Consumer medicine information

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) from certain infectious diseases.
For more information, see Section 1. Why am I being given 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 or clinic nurse if your child being vaccinated was born prematurely. 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 or thigh. 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. Dosing in children is based on their age.

5. What should I know after given PREVENAR 20?

6. Are there any side effects?

Like all vaccines, PREVENAR 20 may cause unwanted side effects.
Common side effects of PREVENAR 20 are local reaction around the injection site such as tenderness or pain, redness, swelling or the formation of hard lumps or scars, headache, fatigue, fever, joint or muscle pain. Serious side effects include allergic reactions.
For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.

1 Name of 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 microgram;
Pneumococcal polysaccharide serotype 3^1,2 2.2 microgram;
Pneumococcal polysaccharide serotype 4^1,2 2.2 microgram;
Pneumococcal polysaccharide serotype 5^1,2 2.2 microgram;
Pneumococcal polysaccharide serotype 6A^1,2 2.2 microgram;
Pneumococcal polysaccharide serotype 6B^1,2 4.4 microgram;
Pneumococcal polysaccharide serotype 7F^1,2 2.2 microgram;
Pneumococcal polysaccharide serotype 8^1,2 2.2 microgram;
Pneumococcal polysaccharide serotype 9V^1,2 2.2 microgram;
Pneumococcal polysaccharide serotype 10A^1,2 2.2 microgram;
Pneumococcal polysaccharide serotype 11A^1,2 2.2 microgram;
Pneumococcal polysaccharide serotype 12F^1,2 2.2 microgram;
Pneumococcal polysaccharide serotype 14^1,2 2.2 microgram;
Pneumococcal polysaccharide serotype 15B^1,2 2.2 microgram;
Pneumococcal polysaccharide serotype 18C^1,2 2.2 microgram;
Pneumococcal polysaccharide serotype 19A^1,2 2.2 microgram;
Pneumococcal polysaccharide serotype 19F^1,2 2.2 microgram;
Pneumococcal polysaccharide serotype 22F^1,2 2.2 microgram;
Pneumococcal polysaccharide serotype 23F^1,2 2.2 microgram;
Pneumococcal polysaccharide serotype 33F^1,2 2.2 microgram.
¹Conjugated to diptheria CRM₁₉₇ protein (approximately 51 microgram per dose).
²Adsorbed 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.

4 Clinical Particulars

4.9 Overdose

Overdose with Prevenar 20 is unlikely due to its presentation as a single dose pre-filled syringe. In the event of overdose, monitoring of vital functions and possible symptomatic treatment is recommended.
For information on the management of overdose, contact the Poisons Information Centre on 131126 (Australia).

5 Pharmacological Properties

5.3 Preclinical Safety Data

Genotoxicity. Prevenar 20 has not been tested for genotoxic potential.
Carcinogenicity. Prevenar 20 has not been tested for carcinogenic potential.

6 Pharmaceutical Particulars

6.7 Physicochemical Properties

No data available.

7 Medicine Schedule (Poisons Standard)

S4 - Prescription Only Medicine.

Summary Table of Changes

https://stagingapi.mims.com/au/public/v2/images/fulltablegif/PRVTWEST.gif