CAPVAXIVE SOLUTION FOR INJECTION IN PRE-FILLED SYRINGE

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

CAPVAXIVE solution for injection in a pre-filled syringe

21-valent pneumococcal polysaccharide conjugate vaccine

This medicinal product is subject to additional monitoring, which will allow quicker detection of new safety information. You can help by reporting any side effects you may experience. Information on how to report side effects is included at the end of section 4.

Read all of this leaflet carefully before receiving this vaccine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• This vaccine has been prescribed for you only, and you should not give it to other people.
• If you experience any side effects, consult your doctor, pharmacist, or nurse, even if they are side effects not listed in this leaflet. See section 4.

Leaflet contents

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

1. What CAPVAXIVE is and what it is used for

CAPVAXIVE is a pneumococcal vaccine administered to:

• individuals 18 years of age and older to help protect them against diseases caused by a bacterium called Streptococcus pneumoniae or 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 produce its own antibodies, which protect against these diseases.

2. What you need to know before receiving CAPVAXIVE

Do 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

Consult your doctor, pharmacist, or nurse before receiving CAPVAXIVE if:

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

Like any vaccine, CAPVAXIVE may not fully protect all vaccinated individuals.

Children and adolescents

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

Other medicines/vaccines and CAPVAXIVE

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

Inform your doctor, pharmacist, or nurse if:

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

Pregnancy and breastfeeding

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

Driving and using machines

The effect of CAPVAXIVE on the ability to drive and use machines is none or negligible. However, some of the side effects mentioned in section 4 “Possible side effects” may temporarily affect the ability to drive or use machines.

CAPVAXIVE contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per 0.5 mL 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

Inform 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 muscle of your upper arm.

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

4. Possible side effects

Like all vaccines, CAPVAXIVE may cause side effects, although not everyone 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 muscles in the airways leading to difficulty breathing (bronchospasm). Seek immediate medical attention if you experience symptoms of an allergic reaction, which may include:

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

Other side effects

The following side effects have been observed following the 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):

• Swollen lymph nodes
• Dizziness
• 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 short-lived.

Reporting of side effects

If you experience any type of side effect, talk to your doctor, pharmacist, or nurse, even if it is a possible side effect not listed in this leaflet. You may also report them 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 stated on the carton and on the label of the pre-filled syringe after EXP.

The expiry date refers to the last day of the month indicated.

Store in a refrigerator (between 2 °C and 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 after removal from the refrigerator. However, in circumstances where CAPVAXIVE is temporarily kept outside the refrigerator, the vaccine remains stable at temperatures up to 25 °C for 96 hours. At the end of this period, CAPVAXIVE must be used or discarded. This information is intended to guide healthcare professionals only in the event of temporary deviations from the recommended storage temperature.

6. Contents of the pack and other information

Composition of CAPVAXIVE

The active substances are:

• Polysaccharides of pneumococcal types 3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 15A, 15B de-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 carrier protein are non-living and do not cause disease.

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

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

Appearance of the product and contents of the pack

CAPVAXIVE is an injectable solution (injection), colourless, ranging from clear to opalescent, supplied in a single-dose 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.

Only certain pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

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

Further information on this medicinal product is available upon request by contacting the local representative of the Marketing Authorisation Holder:

Date of the most recent review 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.

<---------------------------------------------------------------------------------------------------------------->

This information is intended for healthcare professionals only:

• The vaccine should be used as supplied.
• Visually inspect the solution for particles and discoloration prior to administration. Discard the vaccine if particles are present and/or if it appears discolored.
• Attach a Luer Lock needle by turning clockwise until the needle is securely fitted to the syringe.
• CAPVAXIVE must only be administered by intramuscular injection. This vaccine should preferably be administered into the deltoid muscle of the arm in adults, taking care to avoid injection into or near nerves and blood vessels.

CAPVAXIVE may be administered simultaneously with the inactivated quadrivalent influenza vaccine (split virion). Different injectable vaccines should always be administered at separate injection sites.

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