Vaxneuvance Medication / Drug Information

Summary of Consumer Medicines Information (CMI)

The Full MIC on the next page contains more details. If you are worried about using this vaccine, talk to your doctor, nurse or pharmacist.
This vaccine is new or used differently. Please report side effects. To see the
Full MIC for more details.

Why am I being given VAXNEUVANCE?

VAXNEUVANCE is a vaccine given to help protect you against pneumococcal disease caused by 15 types of bacteria called Streptococcus pneumoniae or pneumococcus. VAXNEUVANCE can be given to people aged 18 and over.

What should I know before receiving VAXNEUVANCE?

Do not receive VAXNEUVANCE if you are allergic to any of the ingredients in VAXNEUVANCE listed at the end of the CMI, or to any vaccine containing diphtheria toxoid.

Tell your doctor if you have any other medical conditions, are taking any other medications, are pregnant or plan to become pregnant, or are breastfeeding.

What if I take other medications?

Some medicines can interfere with VAXNEUVANCE and affect how it works. Tell your doctor, nurse or pharmacist if you are taking, have recently taken or might take any other vaccines or medicines, including medicines obtained without a prescription.

How does VAXNEUVANCE give me?

A doctor or nurse will give you this vaccine as an injection into the muscle (preferably in the upper arm).

What should I know after receiving VAXNEUVANCE?

Things to do

Call your doctor right away if you have symptoms of an allergic reaction, which may include wheezing or difficulty breathing, swelling of the face, lips, or tongue, hives, or a rash.

Remind any doctor, nurse or pharmacist you see that VAXNEUVANCE has been given to you.

Driving or using machines

VAXNEUVANCE is not likely to affect your ability to drive or use machines.

Take care of your vaccine

It is unlikely that you will be asked to keep VAXNEUVANCE. If you are, store this vaccine in the refrigerator between 2°C and 8°C. Do not freeze this vaccine. Keep this vaccine in its original package until ready to administer.

Are there any side effects?

The most common side effects are pain, swelling or redness at the injection site, feeling tired, muscle pain, headache and joint pain. These side effects are usually mild and last for a short time.

This vaccine is subject to additional monitoring. This will allow new security information to be quickly identified. You can help by reporting any side effects you may experience. You can report side effects to your doctor or directly to www.tga.gov.au/reporting-problems .

15-valent pneumococcal conjugate vaccine [CRM197 Protein]absorbed

Consumer Drug Information (CMI)

This leaflet provides important information about obtaining VAXNEUVANCE. You should also speak to your doctor, nurse or pharmacist if you want any further information or if you have any concerns or questions about VAXNEUVANCE.

Where to find information in this brochure:

Why am I being given VAXNEUVANCE?

VAXNEUVANCE is a vaccine given to help protect you against pneumococcal disease caused by 15 types of bacteria called
Streptococcus pneumoniae

or pneumococcus. VAXNEUVANCE can be given to people aged 18 and over.

Pneumococcal disease refers to any disease caused by a pneumococcal disease. These bacteria can cause many types of disease, including lung infection (pneumonia), inflammation of the linings of the brain and spinal cord (meningitis), and severe blood infection (bacteremia). These illnesses are more likely to occur in older people and those with certain illnesses or behaviors such as smoking.

VAXNEUVANCE may not protect against diseases caused by types of pneumococci that are not covered by the vaccine.

What should I know before receiving VAXNEUVANCE?

Warnings

Do not receive VAXNEUVANCE if:

You are allergic to any of the ingredients in VAXNEUVANCE listed at the end of this leaflet, or to any vaccine containing diphtheria toxoid.

Always check the ingredients to make sure you can receive this vaccine.

See your doctor if you:

Have or have had other medical conditions or allergies.

If you have a weakened immune system (meaning your body is less able to fight infections) or if you are taking certain medicines that may weaken your immune system (eg immunosuppressants or steroids).

As with other vaccines, VAXNEUVANCE may not fully protect everyone who receives it.

You can get more information from your doctor, nurse or pharmacist, who has more detailed information.

After receiving VAXNEUVANCE, you may be at risk of developing certain side effects. It is important that you understand these risks and how to monitor them. See additional information in section 6. Are there any side effects?

Pregnancy and breastfeeding

Check with your doctor if you are pregnant or planning to become pregnant. They will tell you if you should receive VAXNEUVANCE.

Tell your doctor if you are breastfeeding or planning to breastfeed. They will tell you if you should receive VAXNEUVANCE.

Children

It has not yet been established whether VAXNEUVANCE can be administered to children and adolescents under 18 years of age.

What if I take other medications?

VAXNEUVANCE can be administered at the same time as the flu vaccine (inactivated flu).

Tell your doctor, nurse or pharmacist if you are taking, have recently taken or might take any other vaccines or medicines (eg, immunosuppressants or steroids that may weaken your immune system), including any medicines, vitamins or supplements that you buy without a prescription from your pharmacy, supermarket or health food store.

Check with your doctor, nurse, or pharmacist if you are unsure about any medications, vitamins, or supplements you are taking that affect VAXNEUVANCE.

How does VAXNEUVANCE give me?

How much will we give you

A doctor or nurse will give you this vaccine as an injection into the muscle (preferably in your upper arm).

Other vaccines can be given at the same time, but at a different site.

What should I know after receiving VAXNEUVANCE?

Things to do

Call your doctor right away if you:

Have symptoms of an allergic reaction, which may include wheezing or difficulty breathing, swelling of the face, lips or tongue, hives or a rash.

Remind any doctor, nurse or pharmacist you see that VAXNEUVANCE has been given to you.

Driving or using machines

VAXNEUVANCE is not likely to affect your ability to drive or use machines.

Take care of your vaccine

It is unlikely that you will be asked to keep VAXNEUVANCE. If you are:

Store this vaccine in the refrigerator at a temperature between 2°C and 8°C.

Do not freeze this vaccine.

Keep this vaccine in its original package until ready to administer.

Keep it where young children can’t reach it.

Get rid of any unwanted vaccines

You are unlikely to be asked to get rid of VAXNEUVANCE. However, if you no longer need this vaccine or it has expired, take it to any pharmacy for safe disposal.

Do not receive this vaccine after the expiry date.

Are there any side effects?

All medicines, including vaccines, can have side effects. If you experience side effects, most of them are minor and temporary. However, some side effects may require medical attention.

Review the information below and, if needed, ask your doctor, nurse or pharmacist if you have any further questions about side effects.

Less serious side effects

Serious side effects

Tell your doctor, nurse or pharmacist if you notice anything else that might make you feel unwell.

Other side effects not listed here may occur in some people.

Report side effects

After you have received medical advice for any side effects you experience, you may report side effects to Therapeutic Goods Administration online at www.tga.gov.au/reporting-problems . By reporting side effects, you can help provide more information about the safety of this vaccine.

Product details

This vaccine is only available with a doctor’s prescription.

What VAXNEUVANCE contains

active ingredient

(main ingredient)

Bacterial sugars from 15 types of pneumococci each bound to a protein (CRM197)* as active principle, adsorbed on aluminum (as aluminum phosphate adjuvant^).

Other ingredients

sodium chloride

Histidine

Polysorbates 20

Water for injections

*The sugars from these bacteria and proteins are not alive and do not cause disease.

^The adjuvant is included to help the vaccine work better.

VAXNEUVANCE does not contain any preservatives.

Do not get vaccinated if you are allergic to any of these ingredients.

What VAXNEUVANCE looks like

VAXNEUVANCE is an opalescent suspension for injection.

VAXNEUVANCE is available in a pre-filled syringe (AUST R 350791).

Who distributes VAXNEUVANCE

Merck Sharp & Dohme (Australia) Pty Limited

Level 1, Building A, 26 Talavera Road

Macquarie Park NSW 2113

CCPPI-V114-I-112020

CRM: 000014094-AU

This notice was written on January 17, 2022.

Copyright © (2021) Merck & Co., Inc., Kenilworth, NJ, USA, and its affiliates. All rights reserved.

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