Synflorix

Synflorix

Manufacturer:

GlaxoSmithKline Indonesia
Concise Prescribing Info
Contents
Pneumococcal polysaccharide (serotype 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F, & 23F) & nontypeable Haemophilus influenzae protein D conjugate vaccine, adsorbed
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 subjects w/ acute severe febrile illness. Syncope (fainting) can occur. Thrombocytopenia or any coagulation disorder. A protective immune response may not be elicited in all vaccinees. Does not provide protection against other microorganism. Not for protection against 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. 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
Adequate response may not be elicited w/ immunosuppressants.
ATC Classification
J07AL52 - pneumococcus purified polysaccharides antigen and haemophilus influenzae, conjugated ; Belongs to the class of pneumococcal vaccines.
Presentation/Packing
Form
Synflorix vaccine (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
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