Active Ingredient and Strength	CRM197 PROTEIN - 32 MCG PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 1 (CONJUGATE) - 2.2 MCG PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 14 (CONJUGATE) - 2.2 MCG PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 18C (CONJUGATE) - 2.2 MCG PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 19A (CONJUGATE) - 2.2 MCG PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 19F (CONJUGATE) - 2.2 MCG PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 23F (CONJUGATE) - 2.2 MCG PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 3 (CONJUGATE) - 2.2 MCG PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 4 (CONJUGATE) - 2.2 MCG PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 5 (CONJUGATE) - 2.2 MCG PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 6A (CONJUGATE) - 2.2 MCG PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 6B (CONJUGATE) - 4.4 MCG PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 7F (CONJUGATE) - 2.2 MCG PNEUMOCOCCAL POLYSACCHARIDE SEROTYPE 9V (CONJUGATE) - 2.2 MCG
Dosage Form	INJECTION, SUSPENSION
Manufacturer and Country	PFIZER IRELAND PHARMACEUTICALS - IRELAND
Registration Number	SIN13824P
Licence Holder	PFIZER PRIVATE LIMITED
Forensic Classification	PRESCRIPTION ONLY MEDICINES
Anatomical Therapeutic Chemical (ATC) code	J07AL02

4.1 Therapeutic indications

Children 6 weeks through 17 years of age

Active immunisation for the prevention of invasive disease, pneumonia and acute otitis media caused by Streptococcus pneumoniae in infants and children from 6 weeks to 17 years of age (prior to 18^th birthday). 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.

The use of Prevenar 13 should be determined on the basis of official recommendations taking into consideration the impact of invasive disease in different age groups as well as the variability of serotype epidemiology in different geographical areas.

Adults 18 years through 49 years of age

Active immunisation for the prevention of invasive disease and pneumonia caused by S. pneumoniae in adults ≥18 to 49 years of age.

Adults 50 years of age and older

Active immunisation for the prevention of pneumonia and invasive disease caused by S. pneumoniae.

The need for re-vaccination with a subsequent dose of Prevenar 13 has not been established. For specific guidelines, please refer to local recommendations.

4.2 Posology and method of administration

Method of administration

The vaccine should be given by intramuscular injection only.

The dose is 0.5 mL given intramuscularly, with care to avoid injection into or near nerves and blood vessels. The preferred sites are the anterolateral aspect of the thigh (vastus lateralis muscle) in infants or the deltoid muscle of the upper arm in older children and adult. The vaccine should not be injected in the gluteal area. Do not administer Prevenar 13 intravascularly.

The vaccine should not be injected intradermally, subcutaneously or intravenously, since the safety and immunogenicity of these routes have not been evaluated.

Parenteral products should be inspected visually for particulate matter or discoloration prior to use.

Data on the interchangeability of pneumococcal 7-valent conjugate vaccine or Prevenar 13 with other pneumococcal conjugate vaccines containing a protein carrier different from CRM₁₉₇ are not available.

Pediatric population

The safety and effectiveness of Prevenar 13 in children below the age of 6 weeks have not been established.

Posology

The immunisation schedules for Prevenar 13 should be based on official recommendations.

Infants and children aged 6 weeks to 5 years

It is recommended that infants who receive a first dose of Prevenar 13 complete the vaccination course with Prevenar 13.

Infants aged 6 weeks–6 months

Three-dose primary series
The recommended immunisation series consists of four doses, each of 0.5 mL. The primary infant series consists of three doses, with the first dose usually given at 2 months of age and with an interval of at least 1 month between doses. The first dose may be given as early as six weeks of age. The fourth (booster) dose is recommended between 12 and 15 months of age.

Unvaccinated children ≥7 months of age

Infants aged 7–11 months
Two doses, each of 0.5 mL, with an interval of at least 1 month between doses. A third dose is recommended in the second year of life.

Children aged 12–23 months
Two doses, each of 0.5 mL, with an interval of at least 2 months between doses.

Children aged 2–17 years
One single dose of 0.5 mL.

Prevenar 13 schedule for preterm infants (<37 weeks gestation)

In preterm infants, the recommended immunisation series consists of 4 doses, each of 0.5 mL. The primary infant series consists of 3 doses, with the first dose given at 2 months of age and with an interval of at least 1 month between doses. The first dose may be given as early as 6 weeks of age. The fourth (booster) dose is recommended at approximately 12 months of age.

Prevenar 13 vaccine schedule for infants and children previously vaccinated with Pneumococcal 7-valent conjugate vaccine (S. pneumoniae serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F)

Prevenar 13 contains the same 7 serotypes contained in pneumococcal 7-valent conjugate vaccine, using the same carrier protein CRM₁₉₇.

Infants and children who have begun immunisation with pneumococcal 7-valent conjugate vaccine may switch to Prevenar 13 at any point in the schedule.

Young children (12–59 months) completely immunized with pneumococcal 7-valent conjugate vaccine
Young children who are considered completely immunised with pneumococcal 7-valent conjugate vaccine should receive one dose of 0.5 mL of Prevenar 13 to elicit immune responses to the 6 additional serotypes. This dose of Prevenar 13 should be administered at least 8 weeks after the final dose of pneumococcal 7-valent conjugate vaccine (see section 5.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Children 5–17 years

Children 5 to 17 years of age may receive a single dose of Prevenar 13 if they have been previously vaccinated with one or more doses of pneumococcal 7-valent conjugate vaccine. This dose of Prevenar 13 should be administered at least 8 weeks after the final dose of pneumococcal 7-valent conjugate vaccine (see section 5.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Adults ≥18 years of age, and the elderly

Prevenar 13 is to be administered as a single dose to adults 18 years and older including those previously vaccinated with a pneumococcal polysaccharide vaccine.

The need for re-vaccination with a subsequent dose of Prevenar 13 has not been established. For specific guidelines, please refer to local recommendations.

Special populations

Individuals who may be 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 23-valent pneumococcal polysaccharide vaccine (PPSV23) may receive at least 1 dose of Prevenar 13.

In individuals with a hematopoietic stem cell transplant (HSCT), the recommended immunisation series consists of 4 doses of Prevenar 13, each of 0.5 mL. The primary series consists 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 is 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).

4.3 Contraindications

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

As with other vaccines, the administration of Prevenar 13 should be postponed in subjects suffering from acute, severe febrile illness. However, the presence of a minor infection, such as a cold, should not result in the deferral of vaccination.