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Burden of Disease Prevenar 13® Effectiveness Dosing Risk Prevention Important Safety Information Abbreviated Prescribing Information
Important Safety Information

Therapeutic indications1
Active immunization for the prevention of invasive disease, pneumonia and acute otitis media caused by Streptococcus pneumoniae in infants, children and adolescents from 6 weeks to 17 years of age.

Active immunization for the prevention of invasive disease and pneumonia caused by Streptococcus pneumoniae in adults ≥18 years of age and the elderly.

For intramuscular injection. It is recommended that infants and children aged 6 weeks to 5 years 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 immunization series consists of four doses, each of 0.5 ml.
Preterm infants (< 37 weeks gestation): In preterm infants, the recommended immunization series consists of four doses, each of 0.5 ml.
Children aged 12-23 months: Two doses, each of 0.5 ml, with an interval of at least 2 months between doses.
Children and adolescents aged 2-17 years: One single dose of 0.5 ml.
Adults ≥18 years of age, and the elderly: One single dose of Prevenar 13®.

Dosage form1

Suspension for injection.

Dose strength1

1 dose (0.5 ml).

Most Common Adverse Effects1
The most common adverse reactions reported in clinical studies or from post-marketing experience include: 

Infants and children aged 6 weeks to 5 years: Very common (≥1/10): Decreased appetite, pyrexia, irritability, any vaccination-site erythema, induration/swelling 2.5 cm–7.0 cm (after the booster dose and in older children [age 2 to 5 years]) or pain/tenderness, somnolence, poor quality sleep.
Children and adolescents aged 6 to 17 years of age: Very common (≥1/10): Decreased appetite, Irritability, any vaccination-site erythema, induration/swelling or pain/tenderness, somnolence, poor quality sleep, vaccination-site tenderness (including impaired movement).
Adults ≥18 years and the elderly: Very Common (≥1/10): Decreased appetite, headaches, diarrhea, vomiting (in adults aged 18 to 49 years), rash, chills, fatigue, vaccination-site erythema, vaccination-site induration/swelling, vaccination-site pain/ tenderness (severe vaccination-site pain/tenderness very common in adults aged 18 to 39 years); limitation of arm movement (severe limitation of arm movements very common in adults aged 18 to 39 years), arthralgia; myalgia.



  1. Egyptian drug authority Prevenar 13 leaflet approval date 7/4/2021, revision date November 2020.

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Effectiveness in Otitis Media
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Adverse events should be reported. Adverse events can be reported to [email protected]

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