Basic Information
Prevenar 13 Suspension For Injection
INJECTION, SUSPENSION
Regulatory Information
SIN13824P
July 2, 2010
Prescription Only
Therapeutic
INTRAMUSCULAR
August 10, 2023
May 30, 2025
XJ07AL02
Company Information
Active Ingredients
Strength: 2.2mcg
Strength: 2.2mcg
Strength: 2.2mcg
Strength: 2.2mcg
Strength: 2.2mcg
Strength: 2.2mcg
Strength: 2.2mcg
Strength: 2.2mcg
Strength: 2.2mcg
Strength: 4.4mcg
Strength: 2.2mcg
Strength: 32mcg
Strength: 2.2mcg
Strength: 2.2mcg
Detailed Information
Contraindications
**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.
Indication Information
**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 18th 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. 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.