Prevenar 13

Land: New Zealand

Språk: engelsk

Kilde: Medsafe (Medicines Safety Authority)

Aktiv ingrediens:

Pneumococcal polysaccharide serotype 1 2.2ug (conjugated with Diphtheria CRM 197 protein); Pneumococcal polysaccharide serotype 14 2.2ug (conjugated with Diphtheria CRM 197 protein); Pneumococcal polysaccharide serotype 18C 2.2ug (conjugated with Diphtheria CRM 197 protein); Pneumococcal polysaccharide serotype 19A 2.2ug (conjugated with Diphtheria CRM 197 protein); Pneumococcal polysaccharide serotype 19F 2.2ug (conjugated with Diphtheria CRM 197 protein); Pneumococcal polysaccharide serotype 23F 2.2ug (conjugated with Diphtheria CRM 197 protein); Pneumococcal polysaccharide serotype 3 2.2ug (conjugated with Diphtheria CRM 197 protein); Pneumococcal polysaccharide serotype 4 2.2ug (conjugated with Diphtheria CRM 197 protein); Pneumococcal polysaccharide serotype 5 2.2ug (conjugated with Diphtheria CRM 197 protein); Pneumococcal polysaccharide serotype 6A 2.2ug (conjugated with Diphtheria CRM 197 protein); Pneumococcal polysaccharide serotype 6B 4.4ug (conjugated with Diphtheria CRM 197 protein); Pneumococcal polysaccharide serotype 7F 2.2ug (conjugated with Diphtheria CRM 197 protein); Pneumococcal polysaccharide serotype 9V 2.2ug (conjugated with Diphtheria CRM 197 protein)

Tilgjengelig fra:

Pfizer New Zealand Limited

INN (International Name):

Pneumococcal polysaccharide serotype 6A 2.2 µg (conjugated with Diphtheria CRM 197 protein)

Dosering :

0.5 mL

Legemiddelform:

Suspension for injection

Sammensetning:

Active: Pneumococcal polysaccharide serotype 1 2.2ug (conjugated with Diphtheria CRM 197 protein) Pneumococcal polysaccharide serotype 14 2.2ug (conjugated with Diphtheria CRM 197 protein) Pneumococcal polysaccharide serotype 18C 2.2ug (conjugated with Diphtheria CRM 197 protein) Pneumococcal polysaccharide serotype 19A 2.2ug (conjugated with Diphtheria CRM 197 protein) Pneumococcal polysaccharide serotype 19F 2.2ug (conjugated with Diphtheria CRM 197 protein) Pneumococcal polysaccharide serotype 23F 2.2ug (conjugated with Diphtheria CRM 197 protein) Pneumococcal polysaccharide serotype 3 2.2ug (conjugated with Diphtheria CRM 197 protein) Pneumococcal polysaccharide serotype 4 2.2ug (conjugated with Diphtheria CRM 197 protein) Pneumococcal polysaccharide serotype 5 2.2ug (conjugated with Diphtheria CRM 197 protein) Pneumococcal polysaccharide serotype 6A 2.2ug (conjugated with Diphtheria CRM 197 protein) Pneumococcal polysaccharide serotype 6B 4.4ug (conjugated with Diphtheria CRM 197 protein) Pneumococcal polysaccharide serotype 7F 2.2ug (conjugated with Diphtheria CRM 197 protein) Pneumococcal polysaccharide serotype 9V 2.2ug (conjugated with Diphtheria CRM 197 protein) Excipient: Aluminium phosphate Polysorbate 80 Sodium chloride Succinic acid Water for injection

Enheter i pakken:

Syringe, glass, 1 x type 1 borosilicate glass, latex-free chlorobutyl rubber plunger stop, 0.5 mL

Klasse:

Prescription

Resept typen:

Prescription

Produsert av:

Wyeth Biopharma, Division of Wyeth Pharmaceuticals Inc., a Subsidiary of Pfizer Inc.

Indikasjoner:

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.

Produkt oppsummering:

Package - Contents - Shelf Life: Syringe, glass, 1 x type 1 borosilicate glass, latex-free chlorobutyl rubber plunger stop - 0.5 mL - 36 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light 4 days not refrigerated stored at or below 25°C. After storage outside refrigeration product should be used or discarded. - Syringe, glass, 10 x type 1 borosilicate glass, latex-free chlorobutyl rubber plunger stop - 5 mL - 36 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light 4 days not refrigerated stored at or below 25°C. After storage outside refrigeration product should be used or discarded.

Autorisasjon dato:

2009-01-20

Informasjon til brukeren

PREVENAR 13
®
1
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
C

Preparatomtale

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Supersedes: pfdpreei10719
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NEW ZEALAND DATA SHEET
1.
PRODUCT NAME
PREVENAR 13

: Pneumococcal polysaccharide conjugate vaccine, 13-valent adsorbed
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Prevenar 13 consists of a combination of 13 capsular polysaccharide
antigens of
_Streptococcus _
_pneumoniae_
serotypes. Each serotype is a purified polysaccharide from a
fermentation process,
individually conjugated to non-toxic plasmid-derived
_diphtheria_
CRM
197
protein and adsorbed on
aluminium phosphate (0.565 mg).
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.
For the full list of excipients, see section 6.1.
3
PHARMACEUTICAL FORM
Prevenar 13 is presented as a suspension in 0.5 mL.
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.
Version: pfdpreei10921
Supersedes: pfdpreei10719
Page 2 of 33
Upon storage, a white deposit and clear supernatan