Abbreviated prescribing information
Prevenar*▼
Pneumococcal saccharide conjugated vaccine, adsorbed
Presentation: Each 0.5ml dose of Prevenar contains 2 micrograms of each of the following saccharide serotypes: 4, 9V, 14, 18C, 19F, 23F and 4 micrograms of saccharide serotype 6B. Each saccharide is conjugated to the CRM197 carrier protein and adsorbed on aluminium phosphate.
Indications: Immunisation against disease (including sepsis, meningitis, pneumonia, bacteraemia and acute otitis media) caused by Streptococcus pneumoniae serotypes 4, 6B, 9V, 14, 18C, 19F and 23F in infants and children from 2 months up to 5 years of age.
Dosage and Administration: The vaccine should be given by intramuscular injection. The preferred sites are anterolateral aspect of the thigh (vastus lateralis muscle) in infants or the deltoid muscle of the upper arm in young children.
Infants aged 2-6 months: three doses, each of 0.5 ml, the first dose usually given at 2 months of age and with an interval of at least 1 month between doses. A fourth dose is recommended in the second year of life.
Previously unvaccinated older infants and children:
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 24 months – 5years: one single dose.
The need for a booster dose after these immunisation schedules has not been established.
Contra-indications: Hypersensitivity to the active substances or to any of the excipients, or to diphtheria toxoid.
Warnings and Precautions: Do not administer intravenously. Appropriate treatment must be available in case of anaphylaxis. Impaired immune responsiveness may affect antibody levels. Prevenar does not replace 23-valent polysaccharide vaccine in at risk children ≥ 24 months of age. Children ≥ 24 months of age at high risk, previously immunised with Prevenar should receive 23-valent pneumococcal polysaccharide vaccine whenever recommended. Prophylactic antipyretics recommended when vaccinating children with history of seizure disorders, or when vaccinating simultaneously with whole cell pertussis vaccines. Delay vaccination in acute moderate or severe febrile illness. The immunogenicity of Prevenar has been demonstrated in infants with sickle cell disease. Safety and immunogenicity data are not yet available for children in other specific high-risk groups for invasive pneumococcal disease.
Side Effects: Very common: Decreased appetite, vomiting, diarrhoea, injection site reactions (e.g. erythema, induration/swelling, pain/tenderness), fever equal to or over 38 °C, irritability, drowsiness, restless sleep. Common: Injection site swelling/induration and erythema larger than 2.4cm, tenderness interfering with movement, fever over 39 °C. Uncommon: rash/urticaria. Rare: Seizures including febrile seizures, hypotonic hyporesponsive episode, injection site hypersensitivity reactions (e.g. dermatitis, pruritus, urticaria), hypersensitivity reactions including face oedema, angioneurotic oedema, dyspnoea, bronchospasm, anaphylactic/anaphylactoid reaction including shock. Very rare: Lymphadenopathy localised to the region of the injection site, erythema multiforme.
For full prescribing information and details of other side effects see Summary of Product Characteristics Full prescribing information is available on request from: Wyeth MENA, HealthCare City, Dubai, United Arab Emirates, B. O. Box 7699.
Telephone: 0097143635000
*Trade mark