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This Manual has been designed for use in the NICU at London Health Sciences Centre (LHSC), London, Ontario, Canada, and represents clinical practice at this institution. The information contained within the Manual may not be applicable to other centres. If users of this Manual are not familiar with a drug, it is recommended that the official monograph be consulted before it is prescribed and administered. Any user of this information is advised that the contributors, Editor and LHSC are not responsible for any errors or omissions, and / or any consequences arising from the use of the information in this Manual.

SYNFLORIX ®


Pneumococcal Conjugate Vaccine

Indication

  • SYNFLORIX ® is  a 10 valent pneumococcal polysaccharide vaccine
  • SYNFLORIX ® is indicated for the active immunization of infants and children from 6 weeks up to 24 months of age against Streptococcus pneumoniae serotypes (1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F) and invasive diseases (namely sepsis, meningitis, bacteraemic pneumonia, pleural empyema and bacteraemia) caused by these serotypes
  • S. pneumonia is the primary cause of infectious pneumococcal disease which can result in serious morbidity and mortality

Warnings

  • SYNFLORIX ® will only protect against Streptococcus pneumoniae disease caused by the 10 serotypes indicated above
  • Administration should be postponed in babies suffering from acute severe febrile illness
  • Infants with impaired immune responses may have reduced antibody response to vaccination
  • Do NOT administer intravascularly, intradermally or SC
  • A recent paper (Pyrmula) suggests that acetaminophen reduces the response to Synflorix ® and other immunizations. Additional research is needed to refute or confirm this initial finding.

Pharmacology

  • SYNFLORIX ® is a 10-valent pneumococcal polysaccharide conjugate vaccine.
  • SYNFLORIX ® covers 3 more serotypes than PREVNAR – serotypes 1, 5, and 7F
  • The active ingredients of the vaccine are conjugated to a carrier protein (protein D (PD), tetanus toxoid (TT), or diphtheria toxoid (DT)
  • The carrier proteins (PD, TT, DT) provide T-cell help to B-cells to produce a boostable antibody response of high affinity to the polysaccharide antigens, thereby providing protection against bacterial infections caused by Streptococcus pneumoniae

Side Effects

  • Most common side effects after primary vaccination :  redness at the injection site and irritability in 38.3% and 52.3% of all doses, respectively, during clinical trials
  • Other less common side effects :  fever, injection site swelling, pain

Administration and Dose

  • Shake well before use 
  • Administer as soon as possible after being removed from the refrigerator.
  • 0.5 mL IM (anterolateral aspect of the thigh).
  • Can be co-administered with DPTP-Hib vaccines but should be given in separate site of injection and must be given in a separate syringe
  • SYNFLORIX ® must not be mixed with other medicinal products.

Monitoring

  • 48-72 hours of respiratory monitoring for apnea is recommended for premature infants (born ≤28 weeks of gestation) and particularly for infants with a previous history of respiratory immaturity.

Dosing Schedule

  • A total of 3 doses given at 2, 4 and 6 months of life
  • Recommendation:  A booster dose at least 6 months after the third dose (preferably between 12 and 15 months of age)

Contraindications

  • Hypersensitivity to any component of the vaccine.
  • Thrombocytopenia or coagulation disorders that would contraindicate IM injection.

Availability (at St Joseph’s Hospital)

  • Available as a suspension in 0.5 mL vial

Storage

  • SYNFLORIX ® must be stored in the refrigerator between 2-8°C
  • Do NOT freeze. Discard the vaccine if it has been frozen
  • Discard if exposed to temperatures >37°C
  • SYNFLORIX ® remains stable and can be administered if left up to 3 days in temperatures between 8-25°C
  • Protect from light by storingSYNFLORIX ®in its original package.
  • Upon storage of the vial, a fine white deposit with a clear colourless supernatant may be seen.  This does not constitute a sign of deterioration.

References

  1. SYNFLORIX ® Product Monograph
  2. Prymula R et al. Effect of prophylactic paracetamol administration at time of vaccination on febrile reactions and antibody responses in children : two open labeled, randomized controlled trials. Lancet 2009;374:1339-50.

Prepared by Janica Chan, BScPhm, February 2010
Reviewed By David Knoppert, MScPhm, February 2010
Reviewed by Dr Henry Roukema, March 2010


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