Meningitec

Država: Novi Zeland

Jezik: engleski

Izvor: Medsafe (Medicines Safety Authority)

Aktivni sastojci:

Meningococcal oligosaccharide - Group C 10ug (conjugated with 5 mcg Diphtheria CRM 197 protein);  

Dostupno od:

Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics

INN (International ime):

Meningococcal oligosaccharide - Group C 10 µg (conjugated with 5 mcg Diphtheria CRM 197 protein)

Doziranje:

0.5 mL

Farmaceutski oblik:

Suspension for injection

Sastav:

Active: Meningococcal oligosaccharide - Group C 10ug (conjugated with 5 mcg Diphtheria CRM 197 protein)   Excipient: Aluminium phosphate Sodium chloride Water for injection

Jedinice u paketu:

Syringe, glass, 1s, 0.5 mL

Razred:

Prescription

Tip recepta:

Prescription

Proizveden od:

Crucell Switzerland AG

Terapijske indikacije:

Active immunisation of children from 6 weeks of age, adolescents and adults for the prevention of invasive disease caused by Neisseria meningitidis Serogroup C.

Proizvod sažetak:

Package - Contents - Shelf Life: Syringe, glass, 0.5mL - 1 dose units - 36 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light - Syringe, glass, 0.5mL - 10 dose units - 36 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light - Vial, glass, Ph Eur Type 1 - 3 mL - 36 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze)

Datum autorizacije:

2000-08-31

Uputa o lijeku

MENINGITEC
®

1 
MENINGITEC
®

_Meningococcal Serogroup C Conjugate Vaccine _
CONSUMER MEDICINE INFORMATION 

WHAT IS IN THIS LEAFLET 
This leaflet answers some common 
questions about Meningitec. It does 
not contain all the available 
information. It does not take the 
place of talking to your doctor or 
pharmacist. All medicines, including 
vaccines, have risks and benefits.  
Your doctor has weighed the risks of 
you or your child having Meningitec 
against the benefits they expect it 
will have. 
IF YOU HAVE ANY CONCERNS ABOUT THIS 
VACCINE, ASK YOUR DOCTOR, NURSE OR 
PHARMACIST. 
KEEP THIS LEAFLET. 
You may need to read it again. 
WHAT MENINGITEC IS 
USED FOR 
Meningitec is a vaccine used to help 
prevent meningococcal disease, an 
infection caused by the germ 
(bacteria) Neisseria meningitidis 
group C. The germ can cause 
meningitis, a serious brain infection 
that can cause death or brain damage 
and septicaemia, an infection of the 
blood.  Meningococcal disease is 
rare. It mainly occurs in children 
under 4 years of age and teenagers, 
but anyone can get it, especially if 
they have come into contact with 
someone who has meningococcal 
disease. 
Meningitec does not protect against 
all types of meningococcal disease or 
other germs that cause meningitis or 
septicaemia. It only works against 
Neisseria meningitidis Group C 
bacteria. Meningitec does not work 
against meningococcal disease 
caused by Neisseria meningitidis 
Group A, B, W, Y. 
HOW MENINGITEC WORKS 
Meningitec works by causing your 
body to produce its own protection 
against meningococcal disease.  It 
does this by making substances 
called antibodies in the blood. These 
antibodies fight the germ Neisseria 
meningitidis.  If a vaccinated person 
comes into contact with the germ, the 
body is usually rea

Svojstava lijeka

Version: pfdmenii11110 
Supersedes: Meningitec-PFS-DS-NZ-31Jul08M 
MOH Approved:  29 November 2010 
Commercial/Non-Commercial 
Page 1 of 9 
DATA SHEET 
MENINGITEC


0.5 ML 
MENINGOCOCCAL SEROGROUP C CONJUGATE VACCINE  
NAME OF MEDICINE 
Meningococcal Serogroup C Conjugate Vaccine 
DESCRIPTION  
Meningitec is a sterile, ready to use suspension for intramuscular injection. It contains  _Neisseria meningitidis_ 
(meningococcal) Serogroup C oligosaccharide conjugated to _Corynebacterium diphtheriae_ CRM
197
 protein.  
CRM
197
 is a non-toxic variant of diphtheria toxin isolated from cultures of _Corynebacterium diphtheriae_ strain 
C7 (

 197). 
The manufacture of this product includes exposure to bovine derived materials. No evidence exists that any case 
of  vCJD  (considered  to  be  the  human  form  of  bovine  spongiform  encephalopathy)  has  resulted  from  the 
administration of any vaccine product. 
ACTIVE INGREDIENTS 
Each  0.5mL  dose  contains  10µg  _Neisseria  meningitidis_  Serogroup  C  oligosaccharide  (MnCO)  conjugated  to 
approximately 15µg _Corynebacterium diphtheriae_ CRM
197
 carrier protein.  
EXCIPIENTS  
Aluminium phosphate 
Sodium chloride 
Water for injections 
PHARMACOLOGY  
_Neisseria  meningitidis_  can  cause  severe  systemic  infections,  including  meningitis  and  septicaemia.  The 
incidence of meningococcal disease in Australia is highest in infants under 4 years of age. The next highest risk 
group  is  young  people  aged  15-19  years.  Whilst  the  incidence  is  greatest  in  the  under  4’s,  mortality  for 
Serogroup C disease is highest in the teenage years. 
Vaccination  with  meningococcal  polysaccharides  induces  the  production  of  bactericidal  antibodies  that  are 
s