PREVENAR 13 pneumococcal polysaccharide conjugate vaccine 13 valent adsorbed 0.5 mL syringe

Țară: Australia

Limbă: engleză

Sursă: Department of Health (Therapeutic Goods Administration)

Ingredient activ:

Pneumococcal purified capsular polysaccharides, Quantity: 2.2 microgram; Pneumococcal purified capsular polysaccharides, Quantity: 4.4 microgram

Disponibil de la:

Pfizer Australia Pty Ltd

INN (nume internaţional):

Pneumococcal purified capsular polysaccharides

Forma farmaceutică:

Injection, suspension

Compoziție:

Excipient Ingredients: aluminium phosphate; water for injections; polysorbate 80; Diphtheria CRM197 protein; succinic acid; sodium chloride

Calea de administrare:

Intramuscular

Unități în pachet:

10, 1

Tip de prescriptie medicala:

(S4) Prescription Only Medicine

Indicații terapeutice:

Active immunisation for the prevention of pneumococcal disease caused by Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F in adults and children aged more than 6 weeks of age. The use of Prevenar 13 should be guided by official recommendations.

Rezumat produs:

Visual Identification: Homogenous white suspension.; Container Type: Syringe; Container Material: Glass Type I Clear; Container Life Time: 36 Months; Container Temperature: Store at 2 to 8 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Statutul autorizaţiei:

Registered

Data de autorizare:

2010-03-29

Prospect

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 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 live or
whole bacteria.
As with all vaccines, 100%
protection against the above diseases
cannot be guaranteed.
BEFORE YOU OR YOUR
CHILD IS GIVEN
PREV

Caracteristicilor produsului

Version: pfppreei10820
Supersedes: pfppreei10719
Page 1 of 34
AUSTRALIAN PRODUCT INFORMATION - PREVENAR 13
®
(PNEUMOCOCCAL POLYSACCHARIDE CONJUGATE VACCINE, 13-VALENT
ADSORBED)
1.
NAME OF THE MEDICINE
Prevenar 13: Pneumococcal polysaccharide conjugate vaccine, 13-valent
adsorbed
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
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).
For the full list of excipients, see Section 6.1 List of Excipients.
3.
PHARMACEUTICAL FORM
Prevenar 13 is a ready to use homogeneous white suspension for
intramuscular injection
(0.5 mL), supplied as a pre-filled syringe.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Active immunisation for the prevention of pneumococcal disease caused
by
_Streptococcus _
_pneumoniae _
serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F in
adults and
children aged more than 6 weeks of age.
The use of Prevenar 13 should be guided by official recommendations.
4.2
DOSE AND METHOD OF ADMINISTRATION
The dose of Prevenar 13 is 0.5 mL given intramuscularly only, with
care to avoid injection into or
near nerves and blood vessels. The preferred sites are anterolateral
aspect of the thigh (vastus
lateralis muscle) in infants or the deltoid muscle of the upper arm in
children and adults.
Do not administer Prevenar 13 intravascularly or into the gluteal
area. Do not administer
Prevenar 13 intravenously, subcutaneously or intradermally, since the
safety and immunogenicity
of these routes have not been evaluated.
Upon storage, a white deposit and clear supernatant can be observed.
The vaccine should be well
shaken to obtain a homogeneous white suspension and be inspected
visually for any particulate
Version: pfppreei10820
Supersedes: pfppree