PREVENAR 20 SUSPENSION FOR INJECTION IN SINGLE-DOSE PRE-FILLED SYRINGE 0.5ML [SIN16648P]

Product Info

PREVENAR 20 SUSPENSION FOR INJECTION IN SINGLE-DOSE PRE-FILLED SYRINGE 0.5ML

[SIN16648P]

4.1. Therapeutic indications

Active immunisation for the prevention of invasive disease, pneumonia, and acute otitis media caused by Streptococcus pneumoniae in infants, children, and adolescents from 6 weeks to less than 18 years of age.

Active immunisation for the prevention of invasive disease and pneumonia caused by Streptococcus pneumoniae in individuals 18 years of age and older.

See sections 4.4 and 5.1 for information on protection against specific pneumococcal serotypes – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.

Prevenar 20 should be used in accordance with official recommendations.

4.2. Posology and method of administration

Posology

It is recommended that infants who receive a first dose of Prevenar 20 complete the vaccination course with Prevenar 20.

Paediatric population

No or only limited data are available for Prevenar 20 in infants below 6 weeks, preterm, older unvaccinated, or partially vaccinated infants and children (see sections 4.4, 4.8 and 5.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). The following dosing recommendations are predominantly based on experience with Prevenar 13.

Infants below 6 weeks of age

The safety and efficacy of Prevenar 20 in infants below 6 weeks have not been established. No data are available.

Preterm infants (less than 37 weeks of gestation)

The recommended immunisation series for Prevenar 20 consists of four doses, each of 0.5 mL. The primary infant series consists of three doses, with the first dose given at 2 months of age and with an interval of at least 4 weeks between doses. The first dose may be given as early as 6 weeks of age. The fourth (booster) dose is recommended between 11 and 15 months of age (see sections 4.4 and 5.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Unvaccinated infants 7 months to less than 12 months of age

Two doses, each of 0.5 mL, with an interval of at least 4 weeks between doses. A third dose is recommended in the second year of life.

Unvaccinated children 12 months to less than 24 months of age

Two doses, each of 0.5 mL, with an interval of at least 8 weeks between doses.

Unvaccinated children 2 years to less than 5 years of age

One single dose of 0.5 mL.

Children 15 months to less than 5 years of age previously fully vaccinated with Prevenar 13

One single dose (0.5 mL) given on an individual basis according to official recommendations to elicit immune responses to the additional serotypes.

If Prevenar 13 was administered, at least 8 weeks should elapse before administering Prevenar 20 (see section 5.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Children and adolescents 5 years to less than 18 years of age regardless of prior Prevenar 13 vaccination

One single dose (0.5 mL) given on an individual basis according to official recommendations.

If Prevenar 13 was administered, at least 8 weeks should elapse before administering Prevenar 20 (see section 5.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Special populations

There are no data with Prevenar 20 in special populations.

Experience from clinical studies with Prevenar 13 (a pneumococcal conjugate vaccine consisting of 13 polysaccharide conjugates that are also in Prevenar 20) are available in children and adults at higher risk of pneumococcal infection including immunocompromised children and adults with human immunodeficiency virus (HIV) infection or haematopoietic stem cell transplant (HSCT), and children with sickle cell disease (SCD) (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 SCD 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 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 4 weeks 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).

The recommended dosing of Prevenar 13 may be considered in guiding vaccination with Prevenar 20 in high-risk populations. For information on responses to pneumococcal vaccines in immunocompromised individuals, 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.

Prevenar 20 (0.5 mL) should be given by intramuscular injection in the anterolateral aspect of the thigh (vastus lateralis muscle) in infants or the deltoid muscle of the upper arm in children and adults. The vaccine should not be injected in the gluteal area. Prevenar 20 should be administered with care to avoid injection into or near nerves and blood vessels. Do not administer Prevenar 20 intravascularly.

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.

4.3. Contraindications

Hypersensitivity to the active substances, to any of the excipients listed in section 6.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information, or to diphtheria toxoid.