, the same vaccine should be used throughout.
POSOLOGY
_Primary immunisation_
Infants from 2 months up to 4 months of age:
Two doses, each of 0.5 ml, should be given with an interval of at least two months
Infants from 4 months of age, older children, adolescents and adults:
One dose of 0.5 ml
_Booster doses_
After completion of the primary immunization course in infants aged 2 months up to 12 months of age a booster dose
should be given at approximately 12-13 months of age with at least an interval of 6 months after the last NeisVac-C
vaccination.
The need for bo