II I

FAA184619

191

Package Leaflet: Information for the user

▼ This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects.

Read all of this leaflet carefully before you receive this vaccine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, pharmacist or nurse.
• This vaccine has been prescribed for you only. Do not pass it on to others.
• If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

• 1. What Apexxnar is and what it is used for

• 2. What you need to know before you receive Apexxnar

• 3. How Apexxnar is given

• 4. Possible side effects

• 5. How to store Apexxnar

• 6. Contents of the pack and other information

1. what apexxnar is and what it is used for

Apexxnar is a pneumococcal vaccine given to:

• individuals aged 18 years and older to help prevent disease such as: pneumonia (lung infection), sepsis or bacteraemia (bacteria in the blood stream) and meningitis (inflammation around the brain) caused by 20 types of the bacteria Streptococcus pneumoniae.

Apexxnar provides protection against 20 types of Streptococcus pneumoniae bacteria.

The vaccine works by helping the body to make its own antibodies, which protect you against these diseases.

2. what you need to know before you receive apexxnar

O Apexxnar should not be given

• if you are allergic (hypersensitive) to the active substances or to any of the other ingredients in this medicine (listed in section 6), or to any other vaccine that contains diphtheria toxoid.

O Warnings and precautions

Talk to your doctor, pharmacist or nurse before the vaccination if you:

• have any present or past medical problems after any dose of Apexxnar such as an allergic reaction or problems with breathing,
• have a severe illness or high fever. However, a mild fever or upper respiratory infection (for example having a cold) itself is not a reason to delay vaccination,
• have any bleeding problems or bruise easily,
• have a weakened immune system (such as due to HIV infection); you may not get the full benefit from Apexxnar.

As with any vaccine, Apexxnar will not protect all persons who are vaccinated.

O Other medicines/vaccines and Apexxnar

Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicines, or have recently received any other vaccine.

O Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before receiving this vaccine.

O Driving and using machines

Apexxnar has no or negligible influence on the ability to drive and use machines. However, some of the effects mentioned under section 4 “Possible side effects” may temporarily affect the ability to drive or use machines.

O Apexxnar contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium-free’.

• 3. How Apexxnar is given

The doctor or nurse will inject the recommended dose (0.5 mL) of the vaccine into your arm.

You should receive 1 injection.

Tell your doctor, pharmacist or nurse if you have been given a pneumococcal vaccine before.

If you have any further questions on the use of Apexxnar, ask your doctor, pharmacist or nurse.

4. possible side effects

Like all vaccines, Apexxnar can cause side effects, although not everybody gets them.

O Serious side effects

• Tell your doctor immediately if you notice signs of the following serious side effect (see also section 2): swelling of the face, lips, mouth, tongue or throat (oedema), shortness of breath (dyspnoea), wheezing (bronchospasm) – these may by signs of a severe allergic reaction such as anaphylaxis, including shock.

O Other side effects

Very common: may occur with more than 1 in 10 doses of the vaccine

• Headache.
• Joint pain and muscle pain.
• Pain/tenderness at injection site and tiredness.

Common: may occur up to 1 in 10 doses of the vaccine

• Swelling at injection site, redness at injection site and fever.

Uncommon: may occur up to 1 in 100 doses of the vaccine

• Diarrhoea, nausea, and vomiting.
• Rash and swelling of the face, lips, mouth, tongue or throat, which may cause difficulty in swallowing or breathing (angioedema).
• Itching at injection site, swollen glands in the neck, armpit or groin (lymphadenopathy), hives at the injection site (urticaria), and chills.

O The following side effects were seen with Prevenar 13 and may also be seen with Apexxnar:

• A rash causing itchy red blotches (erythema multiforme).
• Irritation at injection site.
• Decreased appetite.
• Limitation of arm movement.

O Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

5. how to store apexxnar

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton and label after EXP. The expiry date refers to the last day of that month.

Store in a refrigerator (2 °C to 8 °C).

Apexxnar should be used as soon as possible after being removed from refrigeration.

Do not freeze. Discard if vaccine has been frozen.

Stability data indicate that the vaccine is stable for 96 hours when stored at temperatures from 8 °C to 25 °C, or 72 hours when stored at temperatures from 0 °C to 2 °C. At the end of these time periods Apexxnar should be used or discarded. These data are intended to guide healthcare professionals in case of temporary temperature excursion only.

Pre-filled syringes should be stored in the refrigerator horizontally to minimise the resuspension time.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. contents of the pack and other informationo what apexxnar containsthe active substances are polysaccharide crm197 conjugates consisting of:

• 2.2 micrograms of polysaccharide for serotypes 1, 3, 4, 5, 6A, 7F, 8, 9V, 10A, 11 A, 12F, 14,15B.18C, 19A, 19R 22R 23Fand 33R
• 4.4 micrograms of polysaccharide for serotype 6B.

One dose (0.5 mL) contains approximately 51 micrograms CRM197 carrier protein, adsorbed on aluminium phosphate (0.125 mg aluminium).

The other ingredients are sodium chloride, succinic acid, polysorbate 80 and water for injections.

O What Apexxnar looks like and contents of the pack

The vaccine is a white suspension for injection, provided in a single-dose, pre-filled syringe (0.5 mL). It is provided in pack sizes of 1 and 10, with or without needles, and

Marketing Authorisation Holder:

Pfizer Limited Ramsgate Road Sandwich, Kent CT13 9NJ

United Kingdom

Manufacturer responsible for batch release:

Pfizer Manufacturing

Belgium N.V.

Rijksweg 12 2870 Puurs

Belgium

For any information about this medicine, please contact: Medical Information, Pfizer Ltd, Walton Oaks, Dorking Road, Tadworth, Surrey, KT20 7NS.

Telephone 01304 616161.

This leaflet was last revised in <{MM/YYYY}>.

Ref: PE 1_0

O The following information is intended for healthcare professionals only:

During storage, a white deposit and clear supernatant may be observed. This does not constitute a sign of deterioration. Pre-filled syringes should be stored horizontally to minimise the resuspension time.

Preparation for administration

Apexxnar® suspension for injection pneumococcal polysaccharide conjugate vaccine (20-valent, adsorbed)

PAA184620

020

Package Leaflet: Information for the user

This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects.

Read all of this leaflet carefully before you receive this vaccine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, pharmacist or nurse.
• This vaccine has been prescribed for you only. Do not pass it on to others.
• If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

• 1. What Apexxnar is and what it is used for

• 2. What you need to know before you receive Apexxnar

• 3. How Apexxnar is given

• 4. Possible side effects

• 5. How to store Apexxnar

• 6. Contents of the pack and other information

1. what apexxnar is and what it is used for

Apexxnar is a pneumococcal vaccine given to:

• individuals aged 18 years and older to help prevent disease such as: pneumonia (lung infection), sepsis or bacteraemia (bacteria in the blood stream) and meningitis (inflammation around the brain) caused by 20 types of the bacteria Streptococcus pneumoniae.

Apexxnar provides protection against 20 types of Streptococcus pneumoniae bacteria.

The vaccine works by helping the body to make its own antibodies, which protect you against these diseases.

2. what you need to know before you receive apexxnar

O Apexxnar should not be given

• if you are allergic (hypersensitive) to the active substances or to any of the other ingredients in this medicine (listed in section 6), or to any other vaccine that contains diphtheria toxoid.

O Warnings and precautions

Talk to your doctor, pharmacist or nurse before the vaccination if you:

• have any present or past medical problems after any dose of Apexxnar such as an allergic reaction or problems with breathing,
• have a severe illness or high fever. However, a mild fever or upper respiratory infection (for example having a cold) itself is not a reason to delay vaccination,
• have any bleeding problems or bruise easily,
• have a weakened immune system (such as due to HIV infection); you may not get the full benefit from Apexxnar.

As with any vaccine, Apexxnar will not protect all persons who are vaccinated.

O Other medicines/vaccines and Apexxnar

Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicines, or have recently received any other vaccine.

O Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before receiving this vaccine.

O Driving and using machines

Apexxnar has no or negligible influence on the ability to drive and use machines. However, some of the effects mentioned under section 4 “Possible side effects” may temporarily affect the ability to drive or use machines.

O Apexxnar contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium-free’.

• 3. How Apexxnar is given

The doctor or nurse will inject the recommended dose (0.5 mL) of the vaccine into your arm.

You should receive 1 injection.

Tell your doctor, pharmacist or nurse if you have been given a pneumococcal vaccine before.

If you have any further questions on the use of Apexxnar, ask your doctor, pharmacist or nurse.

4. possible side effects

Like all vaccines, Apexxnar can cause side effects, although not everybody gets them.

O Serious side effects

• Tell your doctor immediately if you notice signs of the following serious side effect (see also section 2): swelling of the face, lips, mouth, tongue or throat (oedema), shortness of breath (dyspnoea), wheezing (bronchospasm) – these may by signs of a severe allergic reaction such as anaphylaxis, including shock.

O Other side effects

Very common: may occur with more than 1 in 10 doses of the vaccine

• Headache.
• Joint pain and muscle pain.
• Pain/tenderness at injection site and tiredness.

Common: may occur up to 1 in 10 doses of the vaccine

• Swelling at injection site, redness at injection site and fever.

Uncommon: may occur up to 1 in 100 doses of the vaccine

• Diarrhoea, nausea, and vomiting.
• Rash and swelling of the face, lips, mouth, tongue or throat, which may cause difficulty in swallowing or breathing (angioedema).
• Itching at injection site, swollen glands in the neck, armpit or groin (lymphadenopathy), hives at the injection site (urticaria), and chills.

O The following side effects were seen with Prevenar 13 and may also be seen with Apexxnar:

• A rash causing itchy red blotches (erythema multiforme).
• Irritation at injection site.
• Decreased appetite.
• Limitation of arm movement.

O Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

5. how to store apexxnar

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton and label after EXP. The expiry date refers to the last day of that month.

Store in a refrigerator (2 °C to 8 °C).

Apexxnar should be used as soon as possible after being removed from refrigeration.

Do not freeze. Discard if vaccine has been frozen.

Stability data indicate that the vaccine is stable for 96 hours when stored at temperatures from 8 °C to 25 °C, or 72 hours when stored at temperatures from 0 °C to 2 °C. At the end of these time periods Apexxnar should be used or discarded. These data are intended to guide healthcare professionals in case of temporary temperature excursion only.

Pre-filled syringes should be stored in the refrigerator horizontally to minimise the resuspension time.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. contents of the pack and other informationo what apexxnar containsthe active substances are polysaccharide crm197 conjugates consisting of:

• 2.2 micrograms of polysaccharide for serotypes 1, 3, 4, 5, 6A, 7F, 8, 9V, 10A, 11 A, 12F, 14,15B.18C, 19A, 19R 22R 23Fand 33R
• 4.4 micrograms of polysaccharide for serotype 6B.

O What Apexxnar looks like and contents of the pack

The vaccine is a white suspension for injection, provided in a single-dose, pre-filled syringe (0.5 mL). It is provided in pack sizes of 1 and 10, with or without needles, and

Marketing Authorisation Holder:

Pfizer Limited Ramsgate Road Sandwich, Kent CT13 9NJ

United Kingdom

Manufacturer responsible for batch release:

Pfizer Manufacturing

Belgium N.V.

Rijksweg 12 2870 Puurs

Belgium

For any information about this medicine, please contact: Medical Information, Pfizer Ltd, Walton Oaks, Dorking Road, Tadworth, Surrey, KT20 7NS.

Telephone 01304 616161.

This leaflet was last revised in <{MM/YYYY}>.

Ref: PE 1_0

O The following information is intended for healthcare professionals only:

During storage, a white deposit and clear supernatant may be observed. This does not constitute a sign of deterioration. Pre-filled syringes should be stored horizontally to minimise the resuspension time.

Preparation for administration

Apexxnar® suspension for injection pneumococcal polysaccharide conjugate vaccine (20-valent, adsorbed)

PAA184620

020

Package Leaflet: Information for the user

This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects.

Read all of this leaflet carefully before you receive this vaccine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, pharmacist or nurse.
• This vaccine has been prescribed for you only. Do not pass it on to others.
• If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

• 1. What Apexxnar is and what it is used for

• 2. What you need to know before you receive Apexxnar

• 3. How Apexxnar is given

• 4. Possible side effects

• 5. How to store Apexxnar

• 6. Contents of the pack and other information

1. what apexxnar is and what it is used for

Apexxnar is a pneumococcal vaccine given to:

• individuals aged 18 years and older to help prevent disease such as: pneumonia (lung infection), sepsis or bacteraemia (bacteria in the blood stream) and meningitis (inflammation around the brain) caused by 20 types of the bacteria Streptococcus pneumoniae.

Apexxnar provides protection against 20 types of Streptococcus pneumoniae bacteria.

The vaccine works by helping the body to make its own antibodies, which protect you against these diseases.

2. what you need to know before you receive apexxnar

O Apexxnar should not be given

• if you are allergic (hypersensitive) to the active substances or to any of the other ingredients in this medicine (listed in section 6), or to any other vaccine that contains diphtheria toxoid.

O Warnings and precautions

Talk to your doctor, pharmacist or nurse before the vaccination if you:

• have any present or past medical problems after any dose of Apexxnar such as an allergic reaction or problems with breathing,
• have a severe illness or high fever. However, a mild fever or upper respiratory infection (for example having a cold) itself is not a reason to delay vaccination,
• have any bleeding problems or bruise easily,
• have a weakened immune system (such as due to HIV infection); you may not get the full benefit from Apexxnar.

As with any vaccine, Apexxnar will not protect all persons who are vaccinated.

O Other medicines/vaccines and Apexxnar

Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicines, or have recently received any other vaccine.

O Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before receiving this vaccine.

O Driving and using machines

Apexxnar has no or negligible influence on the ability to drive and use machines. However, some of the effects mentioned under section 4 “Possible side effects” may temporarily affect the ability to drive or use machines.

O Apexxnar contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium-free’.

• 3. How Apexxnar is given

The doctor or nurse will inject the recommended dose (0.5 mL) of the vaccine into your arm.

You should receive 1 injection.

Tell your doctor, pharmacist or nurse if you have been given a pneumococcal vaccine before.

If you have any further questions on the use of Apexxnar, ask your doctor, pharmacist or nurse.

4. possible side effects

Like all vaccines, Apexxnar can cause side effects, although not everybody gets them.

O Serious side effects

• Tell your doctor immediately if you notice signs of the following serious side effect (see also section 2): swelling of the face, lips, mouth, tongue or throat (oedema), shortness of breath (dyspnoea), wheezing (bronchospasm) – these may by signs of a severe allergic reaction such as anaphylaxis, including shock.

O Other side effects

Very common: may occur with more than 1 in 10 doses of the vaccine

• Headache.
• Joint pain and muscle pain.
• Pain/tenderness at injection site and tiredness.

Common: may occur up to 1 in 10 doses of the vaccine

• Swelling at injection site, redness at injection site and fever.

Uncommon: may occur up to 1 in 100 doses of the vaccine

• Diarrhoea, nausea, and vomiting.
• Rash and swelling of the face, lips, mouth, tongue or throat, which may cause difficulty in swallowing or breathing (angioedema).
• Itching at injection site, swollen glands in the neck, armpit or groin (lymphadenopathy), hives at the injection site (urticaria), and chills.

O The following side effects were seen with Prevenar 13 and may also be seen with Apexxnar:

• A rash causing itchy red blotches (erythema multiforme).
• Irritation at injection site.
• Decreased appetite.
• Limitation of arm movement.

O Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

5. how to store apexxnar

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton and label after EXP. The expiry date refers to the last day of that month.

Store in a refrigerator (2 °C to 8 °C).

Apexxnar should be used as soon as possible after being removed from refrigeration.

Do not freeze. Discard if vaccine has been frozen.

Stability data indicate that the vaccine is stable for 96 hours when stored at temperatures from 8 °C to 25 °C, or 72 hours when stored at temperatures from 0 °C to 2 °C. At the end of these time periods Apexxnar should be used or discarded. These data are intended to guide healthcare professionals in case of temporary temperature excursion only.

Pre-filled syringes should be stored in the refrigerator horizontally to minimise the resuspension time.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. contents of the pack and other informationo what apexxnar containsthe active substances are polysaccharide crm197 conjugates consisting of:

• 2.2 micrograms of polysaccharide for serotypes 1, 3, 4, 5, 6A, 7F, 8, 9V, 10A, 11 A, 12F, 14,15B.18C, 19A, 19R 22R 23Fand 33R
• 4.4 micrograms of polysaccharide for serotype 6B.