NeisVac-C

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Neisseria meningitidis Group C polysaccharide 10ug (polysaccharide antigen from strain C11, conjugated to tetanus toxoid)

Available from:

Pfizer New Zealand Limited

INN (International Name):

Neisseria meningitidis Group C polysaccharide 10 µg (polysaccharide antigen from strain C11)

Dosage:

10 mcg/0.5mL

Pharmaceutical form:

Suspension for injection

Composition:

Active: Neisseria meningitidis Group C polysaccharide 10ug (polysaccharide antigen from strain C11, conjugated to tetanus toxoid) Excipient: Aluminium hydroxide Sodium chloride Tetanus toxoid Water for injection

Units in package:

Syringe, glass, single dose, 1 dose unit

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Pfizer Manufacturing Austria GmbH

Therapeutic indications:

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:

Package - Contents - Shelf Life: Syringe, glass, single dose - 1 dose units - 42 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze). Can include 9 months at up to 25°C, but no return to refrigeration - Syringe, glass, single dose - 10 dose units - 42 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze). Can include 9 months at up to 25°C, but no return to refrigeration - Syringe, glass, single dose - 20 dose units - 42 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze). Can include 9 months at up to 25°C, but no return to refrigeration

Authorization date:

2003-10-02

Patient Information leaflet

NeisVac-C
®
1
NEISVAC-C®
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1.
WHY AM I USING NEISVAC-C?
NeisVac-C is a vaccine used to help prevent invasive meningococcal
disease caused by bacteria called _Neisseria meningitidis_ group
C for people from 8 weeks of age.
For more information, see Section 1. Why am I using NeisVac-C? in the
full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE NEISVAC-C?
Do not use if you have ever had an allergic reaction to any
vaccination or any of the ingredients listed at the end of the CMI.
Talk to your doctor if you have any other medical conditions, take any
other medicines, or are pregnant or plan to become
pregnant or are breastfeeding.
For more information, see Section 2. What should I know before I use
NeisVac-C? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with NeisVac-C and affect how it works.
A list of these medicines is in Section 3. What if I am taking other
medicines? in the full CMI.
4.
HOW DO I USE NEISVAC-C?
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.
More instructions can be found in Section 4. How do I use NeisVac-C?
in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING NEISVAC-C?
THINGS YOU
SHOULD DO
•
Tell your doctor or nurse if you or your child have been given other
vaccines.
•
Tell your doctor or nurse if you are pregnant or plan to become
pregnant or are breast-feeding.
THINGS YOU
SHOULD NOT DO
•
Vaccination should not be given to an infant under 8 weeks of age.
•
Do not withhold any information from your treating health
professional.
LOOKING AFTER
YOUR MEDICINE
If you are required to store Neisvac-C:
•
Keep NeisVac-C stored at 2°C to 8°C (in a refrigerator). Do not
freeze.
•
Store it in a cool, dry place away from moisture, heat or sunlight.
•
NeisVac-C can be stored out of t

Summary of Product characteristics

Version: pfdneisi11218
Supersedes: pfdneisi10415
Page 1 of 13
NEW ZEALAND DATA SHEET
1.
PRODUCT NAME
NEISVAC-C
®
Meningococcal group C polysaccharide conjugate vaccine (tetanus toxoid
protein conjugate)
suspension for injection.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE INGREDIENTS
_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.
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.
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.
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 immunisa