Synflorix Dosage & Drug Information

Concise Prescribing Info Full Prescribing Info Contents Description Action Indications/Uses Dosage/Direction for Use Contraindications Special Precautions Adverse Reactions Drug Interactions Caution For Usage Storage MIMS Class ATC Classification Regulatory Classification Presentation/Packing Brand Resources

Concise Prescribing Info

Contents

Pneumococcal polysaccharide & non-typeable H influenzae protein D conjugate vaccine, 10-valent adsorbed

Indications/Uses

Active immunisation of infants & childn from 6 wk-5 yr against disease caused by S 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 non-typeable H influenzae.

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Dosage/Direction for Use

IM Infant from 6 wk-6 mth 3 primary doses w/ at least 1 mth interval between doses or alternatively, as part of routine immunisation programme, 2 primary doses given 2 mth apart. 1st dose may be given as early as 6 wk of age & booster dose may be given from 9 mth of age at least 6 mth after last primary dose. Preterm infant at least 27 wk gestation 4 doses consisting of 3 primary doses w/ 1st dose given at 2 mth & at least 1 mth interval between doses. Booster dose: At least 6 mth after last primary dose. Previously unvaccinated older infant & childn 7-11 mth 2 doses w/ at least 1 mth interval between doses. 3rd dose: Recommended in 2nd yr w/ at least 2 mth interval, 12 mth-5 yr 2 doses w/ at least 2 mth interval between doses.

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Contraindications

Hypersensitivity.

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Special Precautions

Not to be inj intravascularly or intradermally. Not for protection against pneumococcal serogroups. Not to be used as substitute routine immunization w/ diphtheria, tetanus or HIB vaccines. Postpone vaccination in patients w/ acute severe febrile illness. Thrombocytopenia or any coagulation disorder; syncope. Resp monitoring for 48-72 hr in very premature infant (≤28 wk of gestation) & previous history of resp immaturity. High-risk for pneumococcal disease (eg, childn w/ SCD, asplenia, HIV infection, chronic illness or w/ immunocompromising conditions).

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Adverse Reactions

Loss of appetite, irritability, drowsiness, inj site pain, redness & swelling, fever (≥38°C) rectally (age <2 yr). Inj site induration, fever >39°C rectally (age <2 yr).

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Drug Interactions

Adequate response may not be elicited w/ immunosuppressants.

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Caution For Usage

For caution against possible variation of physical aspect of medicine... Click to view Synflorix detailed prescribing information

Storage

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Description

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Action

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MIMS Class

Vaccines, Antisera & Immunologicals

ATC Classification

J07AL52 - pneumococcus purified polysaccharides antigen and haemophilus influenzae, conjugated ; Belongs to the class of pneumococcal vaccines.

Regulatory Classification

Presentation/Packing

Form

Synflorix vaccine (inj) (pre-filled syringe) 0.5 mL

Packing/Price

1's

Synflorix

Manufacturer:

GlaxoSmithKline

Distributor:

Zuellig Pharma