Synflorix

Uses

Active immunisation 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 immunisation for the prevention of invasive disease and pneumonia caused by Streptococcus pneumoniae in adults ≥18 years of age and the elderly. The use of Vaccine should be determined on the basis of official recommendations taking into consideration the risk of invasive disease and pneumonia in different age groups, underlying comorbidities as well as the variability of serotype epidemiology in different geographical areas.

Dosage

Synflorix dosage

Infants from 6 weeks to 6 months of age:

• Three-dose primary series: The recommended immunisation series to ensure optimal protection consists of four doses, each of 0.5 ml. The primary infant series consists of three doses with the first dose usually given at 2 months of age and with an interval of at least 1 month between doses. The first dose may be given as early as six weeks of age. A booster dose is recommended at least 6 months after the last priming dose.
• Two-dose primary series: Alternatively, when it is given as part of a routine infant immunisation programme, a series consisting of three doses, each of 0.5 ml may be given. The first dose may be administered from the age of 2 months, with a second dose 2 months later. A booster dose is recommended at least 6 months after the last primary dose.

• Infants aged 7-11 months: The vaccination schedule consists of two doses 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 with an interval of at least 2 months between doses.
• Children aged 12-23 months: The vaccination schedule consists of two doses of 0.5 ml with an interval of at least 2 months between doses. The need for a booster dose after this immunization schedule has not been established.

Side Effects

Local inj site reactions, warmth, erythema & swelling; fever, headache, malaise.

Precaution

Severe renal, hepatic, cardiac, vascular &/or pulmonary dysfunction. Patients on immunosuppressants may be unable to attain required antibody titres. Pregnancy & lactation. Efficacy may be reduced in multiple myeloma, Hodgkin's and non-Hogkin's lymphoma, especially during treatment and in chronic alcoholism. Vaccine should be given 2 wk before starting immunosuppressive treatment or at least 3 mth after treatment completion.

Interaction

Adequate response may not be elicited with immunosuppressants.

Pregnancy & Breastfeeding use

Pregnancy Category C. Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks

Contraindication

Hypersensitivity to any component of the vaccine. Febrile illness, acute disease, anaphylactic reaction to a previous dose, severe primary immunodeficiency.

Storage Condition

Store refrigerated at 2° to 8°C. Protect vials from light.

Innovators Monograph

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