Important Safety Information

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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.

Dose¹
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.

Reference:

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

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Effectiveness in Pneumonia

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Prevenar 13®

Clinical Information

Support & Services

Effectiveness in IPD

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Effectiveness in Otitis Media

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Prevenar 13® Prescribing Information

PP-PRV-EGY-0027

Adverse events should be reported. Adverse events can be reported to [email protected]

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