Finished product reference

Pneumococcal Vaccine 13-valent

Injection · Parenteral · 0.5 mL

List code
18819
Pharmacologic class
Vaccine (pneumococcal polysaccharide conjugate, 10-valent)

What it is and how it works

Contains capsular polysaccharides of 10 Streptococcus pneumoniae serotypes (1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F, 23F), each conjugated to a carrier protein to elicit a T-cell-dependent immune response. It induces protective antibodies and immunological memory in infants and young children.

Indications

Active immunisation of infants and children from 6 weeks up to 5 years of age against invasive disease, pneumonia and acute otitis media caused by the vaccine serotypes.

Dosage and administration (summary)

Given by intramuscular injection (0.5 mL), usually as a primary series of 2 or 3 doses from 6 weeks of age followed by a booster, according to the national immunisation schedule.

Contraindications

Hypersensitivity to any component or a previous dose; postpone vaccination during acute severe febrile illness.

Warnings and precautions

Appropriate treatment for anaphylaxis must be available. Consider the risk of apnoea in very premature infants and give with caution in thrombocytopenia or coagulation disorders; protection is limited to vaccine serotypes.

Storage and supply

Store at 2–8 °C; do not freeze; protect from light.

Source: reference summary prepared from the EU SmPC/EPAR, BNF and WHO Model Formulary. The approved product information in Iran governs.

Reference information for professional sourcing and registration enquiries, not medical advice or a promotion. Drug information is condensed from US FDA prescribing information (public domain, via openFDA and DailyMed) and does not replace the product’s approved labelling in Iran. Availability, origin and documentation are confirmed per enquiry.

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