CAPVAXIVE® Selected Safety Information 

Indications: • CAPVAXIVE is indicated for active immunisation for the prevention of invasive disease and pneumonia caused by Streptococcus pneumoniae in individuals 18 years of age and older. • The use of CAPVAXIVE should be in accordance with official recommendations. Dosing: Vaccination with CAPVAXIVE is recommended for selected individuals as follows: Individuals 18 years of age and older •1 dose {0.5 ml). • The need for revaccination with a subsequent dose of CAPVAXIVE has not been established. Paediatric population· The safety and efficacy of CAPVAXIVE in children younger than 18 years of age have not been established. No data are available. Contraindications: Hypersensitivity to the active substances including diphtheria toxoid, or to any of the excipients. Precautions:· In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded. • As with all injectable vaccines, appropriate medical treatment and supervision should always be readily available in case of a rare anaphylactic event following the administration of the vaccine. • Vaccination should be postponed in individuals suffering from acute severe febrile illness or acute infection. The presence of a minor infection and/or low-grade fever should not delay vaccination. • As with other intramuscular injections, the vaccine should be given with caution in individuals receiving anticoagulant therapy or those with thrombocytopenia or any coagulation disorder {such as haemophilia) because bleeding or bruising may occur following an intramuscular administration in these individuals. • Anxiety-related reactions, including vasovagal reactions {syncope), hyperventilation or stress-related reactions may occur in association with vaccination as a response to the needle injection. Stress-related reactions are temporary and resolve on their own. It is important that precautions are in place to avoid injury from fainting. • Safety and immunogenicity data on CAPVAXIVE are not available for individuals in immunocompromised groups. Vaccination should be considered on an individual basis. Based on experience with pneumococcal vaccines, immunocompromised individuals, including those receiving immunosuppressive therapy, may have a reduced immune response to CAPVAXIVE. • As with any vaccine, vaccination with CAPVAXIVE may not protect all vaccine recipients. This vaccine will only protect against Streptococcus pneumoniae serotypes included in the vaccine and to the cross-reactive serotype 15B. • This medicinal product contains less than 1 mmol sodium {23 mg) per dose, that is to say, essentially 'sodium-free'. • This medicinal product contains 0.5 mg of polysorbate 20 in each dose. Polysorbates may cause allergic reactions. Adverse events: The most frequently reported adverse reactions following vaccination with CAPVAXIVE in individuals 18 years of age and older were solicited. Overall, the most frequently reported adverse reactions were injection-site pain, fatigue, headache, and myalgia. The majority of local and systemic adverse reactions for individuals who received CAPVAXIVE were mild or moderate {based on intensity or size) and of short duration {s 3 days); severe reactions (defined as an event that prevents normal daily activity or size > 1 0 cm) occurred in s 1.0% of adults. • For detailed side effects, please consult the full prescribing information. Drug interactions: • Different injectable vaccines should always be administered at different injection sites. • CAPVAXIVE can be administered concomitantly with quadrivalent influenza vaccine {split virion, inactivated). There are no data on the concomitant administration of CAPVAXIVE with vaccines other than influenza vaccines. Pregnancy: • There are no data on the use of CAPVAXIVE in pregnant women. • Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryo/foetal development, parturition or post-natal development. • Administration of CAPVAXIVE in pregnancy should only be considered when the potential benefits outweigh any potential risks for the mother and the foetus. Breast-feeding: • It is unknown whether CAPVAXIVE is excreted in human milk. Fertility: • No human data on the effect of CAPVAXIVE on fertility are available. Animal studies in female rats do not indicate harmful effects. 

Before prescribing, please consult the full prescribing information.