Prevenar 13

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

Pneumococcal purified capsular polysaccharides

Available from:

Pfizer Australia Pty Ltd

Class:

Medicine Registered

Patient Information leaflet

PREVENAR 13
®

_Pneumococcal polysaccharide conjugate vaccine, 13-valent adsorbed_
CONSUMER MEDICINE INFORMATION

WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Prevenar 13. 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 you or your
child receiving Prevenar 13 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 13 IS
USED FOR
Prevenar 13 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 13 is usually recommended
for use in babies and children from 6
weeks to 17 years of age, or in adults
50 year and older. Prevenar 13 is a
mixture of the outer sugar coating
(polysaccharide) from 13 different
strains or serotypes of bacteria called
Streptococcus pneumoniae. Each
serotype is joined to a non-toxic
protein to make it work more
effectively. 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 you
or your child to have an ear
operation).
Prevenar 13 can protect against 13 of
the strains of Streptococcus
pneumoniae that can cause these
diseases. Prevenar 13 does not
replace the need for vaccination with
Haemophilus influenzae type b (Hib)
or meningococcal vaccines that
protect against other important
causes of meningitis.
You cannot catch any of the above
diseases from the vaccine itself,
because it is not made with li

Summary of Product characteristics

 
Version: pfppreei10813

Supersedes: pfppreei10613 

Page 1 of 21

PRODUCT INFORMATION 
Prevenar 13
®

NAME OF THE MEDICINE 
Prevenar 13 
Pneumococcal polysaccharide conjugate vaccine, 13-valent adsorbed 
DESCRIPTION 
The  vaccine  is  a  ready  to  use  homogeneous  white  suspension  for  intramuscular  injection, 
supplied as a pre-filled syringe. 
_ACTIVE INGREDIENTS_ 
Each 0.5 mL dose contains: 
2.2 µg  of  pneumococcal  purified  capsular  polysaccharides  for  serotypes  1,  3,  4,  5,  6A,  7F,  9V, 
14, 18C, 19A, 19F and 23F 
4.4 µg of pneumococcal purified capsular polysaccharides for
serotype 6B. 
Each serotype is individually conjugated to non-toxic diphtheria CRM
197
 protein and adsorbed on 
aluminium phosphate (0.565 mg). 
_EXCIPIENTS _
Succinic acid, polysorbate 80, aluminium phosphate,
sodium chloride in 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 including otitis media and
sinusitis.  
_INFANTS AND CHILDREN LESS THAN 5 YEARS OF AGE_ 
Based  on  serotype  surveillance  performed  before  the  introduction  of  Prevenar,  Prevenar  13  is 
estimated  to  cover  93.3%  of  serotypes  causing  IPD  (Invasive  Pneumococcal  Disease)  among 
children  less  than  5  years  of  age  in  Australia  (Watson  M.  et  al.,  _Communicable  Disease _
_Intelligence_  2004;  28(4):  455-464)  and