Prevenar 20 pneumococcal polysaccharide conjugate vaccine

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

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

Available from:

Pfizer Australia Pty Ltd

Pharmaceutical form:

Injection, suspension

Composition:

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

Administration route:

Intramuscular

Units in package:

1, 10

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Active immunisation for the prevention of pneumococcal disease caused by Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, and 33F in individuals from 6 weeks of age and older.,PREVENAR 20 may not prevent disease caused by S. pneumoniae serotypes that are not contained in the vaccine.,PREVENAR 20 should be used in accordance with official recommendations.

Product summary:

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

Authorization status:

Registered

Authorization date:

2022-12-02

Patient Information leaflet

PREVENAR 20
®
P
R
E
V
E
N
A
R
2
0
®
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
▼
This medicine is new or being used in a different way. Please report
side effects. See the full CMI for further details.
1.
WHY AM I BEING GIVEN PREVENAR 20?
PREVENAR 20 contains the active ingredient Pneumococcal polysaccharide
conjugate vaccine (20-valent, adsorbed). PREVENAR
20 is a vaccine, which is a type of medicine. PREVENAR 20 helps to
protect (immunise) adults from certain infectious diseases.
For more information, see Section 1. Why am I getting PREVENAR 20? in
the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I AM GIVEN PREVENAR 20?
Do not use if you have ever had an allergic reaction to pneumococcal
or diphtheria vaccines, or any of the ingredients listed at the
end of this CMI; Tell your doctor if you have a a fever or infection
requiring a visit to the doctor; Tell your doctor or clinic nurse if
you
are having anti-cancer therapy or have an HIV infection or any other
condition that affects the immune response; Tell your doctor
if you have any other disease or medical conditions, take any other
medicines, or are pregnant or plan to become pregnant or are
breastfeeding.
For more information, see Section 2. What should I know before I am
given PREVENAR 20? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Tell your doctor or nurse if you are taking any other medicines,
including medicines you buy without a prescription from a pharmacy,
supermarket or health food shop, or if you have recently been given
any other vaccine.
For more information, see Section 3. What if I am taking other
medicines? in the full CMI.
4.
HOW IS PREVENAR 20 GIVEN?
•
A doctor or a nurse will give the PREVENAR 20 injection. The dose is
injected into a muscle in the upper arm. Other vaccines
might be given at the same time, but not at the same injection site.
•
Adults (18 years and older) are given one single dose.

Summary of Product characteristics

Version: pfpprvni11222
Supersedes: n/a
Page 1 of 22
This vaccine is subject to additional monitoring
IN AUSTRALIA
. This will allow quick
identification of new safety information. Healthcare professionals are
asked to report any
suspected adverse events at www.tga.gov.au/reporting-problems.
AUSTRALIAN
PRODUCT
INFORMATION
–
PREVENAR
20
®
(PNEUMOCOCCAL
POLYSACCHARIDE
CONJUGATE, 20-VALENT ADSORBED) VACCINE
1.
NAME OF THE MEDICINE
Pneumococcal polysaccharide conjugate vaccine (20-valent, adsorbed)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
One dose (0.5 mL) contains:
Pneumococcal polysaccharide serotype 1
1,2
2.2 µg
Pneumococcal polysaccharide serotype 3
1,2
2.2 µg
Pneumococcal polysaccharide serotype 4
1,2
2.2 µg
Pneumococcal polysaccharide serotype 5
1,2
2.2 µg
Pneumococcal polysaccharide serotype 6A
1,2
2.2 µg
Pneumococcal polysaccharide serotype 6B
1,2
4.4 µg
Pneumococcal polysaccharide serotype 7F
1,2
2.2 µg
Pneumococcal polysaccharide serotype 8
1,2
2.2 µg
Pneumococcal polysaccharide serotype 9V
1,2
2.2 µg
Pneumococcal polysaccharide serotype 10A
1,2
2.2 µg
Pneumococcal polysaccharide serotype 11A
1,2
2.2 µg
Pneumococcal polysaccharide serotype 12F
1,2
2.2 µg
Pneumococcal polysaccharide serotype 14
1,2
2.2 µg
Pneumococcal polysaccharide serotype 15B
1,2
2.2 µg
Pneumococcal polysaccharide serotype 18C
1,2
2.2 µg
Pneumococcal polysaccharide serotype 19A
1,2
2.2 µg
Pneumococcal polysaccharide serotype 19F
1,2
2.2 µg
Pneumococcal polysaccharide serotype 22F
1,2
2.2 µg
Pneumococcal polysaccharide serotype 23F
1,2
2.2 µg
Pneumococcal polysaccharide serotype 33F
1,2
2.2 µg
1
Conjugated to diptheria CRM
197
protein (approximately 51 µg per dose)
2
Adsorbed on aluminium phosphate (0.125 mg aluminium per dose)
For the full list of excipients, see section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
Suspension for injection.
The vaccine is a homogeneous white suspension.
▼

Version: pfpprvni11222
Supersedes: n/a
Page 2 of 22
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Active immunis