Prevenar

Ülke: Yeni Zelanda

Dil: İngilizce

Kaynak: Medsafe (Medicines Safety Authority)

Aktif bileşen:

Pneumococcal polysaccharide serotype 14 2ug (conjugated with Diphtheria CRM 197 protein); Pneumococcal polysaccharide serotype 18C 2ug (conjugated with Diphtheria CRM 197 protein); Pneumococcal polysaccharide serotype 19F 2ug (conjugated with Diphtheria CRM 197 protein); Pneumococcal polysaccharide serotype 23F 2ug (conjugated with Diphtheria CRM 197 protein); Pneumococcal polysaccharide serotype 4 2ug (conjugated with Diphtheria CRM 197 protein); Pneumococcal polysaccharide serotype 6B 4ug (conjugated with Diphtheria CRM 197 protein); Pneumococcal polysaccharide serotype 9V 2ug (conjugated with Diphtheria CRM 197 protein)

Mevcut itibaren:

Pfizer New Zealand Limited

INN (International Adı):

Pneumococcal polysaccharide type 14 2 µg (conjugated with Diphtheria CRM 197 protein)

Doz:

0.5 mL

Farmasötik formu:

Suspension for injection

Kompozisyon:

Active: Pneumococcal polysaccharide serotype 14 2ug (conjugated with Diphtheria CRM 197 protein) Pneumococcal polysaccharide serotype 18C 2ug (conjugated with Diphtheria CRM 197 protein) Pneumococcal polysaccharide serotype 19F 2ug (conjugated with Diphtheria CRM 197 protein) Pneumococcal polysaccharide serotype 23F 2ug (conjugated with Diphtheria CRM 197 protein) Pneumococcal polysaccharide serotype 4 2ug (conjugated with Diphtheria CRM 197 protein) Pneumococcal polysaccharide serotype 6B 4ug (conjugated with Diphtheria CRM 197 protein) Pneumococcal polysaccharide serotype 9V 2ug (conjugated with Diphtheria CRM 197 protein) Excipient: Aluminium phosphate Sodium chloride Water for injection

Paketteki üniteler:

Syringe, glass, Type 1, 0.5 mL

Sınıf:

Prescription

Reçete türü:

Prescription

Tarafından üretildi:

Wyeth Pharmaceutical Division of Wyeth Holdings LLC

Ürün özeti:

Package - Contents - Shelf Life: Syringe, glass, Type 1 - 0.5 mL - 48 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) - Vial, glass, Type 1 - 0.5 mL - 36 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze)

Yetkilendirme tarihi:

2000-02-11

Bilgilendirme broşürü

PREVENAR
®

1 
PREVENAR
®

_Pneumococcal conjugate vaccine, 7-valent _
CONSUMER MEDICINE INFORMATION 

WHAT IS IN THIS LEAFLET 
This leaflet answers some common 
questions about Prevenar.   It does 
not contain all the available 
information.   It does not take the 
place of talking to your doctor, clinic 
nurse or pharmacist. 
All vaccinations have benefits and 
risks.  Your doctor or clinic nurse has 
weighed the risks of your child 
receiving Prevenar against the 
benefits this vaccination is expected 
to provide. 
IF YOU HAVE ANY QUESTIONS ABOUT 
THIS VACCINATION, ASK YOUR DOCTOR, 
CLINIC NURSE OR PHARMACIST. 
KEEP THIS LEAFLET.  YOU MAY NEED TO 
READ IT AGAIN. 
WHAT PREVENAR IS USED 
FOR 
Prevenar is a vaccine, which is a type 
of medicine that helps to protect 
(immunise) people from certain 
infectious diseases.  It does this by 
preparing the body's defences to fight 
the infection, before you catch the 
bacteria or virus. 
Prevenar is usually recommended for 
use in babies and young children 
from 6 weeks to 9 years of age. 
Prevenar is a mixture of the outer 
sugar coating (polysaccharide) from 
7 different strains or serotypes of 
bacteria called Streptococcus 
pneumoniae. Each serotype is joined 
to a non-toxic protein to make it 
work more effectively in babies and 
young children. Prevenar is not 
recommended for use in adults or in 
children older than 9 years of age. 
Streptococcus pneumoniae bacteria 
are one of the causes of 
•  meningitis (a serious brain 
infection that could cause death 
or brain damage) 
•  bacteraemia (infection of the 
blood) 
•  pneumonia 
•  otitis media (an ear infection that 
can cause pain and temporary 
hearing loss and may require your 
child to have an ear operation). 
Prevenar can protect against 7 of the 
strains of S

Ürün özellikleri

 
Version: pfdprevi11110 
Supersedes: Prevenar-PFS-DS-NZ-10Nov08M 
MOH Approved:  29 November 2010  
Commercial/Non-Commercial 
Page 1 of 9 
DATA SHEET

PREVENAR


NAME OF VACCINE 
Pneumococcal conjugate vaccine, 7-valent. 
DESCRIPTION  
Prevenar is a sterile, ready to use suspension for intramuscular injection. It contains saccharides of 
the capsular antigen of _Streptococcus pneumoniae_ (pneumococcus) serotypes 4, 6B, 9V, 14, 18C, 
19F and 23F individually conjugated to diphtheria CRM
197
 protein. CRM
197
 is a non-toxic variant 
of diphtheria toxin isolated from cultures of _Corynebacterium diphtheriae _strain_ _C7_ _(

 197)_ _and/or_ _
_Corynebacterium diphtheriae _strain C7 (

 197) pPx 3520_. _

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 0.5 mL dose contains 2 micrograms of saccharide for serotypes 4, 9V, 14, 18C, 19F and 23F 
and 4 micrograms of serotype 6B per dose (16 micrograms total saccharide) conjugated to CRM
197

carrier protein and adsorbed on aluminium phosphate (0.5 mg). 

_EXCIPIENTS  _
Aluminium phosphate 
Sodium chloride 
Water for injections 
PHARMACOLOGY  
_Streptococcus pneumoniae_ is an important cause of morbidity and mortality in persons of all ages 
worldwide. It is a leading cause of death and illness in infants, among the elderly, and in persons 
who  have  certain  underlying  medical  conditions.  The  organism  causes  invasive  infections, 
including bacteraemia and meningitis, pneumonia and other lower respiratory tract infections, and 
upper respiratory tract infections incl