CAPVAXIVE Injectable Solution in Pre-filled Syringe

Introduction

Package Leaflet: Information for the User

CAPVAXIVE injectable solution in pre-filled syringe

Pneumococcal polysaccharide conjugate vaccine (21-valent)

This medicine is subject to additional monitoring, which will allow for the quick detection of new safety information. You can help by reporting any side effects you may get. The last section of the leaflet includes information on 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 to you, do not pass it on to others.
• If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if they are not listed in this leaflet. See section 4.

Contents of the package leaflet

1. What is CAPVAXIVE and what is it used for
2. What you need to know before you receive CAPVAXIVE
3. How CAPVAXIVE is administered
4. Possible side effects
5. Storage of CAPVAXIVE
6. Contents of the pack and further information

1. What is CAPVAXIVE and what is it used for

CAPVAXIVE is a pneumococcal vaccine that is administered to:

• people aged 18 years and olderto help protect them against diseases caused by a bacterium called Streptococcus pneumoniaeor pneumococcus. These diseases include: lung infection (pneumonia), inflammation of the brain and spinal cord (meningitis), and blood infection (bacteremia).

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

2. What you need to know before you receive CAPVAXIVE

You should not receive CAPVAXIVE:

• if you are allergic to the active substances, including diphtheria toxoid, or to any of the other components of this vaccine (listed in section 6).

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before receiving CAPVAXIVE if:

• You have a high fever or a severe infection. In these cases, vaccination may need to be postponed until you have recovered. However, a mild fever or infection (such as a cold) is not a reason to delay vaccination.
• You have bleeding problems, bruise easily, or are taking medicines to prevent blood clots.
• You have injection-related anxiety or have ever fainted after an injection.
• You have a weakened immune system (which means your body is less able to fight infections) or if you are taking certain medicines that can weaken your immune system.

Like all vaccines, CAPVAXIVE may not fully protect all people who are vaccinated.

Children and adolescents

CAPVAXIVE has not been studied in children and adolescents under 18 years of age.

Other medicines and vaccines and CAPVAXIVE

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

Tell your doctor, pharmacist, or nurse if:

• You are taking, have recently taken, or might take any other medicines.
• You have recently received or are scheduled to receive any other vaccine.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor, pharmacist, or nurse before receiving this vaccine.

Driving and using machines

CAPVAXIVE has no or negligible influence on the ability to drive and use machines. However, some of the effects mentioned in section 4 "Possible side effects" may temporarily affect your ability to drive or use machines.

CAPVAXIVE contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per dose; this is essentially "sodium-free".

CAPVAXIVE contains polysorbate 20

This medicine contains 0.5 mg of polysorbate 20 in each 0.5 ml dose of injectable solution. Polysorbates may cause allergic reactions. Inform your doctor if you have any known allergy.

3. How CAPVAXIVE is administered

Tell your doctor, pharmacist, or nurse if you have previously received a pneumococcal vaccine.

Adults

You should receive 1 injection (1 dose of 0.5 ml).

Your doctor or nurse will administer the vaccine into the upper arm muscle.

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

4. Possible side effects

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

Serious side effects

Rare (may affect up to 1 in 1,000 people):

CAPVAXIVE may cause allergic reactions (hypersensitivity), including excessive contraction of the airway muscles that causes difficulty breathing (bronchospasm). Seek immediate medical attention if you have symptoms of an allergic reaction, which may be:

• Wheezing or difficulty breathing
• Swelling of the face, lips, or tongue
• Hives
• Rash

Other side effects

The following side effects have been observed after use of CAPVAXIVE:

Very common(may affect more than 1 in 10 people):

• Headache
• Pain at the injection site
• Feeling tired

Common(may affect up to 1 in 10 people):

• Muscle pain (very common in people aged 18 to 49 years)
• Redness or swelling at the injection site (very common in people aged 18 to 49 years)
• Fever

Uncommon(may affect up to 1 in 100 people):

• Swelling of the lymph nodes
• Dizziness
• Feeling sick (nausea)
• Diarrhea
• Vomiting
• Joint pain
• Itching at the injection site
• Chills
• Bruising at the injection site

These side effects are generally mild or moderate and do not last long.

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if they are not listed in this leaflet. You can also report side effects directly through the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of CAPVAXIVE

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

Do not use this vaccine after the expiry date which is stated on the carton and on the label of the syringe after EXP.

The expiry date is the last day of the month stated.

Store in a refrigerator (2°C to 8°C). Do not freeze. Keep the pre-filled syringe in the outer packaging to protect it from light.

CAPVAXIVE should be administered as soon as possible once it is out of the refrigerator. However, in circumstances where CAPVAXIVE is temporarily stored out of the refrigerator, the vaccine is stable at temperatures up to 25°C for 96 hours. At the end of this period, CAPVAXIVE should be used or discarded. This information is intended to guide healthcare professionals only in case of temporary deviations from the storage temperature.

6. Contents of the pack and further information

Composition of CAPVAXIVE

The active substances are:

• Pneumococcal polysaccharides of types 3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 15A, 15B des-O-acetylated, 16F, 17F, 19A, 20A, 22F, 23A, 23B, 24F, 31, 33F, and 35B (4 micrograms of each type)

Each polysaccharide is conjugated to a carrier protein (CRM197). The polysaccharides and the carrier protein are not live and do not cause disease.

One dose (0.5 ml) contains approximately 65 micrograms of carrier protein.

The other ingredients are sodium chloride (NaCl), histidine, polysorbate 20 (E 432), hydrochloric acid (HCl; for pH adjustment), and water for injections. For more information on polysorbate 20 (E 432), see section 2.

Appearance and pack size of the product

CAPVAXIVE is a colourless, transparent to opalescent injectable solution (injection) that is presented in a pre-filled syringe (0.5 ml). CAPVAXIVE is available in pack sizes of 1 or 10 pre-filled syringes, without needles, with 1 separate needle or with 2 separate needles per pre-filled syringe.

Not all pack sizes may be marketed.

Marketing authorisation holder and manufacturer

Merck Sharp & Dohme B.V., Waarderweg 39, 2031 BN Haarlem, Netherlands.

For further information about this medicine, contact the local representative of the marketing authorisation holder:

Date of last revision of this leaflet:{MM/YYYY}.

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency website: https://www.ema.europa.eu.

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This information is intended only for healthcare professionals:

• The vaccine should be used as supplied.
• Inspect the solution visually for particles and discoloration before administration. Discard the vaccine if particles are present and/or if it appears discolored.
• Attach a needle with a Luer Lock connection by twisting in a clockwise direction until the needle is securely attached to the syringe.
• CAPVAXIVE should only be administered by intramuscular injection. This vaccine should be administered preferably in the deltoid muscle of the arm in adults, with caution to avoid injection into or near nerves and blood vessels.

CAPVAXIVE can be administered at the same time as the tetravalent flu vaccine (inactivated flu vaccine) in adults. Different injectable vaccines should always be administered at different injection sites.

Disposal of unused medicine and all materials that have come into contact with it should be done in accordance with local regulations.