NeisVac-C 0.5 ml Suspension for injection in pre-filled syringe. Meningococcal Group C Polysaccharide Conjugate Vaccine Adsorbed

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Neisseria meningitidis c; Tetanus toxoid

Available from:

Pfizer Healthcare Ireland

ATC code:

J07AH

INN (International Name):

Neisseria meningitidis c; Tetanus toxoid

Dosage:

0.5 millilitre(s)

Pharmaceutical form:

Suspension for injection in pre-filled syringe

Administration route:

Intramuscular injection

Units in package:

Packs of 1 or 10 or 20

Prescription type:

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

Manufactured by:

Pfizer Limited

Therapeutic group:

Meningococcal vaccine

Therapeutic area:

Meningococcal vaccines

Therapeutic indications:

It 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.

Authorization status:

Not marketed

Authorization date:

2001-07-13

Patient Information leaflet

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2022-0075372
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 OR YOUR CHILD RECEIVE
THIS VACCINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor, pharmacist or
nurse.
-
This vaccine has been prescribed for you or your child only. Do not
pass it on to others.
-
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What NeisVac-C is and what it is used for
2.
What you need to know before you receive 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 a vaccine to prevent invasive meningococcal disease
caused by
_Neisseria meningitidis_
group C. This is a type of bacteria that can cause serious infections
sometimes leading to life-threatening
symptoms/reactions such as meningitis and septicaemia (blood
poisoning).
NeisVac-C is given to children from 2 months of age, adolescents and
adults.
The vaccine works by
causing your body to produce its own protection (antibodies) against
the group C bacteria.
This vaccine will only protect against disease caused by the
_Neisseria meningitidis_
group C bacteria. It
will not protect against infections caused by other groups of
_Neisseria meningitidis_
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 (OR YOUR CHILD) RECEIVES NEISVAC-C
DO NOT USE NEISVAC-C
•
if you have ever had an allergic reaction to a previous dose of this
vaccine or to any ingredient of
the vac

Summary of Product characteristics

Health Products Regulatory Authority
09 June 2021
CRN009YPX
Page 1 of 9
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+
Excipient(s) with known effect
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Suspension for injectionin 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 booster doses in subjects aged 12 months or more when
first immunised has n