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Synflorix

Synflorix

Manufacturer:

GlaxoSmithKline Indonesia
Concise Prescribing Info
Contents
Per 0.5 mL Pneumococcal polysaccharide & non-typeable H. influenzae (NTHi) protein D conjugate vaccine, adsorbed (1 mcg of polysaccharide for serotypes 1, 5, 6B, 7F, 9V, 14 & 23F, & 3 mcg for serotypes 4, 18C & 19F)
Indications/Uses
Active immunization against invasive disease including sepsis, meningitis, bacteraemic pneumonia & bacteraemia & acute otitis media caused by Strep pneumoniae (serotype 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F & 23F) in infants & childn from 2 mth up to 5 yr.
Dosage/Direction for Use
IM Infant 2-6 mth 3 primary doses w/ at least 1 mth interval between doses or 2 primary doses given 2 mth apart. 1st dose given at 2 mth of age. Booster dose: Administer at least 6 mth after last primary dose. Pre-term infant born at least 27 wk of gestation 3 primary doses w/ the 1st dose given at 2 mth of age, w/ 1-mth interval between doses. Booster dose: Administer at least 6 mth after the last primary dose. Previously unvaccinated older infant & childn: Childn 12 mth to 5 yr 2 doses of 0.5 mL w/ an interval of at least 2 mth between doses; Infant 7-11 mth 2 doses of 0.5 mL w/ an interval of at least 1 mth between doses. A 3rd dose is recommended in the 2nd yr w/ at least 2 mth interval.
Contraindications
Special Precautions
Should not be administered intravascularly or intradermally. Postpone vaccination in patients w/ acute severe febrile illness. Syncope (fainting) can occur. Thrombocytopenia or any coagulation disorder. Protective immune response may not be elicited in all vaccinees. Does not provide protection against other microorganism. Not for protection against invasive disease, pneumonia or otitis media due to other microorganism; pneomococcal serogroups other than those included in Synflorix. Not to be used as substitute in routine immunization w/ diphtheria, tetanus or HIB vaccines. Childn w/ impaired immune responsiveness, whether due to the use of immunosuppressive therapy, genetic defect, HIV infection; high-risk for pneumococcal disease (eg, SCD, asplenia, HIV infection, chronic illness or those who have other immunocompromising conditions). Prophylactic administration of antipyretics. Potential risk of apnoea & monitor resp function for 48-72 hr in very premature infant (≤28 wk gestation) & those w/ history of resp immaturity.
Adverse Reactions
Loss of appetite, irritability, drowsiness, pain, redness, swelling at inj site, fever ≥38°C rectally (age <2 yr). Inj site induration, fever >39°C rectally (age <2 yr), fever ≥38°C rectally (age 2-5 yr).
Drug Interactions
Different inj vaccines should always be given at different inj sites. Adequate response may not be elicited w/ immunosuppressants.
MIMS Class
Vaccines, Antisera & Immunologicals
ATC Classification
J07AL52 - pneumococcus purified polysaccharides antigen and haemophilus influenzae, conjugated ; Belongs to the class of pneumococcal vaccines.
Presentation/Packing
Form
Synflorix susp for inj
Packing/Price
(pre-filled syringe) 0.5 mL x 10 × 1's; (pre-filled syringe) 0.5 mL x 1's; (vial) 0.5 mL x 10 × 1's; (vial) 0.5 mL x 1's;0.5 mL x 1's
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