APEXXNAR SUSPENSION FOR INJECTION IN SINGLE-DOSE PRE-FILLED SYRINGE 0.5ML

INJECTION, SUSPENSION

**4.2. Posology and method of administration** Posology _Individuals 18 years of age and older_ Apexxnar is to be administered as a single dose to individuals 18 years of age and older. The need for revaccination with a subsequent dose of Apexxnar has not been established. No data on sequential vaccination with other pneumococcal vaccines or a booster dose are available for Apexxnar. Based on the clinical experience with Prevenar 13 (a pneumococcal conjugate vaccine consisting of 13 polysaccharide conjugates that are also in Apexxnar), if the use of 23-valent pneumococcal polysaccharide vaccine (Pneumovax 23 \[PPSV23\]) is considered appropriate, Apexxnar should be given first (see section 5.1 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). _Paediatric population_ The safety and efficacy of Apexxnar in children and adolescents younger than 18 years of age have not been established. No data are available. _Special populations_ There are no data with Apexxnar in special populations. Limited experience from clinical studies with Prevenar 13 (a pneumococcal conjugate vaccine consisting of 13 polysaccharide conjugates that are also in Apexxnar) are available in adults at higher risk of pneumococcal infection either immunocompromised individuals or following bone marrow transplantation (see sections 4.4 and 5.1 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). Based on these data the following posology was recommended for Prevenar 13: - Individuals at higher risk of pneumococcal infection (e.g., individuals with sickle cell disease or HIV infection), including those previously vaccinated with 1 or more doses of PPSV23, were recommended to receive at least 1 dose of Prevenar 13. - In individuals with a hematopoietic stem cell transplant (HSCT), the recommended immunisation series with Prevenar 13 consisted of 4 doses of 0.5 mL each. The primary series consisted of 3 doses, with the first dose given 3 to 6 months after HSCT and with an interval of at least 1 month between doses. A booster dose was recommended 6 months after the third dose (see section 5.1 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). Please also refer to sections 4.4. and 5.1 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_. Method of administration For intramuscular use only. One dose (0.5 mL) of Apexxnar should be administered intramuscularly, preferably in the deltoid muscle, with care to avoid injection into or near nerves and blood vessels. For instructions on the handling of the vaccine before administration, see section 6.6 – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_.