Synflorix Dosage & Drug Information

Concise Prescribing Info Bahasa 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

Concise Prescribing Info

Contents

Per 0.5 mL Pneumococcal polysaccharide 1 mcg for serotypes 1, 5, 6B, 7F, 9V, 14 & 23F, & serotypes 4, 18C & 19F 3 mcg & nontypeable H. 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.

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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. 1^st 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 3^rd dose is recommended in the 2^nd yr w/ at least 2 mth interval.

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Contraindications

Hypersensitivity to any component of Synflorix.

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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.

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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).

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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

View Synflorix storage conditions for details to ensure optimal shelf-life.

Description

View Synflorix description for details of the chemical structure and excipients (inactive components).

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)

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

Synflorix

Manufacturer:

GlaxoSmithKline Indonesia