Synflorix

Synflorix

Manufacturer:

GlaxoSmithKline

Distributor:

Zuellig Pharma
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 of infants & childn from 6 wk up to 5 yr against disease caused by Strep pneumoniae serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F & 23F, & cross-reactive serotype 19A (including sepsis, meningitis, pneumonia, bacteraemia & acute otitis media), & against acute otitis media caused by NTHi.
Dosage/Direction for Use
IM Infant 6 wk-6 mth 3-dose primary series: 4 doses of 0.5 mL (3 primary doses w/ 1st dose given at 6 wk of age w/ at least 1 mth interval between doses & booster dose from 9 mth onwards given at least 6 mth after the last primary dose). 2-dose primary series: 3 doses of 0.5 mL (2 primary doses given 2 mth apart w/ 1st dose given at 6 wk age & booster dose from 9 mth onwards given at least 6 mth after the last primary dose. Preterm infant 27 wk of gestational age 4 doses of 0.5 mL (3 primary doses w/ 1st dose given at 2 mth w/ at least 1 mth interval between doses & booster dose at least 6 mth after the last primary dose). Previously unvaccinated childn & older infant: Childn 12 mth to 5 yr 2 doses of 0.5 mL w/ at least 2 mth interval between doses, 7-11 mth 2 doses of 0.5 mL w/ at least 1 mth interval between doses. 3rd dose is recommended in the 2nd yr of life w/ at least 2 mth interval.
Contraindications
Special Precautions
Not to be administered intravascularly or intradermally. Does not substitute routine immunization w/ diphtheria, tetanus or HIB vaccines. Postpone vaccination in patients suffering from acute severe febrile illness. Syncope. Patients w/ thrombocytopenia or any coagulation disorder; impaired immune responsiveness. Childn at high-risk for pneumococcal disease. Potential risk of apnoea; consider resp monitoring for 48-72 hr in very premature infant (≤28 wk of gestation) & those w/ history of resp immaturity. Perform medical history & clinical exam before vaccination.
Adverse Reactions
Loss of appetite, irritability, drowsiness, pain, redness, inj site swelling, fever (≥38°C) rectally (age <2 yr). Inj site reactions eg, inj site induration, fever (>39°C) rectally (age <2 yr), fever (≥38°C) rectally (age 2-5 yr).
Drug Interactions
Concomitant use 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 vaccine inj
Packing/Price
0.5 mL x 10 × 1's;0.5 mL x 100 × 1's;0.5 mL x 1's;1 mL x 100 × 1's
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