NEISVAC-C VACCINE meningococcal group c polysaccharide conjugate vaccine suspension for injection syringe

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

Tetanus toxoid, Quantity: 20 microgram/mL; Meningococcal polysaccharide group C, Quantity: 20 microgram/mL

Available from:

Pfizer Australia Pty Ltd

INN (International Name):

aluminium hydroxide hydrate,Meningococcal polysaccharide group C,Tetanus toxoid

Pharmaceutical form:

Injection, suspension

Composition:

Excipient Ingredients: sodium chloride; water for injections; aluminium hydroxide hydrate

Administration route:

Intramuscular

Units in package:

20 x Pre-filled syringes, 10 x Pre-filled syringes, 1 x Pre-filled syringe

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

NeisVac-C Vaccine is indicated for active immunisation of children from 8 weeks of age, adolescents and adults, for the prevention of invasive disease caused by Neisseria meningitidis serogroup C.

Product summary:

Visual Identification: HOMOGENEOUS, SEMI-OPAQUE, WHITE TO OFF-WHITE SUSPENSION; Container Type: Syringe; Container Life Time: 42 Months; Container Temperature: Store at 2 to 8 degrees Celsius

Authorization status:

Licence status A

Authorization date:

2002-08-22

Patient Information leaflet

NEISVAC-C
®
_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.
It does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you or your child being
given NeisVac-C against the benefits
it is expected to provide.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS VACCINATION, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET
You may need to read it again.
WHAT NEISVAC-C IS
USED FOR
NeisVac-C is a vaccine, a type of
medicine used to protect against
infectious diseases. NeisVac-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
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.
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.
BEFORE YOU ARE GIVEN
NEISVAC-C
_WHEN YOU OR YOUR CHILD_
_SHOULD NOT BE GIVEN_
_NEISV

Summary of Product characteristics

Version: pfpneisi10219
Supersedes: pfpneisi10915
Page 1 of 13
AUSTRALIAN PRODUCT INFORMATION -
NEISVAC-C ®
MENINGOCOCCAL GROUP C POLYSACCHARIDE
CONJUGATE VACCINE (TETANUS TOXOID PROTEIN CONJUGATE)
SUSPENSION FOR INTRAMUSCULAR INJECTION
1.
NAME OF THE MEDICINE
Meningococcal group C polysaccharide conjugate vaccine (tetanus toxoid
protein conjugate).
2.
QUALITATIVE AND QUANTITATIVE 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 hydrate (adjuvant).
For the full list of excipients, see Section 6.1 List of Excipients.
The manufacturer of this product includes exposure to bovine derived
materials. No evidence
exists that any case of vCJD (considered to be a human form of bovine
spongiform encephalitis)
has resulted from the administration of any vaccine product.
3.
PHARMACEUTICAL FORM
NeisVac-C vaccine is a sterile suspension in water for injection; thus
upon storage, a white
deposit and clear supernatant can be observed. After shaking, the
vaccine should be a
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.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
NeisVac-C vaccine is indicated for active immunisation of children
from 8 weeks of age,
adolescents and adults, for the prevention of invasive disease caused
by
_Neisseria meningitidis_
serogroup C.
4.2
DOSE AND METHOD OF ADMINISTRATION
GENERAL
The vaccine should be shaken thoroughly in order to obtain a
homogenous suspension. After
shaking, the vaccine should be a homogeneous semi-opaque white to
off-white suspension
.
It
should be inspected visually for particulate matter and discolouration
prior to administration
whenever solution and container permit. In the event of eit